{"text_format":"3","workbook":"xlsx","n_sheets":4,"sheets":["产品信息变更","注册证信息变更","进口产品变更总代","产品包装单位信息变更"],"read":"whole","date_system":"1900"}

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["组件编号","变更前：组件名称","变更后：组件名称","变更前：产品商标","变更后：产品商标","变更前：注册证规格","变更后：注册证规格","变更前：注册证型号","变更后：注册证型号","变更前：产品材质","变更后：产品材质","变更前：产品标准","变更后：产品标准","变更前：产品有效期","变更后：产品有效期","变更前：产品包装材质","变更后：产品包装材质","变更前：产品性能组成","变更后：产品性能组成","变更前：产品适用范围","变更后：产品适用范围","变更前：产品使用方法","变更后：产品使用方法","变更后：产品存储条件及有效期","变更后：产品存储条件及有效期1"]
["00131676","抗线粒体M2抗体IgG测定试剂盒（化学发光免疫分析法）","抗线粒体M2抗体IgG测定试剂盒（磁微粒化学发光法）","MAGLUMI",null,"100测试/盒；50测试/盒",null,"100测试/盒；50测试/盒",null,"PP塑料",null,"粤械注准20202401187",null,"12个月",null,"PP塑料",null,"磁性微球冻干品、磁性微球缓冲液、低点校准品、高点校准品、缓冲液、发光标记物、样本稀释液、质控品1、质控品2",null,"本试剂盒用于体外定量测定人血清或血浆样本中抗线粒体M2抗体IgG的含量。临床上主要用于原发性胆汁性肝硬化(PBC)的辅助诊断。",null,"1.\t测试准备：\n-检查仪器内全自动免疫检验系统用底物液、清洗缓冲液、反应杯是否充足，废物袋和废液桶是否需要清空。\n-磁性微球复溶：本试剂盒提供的磁性微球为冻干品。配置中移液器具切勿交叉使用，以免造成测定结果异常或不准确。\n-装载试剂前避免试剂产生泡沫。\n-将试剂盒全自动试剂芯片标签贴近仪器的射频读卡器，仪器自动读取试剂盒信息。\n-将试剂盒插入仪器的试剂仓，使用前确保磁性微球充分混均。\n2.\t定标：\n通过测定试剂盒高、低校准品，将预先定义的试剂盒主曲线调整为一个新的、仪器特异的工作曲线。\n3.\t质量控制：\n 质量控制可以使用本试剂盒配套质控品。\n4.\t分析程序：\n将样本装载到仪器中，在仪器用户软件中编辑样本信息及测试项目，然后点击”开始”按钮，仪器按分析程序进行试验。\n5.\t计量和结果：\n检测中，用定标的检测信号调整整个储存的主曲线到工作曲线，仪器借助工作曲线以及样本中分析物的检测信号，即相对光强度(RLU)，分析测定仪会自动计算每个样本中的被分析物浓度。"]
["00079738","25-羟基维生素D（25-OH Vitamin D）测定试剂盒（化学发光法）","25-羟基维生素D测定试剂盒（化学发光法）","MAGLUMI",null,"50测试/盒、100测试/盒",null,"50测试/盒、100测试/盒",null,"PP塑料",null,"粤械注准20162400316",null,"12个月",null,"PP塑料",null,"由磁性微球溶液（TRIS缓冲液，0.2%NaN3包被羊抗FITC多克隆抗体）、发光标记物（25-OH Vitamin D抗原标记ABEI,含牛血清蛋白，0.2%NaN3)、荧光素标记物(抗25-OH Vitamin D单克隆抗体标记FITC，含牛血清蛋白，0.2%NaN3)、置换剂(酸性缓冲液）、低点校准品（牛血清制品，0.2%NaN3）、高点校准品（牛血清制品，0.2%NaN3）、质控品（牛血清制品，0.2%NaN3）组成。",null,"本试剂盒用于定量测定人血清中25-羟基维生素D（25-OH VitaminD)的D2和D3成分的含量。",null,"储存在2℃-8℃无腐蚀性气体的环境中，未开封有效期为12个月，开封后有效期不少于28天。"]
["00143988","乙型肝炎病毒核心抗体测定试剂盒（磁微粒化学发光法）","乙型肝炎病毒核心抗体检测试剂盒（磁微粒化学发光法）","万泰凯瑞",null,"100人份/盒；200人份/盒；","100人份/盒、100人份/盒（含校准品）、200人份/盒、200人份/盒（含校准品）","100人份/盒；200人份/盒；","100人份/盒、100人份/盒（含校准品）、200人份/盒、200人份/盒（含校准品）","液体",null,"国械注准20163400689",null,"12个月",null,"纸盒",null,"HBcAb试剂1：重组乙肝病毒核心抗原（rHBcAg）包被的磁微粒，置于含蛋白稳定剂和防腐剂ProClin300的缓冲液中；HBcAb试剂2：重组乙肝病毒核心抗原（rHBcAg）标记的吖啶酯，置于含蛋白稳定剂和防腐剂ProClin300的缓冲液中；HBcAb试剂3：含蛋白稳定剂和防腐剂ProClin300的缓冲液。","试剂1：1 瓶（100人份：5mL；200人份：10mL），重组乙肝病毒核心抗原（rHBcAg）包被的磁微粒，置于含蛋白稳定剂和防腐剂ProClin300 的缓冲液中。\n试剂2：1 瓶（100人份：10mL；200人份：20mL），吖啶酯标记的重组乙肝病毒核心抗原（rHBcAg），置于含蛋白稳定剂和防腐剂ProClin300 的缓冲液中。\n试剂3：1 瓶（100人份：5mL；200人份：10mL），含蛋白稳定剂和防腐剂ProClin300 的缓冲液。\n校准品1：2mL×1 瓶，淡黄色，灭活的HBcAb 检测为阳性的人血清或血浆，含有防腐剂ProClin300。\n校准品2：2mL×1 瓶，淡黄色，灭活的HBcAb 检测为阴性的人血清或血浆，含有防腐剂ProClin300。","该产品用于定性检测人血清和血浆中的乙型肝炎病毒核心抗体（HBcAb）。","本产品用于体外定性检测人血清和血浆中的乙型肝炎病毒核心抗体（HBcAb）。","1. 首次将乙型肝炎病毒核心抗体测定试剂盒（化学发光微粒子免疫检测法）装载到Caris 系统上时，需要将试剂1 瓶中的试剂混匀，使在装运期间可能沉淀下来的微粒子重新悬浮。\n2. 检查样本杯中样本量，保证每次检测前样本杯中的样本量保持在310μL 以上。\n3. 必要时，执行校准命令：执行校准命令信息，参见Caris 系统操作手册。\n4. 校准品1 和校准品2 使用前应轻轻翻转5～10 次，混匀。\n5. 进样：有关进样信息，参见Caris 系统操作手册。\n6. 按下Assay start（运行）。","1. 首次将乙型肝炎病毒核心抗体检测试剂盒（磁微粒化学发光法）装载到发光仪上时，需要将试剂 1 瓶中的试剂混匀，使在装运期间可能沉淀下来的微粒子重新悬浮。\n翻转试剂 1 瓶 30 次，翻转时应控制速度避免产生气泡。\n目视检查试剂 1 瓶，以检查微粒子是否悬浮。如果微粒子依然附着在瓶上，则继续翻转直到微粒子完全悬浮。如果没有悬浮，请不要使用。\n2. 检查样本杯中样本量，保证每次检测前样本杯中的样本量保持在 310μL 以上。\n3. 必要时，执行校准命令：执行校准命令信息，参见发光仪操作手册。\n4. 校准品从 2～8℃取出后平衡至室温，使用前，轻轻翻转 5～10 次，使其充分混合。使用完后，盖紧瓶盖并把校准品放回 2～8℃储存。\n5. 进样：有关进样信息，参见发光仪操作手册。\n6. 按下 Assay start（运行）。"]
["00012964","一次性使用电切镜手术电极","一次性使用电切镜手术电极","CONNFORD",null,"双管型、单管长型、单管短型、单管型、粗型、细型、双极、等离子电极","等离子电极、电切电极、开沟电极","EI-9721S、EI-9722S、EI-9723S、EI-9721A、EI-9722A、EI-9721O、EI-9721W、EI-9722W、EE-9724S、EE-9725S、EE-9726S、EE-9723A、EE-9724A、、EE-9722O、EE-9723W、EE-9724W、GE-9727S、GE-9728S、GE-9729S、GE-9725A、GE-9726A、GE-9723O、GE-9725W、GE-9726W、DE-97210S、DE-97211S、DE-97212S、DE-9727A、DE-9728A、DE-9724O、DE-9727W、DE-9728W、PL-9729PA、PL-9729PG、PL-9729PO","电切电极\tGE-9728S\n电切电极\tGE-9729S\n电切电极\tGE-9726A\n电切电极\tGE-97230\n电切电极\tGE-9726W\n开沟电极\tDE-97240\n等离子电极\tPL-9729PG\n等离子电极\tPL-9729PO\n等离子电极\tPL-9734PS\n等离子电极\tPL-9732PB\n等离子电极\tPL-9735PW\n等离子电极\tPL-9731PG\n等离子电极\tPL-9733PS\n等离子电极\tPL-9730PO\n等离子电极\tPL-9730PG\n电切电极\tGE-9727S","钨丝",null,"YZB/国1480-2009",null,"24个月",null,"纸塑",null,"产品由架子组、电切头、尾稍、定位片组成。",null,"“本产品在医疗机构中与电切镜及相关的高频设备配套使用，用于经尿道前列腺电气化切割手术”变更为“本文品在医疗机构中与电切内窥镜及高频手术设备配套使用，用于泌尿外科和妇科手术中对人体组织进行切割、凝血”",null,"为了保证手术顺利进行和获得满意的效果，必须遵循以下方法操作：\n（一）使用前的检查\n    使用前应仔细检查手术电极的绝缘性能，是否有脱落、裂缝、空洞或其他的缺陷存在，一旦出现上述情况请勿使用该电极。请及时与康福特仪器（杭州）有限公司联系\n（二）使用前的灭菌\n腔内泌尿外科手术电极系列出厂时未经灭菌，请灭菌后使用。灭菌前请先清洗干净。适当的灭菌方式为高压蒸汽灭菌和化学液体（2%碱性戊二醛水溶液）浸泡。采用高压蒸汽灭菌时，熏气压为104.0—137.0（kpa）、表压为15—20（ibf/in）、饱和熏气相对湿度为121-126度，所需时间不低于10分钟；采用2%碱性戊二醛溶液浸泡时，电极需完全浸入戊二醛溶液，同时去除电极表面的气泡，浸泡30分钟后取出电极，用无菌蒸馏水反复冲洗干净，并用无菌纱布擦干后使用。本产品不可采用火烧法灭菌和酸类灭菌剂灭菌（例如：过氧乙酸、石碳酸）。\n灭菌具体操作可按《医疗机构消毒技术规范》（卫生部 WS/T 367-2012）执行。\n（三）电切镜的装配\n按照电切镜所附的操作和维护说明书的步骤：装配好窥镜的操作器和电极。各类手术电极插入相配套的电切镜工作件的插入方法，完全相同于电切环电极（LOOP）。装好后应轻轻推拉电极以检查电极的末端是否插入套空内电源插头，并可靠固定，以保证手术安全。\n（四）电切镜和手术电极的兼容性\n当电切镜和手术电极连用使用高频手术设备时，必须给出安全使用的以下内容：\n电切镜和手术电极的高频兼容性，对于每一个要使用的模式的重复峰值电压为700V。\n电切模式：\n使用近似正弦波，频率400kHz±100kHz，峰值电压的1.5倍。\n混合模式：\n使用近似正弦波，频率400kHz±100kHz，峰值电压的1.1倍。\n电凝模式：\n使用脉宽为1.25μS±25%，重复频率40kHz±10kHz，峰值电压的1.1倍。\n（五）电源发生器的功率\n    根据临床手术实践：气化切割电极、气化电极使用STORZ、ACMI、OLYMPUS外科电源发生器，额定输出功率为：180W，凝固为70W，额定附件电压为350Vp。\n    电切电极、开沟电极使用STORZ、ACMI、OLYMPUS外科电源发生器，额定输出功率为：120W，凝固为70W,额定附件电压300Vp。  \n    等离子电极，使用ACMI、GYRUS、OLYMPUS等离子电源发生器，额定输出功率为180W,凝固为80W,额定附件电压为600Vp.      \n（六）电极贮存、使用、处理的环境条件\n      贮存环境温度范围：+10℃～+40℃\n贮存环境湿度范围：30%～75%\n使用环境温度范围：+10℃～+25℃\n使用环境湿度范围：30%～75%\n对使用后报废的电极和超过使用时效的电极均按照当地政府环境保护法规的要求统一处理。\n（七）电气化切割术操作步骤\n步骤一：膀胱颈部及前列腺中叶\n1.从膀胱颈部开始气化，产生宽而浅的纹路通道。\n2.托宽前列腺中叶部，但须防止颈口部切割过深而产生膀胱与前列腺脱离。\n     步骤二：前列腺侧叶\n1.沿前列腺侧叶重复移动，切除增生组织，应全线平衡切除，防止深而窄的沟道以免产生气泡而影响视野。\n2.切除至接近外科膜时即可中止。不必完全切除全部腺体，因气化还有深层组织效应。\n     步骤三：前列腺尖部\n1.在前列腺尖部使气化电切头在视野中，不要移电切镜进行定点气化，再在侧壁的上、下操作。\n2.气化前列腺尖部后，使前列腺尿道内口呈圆形空腔。\n理想的接触压力：在整个手术过程中，以可以见到电极头的一半为度。慢慢地移动气化电切杆（10MM/SEC）整个手术过程中必须保护气化电极在视野中。"]
["00076565","心肌肌钙蛋白I/肌酸激酶同工酶/肌红蛋白三项联合检测试剂盒（时间分辨荧光免疫分析法）","心肌肌钙蛋白I/肌酸激酶同工酶/肌红蛋白三项联合检测试剂盒（免疫荧光干式定量法）","艾美益",null,"25人份/盒、50人份/盒、100人份/盒、200人份/盒","10人份/盒， 25人份/盒，50人份/盒，75人份/盒，100人份/盒，150人份/盒，200人份/盒","25人份/盒、50人份/盒、100人份/盒、200人份/盒","10人份/盒， 25人份/盒，50人份/盒，75人份/盒，100人份/盒，150人份/盒，200人份/盒","硝酸纤维素膜",null,"桂械注准20182400036",null,"20个月",null,"纸盒",null,"该产品由反应板、ID芯片(1个/盒)、缓冲液（探测物质，反应缓冲液）和说明书组成。","\"该产品由反应板、ID芯片(1个/盒)、探测物质、反应缓冲液和说明书组成。\n反应板上的测试线包有肌酸激酶同工酶抗体(0.78±0.4μg)，链霉亲和素(0.78±0.4μg)，肌红蛋白抗体(0.39±0.2μg)，质控线包被有鸡IgY抗体(0.39±0.2μg)。\n探测物质中含有荧光标记的心肌肌钙蛋白I抗体络合物(0.2±0.1μg)，生物素标记的心肌肌钙蛋白I抗体络合物(0.15±0.075μg)，荧光标记的鼠抗鸡IgY抗体络合物(0.02±0.01μg)，荧光标记的肌酸激酶同工酶抗体络合物(0.375±0.188μg)，荧光标记的肌红蛋白抗体络合物(0.075±0.038μg),荧光标记的鼠抗鸡IgY抗体络合物(0.016±0.011μg),牛血清白蛋白。反应缓冲液里含有三(羟甲基)氨基甲烷(100±50mM)。\n(注:不同批号试剂盒中各组分不能互换)\"","该试剂盒用于以时间分辨荧光免疫分析法同时体外定量检测人血液(全血/血浆/血清)中的心肌肌钙蛋白I，肌酸激酶同工酶，肌红蛋白(Tn-I，CK-MB，Myoglobin)的浓度。临床上主要用于心肌梗死、肌病等疾病的辅助诊断。","该试剂盒用于以荧光免疫分析法同时体外定量检测人血液(全血/血浆/血清)中的心肌肌钙蛋白I，肌酸激酶同工酶，肌红蛋白(Tn-I，CK-MB，Myoglobin)的浓度。临床上主要用于心肌梗死、肌病等疾病的辅助诊断。","* A2000\n1) 打开反应板包装袋，取出反应板并水平放置。\n2）用移液器取反应缓冲液150μL，放入探测物质试管。并立\n即用移液器采样(全血、血清、血浆 75μL)并放入装有反\n应缓冲液的探测物质试管。\n3) 盖上缓冲液试管的盖子，摇晃10～15次以确保充分混匀。\n4) 用移液器取75μL的样本混合液，并加样到反应板的样本孔。\n5) 在室温反应12分钟。\n6) 把反应后的反应板插入专用检测设备，按仪器说明书进行\n测试，并确认结果。\n* A5000\n按仪器说明书进行测试。","* A2000\n1) 打开反应板包装袋，取出反应板并水平放置。\n2）用移液器取反应缓冲液150μL，放入探测物质试管。并立即用移液器采样(全血、血清、血浆 75μL)并放入装有反应缓冲液的探测物质试管。\n3) 盖上缓冲液试管的盖子，摇晃10～15次以确保充分混匀。\n4) 用移液器取75μL的样本混合液，并加样到反应板的样本孔。\n5) 在室温反应12分钟。\n6) 把反应后的反应板插入专用检测设备，按仪器说明书进行测试，并确认结果。\n* A2000 PLUS/A3000/A5000/A5000 PLUS\n按仪器说明书进行测试。"]
["00363809","妇科分析用染色液","阴道分泌物染色液",{"$nulls":6},"聚碳酸酯",{"$nulls":13},"2-25℃保存，有效期为12个月，开封有效期为7天。"]
["00036105","一次性使用防针刺静脉采血针",null,"林华",null,"0.55（24G)/0.6(23G)/0.7(22G)/0.8(21G)/0.9(20G)×15、16、17、18、19、20、21、22、23、24、25、26、27、28、29、30",null,"套筒式、软连接式","软连接式、锁定式、套筒式","产品由乳胶、不锈钢OCr18Ni9、聚氯乙烯、聚丙烯、聚乙烯、丙烯腈-丁二烯-苯乙烯三元共聚物制成","乳胶、不锈钢OCr18Ni9、PVC、PP、PE、ABS","国械注准20163151723","国械注准20163221723","36个月",null,"纸塑",null,"一次性使用防针刺静脉采血针分为软连接式采血针和套筒式采血针。软连接式采血针由瓶塞穿刺针管、止血护套、外圆锥针座、内圆锥针座、导管、防针刺卡扣、针柄、静脉穿刺针管、静脉穿刺针护套组成；套筒式采血针由套筒、瓶塞穿刺针管、止血护套、外圆锥锁定针座、内圆锥针座、导管、防针刺卡扣、针柄、静脉穿刺针管、静脉穿刺针护套组成。产品由乳胶、不锈钢OCr18Ni9、聚氯乙烯、聚丙烯、聚乙烯、丙烯腈-丁二烯-苯乙烯三元共聚物制成，产品经环氧乙烷灭菌，一次性使用。",null,"该产品与一次性使用真空采血管配套供人体静脉采血样用。",null,"1、按包装上箭头标示撕开包装袋，取出采血针，采血针使用前请拧紧软管与瓶塞穿刺针针座间接口； \n2、将采血针管塞端拧入配合使用的持针器内（套筒式产品无需该步骤，后端套筒可视为持针器）；\n3、除去静脉针护套，以正常的方式进行静脉穿刺（卸去静脉穿刺针护套的采血针应及时使用，以防污染）；\n4、穿刺见回血后，手执瓶塞穿刺针下端手柄处将针垂直刺入采血管胶塞，利用压差使血液自动流入采血器；\n5、使用完成将采血针管拔出时，针管卡防针刺卡扣内，防针刺保护装置被激活，针尖被屏蔽；\n6、将使用后针尖被屏蔽的采血针丟入专用收集箱中集中销毁。"]
["00131756","胃泌素释放肽前体测定试剂盒（化学发光免疫分析法）","胃泌素释放肽前体测定试剂盒（磁微粒化学发光法）","MAGLUMI",null,"50测试/盒；100测试/盒；",null,"50测试/盒；100测试/盒；",null,"PP塑料",null,"国械注准20203400781","粤械注准20252400036","12个月",null,"PP塑料",null,"磁性微球、低点校准品、高点校准品、缓冲液、发光标记物、样本稀释液、质控品1、质控品2。",null,"本试剂盒用于体外定量测定人血清或血浆样本中胃泌素释放肽前体(ProGRP)的含量。主要用于对恶性肿瘤患者进行动态监测以辅助判断疾病进程或治疗效果，不能作为恶性肿瘤早期诊断或确诊的依据，不能用于普通人群。",null,"1.\t测试准备：\n-检查仪器内全自动免疫检验系统用底物液、清洗液、反应杯是否充足，废物袋和废液桶是否需要清空。\n-试剂装载前避免试剂产生泡沫。\n-将试剂盒全自动试剂芯片标签贴近仪器的射频读卡器，仪器自动读取试剂盒信息。\n-将试剂盒插入仪器的试剂仓，使用前确保磁性微球充分混均。\n2.\t定标：\n通过测定试剂盒低、高点校准品，将预先定义的试剂盒主曲线调整为一个新的、仪器特异的工作曲线。\n3.\t质量控制：\n 质量控制可以使用本试剂盒配套质控品或专用的商业质控。\n4.\t分析程序：\n将样本装载到仪器中，在仪器用户软件中编辑样本信息及测试项目，然后点击”开始”按钮，仪器按分析程序进行试验。\n5.\t计量和结果：\n检测中，用定标的检测信号调整整个储存的主曲线到工作曲线，仪器借助工作曲线以及样本中分析物的检测信号，即相对光强度(RLU)，会自动计算每个样本中的被分析物浓度。"]
["00265751","一次性腹腔镜软器械鞘管","一次性多通道单孔腹腔镜穿刺器",null,null,"AF-Ⅰ型、AF-Ⅱ型、AF-Ⅲ型","A×90/90 -(2＋2)、A×70/50 -(2＋2)、A×50/40 -(2＋1)","AF-Ⅰ型、AF-Ⅱ型、AF-Ⅲ型","AF-Ⅰ、AF-Ⅱ、AF-Ⅲ","ABS",null,"皖械注准20202020550",null,"24",null,"吸塑盒",null,"由通道固定座、器械密封通道、注气阀、锁紧帽（AF-Ⅰ型、AF-Ⅱ型）、弯头（AF-Ⅲ型）、切口保护套（外卡环、薄膜通道、置入环）组成。其中 AF-I型通道固定座由聚碳酸酯、热塑聚氨酯弹性体制成，AF-Ⅱ型、AF-Ⅲ型通道固定座由硅胶制成，器械密封通道由热塑聚氨酯弹性体、ABS、硅胶制成，锁紧帽、弯头由ABS 制成，注气阀由聚碳酸酯、聚丙烯制成，切口保护套由热塑聚氨酯弹性体制成。产品经环氧乙烷灭菌，应无菌。","由多通道密封体、吸引管(AF-Ⅰ型、AF-Ⅱ 型、AF-Ⅶ 型)、切口保护套(薄膜型)或切口保护套(硅胶型)(AF-Ⅱ型、AF-Ⅳ型、AF-Ⅴ型、AF-Ⅵ型)组成；其中,AF-Ⅰ、 AF-Ⅲ、AF-Ⅳ 和 AF-Ⅶ 型产品的多通道密封体由通道固定座、器械密封通道和注气阀组成；AF-Ⅱ型产品的多通道密封体由通道固定座和器械密封通道组成；AF-Ⅴ型产品的多通道密封体由通道固定座、器械密封通道组成； AF-Ⅵ型产品的多通道密封体由通道固定座、器械密封通道,穿刺杆、穿刺套管组成；切口保护套(薄膜型)由外卡环、薄膜通道、置入环和拉环组成；切口保护套(硅胶型)由外卡环、硅胶通道、置入环组成；吸引管由管身和注气阀组成。产品经环氧乙烷灭菌，应无菌。","用于腹腔镜手术中作为内窥镜和器械的操作通道。",null,"1、开启小包装，取出一次性腹腔镜软器械鞘管；2、术前，应在患者腹部先行切一个足以置入切口保护套的皮肤手术切口（切口大小应根据手术需要确定）；3、将切口保护套从多通道密封套上取下，再将切口保护套的置入环捏扁后从患者腹部切口处放入，并根据患者的腹腔组织厚度，翻转外卡环调节至切口保护套所需的高度；4、将切口保护套的外卡环装配到多通道密封套的锁紧帽或开槽内； 5、将气腹机的进气管与注气阀进行连接，关闭其余的注气阀，建立气腹；6、上述操作步骤完成后，腹腔镜和微创手术器械可通过器械密封通道进入腹腔内，然后进行手术操作；8、手术结束前，将腹腔镜和微创手术器械全部抽出，卸除多通道密封套，可将切除的腔内组织通过切口保护套取出；再用手指通过腹部切口将切口保护套取出，进行切口清创处理，而后缝合切口，手术完成。","【操作步骤（AF-Ⅰ型；AF-Ⅱ型；AF-Ⅲ型；AF-Ⅳ型；AF-Ⅶ型）】\n1）切口保护套放置\n1.1）切口保护套（薄膜型）放置\n①将切口保护套置入环捏扁呈长舌状，推入切口，置入环自动弹性展开，卡住切口内壁；\n②双手捏住外卡环两侧位置，向上轻提外卡环，使切口保护套的薄膜通道在切口展开，然后双手向内翻卷外卡环，使薄膜通道不断缩短，薄膜通道的径向张力不断增加，直至外环翻卷困难，再微微向上提拉并翻卷一次，切口得到充分的扩张和保护，外卡环作为多通道密封体的定位。\n1.2）切口保护套（硅胶型）放置\n①将切口保护套置入环捏扁呈长舌状，推入切口，置入环自动弹性展开，卡住切口内壁；\n②双手捏住外卡环两侧位置，向上轻提外环，使切口保护套硅胶通道在切口展开，切口得到充分的扩张和保护，外卡环作为多通道密封体的定位。\n2）多通道密封体与切口保护套嵌合\n①将多通道密封体的通道固定座放在切口保护套外卡环上，沿通道固定座周圈用手压合嵌入；\n②通过注气阀连接气腹机；\n③根据手术要求调节腹腔压力，进行器械操作。\n3）术后拆卸\n①取下多通道密封体：上揭通道固定座周圈局部，即可分离多通道密封体和外卡环；\n②取出切口保护套（薄膜型）：通过切口保护套置入环拉环，将置入环直接拉拽变形从切口取出；或通过手指伸进薄膜通道内扣住置入环的边缘，将置入环顺着薄膜通道向外牵拉取出。\n③取出切口保护套（硅胶型）：通过手指伸进硅胶通道内扣住置入环的边缘，将置入环顺着硅胶通道向外牵拉取出。\n【操作步骤（AF-Ⅴ型；AF-Ⅵ型）】\n1）切口保护套放置\n1.1）切口保护套（薄膜型）放置\n①将切口保护套置入环捏扁呈长舌状，推入切口，置入环自动弹性展开，卡住切口内壁；\n②双手捏住外卡环两侧位置，向上轻提外卡环，使切口保护套薄的膜通道在切口展开，然后双手向内翻卷外卡环，使薄膜通道不断缩短，薄膜通道的径向张力不断增加，直至外环翻卷困难，再微微向上提拉并翻卷一次，切口得到充分的扩张和保护，外卡环作为多通道密封体的定位。\n1.2）切口保护套（硅胶型）放置\n①将切口保护套置入环捏扁呈长舌状，推入切口，置入环自动弹性展开，卡住切口内壁；\n②双手捏住外卡环两侧位置，向上轻提外环，使切口保护套硅胶通道在切口展开，切口得到充分的扩张和保护，外卡环作为多通道密封体的定位。\n2）多通道密封体配装\n将穿刺器或其他器械插入多通道密封体对应直径器械密封通道，完成多通道密封体配装。\n3）多通道密封体与切口保护套嵌合\n①将多通道密封体的通道固定座放在切口保护套外卡环上，沿通道固定座周圈用手压合嵌入；\n②通过注气阀连接气腹机；\n③根据手术要求调节腹腔压力，进行器械操作。\n4）术后拆卸\n①取下多通道密封体：上揭通道固定座周圈局部，即可分离多通道密封体和外卡环；\n②取出切口保护套（薄膜型）：通过切口保护套置入环拉环，将置入环直接拉拽变形从切口取出；通过切口保护套置入环拉环，将置入环直接拉拽变形从切口取出；或通过手指伸进薄膜通道内扣住置入环的边缘，将置入环顺着薄膜通道向外牵拉取出。\n③取出切口保护套（硅胶型）：通过手指伸进硅胶通道内扣住置入环的边缘，将置入环顺着硅胶通道向外牵拉取出。"]
["00078181","黄体生成素（LH）测定试剂盒（化学发光法）","黄体生成素测定试剂盒（化学发光法）","MAGLUMI",null,"50测试/盒、100测试/盒",null,"50测试/盒、100测试/盒",null,"PP塑料",null,"粤械注准20162400463",null,"12个月",null,"PP塑料",null,"由磁性微球溶液、发光标记物、荧光素标记物、低点校准品、高点校准品、质控品组成。",null,"该试剂盒用于体外定量测定人血清或血浆中LH的含量。",null,"储存在2℃-8℃无腐蚀性气体的环境中，未开封有效期为12个月，开封后有效期不少于28天。"]
["00382517","血气、电解质、代谢物定标液",{"$nulls":4},"定标液2（产品编号：944-129）：200mL/包装",null,"定标液2（产品编号：944-129）：200mL/包装","液体",{"$nulls":13},"2～25℃保存，定标液2有效期24 个月。"]
["00345116","血糖试条（电化学法）","血糖试纸（葡萄糖脱氢酶法)",{"$nulls":6},"/",{"$nulls":13},"储存条件：试条应在4℃～37℃环境温度下干燥密封保存。有效期：未开封试条的有效期为18个月，有效日期见包装，桶装试条开封后储存有效期为3个月。"]
["00041145","一次性腹腔镜软器械鞘管","一次性多通道单孔腔镜手术穿刺器","航天卡迪",null,"HK-FDDC-3FD；HK-FDDC-4FD；HK-FDDC-3FGD；HK-FDDC-4FGD；HK-FDDC-3FX；HK-FDDC-4FX；HK-FDDC-5FX；HK-FDDC-4NOS；HK-FDDC-5NOS；HK-FDDC-4TNOS；HK-FDDC-5TNOS；HK-FDDC-1XF。",null,"HK-FDDC-3FD；HK-FDDC-4FD；HK-FDDC-3FGD；HK-FDDC-4FGD；HK-FDDC-3FX；HK-FDDC-4FX；HK-FDDC-5FX；HK-FDDC-4NOS；HK-FDDC-5NOS；HK-FDDC-4TNOS；HK-FDDC-5TNOS；HK-FDDC-1XF。",null,"聚氨酯，硅橡胶，PVC，PC。",null,"京械注准20172660810",null,"36个月",null,"塑料",null,"本产品由一次性切口牵开固定器（套）、多通道密封体和通气管道组成。",null,"用于需要做腹腔镜手术的患者的内镜和器械的通道。",null,"1.术前准备\n1) 检查产品包装,确认包装无破损再使用。\n2) 检查产品外观及型号规格。\n3) 按无菌操作规程从双层包装中取出产品。\n4）将手术器械用润滑剂润滑。\n2.操作\n1）切口保护套放置\n  A 构型准备：将切口保护套内卡环捏扁成长舌形，推入切口，内环弹性展开，卡住切口内壁。\nB 嵌入切口：双手捏住外卡环3点钟和9点钟位置，向内翻卷，令管道不断缩短，管道的径向扩张力不断增加，直至外卡环翻卷困难，再微微向上提拉并翻卷一次，切口得到充分的扩张和保护，外卡环作为基座定位稳定。\n2）密封体和切口保护套嵌合\n将多通道密封体定位环放在切口保护套外卡环上，沿环沿用手压合嵌入。（定位环设有裙边的，下翻裙边包住外卡环；定位环设有卡箍的，闭合卡箍进行  \n加固）。\n3）通过通气管道连接气腹机。\n4）根据手术要求调节腹腔压力，进出操作器械。\n5）取下密封体：上掀定位环局部，即可分离密封体和外卡环。（设有裙边的，掀起裙边，用手从一边缘拉出；设有卡箍的，将卡箍打开到最大，上掀定位环即可）\n6）取出切口保护套：用手指伸入切口内，扣住内卡环拉出或从管道外推内卡环，移位后拉出，也可使用带钩器具拉出。"]
["00143993","糖类抗原125（CA 125）测定试剂盒（磁微粒化学发光法）","糖类抗原125（CA125）测定试剂盒（磁微粒化学发光法）","万泰凯瑞",null,"50人份/盒、50人份/盒（含校准品）、100人份/盒、100人份/盒（含校准品）、200人份/盒、200人份/盒（含校准品）、300人份/盒、300人份/盒（含校准品）、500人份/盒、500人份/盒（含校准品）、2×100人份/盒、2×100人份/盒（含校准品）、3×100人份/盒、3×100人份/盒（含校准品）、5×100人份/盒、5×100人份/盒（含校准品）",null,"50人份/盒、50人份/盒（含校准品）、100人份/盒、100人份/盒（含校准品）、200人份/盒、200人份/盒（含校准品）、300人份/盒、300人份/盒（含校准品）、500人份/盒、500人份/盒（含校准品）、2×100人份/盒、2×100人份/盒（含校准品）、3×100人份/盒、3×100人份/盒（含校准品）、5×100人份/盒、5×100人份/盒（含校准品）",null,"液体",null,"国械注准20153401967","闽械注准20152401967","12个月",null,"纸盒",null,"试剂1：1瓶（50人份：2.5mL；100人份：5mL；200人份：10mL；300人份：15mL；500人份：25mL），CA125 抗体包被的磁微粒。\n试剂2：1瓶（50人份：2.5mL；100人份：5 mL；200人份：10mL；300人份：15mL；500人份：25mL），吖啶酯标记的CA125抗体。\n校准品1：0.5mL×1瓶，30U/mL的糖类抗原125，含牛血清的磷酸盐缓冲液，含有ProClin300防腐剂。\n校准品2：0.5mL×1 瓶，600U/mL的糖类抗原125，含牛血清的磷酸盐缓冲液，含有ProClin300防腐剂。",null,"本产品用于定量检测人血清或血浆中的糖类抗原125(CA125)。主要用于对恶性肿瘤患者进行动态监测以辅助判断疾病进程或治疗效果，不能作为恶性肿瘤早期诊断或确诊的依据，不能用于普通人群的肿瘤筛查。",null,"1.首次将糖类抗原125（CA 125）测定试剂盒（磁微粒化学发光法）装载到发光仪上时，需要将试剂1瓶中的试剂混匀，使在装运期间可能沉淀下来的微粒子重新悬浮。\n2.检查样本杯中样本量，保证每次检测前样本杯中的样本量保持在200μL以上。\n3.必要时，执行校准命令：执行校准命令信息，参见发光仪操作手册。\n4.校准品从2℃～8℃取出后平衡至室温，使用前，轻轻翻转5～10次，使其充分混合。使用后，盖紧瓶盖并把校准品放回2℃～8℃储存。\n5.进样：有关进样信息，参见发光仪操作手册。\n6.按下Assay start（运行）。","1. 首次将糖类抗原125（CA125）测定试剂盒（磁微粒化学发光法）装载到发光仪上时，需要将试剂1瓶中的试剂混匀，使在装运期间可能沉淀下来的微粒子重新悬浮。\n翻转试剂 1 瓶 30 次，翻转时应控制速度避免产生气泡。\n目视检查试剂瓶，以检查微粒子是否悬浮。如果微粒子依然附着在瓶上，则继续翻转直到微粒子完全悬浮。如果没有悬浮，请不要使用。\n2. 检查样本杯中样本量，保证每次检测前样本杯中的样本量保持在200μL 以上。\n3. 必要时，执行校准命令：执行校准命令信息，参见发光仪操作手册。\n4. 校准品从2～8℃取出后平衡至室温，使用前，轻轻翻转5～10次，使其充分混合。使用完后，盖紧瓶盖并把校准品放回2～8℃储存。\n5. 进样：有关进样信息，参见发光仪操作手册。\n6. 按下 Assay start（运行）。"]
["00042579","微创筋膜闭合器","微创筋膜缝合（闭合）器","AOFO",null,"10mm～15mm",null,"AF-BHQ型","AF-BHQ-I","PC",null,"皖械注准20172660138","皖械注准20172020138","24个月",null,"纸塑袋","吸塑盒","产品为一次性使用无菌产品，经环氧乙烷灭菌，其环氧乙烷残留量应不大于10ug/g。产品由闭合固件和缝线穿引器两个部件共同组成（本产品不含缝线，但需要与0或2-0缝线配合使用）；其中，闭合固件由手环、传动杆、器身、近端活动翼板和窗口膜片组成，缝线穿引器由穿引针和手柄组成。手环、器身、近端活动翼板采用聚碳酸酯（PC）制成，传动杆采用丙烯腈-丁二烯-苯乙烯（ABS）树脂制成，窗口膜片采用热塑性聚氨酯弹性体（TPU）制成，穿引针采用302不锈钢（奥氏体）材料制成。产品应无菌。","该产品由闭合固件和缝线穿引器两个部件共同组成(本品不 含缝线，但需要与0或0-2缝线配合使用);其中，闭合固件  由器身、传动杆、近端活动翼板、手环、窗口膜片组成，缝 线穿引器由穿引针和手柄组成。AF-BHQ-I型手环、器身、近 端活动翼板采用聚碳酸酯(PC)制成，传动杆采用丙烯腈-丁二 烯一苯乙烯(ABS)树脂制成，窗口膜片采用热塑性聚氨酯弹性 体(TPU)制成，穿引针采用302不锈钢(奥氏体)材料制成； AF-BHQ-II型器身采用聚碳酸酯(PC)和丙烯腈-丁二烯一苯乙 烯(ABS)树脂制成，传动杆采用聚碳酸酯(PC)制成，近端活动 翼板采用聚丙烯(PP)制成，手环采用丙烯腈-丁二烯一苯乙 烯(ABS)树脂制成，窗口膜片采用热塑性聚氨酯弹性体(TPU), 穿引针采用420不锈钢材料制成。产品应无菌。","用于在腹腔镜手术中收拢组织、经皮缝合、以便闭合手术切口。",null,"在实施手术前，由临床医生判定该规格是否适用腹腔镜手术穿刺孔（切口）的筋膜闭合的缝合，同时，将预期配合使用的0或2-0可吸收缝合线，约500mm长，备用（建议使用0缝线）。"]
["00131734","抗着丝点抗体IgG测定试剂盒（化学发光免疫分析法）","抗着丝点抗体IgG测定试剂盒（磁微粒化学发光法）","MAGLUMI",null,"100测试/盒；50测试/盒",null,"100测试/盒；50测试/盒",null,"PP塑料",null,"粤械注准20202401188",null,"12个月",null,"PP塑料",null,"磁性微球冻干品、磁性微球缓冲液、低点校准品、高点校准品、缓冲液、发光标记物、样本稀释液、质控品1、质控品2",null,"本试剂盒用于体外定量测定人血清或血浆样本中抗着丝点抗体IgG的含量。临床上主要用于局限性系统性硬化症(LSSc)的辅助诊断。",null,"1.\t测试准备：\n-检查仪器内全自动免疫检验系统用底物液、清洗缓冲液、反应杯是否充足，废物袋和废液桶是否需要清空。\n-磁性微球复溶：本试剂盒提供的磁性微球为冻干品。配置中移液器具切勿交叉使用，以免造成测定结果异常或不准确。\n-装载试剂前避免试剂产生泡沫。\n-将试剂盒全自动试剂芯片标签贴近仪器的射频读卡器，仪器自动读取试剂盒信息。\n-将试剂盒插入仪器的试剂仓，使用前确保磁性微球充分混均。\n2.\t定标：\n通过测定试剂盒高、低校准品，将预先定义的试剂盒主曲线调整为一个新的、仪器特异的工作曲线。\n3.\t质量控制：\n 质量控制可以使用本试剂盒配套质控品。\n4.\t分析程序：\n将样本装载到仪器中，在仪器用户软件中编辑样本信息及测试项目，然后点击”开始”按钮，仪器按分析程序进行试验。\n5.\t计量和结果：\n检测中，用定标的检测信号调整整个储存的主曲线到工作曲线，仪器借助工作曲线以及样本中分析物的检测信号，即相对光强度(RLU)，分析测定仪会自动计算每个样本中的被分析物浓度。"]
["00144083","乙型肝炎病毒核心IgM抗体测定试剂盒（磁微粒化学发光法）","乙型肝炎病毒核心IgM抗体检测试剂盒（磁微粒化学发光法）","万泰凯瑞",null,"50人份/盒、50人份/盒（含校准品）、100人份/盒、100人份/盒（含校准品）、200人份/盒、200人份/盒（含校准品）、2×100人份/盒、2×100人份/盒（含校准品）",null,"50人份/盒、50人份/盒（含校准品）、100人份/盒、100人份/盒（含校准品）、200人份/盒、200人份/盒（含校准品）、2×100人份/盒、2×100人份/盒（含校准品）",null,"液体",null,"国械注准20163401361",null,"12个月",null,"纸盒",null,"试剂1：1瓶（50人份：2.5mL；100人份：5mL；200人份：10mL），抗-人IgM的抗体包被的磁微粒，置于含蛋白稳定剂和防腐剂ProClin300的缓冲液中。\n试剂2：1瓶（50人份：5mL；100人份：10mL；200人份：20mL），吖啶酯标记的乙肝核心抗原复合物，置于含蛋白稳定剂和防腐剂ProClin300的缓冲液中。\n试剂3：1瓶（50人份：2.5mL；100人份：5mL；200人份：10mL），含蛋白稳定剂和防腐剂ProClin300的缓冲液。\n校准品1：0.5mL×1瓶，淡黄色，用含蛋白保护剂的稀释液稀释，对Anti-HBc IgM检测呈阳性，含ProClin300防腐剂。\n校准品2：0.5mL×1瓶，淡黄色，在人血清（灭活）中制备，对Anti-HBc IgM检测呈阴性，含ProClin300防腐剂。",null,"该产品用于定性检测人血清和血浆中的乙型肝炎病毒核心IgM抗体（Anti-HBc IgM）。",null,"1.首次将乙型肝炎病毒核心IgM抗体测定试剂盒（磁微粒化学发光法）装裁到发光仪上时，需要将试剂1瓶中的试剂混匀,使在装运期间可能沉淀下来的微粒子重新悬浮。\n2.检查样本杯中样本量，保证每次检测前样本怀中的样本量保持在310uL以上。\n3.必要时，执行校准命令：执行校准命令信息，参见发光仪操作手册。\n4.校准品从2℃~8℃取出后平衡至室温，使用前，轻轻翻转5~10次，使其充分混合。使用完后，盖紧瓶盖并把校准品放回2℃~8℃储存。\n5.进样：有关进样信息，参见发光仪操作手册。\n6.按下Assay start（运行）。","1. 首次将乙型肝炎病毒核心 IgM 抗体检测试剂盒（磁微粒化学发光法）装载到发光仪上时，需要将试剂 1 瓶中的试剂混匀，使在装运期间可能沉淀下来的微粒子重新悬浮。\n翻转试剂 1 瓶 30 次，翻转时应控制速度避免产生气泡。\n目视检查试剂 1 瓶，以检查微粒子是否悬浮。如果微粒子依然附着在瓶上，则继续翻转直到微粒子完全悬浮。如果没有悬浮，请不要使用。\n2. 检查样本杯中样本量，保证每次检测前样本杯中的样本量保持在 310μL 以上。\n3. 必要时，执行校准命令：执行校准命令信息，参见发光仪操作手册。\n4. 校准品从 2～8℃取出后平衡至室温，使用前，轻轻翻转 5～10 次，使其充分混合。使用后，盖紧瓶盖并把校准品放回 2～8℃储存。\n5. 进样：有关进样信息，参见发光仪操作手册。\n6. 按下 Assay start（运行）。"]
["00104030","一次性消化道斑马导丝","一次性使用消化道斑马导丝","益赛通",null,"HHEZS-25-260、 HHEZS-25-450 、HHEZS-35-260 \nHHEZA-35-260. HHEZS-35-450. HHEZA-35-450",null,"HHEZS-25-260、 HHEZS-25-450 、HHEZS-35-260 \nHHEZA-35-260. HHEZS-35-450. HHEZA-35-450",null,"一次性使用消化道斑马导丝由导丝和盘管系统组成， 导丝内芯为镍钛合金， 导丝包塑层为聚四氟乙烯及聚氨酯，盘管系统为高密度聚乙烯，经环氧乙烷灭菌，产品应无菌。",null,"川械注准20192020176",null,"2年",null,"外包装：300克白卡+白板F瓦，内包材：盘管系统材",null,"产品可分为弯型和直型软头两种，每种根据导丝直径、长度不同可分为若干规格。产品主要性能如下：\n1.导丝应能被X射线探测到。\n2.破裂试验：按照YY0450.1-2003《一次性使用无菌血管内导管辅件第1部分导引器械》附录F试验时，除试验固定部分和第一圈外,其余应无破裂痕迹。\n3.弯曲试验：按照YY0450.1-2003《一次性使用无菌血管内导管辅件第1部分导引器械》附录G试验时，导丝的头端和其余部分均应无缺陷和损坏的痕迹。\n4.产品经环氧乙烷灭菌，应无菌。环氧乙烷残留量应不大于10μg/g。\n一次性使用消化道斑马导丝通过消化道内窥镜进入腔内，用于引导各种导管到指定位置；由导丝和盘管系统组成。",null,"一次性使用消化道斑马导丝通过消化道内窥镜进入腔内，用于引导各种导管到指定位置。适用于：消化道系统疾病常见可能出现病变的部位有食道、贲门，胃、十二指肠，结、直肠等以及胆管结石和胆总管，狭窄、梗阻等。如：消化道良恶性肿瘤，狭窄需要内镜介入引流、扩张的患者；食道、贲门，胃、十二指肠，结、直肠狭窄需要内镜介入引流、扩张的患者；胆管结石和胆总管狭窄、梗阻需要内镜介入引流、扩张、取石的患者。",null,"1．在X射线监视下，将产品经自然腔道或穿刺道插入非血管腔道，穿过狭窄段并尽可能深入，此时可利用此导丝引入球囊导管或支架植入器等进行扩张治疗。\n2．在内窥镜监视下，通过内窥镜的钳道将产品穿过狭窄腔道并尽可能深入，在此导丝引导下进行扩张治疗。"]
["00339799","脑利钠肽测定试剂盒（磁微粒化学发光法）","B型钠尿肽（BNP）测定试剂盒（磁微粒化学发光法）",{"$nulls":6},"液体",{"$nulls":13},"2~8℃保存；有效期12个月。"]
["00144209","乙型肝炎病毒e抗体测定试剂盒（磁微粒化学发光法）","乙型肝炎病毒e抗体检测试剂盒（磁微粒化学发光法）","万泰凯瑞",null,"100人份/盒；200人份/盒；","100人份/盒、100人份/盒（含校准品）、200人份/盒、200人份/盒（含校准品）","100人份/盒；200人份/盒；","100人份/盒、100人份/盒（含校准品）、200人份/盒、200人份/盒（含校准品）","液体",null,"国械注准20163401243",null,"12个月",null,"纸盒",null,"试剂1：乙肝病毒e抗体包被的磁微粒，在含有蛋白稳定剂的TRIS缓冲液中配制，含ProClin 300防腐剂；试剂2：乙肝病毒e抗体标记的吖啶酯，在含有蛋白稳定剂的TRIS缓冲液中配制，含ProClin 300防腐剂；试剂3:重组乙肝病毒e抗原（rHBeAg），在含有蛋白稳定剂的TRIS缓冲液，含ProClin 300防腐剂。","试剂1：1 瓶（100人份：5mL；200人份：10mL），乙肝病毒e 抗体包被的磁微粒，在含有蛋白稳定剂的TRIS 缓冲液中配制，含ProClin300 防腐剂。\n试剂2：1 瓶（100人份：10mL；200人份：20mL），吖啶酯标记的乙肝病毒e 抗体，在含有蛋白稳定剂的TRIS 缓冲液中配制，含ProClin300 防腐剂。\n试剂3：1 瓶（100人份：5mL；200人份：10mL），重组乙肝病毒e 抗原（rHBeAg），在含有蛋白稳定剂的TRIS 缓冲液，\n含ProClin300 防腐剂。\n校准品1：2mL×1 瓶，含免疫机体后产生的HBeAb，对乙型肝炎病毒e 抗体测定呈阳性。\n校准品2：2mL×1 瓶，含正常献血员的血浆，对乙型肝炎病毒e 抗体测定呈阴性。","该产品用于定性检测人血清和血浆中的乙型肝炎病毒e抗体（HBeAb）。","本产品用于体外定性检测人血清和血浆中的乙型肝炎病毒e抗体（HBeAb）。","1. 首次将乙型肝炎病毒e抗体测定试剂盒（化学发光微粒子免疫检测法）装载到Caris 系统上时，需要将试剂1 瓶中的试剂混匀，使在装运期间可能沉淀下来的微粒子重新悬浮。\n2. 检查样本杯中样本量，保证每次检测前样本杯中的样本量保持在310μL 以上。\n3. 必要时，执行校准命令：执行校准命令信息，参见Caris 系统操作手册。\n4. 校准品1 和校准品2 使用前应轻轻翻转5～10 次，混匀。\n5. 进样：有关进样信息，参见Caris 系统操作手册。\n6. 按下Assay start（运行）","1. 首次将乙型肝炎病毒 e 抗体检测试剂盒（磁微粒化学发光法）装载到发光仪上时，需要将试剂 1 瓶中的试剂混匀，使在装运期间可能沉淀下来的微粒子重新悬浮。\n翻转试剂 1 瓶 30 次，翻转时应控制速度避免产生气泡。\n目视检查试剂 1 瓶，以检查微粒子是否悬浮。如果微粒子依然附着在瓶上，则继续翻转直到微粒子完全悬浮。如果没有悬浮，请不要使用。\n2. 检查样本杯中样本量，保证每次检测前样本杯中的样本量保持在 310μL 以上。\n3. 必要时，执行校准命令：执行校准命令信息，参见发光仪操作手册。\n4. 校准品从 2～8℃取出后平衡至室温，使用前，轻轻翻转 5～10 次，使其充分混合，使用后，盖紧瓶盖并把校准品放回 2～8℃储存。\n5. 进样：有关进样信息，参见发光仪操作手册。\n6. 按下 Assay start（运行）。"]
["00144181","乙型肝炎病毒e抗原测定试剂盒（磁微粒化学发光法）","乙型肝炎病毒e抗原检测试剂盒（磁微粒化学发光法）","万泰凯瑞",null,"100人份/盒；200人份/盒；","100人份/盒、100人份/盒（含校准品）、200人份/盒、200人份/盒（含校准品）","100人份/盒；200人份/盒；","100人份/盒、100人份/盒（含校准品）、200人份/盒、200人份/盒（含校准品）","液体",null,"国械注准20163401240",null,"12个月",null,"纸盒",null,"试剂1：磁微粒包被的抗-HBe抗体，在TRIS缓冲液中配制，含ProClin 300防腐剂；试剂2：吖啶酯标记的抗-HBe抗体结合物，在含有蛋白稳定剂的TRIS缓冲液中配制，含ProClin 300防腐剂；试剂3:含有蛋白稳定剂的TRIS缓冲液，含ProClin 300防腐剂。","试剂 1：1 瓶（100 人份：5mL；200 人份：10mL），磁微粒包被的抗-HBe 抗体，在 TRIS 缓冲液中配制，含 ProClin300 防腐剂。\n试剂 2：1 瓶（100 人份：10mL；200 人份：20mL），吖啶酯标记的抗-HBe 抗体结合物，在含有蛋白稳定剂的 TRIS 缓冲液中配制，含 ProClin300\n防腐剂。\n试剂 3：1 瓶（100 人份：5mL；200 人份：10mL），含有蛋白稳定剂的 TRIS 缓冲液，含 ProClin300 防腐剂。\n校准品 1：2mL×1 瓶，不同浓度基因表达的 HBeAg 稀释于不含 HBeAg 的灭活人血清或血浆中，含有 ProClin300 防腐剂。\n校准品 2：2mL×1 瓶，含正常献血员的血浆，对乙型肝炎病毒 e 抗原检测试剂盒呈阴性，含有 ProClin300 防腐剂。","该产品用于定性检测人血清和血浆中的乙型肝炎病毒e抗原（HBeAg）。","本产品用于定性检测人血清和血浆中的乙型肝炎病毒e抗原（HBeAg）。","1. 首次将乙型肝炎病毒e抗原测定试剂盒（化学发光微粒子免疫检测法）装载到Caris 系统上时，需要将试剂1瓶中的试剂混匀，使在装运期间可能沉淀下来的微粒子重新悬浮。\n2. 检查样本管中样本量，保证每次检测前样本管中的样本量保持在310μL 以上。\n3. 必要时，执行校准命令：执行校准命令信息，参见Caris 系统操作手册。\n4. 校准品1 和校准品2 使用前应轻轻翻转5～10 次，混匀。\n5. 进样：有关进样信息，参见Caris 系统操作手册。\n6. 按下Assay start（运行）。","1. 首次将乙型肝炎病毒 e 抗原检测试剂盒（磁微粒化学发光法）装载到发光仪上时，需要将试剂 1 瓶中的试剂混匀，使在装运期间可能沉淀下来的微粒子重新悬浮。\n翻转试剂 1 瓶 30 次，翻转时应控制速度避免产生气泡。\n目视检查试剂 1 瓶，以检查微粒子是否悬浮。如果微粒子依然附着在瓶上，则继续翻转直到微粒子完全悬浮。如果没有悬浮，请不要使用。\n2. 检查样本杯中样本量，保证每次检测前样本杯中的样本量保持在 310μL 以上。\n3. 必要时，执行校准命令：执行校准命令信息，参见发光仪操作手册。\n4. 校准品从 2～8℃取出后平衡至室温，使用前，轻轻翻转 5～10 次，使其充分混合，使用完后，盖紧瓶盖并把校准品放回 2～8℃储存。\n5. 进样：有关进样信息，参见发光仪操作手册。\n6. 按下 Assay start（运行）。"]
["00131315","抗组蛋白抗体IgG测定试剂盒（化学发光免疫分析法）","抗组蛋白抗体IgG测定试剂盒（磁微粒化学发光法）","MAGLUMI",null,"100测试/盒；50测试/盒",null,"100测试/盒；50测试/盒",null,"PP塑料",null,"粤械注准20202401146",null,"12个月",null,"PP塑料",null,"由磁性微球冻干品、磁性微球缓冲液、低点校准品、高点校准品、缓冲液、发光标记物、样本稀释液、质控品1、质控品2组成",null,"本试剂盒用于体外定量测定人血清或血浆样本中抗组蛋白抗体IgG的含量，临床上主要用于系统性红斑狼疮(SLE)的辅助诊断。",null,"1.\t测试准备：\n-检查仪器内全自动免疫检验系统用底物液、清洗缓冲液、反应杯是否充足，废物袋和废液桶是否需要清空。\n-磁性微球复溶：本试剂盒提供的磁性微球为冻干品。配置中移液器具切勿交叉使用，以免造成测定结果异常或不准确。\n-装载试剂前避免试剂产生泡沫。\n-将试剂盒全自动试剂芯片标签贴近仪器的射频读卡器，仪器自动读取试剂盒信息。\n-将试剂盒插入仪器的试剂仓，使用前确保磁性微球充分混均。\n2.\t定标：\n通过测定试剂盒高、低校准品，将预先定义的试剂盒主曲线调整为一个新的、仪器特异的工作曲线。\n3.\t质量控制：\n 质量控制可以使用本试剂盒配套质控品。\n4.\t分析程序：\n将样本装载到仪器中，在仪器用户软件中编辑样本信息及测试项目，然后点击”开始”按钮，仪器按分析程序进行试验。\n5.\t计量和结果：\n检测中，用定标的检测信号调整整个储存的主曲线到工作曲线，仪器借助工作曲线以及样本中分析物的检测信号，即相对光强度(RLU)，分析测定仪会自动计算每个样本中的被分析物浓度。"]
["00079949","D－二聚体（D-dimer）测定试剂盒（化学发光法）","D－二聚体测定试剂盒（化学发光法）","MAGLUMI",null,"100测试/盒 、50测试/盒",null,"100测试/盒 、50测试/盒",null,"PP塑料",null,"粤械注准20162400315",null,"12个月",null,"PP塑料",null,"由磁性微球溶液（TRIS缓冲液，0.2%NaN3，包被羊抗FITC多克隆抗体）、发光标记物（抗D-dimer单克隆抗体标记ABEI，含牛血清蛋白，0.2%NaN3）、荧光素标记物（抗D-dimer单克隆抗体标记FITC，含牛血清蛋白，0.2%NaN3）、低点校准品（牛血清制品，0.2%NaN3）、高点校准品（牛血清制品，0.2%NaN3）、质控品（牛血清制品，0.2%NaN3）组成。",null,"本试剂盒用于定量测定人血浆中D－二聚体（D-dimer)的含量。",null,"储存在2℃-8℃无腐蚀性气体的环境中，未开封有效期为12个月，开封后有效期不少于28天。"]
["00368436","心肌肌钙蛋白I/肌酸激酶同工酶/肌红蛋白三项联合检测试剂盒(时间分辨荧光免疫分析法)","心肌肌钙蛋白I/肌酸激酶同工酶/肌红蛋白三项联合检测试剂盒（免疫荧光干式定量法）",{"$nulls":6},"硝酸纤维素膜",{"$nulls":13},"1. 反应板、探测物质、反应缓冲液应保持密封且在2℃~30℃条件下保存，有效期为20个月。 2. 单人份反应板开封后请立刻使用。 3. 多人份反应板和反应缓冲液开封后保持常开状态25℃建议 24小时内使用，开封后装回密封铝箔袋25℃建议5天"]
["00368438","心肌肌钙蛋白I/肌酸激酶同工酶/肌红蛋白三项联合检测试剂盒（时间分辨荧光免疫分析法）","心肌肌钙蛋白I/肌酸激酶同工酶/肌红蛋白三项联合检测试剂盒（免疫荧光干式定量法）",{"$nulls":6},"硝酸纤维素膜",{"$nulls":13},"\"1. 反应板、探测物质、反应缓冲液应保持密封且在2℃~30℃条件下保存，有效期为20个月。 2. 单人份反应板开封后请立刻使用。 3. 多人份反应板和反应缓冲液开封后保持常开状态25℃建议 24小时内使用，开封后装回密封铝箔袋25℃建议5"]
["00032025","骨科外固定支架（手部专用）","骨科外固定支架（手足专用）","泰夫德",null,"A.B.C.D",null,"A型B型C型D型",null,"本产品为医用高分子材料制成的固定材料",null,"冀械注准20162100097",null,"2年",null,"外：瓦楞纸 内：塑料薄膜",null,"产品由：1.手臂固定板 2.手掌固定板 3.手指固定板 4.弹性固定带 5.储液槽 6.排水管组成","由托板，储液盘、排水管、弹性紧固带、手掌挡板、手指挡板、组合拉钩、弹性拉钩组成。主要原料为医用ABS。","用于对手指、手掌、前臂进行医疗操作（如手术、理疗）时的固定","用于对手指、手掌、前臂及足部进行医疗操作（如手术，理疗）时的固定。","有一定强度的板状结构，配合弹性固定带起到固定手指、手掌及部分前臂的功能，以利于医疗操作","做手部手术时，根据患者症状、体征和通过影像学检查确定手术方案，将手指挡板（如需要）及手掌挡板（如需要）安装于托板上，将排水管（如配置）安装于储液盘（如配置）下方右侧出水口，将患者手部放于托盘，并用I型和II型弹性紧固带进行固定手指、手掌和前臂，如伤口需牵开，可用组合拉钩或弹性拉钩进行牵开。\n做足部手术时，根据患者症状、体征和通过影像学检查确定手术方案，将患者足部放于托板之上，将排水管（如配置）安装于储液盘（如配置）下方右侧出水口，并用I型弹性紧固带进行固定小腿及足部，根据患者受伤部位进行调整足部角度。"]
["00144090","EB病毒衣壳抗原（VCA）IgA抗体测定试剂盒（磁微粒化学发光法）","EB病毒衣壳抗原（VCA）IgA抗体检测试剂盒（磁微粒化学发光法）","万泰凯瑞",null,"50人份/盒、50人份/盒（含校准品）、100人份/盒、100人份/盒（含校准品）、200人份/盒、200人份/盒（含校准品）、2×100人份/盒、2×100人份/盒（含校准品）",null,"50人份/盒、50人份/盒（含校准品）、100人份/盒、100人份/盒（含校准品）、200人份/盒、200人份/盒（含校准品）、2×100人份/盒、2×100人份/盒（含校准品）",null,"液体",null,"国械注准20163400802",null,"12个月",null,"纸盒",null,"试剂1：1 瓶（50人份：2.5mL；100人份：5mL；200人份：10mL），VCA 抗原包被的磁微粒。\n试剂2：1 瓶（50人份：2.5mL；100人份：5mL；200人份：10mL），吖啶酯标记抗人IgA 抗体。\n试剂3：1 瓶（50人份：5mL；100人份：10mL；200人份：20mL），含蛋白稳定剂的磷酸盐缓冲液。\n校准品1：0.5mL×1 瓶，抗VCA IgA 抗体阳性血清或血浆稀释于不含抗VCA IgA 抗体的灭活人血清或血浆中，含有ProClin300防腐剂。\n校准品2：0.5mL×1 瓶，不含抗VCA IgA 抗体的灭活人血清或血浆，含有ProClin300 防腐剂。",null,"本产品用于定性检测人血清或血浆中的衣壳抗原（VCA）IgA抗体。",null,"1. 首次将EB病毒衣壳抗原（VCA）IgA 抗体测定试剂盒（磁微粒化学发光法）装载到发光仪上时，需要将试剂1 瓶中的试剂混匀，使在装运期间可能沉淀下来的微粒子重新悬浮。\n2. 检查样本杯中样本量，保证每次检测前样本杯中的样本量保持在200μL 以上。\n3. 必要时，执行校准命令：执行校准命令信息，参见发光仪操作手册。\n4. 校准品从2℃～8℃取出后平衡至室温，使用前，轻轻翻转5～10 次，使其充分混合。使用后，盖紧瓶盖并把校准品放回2℃～8℃储存。\n5. 进样：有关进样信息，参见发光仪操作手册。\n6. 按下Assay start（运行）","1. 首次将 EB 病毒衣壳抗原(VCA)IgA 抗体检测试剂盒（磁微粒化学发光法）装载到发光仪上时，需要将试剂 1 瓶中的试剂混匀，使在装运期间可能沉淀下来的微粒子重新悬浮。\n翻转试剂 1 瓶 30 次，翻转时应控制速度避免产生气泡。\n目视检查试剂 1 瓶，以检查微粒子是否悬浮。如果微粒子依然附着在瓶上，则继续翻转直到微粒子完全悬浮。如果没有悬浮，请不要使用。\n2. 检查样本杯中样本量，保证每次检测前样本杯中的样本量保持在 200μL 以上。\n3. 必要时，执行校准命令：执行校准命令信息，参见发光仪操作手册。\n4. 校准品从 2～8℃取出后平衡至室温，使用前，轻轻翻转 5～10 次，使其充分混合。使用后，盖紧瓶盖并把校准品放回 2～8℃储存。\n5. 进样：有关进样信息，参见发光仪操作手册。\n6. 按下 Assay start（运行）。"]
["00131629","抗核糖体核蛋白抗体IgG测定试剂盒（化学发光免疫分析法）","抗核糖体核蛋白抗体IgG测定试剂盒（磁微粒化学发光法）","MAGLUMI",null,"100测试/盒；50测试/盒",null,"100测试/盒；50测试/盒",null,"PP塑料",null,"粤械注准20202401186",null,"12个月",null,"PP塑料",null,"磁性微球冻干品、磁性微球缓冲液、低点校准品、高点校准品、缓冲液、发光标记物、样本稀释液、质控品1、质控品2",null,"本试剂盒用于体外定量测定人血清或血浆样本中抗核糖体P0蛋白抗体IgG的含量。临床上主要用于神经精神狼疮的精神症状及病情活动度的辅助诊断。",null,"1.\t测试准备：\n-检查仪器内全自动免疫检验系统用底物液、清洗缓冲液、反应杯是否充足，废物袋和废液桶是否需要清空。\n-磁性微球复溶：本试剂盒提供的磁性微球为冻干品。配置中移液器具切勿交叉使用，以免造成测定结果异常或不准确。\n-装载试剂前避免试剂产生泡沫。\n-将试剂盒全自动试剂芯片标签贴近仪器的射频读卡器，仪器自动读取试剂盒信息。\n-将试剂盒插入仪器的试剂仓，使用前确保磁性微球充分混均。\n2.\t定标：\n通过测定试剂盒高、低校准品，将预先定义的试剂盒主曲线调整为一个新的、仪器特异的工作曲线。\n3.\t质量控制：\n 质量控制可以使用本试剂盒配套质控品。\n4.\t分析程序：\n将样本装载到仪器中，在仪器用户软件中编辑样本信息及测试项目，然后点击”开始”按钮，仪器按分析程序进行试验。\n5.\t计量和结果：\n检测中，用定标的检测信号调整整个储存的主曲线到工作曲线，仪器借助工作曲线以及样本中分析物的检测信号，即相对光强度(RLU)，分析测定仪会自动计算每个样本中的被分析物浓度。"]
["00079720","血清降钙素（CT）测定试剂盒（化学发光法）","血清降钙素测定试剂盒（化学发光法）","MAGLUMI",null,"50测试/盒、100测试/盒",null,"50测试/盒、100测试/盒",null,"PP塑料",null,"粤械注准20162400461",null,"12个月",null,"PP塑料",null,"由磁性微球溶液、发光标记物、荧光素标记物、低点校准品、高点校准品和质控品组成。",null,"本试剂盒用于测定人血清中血清降钙素（CT)的含量。",null,"储存在2℃-8℃无腐蚀性气体的环境中，未开封有效期为12个月，开封后有效期不少于28天。"]
["00079426","Sangtec-100蛋白质(S-100)测定试剂盒（化学发光法）","Sangtec-100蛋白质测定试剂盒（化学发光法）","MAGLUMI",null,"50测试/盒、100测试/盒",null,"50测试/盒、100测试/盒",null,"PP塑料",null,"粤械注准20152400970",null,"12个月",null,"PP塑料",null,"由磁性微球溶液、发光标记物、荧光素标记物、低点校准品、高点校准品和质控品组成。",null,"用于定量测定人血清中Sangtec-100蛋白质的含量。",null,"储存在2℃-8℃无腐蚀性气体的环境中，未开封有效期为12个月，开封后有效期不少于28天。"]
["00049440","一次性腔镜切割缝合（器）及套件",{"$nulls":3},"HD1010111；HD1010112；HD1010113；HD1010114；HD1010115；HD1010116；HD1010117；HD1010118；HD1010119；HD10101110；HD10101111；HD10101112；HD10101113；HD10101114；HD10101119；HD1010211；HD1010212；HD1010213；HD1010214；HD1010215；HD1010216；HD1010217；HD1010311；HD1010312；HD1010313；HD1010314；HD1010315；HD1010316；HD1010317；HD1010511；HD1010512；HD1010513；HD1010514；HD1010515；HD1020111；HD1020112；HD1020113；HD1020114；HD1020115；HD1020211；HD1020212；HD1020213；HD1020311；HD1020312；HD1020313；HD1020314；HD1020511；HD1020512；HD1010101；HD1010102；HD1010103；HD1010104；HD1010105；HD10101019；HD1010201；HD1010202；HD1010203；HD1010301；HD1010302；HD1010303；HD1010304；HD1010501；HD1010502；HD1010131；HD1010132；HD1010133；HD1010134；HD1010135；HD10101319；HD1010231；HD1010232；HD1010233；HD1010331；HD1010332；HD1010333；HD1010334；HD1010531；HD1010532；HD1020401；HD1020402；HD1020431；HD1020432；HD1010601；HD1010602；HD1010603；HD1010604；HD1020701；HD1020702；HD1020703；HD1020704；HD1020705；HD1010801；HD1020802；HD10101116；HD10101117；HD10101118；HD1010218；HD1010219；HD10102110；HD1010318；HD1010319；HD10103110；HD1010516；HD1010517；HD1010518；HD1010519；HD10105110；HD10105111；HD10101016；HD10101017；HD10101018；HD1010208；HD1010209；HD10102010；HD1010308；HD1010309；HD10103010；HD1010506；HD1010507；HD1010508；HD1010509；HD10105010；HD10105011；","整体式组织抓钳(非锁止型）；整体式轻型组织抓钳（非锁止型）；整体式重型组织抓钳（非锁止型）；整体式胆囊抓钳（非锁止型）；整体式子宫抓钳（非锁止型）；整体式胃抓钳（非锁止型）；整体式细直分离钳(非锁止型)；整体式直角分离钳（非锁止型）；整体式30度弯分离钳（非锁止型）；整体式细直分离钳（单动）（非锁止型）；整体式分离钳R（非锁止型）；整体式无损伤肠钳（非锁止型）；整体式无损伤肺叶钳（非锁止型）；整体式无损伤抓钳（非锁止型）；整体式直剪（非锁止型）；整体式弯剪（非锁止型）；整体式直型持针缝合钳；整体式弯型持针缝合钳；整体式非锁止型30度弯分离钳14mm（3mm）；整体式非锁止型无损伤抓钳（3mm）；整体式弯剪13mm（3mm）；二分体组织抓钳；二分体轻型组织抓钳；二分体重型组织抓钳；二分体胆囊抓钳；二分体子宫抓钳；二分体胃抓钳；二分体细直分离钳；二分体直角分离钳；二分体30度弯分离钳；二分体无损伤肠钳；二分体无损伤肺叶钳；二分体无损伤抓钳\n二分体直剪；二分体弯剪；非锁止型手柄（蛋形指圈）；二分体直型持针缝合钳；二分体弯型持针缝合钳；持针钳专用燕尾手柄；","组织抓钳 轻型组织抓钳 重型组织抓钳 胆囊抓钳 子宫抓钳 胆道造影抓钳 虎口抓钳 鼠齿抓钳 鸭嘴抓钳 勺形抓钳 输尿管抓钳 粘连分离抓钳 输卵管抓钳 卵巢抓钳 胃抓钳 细直分离钳 直角分离钳 30°弯分离钳 细直分离钳 分离钳R 海豚鼻分离钳 45°弯分离钳 无损伤肠钳 无损伤肺叶钳 无损伤抓钳 无损伤抓钳B 无损伤肠钳 无损伤肺叶钳 无损伤抓钳 直剪 弯剪 直剪 弯剪 勾剪 组织抓钳 轻型组织抓钳 重型组织抓钳 胆囊抓钳 子宫抓钳 细直分离钳 直角分离钳 30°弯分离钳 无损伤肠钳 无损伤肺叶钳 无损伤抓钳 无损伤抓钳B 直剪 弯剪 组织抓钳 轻型组织抓钳 重型组织抓钳 胆囊抓钳 子宫抓钳 胃抓钳 细直分离钳 直角分离钳 30°弯分离钳 无损伤肠钳 无损伤肺叶钳 无损伤抓钳 无损伤抓钳B 直剪 弯剪 组织抓钳 轻型组织抓钳 重型组织抓钳 胆囊抓钳 子宫抓钳 胃抓钳 细直分离钳 直角分离钳 30°弯分离钳 无损伤肠钳 无损伤肺叶钳 无损伤抓钳 无损伤抓钳B 直剪 弯剪 直型持针钳 弯型持针钳 直型持针钳 弯型持针钳 蛋形指圈手柄 C型手柄 快拆式C型手柄 舒适款C型手柄 蛋形指圈手柄 持针钳专用燕尾手柄 C型手柄 快拆式C型手柄 舒适款C型手柄 非锁止型手柄和三分体钳杆 锁止型手柄和三分体钳杆 组织抓钳 重型组织抓钳 虎口抓钳 直角分离钳 30°弯分离钳 30°弯分离钳 无损伤肠钳 无损伤抓钳 无损伤抓钳 直剪 直剪 弯剪 弯剪 弯剪 勾剪 组织抓钳 重型组织抓钳 虎口抓钳 直角分离钳 30°弯分离钳 30°弯分离钳 无损伤肠钳 无损伤抓钳 无损伤抓钳 直剪 直剪 弯剪 弯剪 弯剪 勾剪","HD1010111；HD1010112；HD1010113；HD1010114；HD1010115；HD10101119；HD1010211；HD1010212；HD1010213；HD1010214；HD1010215；HD1010311；HD1010312；HD1010313；HD1010511；HD1010512；HD1020431；HD1020432；HD1010219；HD1010319；HD1010518；HD1010101；HD1010102；HD1010103；HD1010104；HD1010105；HD10101019；HD1010201；HD1010202；HD1010203；HD1010301；HD1010302；HD1010303；HD1010501；HD1010502；HD1010601；HD1020401；HD1020402；HD1020702；","钳类和剪类刃口采用OCr17Ni4Cu4，钳杆杆身采用SUS303或SUS303不锈钢；手柄采用PA6 50%GF或PEEK、ABS或者PA6 50%GF复合材料；其他金属部件采用0Cr17Ni4Cu4。",null,"湘械注准20192020075",null,"36个月",null,"APET/TYVEK",null,"根据操作手柄分为锁止型和非锁止型，由钳头（剪刀头）、杆、操作手柄三部分组成，根据各部分连接方式的不同，分为整体式、二分体、三分体三种结构形式。整体式结构为钳头（剪刀头）、杆、操作手柄整体连接，各部件不可拆分，整体一次性使用；二分体结构为钳头（剪刀头）与杆固定连接为钳头杆，与操作手柄之间可拆分，钳头杆为一次性使用，操作手柄可重复使用；三分体结构为钳头（剪刀头）、杆、操作手柄三部分均可拆分，钳头（剪刀头）一次性使用，杆、操作手柄可重复使用。",null,"该产品供各种腔镜下进行的微创外科手术中对缝合针进行夹持、对组织进行夹持、分离、剪切等操作。",null,"1. 整体式包装的产品，钳头杆与操作手柄已组装完毕。使用者根据临床要求，选择适合的规格型号后在洁净环境拆启包装取出后即可使用。\n 2. 二分体产品，手柄与钳头杆分开独立包装，按照下述方法使用：\n  2.1 根据临床要求，选择适合的钳头杆型号及手柄后在洁净环境分别拆启包装。\n  2.2 旋开手柄拨轮上的锁紧螺帽，手柄置于完全打开状态，将钳头杆插入手柄中，并闭合手柄，如钳头随手柄动作而开闭，说明安装到位，可旋紧锁紧螺帽，按操作规程要求开始使用。如钳头不随手柄动作开闭，则需抽出钳杆，按上述步骤重新操作，直至符合要求。\n 3. 三分体产品，按照下述方法装配使用：\n  3.1根据临床要求，选择适合的钳头型号及钳杆加手柄后在洁净环境分别拆启包装。\n3.2 ①将手柄打开，使手柄上两个箭头对准，②然后将钳头从杆身前端顺时针旋转，③使得钳头锁紧在杆身上，钳头后端与杆身前端贴合，④钳头能随手柄动作自由开合，说明组装到位。\n4.快拆式C型手柄，按照下述方法装配和拆卸使用：\n4.1装配：①手柄置于完全打开状态 ②将钳头杆插入手柄拨轮中并旋转一定角度直至装配到位 ③闭合手柄，如钳头随手柄动作而开闭，说明安装到位，按操作规程要求开始使用。如钳头不随手柄动作开闭，则需抽出钳杆，按上述步骤重新操作，直至符合要求。4.2拆卸：①手柄置于完全打开状态 ②将拨轮往后拨动4~5mm ③将钳杆拔出即可。","按产品说明书所示。"]
["00079864","肌酸激酶同工酶（CK-MB）测定试剂盒（化学发光法）",null,"MAGLUMI",null,"50测试/盒、100测试/盒",null,"50测试/盒、100测试/盒",null,"PP塑料",null,"粤械注准20162400459",null,"12个月",null,"PP塑料",null,"由磁性微球溶液、发光标记物、荧光素标记物、低点校准品、高点校准品、质控品组成。",null,"本试剂盒用于测定人血清肌酸激酶同工酶（CK-MB)的含量。",null,"储存在2℃-8℃无腐蚀性气体的环境中，未开封有效期为12个月，开封后有效期不少于28天。"]
["00151234","齿科藻酸盐印模粉",{"$nulls":3},"454克，500克，908克，1000克",null,"通用型、变色型",null,"粉末",null,"标准YY1027-2001《齿科藻酸盐印模材料》",null,"30个月",null,"铝箔袋/塑料桶",null,"产品成份为硅藻土、海藻酸盐、石膏和磷酸盐。",null,"用于制取牙齿和口腔组织印模。",null,"1.按粉水比分别称取水和印模粉先后加入调和橡皮碗中，迅即搅拌约30秒，至均匀。此时的变色型产品，混合物\n呈紫红色。\n2.从调和开始至将混合物装在牙托盘内，应在1分30秒内完成。此时的变色型产品，混合物颜色变淡红色。\n3.将装有混合物的托盘置入口内取模，保持印模托盘约1分钟不动直至印模固化。此时的变色型产品，充分固化后\n的印模颜色转变成白色。\n4.混合物固化后，从口中取出印模，用冷水冲洗唾液或碎渣，甩干水后，立即浇注石膏，待石膏充分硬化后脱出。"]
["00144082","糖类抗原19-9（CA19-9）测定试剂盒（磁微粒化学发光法）",null,"万泰凯瑞",null,"50人份/盒、50人份/盒（含校准品）、100人份/盒、100人份/盒（含校准品）、200人份/盒、200人份/盒（含校准品）、300人份/盒、300人份/盒（含校准品）、500人份/盒、500人份/盒（含校准品）、2×100人份/盒、2×100人份/盒（含校准品）、3×100人份/盒、3×100人份/盒（含校准品）、5×100人份/盒、5×100人份/盒（含校准品）",null,"50人份/盒、50人份/盒（含校准品）、100人份/盒、100人份/盒（含校准品）、200人份/盒、200人份/盒（含校准品）、300人份/盒、300人份/盒（含校准品）、500人份/盒、500人份/盒（含校准品）、2×100人份/盒、2×100人份/盒（含校准品）、3×100人份/盒、3×100人份/盒（含校准品）、5×100人份/盒、5×100人份/盒（含校准品）",null,"液体",null,"国械注准20153401965","闽械注准20152401965","12个月",null,"纸盒",null,"试剂1：1 瓶（50人份：2.5mL；100人份：5mL；200人份：10mL；300人份：15mL；500人份：25mL），CA19-9 抗体包被的磁微粒，在磷酸盐缓冲液中配制，含ProClin300 防腐剂。\n试剂2：1 瓶（50人份：2.5mL；100人份：5mL；200人份：10mL；300人份：15mL；500人份：25mL），吖啶酯标记的CA19-9 抗体，在磷酸盐缓冲液中配制，含ProClin300 防腐剂。\n校准品1：0.5mL×1 瓶，10U/mL 的糖类抗原19-9，含磷酸盐缓冲液，含有ProClin 300 防腐剂。\n校准品2：0.5mL×1 瓶，100U/mL 的糖类抗原19-9，含磷酸盐缓冲液，含有ProClin 300 防腐剂。",null,"本试剂用于定量检测人血清或血浆中的糖类抗原19-9。主要用于对恶性肿瘤患者进行动态监测以辅助判断疾病进程或治疗效果，不能作为恶性肿瘤早期诊断或确诊的依据，不能用于普通人群的肿瘤筛查。",null,"1. 首次将糖类抗原19-9（CA19-9）测定试剂盒（磁微粒化学发光法）装载到发光仪上时，需要将试剂1瓶中的试剂混匀，使在装运期间可能沉淀下来的微粒子重新悬浮。\n2. 检查样本杯中样本量，保证每次检测前样本杯中的样本量保持在200μL 以上。\n3. 必要时，执行校准命令：执行校准命令信息，参见发光仪操作手册。\n4. 校准品从2℃～8℃取出后平衡至室温，使用前，轻轻翻转5～10次，使其充分混合，取完后，盖紧瓶盖并把校准品放回2℃～8℃储存。\n5. 进样：有关进样信息，参见发光仪操作手册。\n6. 按下Assay start（运行）。","1. 首次将糖类抗原19-9（CA19-9）测定试剂盒（磁微粒化学发光法）装载到发光仪上时，需要将试剂1瓶中的试剂混匀，使在装运期间可能沉淀下来的微粒子重新悬浮。\n翻转试剂 1 瓶 30 次，翻转时应控制速度避免产生气泡。\n目视检查试剂 1 瓶，以检查微粒子是否悬浮。如果微粒子依然附着在瓶上，则继续翻转直到微粒子完全悬浮。如果没有悬浮，请不要使用。\n2. 检查样本杯中样本量，保证每次检测前样本杯中的样本量保持在200μL 以上。\n3. 必要时，执行校准命令：执行校准命令信息，参见发光仪操作手册。\n4. 校准品从2～8℃取出后平衡至室温，使用前，轻轻翻转5～10次，使其充分混合，取完后，盖紧瓶盖并把校准品放回2～8℃储存。\n5. 进样：有关进样信息，参见发光仪操作手册。\n6. 按下 Assay start（运行）。"]
["00319783","超敏降钙素原(PCTPlus)检测试剂盒(免疫荧光干式定量法)","降钙素原(PCT)检测试剂盒(免疫荧光干式定量法)",{"$nulls":6},"硝酸纤维素膜",{"$nulls":13},"1.储存条件：反应板包装袋应保持密封且在2℃～30℃条件下保存， 探测物质、反应缓冲液在2℃～30℃条件下保存。2.有效期：20个月。3.未使用时请不要打开反应板、探测物质、反应缓冲液包装，一旦打开请立刻使用。"]
["00143022","甲型肝炎病毒抗体测定试剂盒（磁微粒化学发光法）","甲型肝炎病毒抗体检测试剂盒（磁微粒化学发光法）","万泰凯瑞",null,"50人份/盒、50人份/盒（含校准品）、100人份/盒、100人份/盒（含校准品）、200人份/盒、200人份/盒（含校准品）、2×100人份/盒、2×100人份/盒（含校准品）、300人份/盒、300人份/盒（含校准品）、3×100人份/盒、3×100人份/盒（含校准品）、500人份/盒、500人份/盒（含校准品）、5×100人份/盒、5×100人份/盒（含校准品）","50人份/盒、50人份/盒（含校准品）、100人份/盒、100人份/盒（含校准品）、200人份/盒、200人份/盒（含校准品）、300人份/盒、300人份/盒（含校准品）、500人份/盒、500人份/盒（含校准品）、2×100人份/盒、2×100人份/盒（含校准品）、3×100人份/盒、3×100人份/盒（含校准品）、5×100人份/盒、5×100人份/盒（含校准品）","50人份/盒、50人份/盒（含校准品）、100人份/盒、100人份/盒（含校准品）、200人份/盒、200人份/盒（含校准品）、2×100人份/盒、2×100人份/盒（含校准品）、300人份/盒、300人份/盒（含校准品）、3×100人份/盒、3×100人份/盒（含校准品）、500人份/盒、500人份/盒（含校准品）、5×100人份/盒、5×100人份/盒（含校准品）","50人份/盒、50人份/盒（含校准品）、100人份/盒、100人份/盒（含校准品）、200人份/盒、200人份/盒（含校准品）、300人份/盒、300人份/盒（含校准品）、500人份/盒、500人份/盒（含校准品）、2×100人份/盒、2×100人份/盒（含校准品）、3×100人份/盒、3×100人份/盒（含校准品）、5×100人份/盒、5×100人份/盒（含校准品）","液体",null,"国械注准20163401356",null,"12个月",null,"纸盒",null,"试剂1：1瓶（50 人份：2.5mL；100人份：5mL；200人份：10mL；300人份：15mL；500人份：25mL），HAV单抗和HAV抗原包被的磁微粒，置于含表面活性剂和防腐剂ProClin300的缓冲液中。\n试剂2：1瓶（50 人份：1.25mL；100人份：2.5mL；200人份：5mL；300人份：7.5mL；500人份：12.5mL），吖啶酯标记的HAV单抗，置于含蛋白保护剂、表面活性剂和防腐剂ProClin300的缓冲液中。\n试剂3：1瓶（50 人份：1mL；100人份：2mL；200人份：4mL；300人份：6mL；500人份：10mL），含蛋白保护剂、表面活性剂和防腐剂ProClin300的缓冲液。\n校准品1：1mL×1瓶，淡黄色，灭活的HAV Ab检测为阳性的人血清或血浆，防腐剂：ProClin300。\n校准品2：1mL×1瓶，淡黄色，灭活的HAV Ab检测为阴性的人血清或血浆，防腐剂：ProClin300。",null,"本产品用于体外定性检测人血清或血浆中的甲型肝炎病毒总抗体。",null,"1.首次将甲型肝炎病毒抗体测定试剂盒（磁微粒化学发光法）装载到发光仪上时，需要将试剂1瓶中的试剂混匀，使在装运期间可能沉淀下来的微粒子重新悬浮。\n2.？检查样本杯中样本量，保证每次检测前样本杯中的样本量保持在310μL以上。\n3.？必要时，执行校准命令：执行校准命令信息，参见发光仪操作手册。\n4.？校准品从2℃～8℃取出后平衡至室温，使用前，轻轻翻转5～10次，使其充分混合。使用后，盖紧瓶盖并把校准品放回2℃～8℃储存。\n5.？进样：有关进样信息，参见发光仪操作手册。\n6.按下Assay start（运行）。","1. 首次将甲型肝炎病毒抗体检测试剂盒（磁微粒化学发光法）装载到发光仪上时，需要将试剂 1 瓶中的试剂混匀，使在装运期间可能沉淀下来的微粒子重新悬浮。\n翻转试剂 1 瓶 30 次，翻转时应控制速度避免产生气泡。\n目视检查试剂 1 瓶，以检查微粒子是否悬浮。如果微粒子依然附着在瓶上，则继续翻转直到微粒子完全悬浮。如果没有悬浮，请不要使用。\n2. 检查样本杯中样本量，保证每次检测前样本杯中的样本量保持在 310μL 以上。\n3. 必要时，执行校准命令：执行校准命令信息，参见发光仪操作手册。\n4. 校准品从 2～8℃取出后平衡至室温，使用前，轻轻翻转 5～10 次，使其充分混合。使用后，盖紧瓶盖并把校准品放回 2～8℃储存。\n5. 进样：有关进样信息，参见发光仪操作手册。\n6. 按下 Assay start（运行）。"]
["00318920","超敏肌钙蛋白I检测试剂盒（磁微粒化学发光法）","高敏肌钙蛋白I检测试剂盒（磁微粒化学发光法）",{"$nulls":6},"液体",{"$nulls":13},"1.未开瓶试剂盒（包含质控品和校准品）于2℃～8℃密闭避光保存有效期为15个月。 试剂开瓶后2℃～8℃避光保存可稳定28天； 校准品开瓶后2℃～8℃可保存28天； 质控品开瓶后2℃～8℃可保存28天。 2.运输和保存均应在2℃～8℃低温条件"]
["00007332","一次性使用压力防针刺留置针","一次性使用静脉留置针","林华",null,"18G*0.75IN(1.3*19mm)、18G*1.00IN(1.3*25mm)、18G*1.16IN(1.3*30mm)、18G*1.80IN(1.3*45mm)、18G*1.90IN(1.3*48mm)、18G*2.00IN(1.3*51mm)、20G*0.75IN(1.1*19mm)、20G*1.00IN(1.1*25mm)、20G*1.16IN(1.1*30mm)、22G*0.75IN(0.9*19mm)、22G*1.00IN(0.9*25mm)、24G*0.60IN(0.7*15mm)、24G*0.75IN(0.7*19mm)、26G*0.5IN(0.6*13mm)、26G*0.63IN(0.6*16mm)、26G*0.75IN(0.6*19mm)",null,"YFⅡ-A、YFⅡ-B","YFII-A型、YFII-B型","氟化乙烯丙烯共聚物、奥氏体不锈钢SUS305(1Cr18Ni12)、丙酸纤维素（CAP)、不锈钢0Cr18Ni9、丙烯腈-丁二烯-苯乙烯三元共聚物、丙烯腈-丁二烯-苯乙烯三元共聚物、聚异戊二烯","FEP","YZB/国0312-2015","国械注准20153140310","3年",null,"纸塑","吸塑","留置针由针管护套、导管组件、针管组件、耐高压垫片、防针刺组件、长导管组件、止流夹、端帽及肝素帽构成，其中导管组件由导管、金属楔、隔离塞和三通导管座组成；针管组件由针管和针座组成；长导管组件由长导管和长导管连接座（二通、多通组成）。","留置针由针管护套、导管组件、针管组件、耐高压垫片、防针刺组件、长导管组件、止流夹、端帽及肝素帽构成，其中导管组件由导管、金属楔、隔离塞和三通导管座组成；针管组件由针管和针座组成；长导管组件由长导管和长导管连接座（两通、三通）组成。与药液接触部件原材料：导管由氟化乙烯丙烯共聚物、金属楔由奥氏体不锈钢SUS305(1CR18Ni12)、三通导管座和长导管连接座由共聚聚酯、针管由不锈钢0Cr18Ni9、肝素帽由共聚聚酯和聚异戊二烯、长导管由聚氯乙烯制造。","该产品供插入人体外周血管静脉系统输液用，可耐受最大输注压力200psi,留置时间不大于72小时。",null,"1、打开单包装，取出留置针。\n2、旋紧肝素帽6或取下肝素帽直接接上输液器具.。\n3、用拇指和食指同时握住三通导管座和针座，旋松并取下针管护套。\n4、手持针座进行静脉穿刺，观察回血流经导管；\n5、将导管推入静脉血管内，同时抽出针管组件(针管、针座) ，抽出过程中针管针尖卡入防针刺保护装置内，防针刺保护装置被激活。\n6、把针尖被屏蔽的针管组件丢入专用收集箱中。\n7、按照操作程序或护理规则固定导管组件(导管、三通导管座)和其他器件。\n8、输液完毕，将输液器具与肝素帽15分离。\n9、使用稀释肝素或生理盐水封管。\n10、再次输液时，将肝素帽胶垫消毒，与排气后的输液器具连接进行常规输液。\n11、结束输液时，揭开敷贴，把无菌棉签放于穿刺点上方迅速拔出导管，按压穿刺点。"]
["00318917","超敏肌钙蛋白I检测试剂盒（磁微粒化学发光法）","高敏肌钙蛋白I检测试剂盒（磁微粒化学发光法）",{"$nulls":6},"液体",{"$nulls":13},"1.未开瓶试剂盒（包含质控品和校准品）于2℃～8℃密闭避光保存有效期为15个月。 试剂开瓶后2℃～8℃避光保存可稳定28天； 校准品开瓶后2℃～8℃可保存28天； 质控品开瓶后2℃～8℃可保存28天。 2.运输和保存均应在2℃～8℃低温条件"]
["00076781","超敏降钙素原（PCT Plus）检测试剂盒（免疫荧光干式定量法）","降钙素原(PCT)检测试剂盒(免疫荧光干式定量法)","艾美益",null,"25人份/盒、50人份/盒、100人份/盒、200人份/盒","10人份/盒， 25人份/盒，50人份/盒，75人份/盒，100人份/盒，150人份/盒，200人份/盒","25人份/盒、50人份/盒、100人份/盒、200人份/盒","10人份/盒， 25人份/盒，50人份/盒，75人份/盒，100人份/盒，150人份/盒，200人份/盒","硝酸纤维素膜",null,"桂械注准20192400082",null,"12个月","20个月","纸盒",null,"该产品由反应板，一次性使用末梢采血管（35μL）,ID芯片（1个/盒）和缓冲液（探测物质，反应缓冲液）和说明书组成。（注：包装规格100人份/盒，200人份/盒不包含一次性使用末梢采血管）。反应板上的测试线和质控线分别包被有链霉亲和素（0.78μg±0.4g）和chicken IgY(0.39μg±0.2μg)。探测物质含有荧光标记的PCT抗体络合物(0.4μg±0.2μg)，生物素标记的PCT抗体络合物(0.2μg±0.1μg)，荧光标记的anti-chicken IgY 络合物(0.025μg±0.013μg)，牛血清蛋白和防腐剂。反应缓冲液里含有牛血清蛋白和防腐剂。","\"该产品由反应板，一次性使用末梢采血管(35μl)，ID芯片(1个/盒)，探测物质，反应缓冲液和说明书组成。\n(注:仅10人份/盒，25人份/盒包装规格包含一次性使用末梢采血管)\n反应板上的测试线和质控线分别包被有链霉亲和素(0.78μg±0.4μg)和鸡IgY抗体(0.39μg±0.2μg)。\n探测物质含有荧光标记的降钙素原抗体络合物(0.4μg±0.2μg),生物素标记的降钙素原抗体络合物(0.2μg±0.1μg),荧光标记的鼠抗鸡IgY抗体络合物(0.025μg±0.013μg),牛血清白蛋白(5%)。反应缓冲液里含有牛血清白蛋白(1%)。(注:不同批号试剂盒中各组分不能互换)\"","该产品用于以免疫荧光分析法体外定量检测人血液（全血/血浆/血清）中的降钙素原的浓度，主要用于细菌感染和脓毒症的辅助诊断。","该产品用于以荧光免疫分析法体外定量检测人血液(全血/血浆/血清)中的降钙素原的浓度。主要用于细菌感染和脓毒症的辅助诊断。","* A2000\n1) 打开反应板包装袋，取出反应板并水平放置。\n2) 用移液器取反应缓冲液150μL，放入探测物质试管。并立\n即用一次性使用末梢采血管\n* * 或移液器采样(全血、血清、\n血浆 35μL)并放入装有反应缓冲液的探测物质试管。\n3) 盖上缓冲液试管的盖子，摇晃10～15次以确保充分混匀。\n4) 用移液器取75μL的样本混合液，并加样到反应板的样本\n孔。\n5) 在室温反应12分钟。\n6) 把反应后的反应板插入专用检测设备，按仪器说明书进行\n测试，并确认结果。\n* A5000\n按仪器说明书进行测试。","* A2000 1) 打开反应板包装袋，取出反应板并水平放置。 2) 用移液器取反应缓冲液150μL，放入探测物质试管。并立即用一次性使用末梢采血管*或移液器采样(全血、血清、血浆 35μL)并放入装有反应缓冲液的探测物质试管。 3) 盖上缓冲液试管的盖子，摇晃10～15次以确保充分混匀。 4) 用移液器取75μL的样本混合液，并加样到反应板的样本孔。 5) 在室温反应12分钟。 6) 把反应后的反应板插入专用检测设备，按仪器说明书进行测试，并确认结果。 * A2000 PLUS/A3000/A5000/A5000 PLUS 按仪器说明书进行测试。"]
["00318922","超敏肌钙蛋白I检测试剂盒（磁微粒化学发光法）","高敏肌钙蛋白I检测试剂盒（磁微粒化学发光法）",{"$nulls":6},"液体",{"$nulls":13},"1.未开瓶试剂盒（包含质控品和校准品）于2℃～8℃密闭避光保存有效期为15个月。 试剂开瓶后2℃～8℃避光保存可稳定28天； 校准品开瓶后2℃～8℃可保存28天； 质控品开瓶后2℃～8℃可保存28天。 2.运输和保存均应在2℃～8℃低温条件"]
["00079924","脑自然肽N端前体蛋白测定试剂盒（化学发光法）","N末端B型利钠肽前体测定试剂盒（化学发光法）","MAGLUMI",null,"50测试/盒、100测试/盒",null,"50测试/盒、100测试/盒",null,"PP塑料",null,"粤械注准20152401077",null,"12个月",null,"PP塑料",null,"由磁性微球溶液、发光标记物、荧光素标记物、低点校准品、高点校准品和质控品组成。",null,"本试剂用于定量测定人血清内的脑自然N端前体蛋白（NT-ProBNP）的含量。",null,"2℃-8℃储存，未开封有效期12个月，开封后保存在2℃-8℃有效期为28天，放置在正常运行的仪器上有效期为28天。"]
["00144197","癌胚抗原测定试剂盒（磁微粒化学发光法）",null,"万泰凯瑞",null,"50人份/盒、50人份/盒（含校准品）、100人份/盒、100人份/盒（含校准品）、200人份/盒、200人份/盒（含校准品）、300人份/盒、300人份/盒（含校准品）、500人份/盒、500人份/盒（含校准品）、2×100人份/盒、2×100人份/盒（含校准品）、3×100人份/盒、3×100人份/盒（含校准品）、5×100人份/盒、5×100人份/盒（含校准品）",null,"50人份/盒、50人份/盒（含校准品）、100人份/盒、100人份/盒（含校准品）、200人份/盒、200人份/盒（含校准品）、300人份/盒、300人份/盒（含校准品）、500人份/盒、500人份/盒（含校准品）、2×100人份/盒、2×100人份/盒（含校准品）、3×100人份/盒、3×100人份/盒（含校准品）、5×100人份/盒、5×100人份/盒（含校准品）",null,"液体",null,"国械注准20153401962","闽械注准20152401962","12个月",null,"纸盒",null,"试剂1：1瓶（50人份：2.5mL；100人份：5mL；200人份：10mL；300 人份：15mL；500人份：25mL），CEA抗体包被的磁微粒。\n试剂2：1瓶（50人份：2.5mL；100人份：5ml；200人份：10mL；300 人份：15mL；500人份：25mL），吖啶酯标记CEA抗体。\n试剂3：1瓶（50人份：2.5mL；100人份：5mL；200 人份：10mL；300人份：15mL；500人份：25mL），反应稀释液。\n校准品1： 1mL×1 瓶，10.00ng/mL 的癌胚抗原，含牛血清的磷酸盐缓冲液，含有ProClin300防腐剂。\n校准品2： 1mL×1 瓶，100.00ng/mL 的癌胚抗原，含牛血清的磷酸盐缓冲液，含有ProClin300防腐剂。",null,"本产品用于定量检测人血清或血浆中的癌胚抗原。主要用于对恶性肿瘤患者进行动态监测以辅助判断疾病进程或治疗效果，不能作为恶性肿瘤早期诊断或确诊的依据，不能用于普通人群的肿瘤筛查。",null,"1.首次将癌胚抗原测定试剂盒（磁微粒化学发光法）装载到发光仪上时，需要将试剂1瓶中的试剂混匀，使在装运期间可能沉淀下来的微粒子重新悬浮。\n2.检查样本杯中样本量，保证每次检测前样本杯中的样本量保持在200μL以上。\n3.必要时，执行校准命令：执行校准命令信息，参见发光仪操作手册。\n4.校准品从2℃～8℃取出后平衡至室温，使用前，轻轻翻转5～10次，使其充分混合。使用后，盖紧瓶盖并把校准品放回2℃～8℃储存。\n5.进样：有关进样信息，参见发光仪操作手册。\n6.按下Assay start（运行）。","1. 首次将癌胚抗原测定试剂盒（磁微粒化学发光法）装载到发光仪上时，需要将试剂 1 瓶中的试剂混匀，使在装运期间可能沉淀下来的微粒子重新悬浮。\n翻转试剂 1 瓶 30 次，翻转时应控制速度避免产生气泡。\n目视检查试剂 1 瓶，以检查微粒子是否悬浮。如果微粒子依然附着在瓶上，则继续翻转直到微粒子完全悬浮。如果没有悬浮，请不要使用。\n2. 检查样本杯中样本量，保证每次检测前样本杯中的样本量保持在 200μL 以上。\n3. 必要时，执行校准命令：执行校准命令信息，参见发光仪操作手册。\n4. 校准品从 2～8℃取出后平衡至室温，使用前，轻轻翻转 5～10 次，使其充分混匀。使用后，盖紧瓶盖并把校准品放回 2～8℃储存。\n5. 进样：有关进样信息，参见发光仪操作手册。\n6. 按下 Assay start（运行）。"]
["00123983","皮肤组织钻孔器","显微皮肤活检环钻",null,null,"∅1.5mm、∅2mm、∅2.5mm、∅3mm、∅3.5mm、∅4mm","？1mm、？1.5 mm、 ？2 mm、？2.5 mm、？3 mm、？3.5 mm、？4 mm、1、1.5、2、2.5、3、3.5、4","平口型（BN-MCR-1）、豁口型（BN-MCR-2）","平口型（BN-MCR-1）、豁口型（BN-MCR-2）、BN-MCR-3","医用9Cr18不锈钢、ABS",null,"皖蚌械备20180005号","皖蚌械备20180005","24个月",null,"纸塑袋","吸塑盒","皮肤组织钻孔器由钻孔锥、锁紧接头和手柄共同组成，主要采用医用9Cr18不锈钢和医用级丙烯腈-丁二烯-苯乙烯（ABS）树脂制作，按临床需求不同的方式分为单件包装和组合包装二种方式，非无菌提供。","平口型(BN-MCR-1)和豁口型(BN-MCR-2)产品由钻孔锥、锁紧接头和手柄共同组成；主要采用医用9Cr18不锈钢和医用级丙烯腈-丁二烯-苯乙烯(ABS)树脂制作；BN-MCR-3型产品由钻孔锥、防护帽和手柄共同组成；主要采用医用级304不锈钢、医用级热塑性聚氨酯(TPU)、医用级丙烯腈-丁二烯-苯Z烯(ABS)树脂和聚碳酸酯(PC)树脂制作；产品按临床需求不同的方式分为单件包装和组合包装二种方式；非无菌提供，使用前由使用机构根据说明书进行灭菌。不接触中枢神经系统或血液循环系统。不在内窥镜下使用，","产品主要适用于钻取人体表皮和组织（不接触中枢神经系统或血液循环系统），用于活检手术和病理检查。","用于组织打孔，建立通路。","/"]

{"sheet":"注册证信息变更","index":1,"n_rows":827,"n_cols":30,"rows_kept":827}
["变更前：注册证编号","变更后：注册证编号","变更前：注册证产品名称","变更后：注册证产品名称","变更前：生产国家/地区","变更后：生产国家/地区","变更前：售后服务机构","变更后：售后服务机构","变更前：批准日期","变更后：批准日期","变更前：变更日期","变更后：变更日期","变更前：注册证有效期起","变更后：注册证有效期起","变更前：注册证有效期止","变更后：注册证有效期止","变更前：产品标准","变更后：产品标准","变更前：代理人名称/生产单位","变更后：代理人名称/生产单位","变更前：生产厂商(英文)","变更后：生产厂商(英文)","变更前：受理证号","变更后：受理证号","变更前：产品性能结构及组成","变更后：产品性能结构及组成","变更前：产品适用范围","变更后：产品适用范围","变更前：管理类别","变更后：管理类别"]
["湘械注准20202140212",null,"医用外科口罩",{"$nulls":9},"2020-09-03","2025-09-03","2025-09-02","2030-09-02",{"$nulls":12},"2"]
["国械注准20153130489",null,"金属接骨螺钉",{"$nulls":9},"2020-03-02","2025-04-01","2025-03-01","2030-03-31",{"$nulls":12},"3"]
["国械注进20153032306",null,"球囊导管",{"$nulls":9},"2020-08-18","2025-09-29","2025-08-17","2030-09-28",{"$nulls":9},"球囊导管由导管轴，球囊，应力保护管和导管座组成。 导管轴由聚酰胺树脂制成，球囊由聚酰胺树脂制成，导 管座由聚碳酸酯树脂制成。产品经环氧乙烷灭菌， 一次 性使用，货架有效期3年。",null,null,"3"]
["国械注准20153171554",null,"种植牙系统",{"$nulls":9},"2020-09-09","2025-09-09","2025-09-08","2030-09-08",{"$nulls":12},"3"]
["国械注准20163452317","国械注准20163102317","血液透析浓缩液",{"$nulls":9},"2016-11-21","2020-09-14","2021-11-20","2025-09-13",{"$nulls":3},"广州万益特医疗用品有限公司",{"$nulls":8},"3"]
["鲁械注准20152400438",null,"载脂蛋白E测定试剂盒（免疫透射比浊法）",{"$nulls":9},"2020-08-07","2025-08-07","2025-08-06","2030-08-06",{"$nulls":12},"2"]
["苏械注准20152080375",null,"经皮气管切开组套",{"$nulls":9},"2020-04-14","2025-04-22","2025-04-13","2030-04-21",{"$nulls":12},"2"]
["陕械注准20202140128",null,"一次性使用脑科引流装置",{"$nulls":9},"2020-08-21","2025-08-21","2025-08-20","2030-08-20",{"$nulls":12},"2"]
["国械注准20153402068",null,"白色念珠菌、阴道毛滴虫、加德纳杆菌抗原 联合检测试剂盒（乳胶法）",{"$nulls":9},"2020-09-07","2025-09-07","2025-09-06","2030-09-06",{"$nulls":12},"3"]
["京械注准20152401143",null,"脑脊液与尿蛋白(CSF)测定试剂盒(连苯三酚红法）",{"$nulls":6},"2025-02-13",null,null,"2020-10-28","2025-10-28","2025-10-27","2030-10-27",{"$nulls":11},"本产品用于体外定量测定人脑脊液与尿液样本中总蛋白的含量。","2"]
["豫械注准20202140474",null,"一次性使用无菌胃镜检查包",{"$nulls":9},"2020-07-07","2025-07-07","2025-07-06","2030-07-06",{"$nulls":12},"2"]
["国械注准20163400802",null,"EB病毒衣壳抗原（VCA）IgA抗体测定试剂盒（磁微粒化学发光法）","EB病毒衣壳抗原（VCA）IgA抗体检测试剂盒（磁微粒化学发光法）",{"$nulls":8},"2021-03-01",null,"2026-02-28",{"$nulls":3},"厦门万泰凯瑞生物技术有限公司",{"$nulls":5},"试剂1：1 瓶（50人份：2.5mL；100人份：5mL；200人份：10mL），VCA 抗原包被的磁微粒。\n试剂2：1 瓶（50人份：2.5mL；100人份：5mL；200人份：10mL），吖啶酯标记抗人IgA 抗体。\n试剂3：1 瓶（50人份：5mL；100人份：10mL；200人份：20mL），含蛋白稳定剂的磷酸盐缓冲液。\n校准品1：0.5mL×1 瓶，抗VCA IgA 抗体阳性血清或血浆稀释于不含抗VCA IgA 抗体的灭活人血清或血浆中，含有ProClin300防腐剂。\n校准品2：0.5mL×1 瓶，不含抗VCA IgA 抗体的灭活人血清或血浆，含有ProClin300 防腐剂。",null,"本产品用于定性检测人血清或血浆中的衣壳抗原（VCA）IgA抗体。",null,"3"]
["浙械注准20202400759",null,"食物特异性抗体IgG4检测试剂盒（蛋白芯片法）",{"$nulls":9},"2020-08-28","2025-09-17","2025-08-27","2030-09-16",{"$nulls":12},"2"]
["国械注准20153402064",null,"肺炎支原体IgG抗体检测试剂盒（乳胶法）",{"$nulls":9},"2020-09-07","2025-09-07","2025-09-06","2030-09-06",{"$nulls":12},"3"]
["国械注准20153402065",null,"加德纳杆菌抗原检测试剂盒（乳胶法）",{"$nulls":9},"2020-08-31","2025-08-31","2025-08-30","2030-08-30",{"$nulls":12},"3"]
["国械注准20153402075",null,"阴道毛滴虫抗原检测试剂盒（乳胶法）",{"$nulls":9},"2020-09-07","2025-09-07","2025-09-06","2030-09-06",{"$nulls":12},"3"]
["豫械注准20202140553",null,"医用棉球",{"$nulls":9},"2020-08-31","2025-08-31","2025-08-30","2030-08-30",{"$nulls":12},"2"]
["国械注准20163130252",null,"金属解剖型接骨板",{"$nulls":9},"2020-11-27","2025-11-27","2025-11-26","2030-11-26",{"$nulls":9},"不可吸收带线锚钉由锚钉（带钉翼或不带钉翼）、插入器和缝线（带缝合针或不带缝合针）组成。锚钉由符合GB/T 13810标准规定的TC4（Ti6Al4V）钛合金材料制成，表面经黑灰色阳极氧化处理。锚钉钉翼由符合GB 24627标准规定的镍钛记忆合金材料制成，表面未经阳极氧化处理。缝线有两种单股编织缝线：白线和蓝白线。其中白线由超高分子量聚乙烯材料制成；蓝白线由超高分子量聚乙烯和聚丙烯材料制成，并含有符合USP要求的酞菁铜蓝色染料（CAS ：147-14-8）。缝合针由符合GB/T 4240标准规定的12Cr18Ni9不锈钢材料制成。该产品预装插入器，插入器与人体接触部分由符合ASTM F899规定的316或630不锈钢制成。产品采用环氧乙烷灭菌，灭菌有效期5年。",null,"该产品用于软组织从骨性结构撕脱或撕裂的修复手术，适用于骨与软组织的连接固定。","3"]
["粤械注准20222400681",null,"脂联素测定试剂盒（胶乳免疫比浊法）",{"$nulls":3},"珠海鎏联生物技术有限公司",null,"2022-06-01",{"$nulls":3},"2022-06-01",null,"2027-05-31",{"$nulls":3},"珠海鎏联生物技术有限公司",{"$nulls":5},"【产品性能指标】\n1.在波长570nm，试剂空白吸光度A≤1.50。\n2.分析灵敏度，测定浓度为10.0ug/mL的被测物时，吸光度差值（ΔA）应在0.05~0.500范围内。\n3.空白限：空白限应不大于0.50μg/mL。\n4.准确度：回收率（R）应在85%~115%。\n5.线性区间：试剂（盒）线性在[1.12，40.0]ug/mL区间内，线性相关系数│r│应不小于0.9900；在[1.12，15.0]ug/mL范围内，线性绝对偏差的绝对值≤1.50ug/mL，在（15.0，40.0]ug/mL范围内，线性相对偏差的绝对值≤10%。\n6.精密度：a）重复性：重复性CV≤8%；b）批间差：批间变异系数（CV）应≤10%。\n【主要组成成分】\nR1：甘氨酸缓冲液（0.05mol/L）；Proclin300 0.2%。\nR2：甘氨酸缓冲液（0.02mol/L）；胶乳微球包被的脂联素抗体。\n校准品（选配）：5*0.5mL/瓶；脂联素抗原（含小牛血清的磷酸盐缓冲液基质液体校准品）\n质控品（选配）：2*0.75mL/瓶；脂联素抗原（含小牛血清的磷酸盐缓冲液基质液体质控品）",null,"用于体外定量测定人血清中的脂联素（ADPN）的含量。临床上用于II型糖尿病的辅助诊断。",null,"2"]
["国械注准20153130844",null,"同种异体骨制品",{"$nulls":9},"2019-11-14",null,"2024-11-13","2029-11-13",{"$nulls":12},"3"]
["国械注准20153131765",null,"无张力疝修补装置",{"$nulls":9},"2020-09-04","2024-11-19","2025-09-03","2030-09-03",{"$nulls":12},"3"]
["粤械注准20152400970",null,"Sangtec-100蛋白质(S-100)测定试剂盒（化学发光法）","Sangtec-100蛋白质测定试剂盒（化学发光法）",{"$nulls":8},"2020-08-14","2025-08-14","2025-08-13","2030-08-13",{"$nulls":12},"2"]
["粤械注准20152071459",null,"一次性无创脑电传感器",{"$nulls":9},"2020-08-06","2025-08-11","2025-08-05","2030-08-10",{"$nulls":12},"2"]
["豫械注准20202141294",null,"一次性使用透析护理包",{"$nulls":9},"2020-10-16","2025-10-16","2025-10-15","2030-10-15",{"$nulls":12},"2"]
["津械注准20202040184",null,"一次性无菌铣刀",{"$nulls":6},"2024-12-03",null,null,"2020-08-28","2025-08-28","2025-08-27","2030-08-27",{"$nulls":12},"2"]
["国械注准20153130869",null,"金属锁定型接骨板",{"$nulls":9},"2020-05-15","2025-05-19","2025-05-14","2030-05-18",{"$nulls":9},"该产品由符合GB4234.1标准规定的00Cr18Ni14Mo3不锈钢或符合GB/T13810标准规定的TC4钛合金或TA2G、TA3G纯钛材料制成，纯钛和钛合金材料制造的产品表面以着色阳极氧化、黑灰色阳极氧化或非阳极氧化形式提供，产品以非无菌状态交付。",null,"该产品适用于四肢骨折内固定。","3"]
["豫械注准20202041098",null,"骨科外固定支架",{"$nulls":9},"2019-05-29","2025-05-29","2025-05-28","2030-05-28",{"$nulls":12},"2"]
["苏械注准20152540754",null,"脉冲冲洗泵",{"$nulls":9},"2015-07-17","2025-07-07","2020-07-16","2030-07-06",{"$nulls":12},"2"]
["国械注准20153130888",null,"脊柱固定器",{"$nulls":9},"2020-05-26","2025-05-26","2025-05-25","2030-05-25",{"$nulls":12},"3"]
["国械注准20203140267",null,"一次性使用输液器 带针",{"$nulls":9},"2020-03-20","2025-05-26","2025-03-19","2030-05-25",{"$nulls":12},"3"]
["湘械注准20202140320",null,"医用防护口罩",{"$nulls":9},"2020-07-21","2025-07-21","2025-07-20","2030-07-20",{"$nulls":12},"2"]
["苏械注准20202010790",null,"多功能手术解剖器",{"$nulls":9},"2020-07-01","2025-07-01","2025-06-30","2030-06-30",{"$nulls":12},"2"]
["苏械注准20202180993",null,"一次性使用子宫颈活体取样钳",{"$nulls":6},"2025-04-29",null,null,"2020-08-21","2025-08-21","2025-08-20","2030-08-20",{"$nulls":9},"一次性使用子宫颈活体取样钳由上、下钳头、外管、推杆、手柄组件、弹簧组成。产品按手柄款型（分为 A 款、B 款）、钳头类型（分为长圆头、圆头）、钳头尺寸（分为 3.5、6.5、5.5、8.5）、取样钳长度（分为 180、240）分为十六种规格。该产品以无菌状态提供，经环氧乙烷灭菌，一次性使用。",null,null,"2"]
["赣械注准20202140585",null,"医用一次性防护服",{"$nulls":9},"2020-10-09","2025-10-09","2025-10-08","2029-10-08",{"$nulls":9},"本产品由复合无纺布制成，由连帽上衣、裤子及靴套（若有）组成，型式为连身式；袖口、脚踝口、帽子面部收口\n为弹性收口，袖口为螺纹袖口，脚踝口和帽子面部收口为松紧带材质。产品分为无菌型和非无菌型，无菌型产品经环氧乙烷灭菌，产品无菌。",null,null,"2"]
["国械注准20203400754","苏械注准20252400488","肿瘤相关抗原50（CA50）测定试剂盒（化学发光免疫分析法）","糖类抗原50测定试剂盒（化学发光免疫分析法）",{"$nulls":4},"2022-07-14","2025-03-25",null,null,"2020-09-21","2025-09-21","2025-09-20","2030-09-20",{"$nulls":9},"试剂 1：内含有生物素化抗肿瘤相关抗原50 特异性单克隆抗体（小鼠），蛋白缓冲液，0.1%Proclin300；\n试剂 2：内含有吖啶酯标记的抗肿瘤相关抗原50 特异性单克隆抗体（小鼠），蛋白缓冲液，0.1%Proclin300；\n磁颗粒：内含链霉亲和素包被的微粒，经防腐处理；\n校准品 1、校准品2、校准品3：内含人源性的肿瘤相关抗原50 抗原，蛋白缓冲液，0.1%Proclin300。(具体内容详见产品说明书)",null,"用于体外定量测定人血清中肿瘤相关抗原 50 的浓度。临床上用于消化系统肿瘤（如胰腺癌）的病情进程及疗效监测，不能作为恶性肿瘤早期诊断或确诊的依据，不能用于普通人群的肿\n瘤筛查。","3","2"]
["粤械注准20162400459",null,"肌酸激酶同工酶（CK-MB）测定试剂盒（化学发光法）","肌酸激酶同工酶测定试剂盒（化学发光法）",{"$nulls":8},"2020-07-02","2025-07-02","2025-07-01","2030-07-01",{"$nulls":12},"2"]
["鲁械注准20202400246",null,"抗环瓜氨酸肽抗体测定试剂盒（胶乳免疫比浊法）",{"$nulls":9},"2020-03-05","2025-03-05","2025-03-04","2030-03-04",{"$nulls":12},"2"]
["苏械注准20152060369",null,"一次性使用取物袋",{"$nulls":9},"2025-04-14","2025-04-14","2030-04-13","2030-04-13",{"$nulls":8},"一次性使用取物袋由张开装置、套管、套管座、手\n柄、纳物袋组成。取物袋根据张开装置外形不同分\n为 A 型（圆形）、B 型（椭圆形）两种型号；根据\n张开装置规格不同分为 40、60、80、100、130 五\n种规格。该产品以无菌状态提供，经环氧乙烷灭菌\n，一次性使用。",{"$nulls":3},"2"]
["苏械注准20202021560",null,"一次性使用痔吻合器及附件",{"$nulls":6},"2025-05-12",null,null,"2020-10-10","2025-10-10","2025-10-09","2030-10-09",{"$nulls":9},"一次性使用痔吻合器及附件由抵钉座、吻切组件、指示视窗、固定手柄、调节螺母、活动手柄、保险块、环形刀、吻合钉、垫刀圈及附件组成，其中附件包括无孔扩张器、单孔扩张器、双孔扩张器、三孔扩张器、导入器（短）、导入器（长）、穿线器、引线钩。产品根据组件外径可分为 32、34 两种规格，根据是否含附件以及含有附件的种类可分为三种。该产品以无菌状态提供，经环氧乙烷灭菌，一次性使用。",null,null,"2"]
["赣械注准20202140588",null,"医用防护口罩",{"$nulls":9},"2020-10-09","2025-10-09","2025-10-08","2029-10-08",{"$nulls":9},"医用防护口罩由口罩体、鼻夹、口罩带和耳带调节装置组成。本\n产品为四层结构，外层和里层材料为非织造无纺布复合材料；中\n间层材料：MYM1860（折叠式）、MYM1860（头戴式）为熔喷布和\n热风棉，MYMN95（折叠式）、MYMN95（头戴式）为熔喷布和非织\n造无纺布，MYMN95（拱形）为熔喷布和热风棉；鼻夹为可塑性材质，耳带调节装置为塑性材质或橡胶材质；口罩带为弹性材料制成。产品经环氧乙烷灭菌，产品无菌。",null,null,"2"]
["国械注准20203120526",null,"临时起搏电极导管","临时起搏电极导管",{"$nulls":8},"2020-05-27","2025-05-27","2025-05-26","2030-05-26",{"$nulls":12},"3"]
["苏械注准20202401037",null,"25-羟基维生素D检测试剂盒（化学发光免疫分析法）",{"$nulls":6},"2025-03-19",null,null,"2020-09-10","2025-09-10","2025-09-09","2030-09-09",{"$nulls":9},"试剂R1：含解离剂（5.0-50.0g/L)，pH约为7.4的磷酸盐缓冲液（约10mmol/L),0.1%Proclin300;\n试剂R2：含吖啶酯标记的25-羟基维生素D单克隆抗体（约200ng/ml，羊源性），pH约为7.4的磷酸盐缓冲液（约50mmol/L)，0.1% Proclin300；\n试剂R3：含生物素标记的25-羟基维生素D（约200ng/ml，人工合成），pH约为6.0的MES缓冲液（约50mmol/L)，0.1%Proclin300；\n试剂M：含链霉亲和素包被的磁颗粒（约0.9mg/ml）；\n校准品1：含人工合成的25-羟基维生素D抗原（约15ng/mL），马血清，0.1%Proclin300；\n校准品2：含人工合成的25-羟基维生素D抗原（约100ng/mL），马血清，0.1%Proclin300；\n校准品3：含人工合成的25-羟基维生素D抗原（约40ng/mL），马血清，0.1%Proclin300。",null,"用于体外定量检测人血清中25-羟基维生素D的浓度","2"]
["京械注准20202400270",null,"血糖试条（葡萄糖脱氢酶法）（型号：H5）","血糖试条（葡萄糖脱氢酶法）",{"$nulls":8},"2020-07-08","2025-07-08","2025-07-07","2030-07-07",{"$nulls":12},"2"]
["国械注准20153141777",null,"一次性使用引流导管包",{"$nulls":9},"2020-08-31","2025-08-31","2025-08-30","2030-08-30",{"$nulls":12},"3"]
["粤械注准20162400316",null,"25-羟基维生素D（25-OH Vitamin D）测定试剂盒（化学发光法）","25-羟基维生素D测定试剂盒（化学发光法）",{"$nulls":8},"2020-07-17",null,"2025-07-16",{"$nulls":13},"2"]
["国械注准20153402294","京械注准20242400733","酸性磷酸酶测定试剂盒（α-磷酸萘酚底物法）",{"$nulls":6},"2024-11-26",null,null,"2020-09-24","2025-09-24","2025-09-23","2030-09-23",{"$nulls":11},"本产品用于体外定量测定人血清中酸性磷酸酶的含量。","3","2"]
["国械注准20153031337","京械注准20242030802","导丝",{"$nulls":9},"2020-07-10","2025-07-10","2025-07-09","2030-07-09",{"$nulls":12},"3","2"]
["国械注准20163401361",null,"乙型肝炎病毒核心IgM抗体测定试剂盒（磁微粒化学发光法）","乙型肝炎病毒核心IgM抗体检测试剂盒（磁微粒化学发光法）",{"$nulls":8},"2021-07-21",null,"2026-07-20",{"$nulls":3},"厦门万泰凯瑞生物技术有限公司",{"$nulls":5},"试剂1：1瓶（50人份：2.5mL；100人份：5mL；200人份：10mL），抗-人IgM的抗体包被的磁微粒，置于含蛋白稳定剂和防腐剂ProClin300的缓冲液中。\n试剂2：1瓶（50人份：5mL；100人份：10mL；200人份：20mL），吖啶酯标记的乙肝核心抗原复合物，置于含蛋白稳定剂和防腐剂ProClin300的缓冲液中。\n试剂3：1瓶（50人份：2.5mL；100人份：5mL；200人份：10mL），含蛋白稳定剂和防腐剂ProClin300的缓冲液。\n校准品1：0.5mL×1瓶，淡黄色，用含蛋白保护剂的稀释液稀释，对Anti-HBc IgM检测呈阳性，含ProClin300防腐剂。\n校准品2：0.5mL×1瓶，淡黄色，在人血清（灭活）中制备，对Anti-HBc IgM检测呈阴性，含ProClin300防腐剂。",null,"该产品用于定性检测人血清和血浆中的乙型肝炎病毒核心IgM抗体（Anti-HBc IgM）。",null,"3"]
["浙械注准20152400411",null,"大便隐血检测试剂（胶体金法）",{"$nulls":9},"2020-05-26","2025-05-26","2025-05-25","2030-05-25",{"$nulls":9},"本试剂主要原材料包括包被抗人血红蛋白单克隆抗体、标记用抗人血红蛋白单克隆抗体、羊抗鼠多克隆抗体、硝酸纤维素膜、聚酯纤维素膜。（具体内容详见说明书）",null,"用于定性检测人粪便中微量的人血红蛋白。","2"]
["浙械注准20152400409",null,"肌钙蛋白I/肌红蛋白/肌酸激酶同工酶三合一检测试剂（胶体金法）",{"$nulls":9},"2020-05-26","2025-05-26","2025-05-25","2030-05-25",{"$nulls":12},"2"]
["浙械注准20152400324",null,"心肌肌钙蛋白I检测试剂（胶体金法）",{"$nulls":9},"2020-05-26","2025-05-26","2025-05-25","2030-05-25",{"$nulls":9},"主要原材料包括包被用抗心肌肌钙蛋白I抗体、标记用抗心肌肌钙蛋白I抗体、羊抗鼠多克隆抗体、硝酸纤维素膜、聚酯纤维素膜。试剂包装中的组件包含一次性塑料吸管/玻璃毛细管、缓冲液。（具体内容详见说明书）",null,"用于定性检测人全血/血清/血浆样本中的心肌肌钙蛋白I。","2"]
["国械注准20153402063",null,"B族链球菌抗原检测试剂盒（乳胶法）",{"$nulls":9},"2020-11-27",null,"2025-11-26","2030-11-26",{"$nulls":12},"3"]
["国械注准20153402061",null,"沙眼衣原体抗原检测试剂盒（乳胶法）",{"$nulls":9},"2020-11-27",null,"2025-11-26","2030-11-26",{"$nulls":12},"3"]
["鲁械注准20162040033",null,"XS-螺旋推进器",{"$nulls":9},"2020-09-07","2025-09-07","2025-09-06","2030-09-06",{"$nulls":12},"2"]
["苏械注准20202021153",null,"一次性使用包皮切割吻合器",{"$nulls":6},"2025-04-29",null,null,"2020-10-23","2025-10-23","2025-10-22","2030-10-22",{"$nulls":9},"一次性使用包皮切割吻合器根据结构分为 A、B、C三种型号；根据环形刀外径分为 11、13、15、17、18、22、25、29、32、34 共 10 种规格。A 型一次性使用包皮切割吻合器由龟头罩、钉仓套、保险块、连杆、手柄、套管、调节螺母、抵钉座、环形刀组件、吻合钉组成；B 型一次性使用包皮切割吻合器由龟头罩、钉仓套、保险块、连杆、手柄、套管、调节螺母、抵钉座、环形刀组件、吻合钉、硅胶垫组成；C 型一次性使用包皮切割吻合器由龟头罩、钉仓套、连杆、手柄、套管、保险块、调节螺母、抵钉座、环形刀组件、吻合钉、硅胶垫、调节螺母把手组成。该产品以无菌状态提供，经环氧乙烷灭菌，一次性使用。",null,null,"2"]
["国械注准20153401650",null,"乙型肝炎病毒表面抗原、表面抗体、e抗原、e抗体、核心抗体检测试剂盒(胶体金法)",{"$nulls":6},"2024-10-24",null,null,"2020-08-20","2025-08-20","2025-08-19","2030-08-19",{"$nulls":9},"1.乙型肝炎病毒HBsAg、抗HBs、HBeAg、抗HBe、抗HBc联合检测卡；2.采样吸管。（具体内容详见说明书）",null,"本产品用于体外定性检测人血清或血浆样品中HBsAg、抗HBs、HBeAg、抗HBe、抗HBc。","3"]
["国械注进20163130128",null,"组配式髋关节假体柄系统",{"$nulls":9},"2020-11-27","2025-11-27","2025-11-26","2030-11-26",{"$nulls":12},"3"]
["冀械注准20212400168",null,"糖化血红蛋白测定试剂盒（磁微粒化学发光免疫分析法）",{"$nulls":9},"2021-04-13","2026-04-13","2026-04-12","2031-04-12",{"$nulls":12},"2"]
["国械注准20153081853",null,"一次性使用麻醉穿刺包",{"$nulls":9},"2020-08-06","2025-08-06","2025-08-05","2030-08-05",{"$nulls":12},"3"]
["国械注准20153101748",null,"一次性使用吸引管",{"$nulls":9},"2020-09-07","2025-09-07","2025-09-06","2030-09-06",{"$nulls":12},"3"]
["国械注准20153100004",null,"一次性使用静脉插管",{"$nulls":9},"2020-06-09","2025-06-09","2025-06-08","2030-06-08",{"$nulls":12},"3"]
["国械注准20163030179",null,"一次性使用桡动脉血管鞘组","一次性使用血管鞘组",{"$nulls":5},"2025-08-20",null,null,"2020-12-18","2025-12-18","2025-12-17","2030-12-17",{"$nulls":9},"一次性使用血管鞘组分为全包和简包两种包装类型，全包包括血管鞘、配件涂层导丝/不锈钢导丝、套管针/穿刺针、手术刀和注射器；简包包括血管鞘、配件涂层导丝/不锈钢导丝、套管针/穿刺针。其中血管鞘包括导管鞘和扩张器，导管鞘和扩张器表面均涂覆亲水涂层，导管鞘连接有三通。产品一次性使用，环氧乙烷灭菌。",null,"该产品经皮插入血管中，用于介入诊断和治疗用器械的导入、止血、采样和药物注射。","3"]
["苏械注准20152010884",null,"高频消融止血电极",{"$nulls":9},"2020-08-26","2025-08-26","2025-08-25","2030-08-25",{"$nulls":12},"2"]
["京械注准20152030593",null,"一次性使用心脏固定器",{"$nulls":6},"2025-01-26",null,null,"2020-07-03","2025-07-03","2025-07-02","2030-07-02",{"$nulls":9},"该产品由固定支座、锁紧旋钮、转动架、转动架旋钮、活节臂、固定终端（两种规格）、前端吸管、三通、后端吸管、鲁尔接头、过滤管路部分组成。",null,"适用于不停跳心脏冠状动脉搭桥手术，使心脏位置相对固定并减少心脏搏动对手术的影响。","2"]
["豫(漯)械备20150005号","豫漯械备20150005号","骨牵引针",{"$nulls":9},"2015-03-31","2022-11-29","2099-12-31","2099-12-31",{"$nulls":12},"1"]
["苏械注准20202020696",null,"一次性气道三级球囊扩张导管",{"$nulls":9},"2020-06-08","2025-06-08","2025-06-07","2030-06-07",{"$nulls":12},"2"]
["国械注准20153402062",null,"肺炎衣原体IgG抗体检测试剂盒（乳胶法）",{"$nulls":9},"2020-11-27",null,"2025-11-26","2030-11-26",{"$nulls":12},"3"]
["国械注进20162141059",null,"自动活检装置Disposable Automatic Biopsy Instrument",null,null,"美国",null,"爱琅（上海）医疗器械有限公司",null,"2024-05-10",null,null,"2020-07-21","2025-07-21","2025-07-20","2030-07-20",{"$nulls":3},"爱琅（上海）医疗器械有限公司",null,"Argon Medical Devices, Inc.",{"$nulls":3},"该活检装置由手柄和活检针组成。手柄用聚碳酸酯材料制成，活检针的针管和针芯均由304不锈钢材料制成。环氧乙烷灭菌，产品一次性使用。",null,"适用于从软组织中获取多个组织样本，如肝、肾、前列腺、乳房等。产品不适用于骨头。","2"]
["国械注准20153131015",null,"金属锁定接骨板系统",{"$nulls":9},"2020-06-19","2025-06-19","2025-06-18","2030-06-18",{"$nulls":9},"金属锁定接骨板系统由金属锁定接骨板、金属锁定接骨螺钉、金属接骨螺钉和骨板填塞钉组成。其中，金属锁定接骨板的螺孔型式包含普通型、锥型、复合型、多角度型，金属锁定接骨螺钉和金属接骨螺钉的螺纹型式包含浅螺纹型、深螺纹型、对称螺纹型、不对称螺纹型，金属锁定接骨螺钉的头部型式包含直型和锥型，金属接骨螺钉的头部型式包含球型和锥型。金属锁定接骨板由符合GB/T 13810规定的TA3G纯钛材料或符合GB 23102规定的Ti6Al7Nb钛合金材料制成，螺钉由符合GB/T 13810规定的TC4钛合金材料或符合GB 23102规定的Ti6Al7Nb钛合金材料制成。产品表面可经着色阳极氧化和黑灰色阳极氧化处理。非灭菌包装。",null,"适用于四肢骨折内固定。","3"]
["苏械注准20152021184",null,"一次性使用皮肤吻（缝）合器及附件","一次性使用皮肤吻合器及附件",{"$nulls":8},"2020-07-01","2025-07-01","2025-06-30","2030-06-30",null,null,"芜湖华云创展医疗器械有限公司",{"$nulls":6},"一次性使用皮肤吻合器及附件由上手柄、下手柄、缝合钉、钉仓、推钉板、压钉板、固定架组成，拆钉器由拆钉器左钳体和拆钉器右钳体组成，拆钉器为皮肤吻合器的附件。产品以无菌状态提供，经环氧乙烷灭菌，一次性使用。拆钉器为重复使用产品产品出厂前无需灭菌，临床使用前按常规方法消毒后使用。",null,null,"2"]
["苏械注准20152021207",null,"一次性使用直线切割吻合器及钉仓组件",{"$nulls":9},"2020-07-01","2025-07-01","2025-06-30","2030-06-30",null,null,"芜湖华云创展医疗器械有限公司",{"$nulls":9},"2"]
["国械注准20153401478",null,"HER-2/neu蛋白测定试剂盒（化学发光免疫分析法）",{"$nulls":6},"2024-11-25",null,null,"2020-08-19","2025-08-19","2025-08-18","2030-08-18",{"$nulls":9},"试剂1、试剂2、磁颗粒、校准品1、校准品2、校准品3（具体内容详见说明书）",null,"本试剂盒用于体外定量检测人血清中HER-2/neu蛋白的浓度。主要用于对恶性肿瘤患者进行动态监测，以辅助判断疾病进程或者治疗效果，不能作为恶性肿瘤早期诊断或确诊的依据，不能用于普通人群的肿瘤筛查。","3"]
["豫械注准20202140590",null,"一次性使用引流袋",{"$nulls":9},"2020-10-16","2025-10-16","2025-10-15","2030-10-15",{"$nulls":12},"2"]
["国械注进20153033119",null,"PTCA球囊扩张导管Emerge PTCA Dilatation Catheter",{"$nulls":9},"2020-08-11","2025-08-11","2025-08-10","2030-08-10",{"$nulls":12},"3"]
["国械注准20153141544",null,"密闭式防针刺伤型静脉留置针",{"$nulls":9},"2020-07-31","2025-07-31","2025-07-30","2030-07-30",{"$nulls":12},"3"]
["浙械注准20152400913",null,"载脂蛋白E检测试剂盒（免疫比浊法）",{"$nulls":9},"2020-07-06","2025-07-06","2025-07-05","2030-07-05",{"$nulls":12},"2"]
["浙械注准20152400910",null,"前白蛋白检测试剂盒（免疫比浊法）",{"$nulls":9},"2020-07-06","2025-07-06","2025-07-05","2030-07-05",{"$nulls":12},"2"]
["浙械注准20152400908",null,"甘胆酸检测试剂盒（胶乳增强免疫比浊法）",{"$nulls":9},"2020-07-06","2025-07-06","2025-07-05","2030-07-05",{"$nulls":12},"2"]
["豫械注准20202140577",null,"一次性使用脑压包",{"$nulls":9},"2020-09-14","2025-09-14","2025-09-13","2030-09-13",{"$nulls":12},"2"]
["国械注进20162141058",null,"自动活检装置Automatic Biopsy Instrument",null,null,"美国",null,"爱琅（上海）医疗器械有限公司",null,"2024-05-15",null,null,"2020-07-16","2025-07-16","2025-07-15","2030-07-15",{"$nulls":3},"爱琅（上海）医疗器械有限公司",null,"Argon Medical Devices, Inc.",{"$nulls":3},"自动活检装置由活检枪、活检针组成。活检枪为重复使用非灭菌产品，活检枪枪盖（前）材料为316不锈钢、激发按钮（前）材料为302不锈钢、螺丝材料为18-8不锈钢、外壳上/下部材料为铝合金、活检枪枪盖（后）材料为包覆铝、上膛手柄材料为包覆铝、激发按钮（后）材料为302不锈钢、安全按钮材料为416不锈钢；活检针针管和针芯材料均为304不锈钢，手柄材料为聚碳酸酯，活检针经环氧乙烷灭菌，为一次性使用无菌产品。",null,"适用于从人体软组织中获取多个组织样本，如肝脏、肾脏、肺、前列腺、乳房。此产品不适用于骨。","2"]
["国械注准20203130575",null,"疝修补补片",{"$nulls":9},"2020-06-19","2025-06-19","2025-06-18","2030-06-18",{"$nulls":12},"3"]
["国械注准20163010558",null,"超声手术刀系统",{"$nulls":6},"2025-06-26",null,null,"2020-11-02","2025-11-02","2025-11-01","2030-11-01",{"$nulls":9},"由主机（型号AH-611）、手柄（型号AH-636、AH-636-B）、换能器（AH-616）、脚踏开关（AH-618）和刀具（型号AH-631-L、AH-631-S）组成。",null,"适用于腔镜手术和常规开放手术中，对软组织的分离、切割和止血。不得单独用于闭合直径3mm以上的血管。产品不适用于骨切除、输卵管结扎、神经外科。","3"]
["国械注准20153142009",null,"一次性无菌输液接头",{"$nulls":6},"2025-01-07",null,null,"2020-06-23","2025-06-23","2025-06-22","2030-06-22",{"$nulls":12},"3"]
["国械注进20162141894",null,"活检针Biopsy Set for Bone and Bone Marrow",null,null,"美国",null,"爱琅（上海）医疗器械有限公司",null,"2025-02-19",null,null,"2020-06-04","2025-06-04","2025-06-03","2030-06-03",{"$nulls":3},"爱琅（上海）医疗器械有限公司",null,"Argon Medical Devices, Inc.",{"$nulls":3},"活检针由针管、针芯、手柄、鲁尔帽和 定位钮组成。其中针管和针芯的材料 均为 304 不锈钢、手柄和定位钮材料 为 ABS 工程塑料，鲁尔帽材料为聚丙 烯。\n活检针配件包括取样管（管体、座、外 套）、闭孔探针（针芯、座、外套）、探 针导向器、可调节针阻器和安全针装置。\n活检针配件的材料：取样管（管体：304 不锈钢；座：ABS 工程塑料；外套：聚 乙烯）；闭孔探针（针芯：304 不锈钢； 座：聚丙烯；外套：聚乙烯）；安全针 装置：ABS 工程塑料；可调节针阻器： ABS 工程塑料；探针导向器：聚丙烯。 为一次性使用无菌产品。",null,"适用于获取骨和/或骨髓样本。","2"]
["国械注准20153401479","苏械注准20252400025","S100蛋白测定试剂盒（化学发光免疫分析法）",{"$nulls":6},"2025-01-03",null,null,"2020-07-20","2025-07-20","2025-07-19","2030-07-19",{"$nulls":9},"试剂 1：内含生物素化抗 S100 特异性单克隆抗体（单抗，小鼠），0.1M pH 值 7.0 磷酸盐缓冲液，0.1%生物防腐剂；\n试剂 2：内含吖啶酯标记的抗 S100 单克隆抗体（单抗，小鼠），0.1M pH 值 7.0 磷酸盐缓冲液，0.1%生物防腐剂；\n磁颗粒：内含链霉亲和素包被的微粒，经防腐处理；\n校准品 1、校准品 2、校准品 3：内含人源性的S100 抗原，0.1M pH 值 7.0 磷酸盐缓冲液，小牛血清白蛋白，0.1%生物防腐剂。（校准品溯源至工作校准品）",null,"用于体外定量检测人血清中 S100 蛋白的浓度。主要用于对恶性肿瘤患者进行动态监测，以辅助判断疾病进程或者治疗效果，不能作为恶性肿瘤早期诊断或确诊的依据，不能用于普通人群的肿瘤筛查。","3","2"]
["国械注准20153401473",null,"ɑ-肿瘤坏死因子测定试剂盒（化学发光免疫分析法）",{"$nulls":6},"2024-11-25",null,null,"2020-07-20","2025-07-20","2025-07-19","2030-07-19",{"$nulls":9},"试剂1、试剂2、磁颗粒、校准品1、校准品2、校准品3（具体内容详见说明书）",null,"本试剂盒用于体外定量检测人血清中α-肿瘤坏死因子的浓度。主要用于对恶性肿瘤患者进行动态监测，以辅助判断疾病进程或者治疗效果，不能作为恶性肿瘤早期诊断或确诊的依据，不能用于普通人群的肿瘤筛查。","3"]
["浙械注准20162400457","浙温械备20250034","厌氧菌培养基","厌氧菌琼脂培养基",{"$nulls":8},"2021-01-15","2025-04-09","2026-01-14","2099-12-31",{"$nulls":12},"2","1"]
["浙械注准20152400920",null,"糖化血红蛋白检测试剂盒（胶乳增强免疫比浊法）",{"$nulls":9},"2020-07-03","2025-07-03","2025-07-02","2030-07-02",{"$nulls":12},"2"]
["浙械注准20152400919",null,"尿微量白蛋白检测试剂盒（免疫比浊法）",{"$nulls":9},"2020-07-06","2025-07-06","2025-07-05","2030-07-05",{"$nulls":12},"2"]
["浙械注准20152400918",null,"心型脂肪酸结合蛋白检测试剂盒（胶乳增强免疫比浊法 ）",{"$nulls":9},"2020-07-06","2025-07-06","2025-07-05","2030-07-05",{"$nulls":12},"2"]
["粤械注准20162400313",null,"尿酸测定试剂(盒)(尿酸酶-过氧化物酶偶联法)",{"$nulls":9},"2020-08-25","2025-08-25","2025-08-24","2030-08-24",{"$nulls":12},"2"]
["国械注准20153131541",null,"同种异体骨植入材料",{"$nulls":9},"2020-08-18","2025-08-18","2025-08-17","2030-08-17",{"$nulls":12},"3"]
["苏械注准20182250569","苏械注准20182010569","一次性使用滴水双极电凝镊",{"$nulls":9},"2018-03-09","2023-03-10","2023-03-08","2028-03-09",{"$nulls":9},"一次性使用滴水双极电凝镊由尾座、输液管、三通、连线插头、镊子片、镊子头、滴水管、定位卡、保护套组成。按总长度和镊子头材料的不同分为十五种型号。该产品以无菌状态提供，经辐照灭菌，一次性使用。",null,"作为手术电极与高频电刀配套使用，在双极工作模式下对组织进行电凝用。","2"]
["国械注准20153401876",null,"乙型肝炎病毒表面抗原检测试剂盒(化学发光法)",{"$nulls":6},"2024-10-24",null,null,"2020-08-31","2025-08-31","2025-08-30","2030-08-30",{"$nulls":9},"预包被板（包被链霉亲和素）、HBsAg标记物1（含生物素标记鼠抗HBs单抗）、HBsAg标记物2（含碱性磷酸酶标记羊抗HBs）、HBsAg校准品（含不同浓度的HBsAg，以牛血清配制而成）、弱阳性（Q1）、强阳性（Q2）对照（含一定量浓度的HBsAg，以人血清配制而成）、浓缩清洗液（20×）（含表面活性剂、防腐剂）、发光底物液（含发光剂及增强剂）、阴性对照（含阴性人血清）、样品稀释液（新生牛血清）、自封袋。(具体内容详见说明书)",null,"用于定性检测人血清、血浆（肝素抗凝）中HBsAg，并定量测定HBsAg阳性样品中HBsAg含量。","3"]
["国械注进20162400915",null,"补体C4测定试剂(免疫比浊法)",{"$nulls":9},"2020-09-27","2025-09-27","2025-09-26","2030-09-26",{"$nulls":12},"2"]
["国械注准20153131848",null,"动脉导管未闭封堵器",{"$nulls":9},"2020-11-12","2025-11-12","2025-11-11","2030-11-11",{"$nulls":12},"3"]
["国械注许20162400010",null,"血糖试纸 Blood Glucose Test Strip",{"$nulls":9},"2020-08-18","2025-08-18","2025-08-17","2030-08-17",{"$nulls":12},"2"]
["粤械注准20162400315",null,"D－二聚体（D-dimer）测定试剂盒（化学发光法）","D－二聚体测定试剂盒（化学发光法）",{"$nulls":8},"2020-07-06","2025-07-06","2025-07-05","2030-07-05",{"$nulls":12},"2"]
["国械注准20153402096",null,"葡萄糖-6-磷酸脱氢酶测定试剂盒(葡萄糖-6-磷酸底物法)",{"$nulls":6},"2024-05-08",null,null,"2020-07-24","2025-07-24","2025-07-23","2030-07-23",{"$nulls":11},"本产品用于体外定量测定人体全血中葡萄糖6磷酸脱氢酶的活性。","3"]
["国械注进20163171284",null,"光固化流体树脂",{"$nulls":9},"2020-06-10","2025-06-10","2025-06-09","2030-06-09",{"$nulls":12},"3"]
["国械注进20163170735",null,"双固化树脂粘接材料",{"$nulls":9},"2020-05-21","2025-05-21","2025-05-20","2030-05-20",{"$nulls":12},"3"]
["国械注准20153142208",null,"密闭式静脉留置针",{"$nulls":9},"2020-10-27","2025-10-27","2025-10-26","2030-10-26",{"$nulls":12},"3"]
["国械注进20153133619",null,"髋关节陶瓷球头",{"$nulls":9},"2020-10-26","2025-10-26","2025-10-25","2030-10-25",{"$nulls":12},"3"]
["国械注进20153133915",null,"组配式髋关节假体柄组件",{"$nulls":9},"2020-10-26","2025-10-16","2025-10-25","2030-10-25",{"$nulls":12},"3"]
["苏械注准20152020370",null,"一次性使用取石网篮",{"$nulls":9},"2020-04-14","2025-06-11","2025-04-13","2030-06-10",{"$nulls":12},"2"]
["湘械注准20202021029",null,"一次性套管穿刺器",{"$nulls":9},"2020-05-29","2025-05-29","2025-05-28","2030-05-28",{"$nulls":12},"2"]
["国械注进20152163093",null,"眼科手术刀",{"$nulls":6},"2024-05-22",null,null,"2020-07-31","2025-07-31","2025-07-30","2030-07-30",{"$nulls":9},"该产品由SUS302不锈钢材料和塑料柄构成，部分产品带有安全套管。环氧乙烷灭菌包装，一次性使用。",null,null,"2"]
["国械注准20153131352",null,"镍钛合金聚髌爪",{"$nulls":9},"2020-05-29","2025-05-29","2025-05-28","2030-05-28",{"$nulls":12},"3"]
["沪械注准20202140462",null,"一次性使用球式灌洗器",{"$nulls":6},"2025-04-17",null,null,"2020-09-23","2025-09-23","2025-09-22","2030-09-22",{"$nulls":12},"2"]
["国械注准20153100033",null,"预充式透析器/透析管路冲洗器",{"$nulls":9},"2020-06-23","2025-06-23","2025-06-22","2030-06-22",{"$nulls":12},"3"]
["国械注进20153103778",null,"血浆分离器与管路配套",{"$nulls":9},"2020-06-28","2025-06-28","2025-06-27","2030-06-27",{"$nulls":12},"3"]
["湘械注准20202401727",null,"枫叶梧桐T011过敏原特异性IgE抗体检测试剂盒(荧光免疫法)",{"$nulls":7},"2022-11-11",null,"2020-12-03","2025-12-03","2025-12-02","2030-12-02",{"$nulls":12},"2"]
["国械注准20153141953",null,"一次性使用输液延长管",{"$nulls":6},"2025-04-10",null,null,"2020-11-23","2025-11-23","2025-11-22","2030-11-22",{"$nulls":12},"3"]
["国械注准20143661840",null,"硬脊膜外麻醉导管",{"$nulls":6},"2025-02-07",null,null,"2014-10-11","2025-07-31","2019-10-10","2030-07-30",{"$nulls":12},"3"]
["豫械注准20202141284",null,"一次性使用病房护理包",{"$nulls":9},"2020-10-21","2025-10-21","2025-10-20","2030-10-20",{"$nulls":12},"2"]
["苏械注准20152401397",null,"阴道炎联合检测试剂盒（干化学酶法）",{"$nulls":9},"2020-05-28","2025-05-28","2025-05-27","2030-05-27",{"$nulls":12},"2"]
["国械注准20163400798",null,"人感染H7N9禽流感病毒RNA检测试剂盒（荧光PCR法）",{"$nulls":9},"2020-10-29","2025-10-29","2025-10-28","2030-10-28",{"$nulls":12},"3"]
["湘械注准20152400187",null,"直接胆红素测定试剂盒（钒酸盐氧化法）",{"$nulls":9},"2020-12-09","2025-12-09","2025-12-08","2030-12-08",{"$nulls":12},"2"]
["湘械注准20152400190",null,"总胆汁酸测定试剂盒（循环酶法）",{"$nulls":9},"2020-12-11","2025-12-11","2025-12-10","2030-12-10",{"$nulls":12},"2"]
["湘械注准20152400183",null,"α1-微球蛋白测定试剂盒（胶乳增强免疫比浊法）",{"$nulls":9},"2020-12-09","2025-12-09","2025-12-08","2030-12-08",{"$nulls":12},"2"]
["湘械注准20152400186",null,"中性粒细胞明胶酶相关脂质运载蛋白测定试剂盒（胶乳增强免疫比浊法）",{"$nulls":9},"2020-12-08","2025-12-08","2025-12-07","2030-12-07",{"$nulls":12},"2"]
["湘械注准20152400193",null,"甘油三酯测定试剂盒（GPO-PAP法）",{"$nulls":9},"2020-12-09","2025-12-09","2025-12-08","2030-12-08",{"$nulls":12},"2"]
["湘械注准20152400182",null,"肌酸激酶同工酶测定试剂盒（抗体免疫抑制法）",{"$nulls":9},"2020-12-08","2025-12-08","2025-12-07","2030-12-07",{"$nulls":12},"2"]
["湘械注准20152400181",null,"肌红蛋白测定试剂盒（胶乳增强免疫比浊法）",{"$nulls":9},"2020-12-09","2025-12-09","2025-12-08","2030-12-08",{"$nulls":12},"2"]
["湘械注准20152400170",null,"血糖分析试条（电化学分析法）",{"$nulls":9},"2020-10-28","2025-10-28","2025-10-27","2030-10-27",{"$nulls":12},"2"]
["湘械注准20152400167",null,"尿酸分析试条（电化学分析法）",{"$nulls":9},"2020-10-28","2025-10-28","2025-10-27","2030-10-27",{"$nulls":12},"2"]
["湘械注准20152400168",null,"胆固醇分析试条（电化学分析法）",{"$nulls":9},"2020-10-28","2025-10-28","2025-10-27","2030-10-27",{"$nulls":12},"2"]
["豫械注准20202141271",null,"一次性使用医用口罩",{"$nulls":9},"2020-09-30","2025-09-30","2025-09-29","2030-09-29",{"$nulls":12},"2"]
["国械注准20163130280",null,"外固定架配合用金属骨针",{"$nulls":9},"2020-08-04","2025-08-04","2025-08-03","2030-08-03",{"$nulls":12},"3"]
["国械注准20153101502",null,"透析粉",{"$nulls":9},"2020-10-13","2025-10-13","2025-10-12","2030-10-12",{"$nulls":12},"3"]
["鲁淄械备20170058号",null,"透气胶贴",{"$nulls":9},"2017-08-09",null,"2099-12-31",{"$nulls":13},"1"]
["湘械注准20152400196",null,"碱性磷酸酶测定试剂盒（速率法）",{"$nulls":9},"2020-12-09","2025-12-09","2025-12-08","2030-12-08",{"$nulls":12},"2"]
["国械注准20163400782",null,"乙型肝炎病毒e抗原校准品",{"$nulls":9},"2020-11-02","2025-11-02","2025-11-01","2030-11-01",{"$nulls":12},"3"]
["湘械注准20152400192",null,"转铁蛋白测定试剂盒（免疫比浊法）",{"$nulls":9},"2020-12-09","2025-12-09","2025-12-08","2030-12-08",{"$nulls":12},"2"]
["豫械注准20192140804",null,"医用棉球",{"$nulls":9},"2019-10-16","2024-10-16","2024-10-15","2029-10-15",{"$nulls":12},"2"]
["湘械注准20152400188",null,"胃蛋白酶原II测定试剂盒（胶乳增强免疫比浊法）",{"$nulls":9},"2020-12-09","2025-12-09","2025-12-08","2030-12-08",{"$nulls":12},"2"]
["沪械注准20182660171",null,"胸腔闭式引流袋",{"$nulls":6},"2023-05-08",null,null,"2018-05-09","2023-05-09","2023-05-08","2023-05-08",{"$nulls":12},"2"]
["国械注进20153131408",null,"髋关节假体（非骨水泥型）-股骨柄",{"$nulls":9},"2020-03-02","2025-03-02","2025-03-01","2030-03-01",{"$nulls":12},"3"]
["豫械注准20202140527",null,"一次性口腔护理包",{"$nulls":9},"2020-08-21","2025-08-21","2025-08-20","2030-08-20",{"$nulls":12},"2"]
["国械注准20163101081",null,"一次性动静脉穿刺针",{"$nulls":9},"2020-11-23","2025-11-23","2025-11-22","2030-11-22",{"$nulls":8},"由穿刺针（针头）、针柄（蝴蝶柱和蝴蝶翼）、软管（管路）、止流夹（止血夹）、防针刺保护装置（防针刺护套）、内圆锥接头（母针基）、接头保护套（母针基盖)、穿刺针保护套（穿刺针护套）组成。该产品为环氧乙烷灭菌，一次性使用。",null,null,"本产品用于血液透析治疗中进行动静脉穿刺。","3"]
["豫械注准20202181296",null,"一次性使用无菌阴道扩张器",{"$nulls":9},"2020-10-16","2025-10-16","2025-10-15","2030-10-15",{"$nulls":12},"2"]
["豫械注准20202021285",null,"一次性使用备皮包",{"$nulls":9},"2020-10-21","2025-10-21","2025-10-20","2030-10-20",{"$nulls":12},"2"]
["苏械注准20142020479",null,"一次性使用无菌腹腔镜穿刺器套件",{"$nulls":9},"2020-07-07","2025-07-07","2025-07-06","2030-07-06",{"$nulls":12},"2"]
["豫械注准20202140526",null,"一次性会阴护理包",{"$nulls":9},"2020-08-21","2025-08-21","2025-08-20","2030-08-20",{"$nulls":12},"2"]
["苏械注准20152021183",null,"一次性使用管型吻合器",{"$nulls":9},"2020-07-01","2025-07-01","2025-06-30","2030-06-30",null,null,"芜湖华云创展医疗器械有限公司",{"$nulls":9},"2"]
["苏械注准20152021212",null,"一次性使用肛肠吻合器及附件",{"$nulls":9},"2020-07-01","2025-07-01","2025-06-30","2030-06-30",null,null,"芜湖华云创展医疗器械有限公司",{"$nulls":9},"2"]
["国械注准20163400476",null,"乙型肝炎病毒e抗体测定试剂盒（化学发光免疫分析法）",{"$nulls":5},"2022-11-16","2024-11-25",null,null,"2020-08-26","2025-08-26","2025-08-25","2030-08-26",{"$nulls":9},"磁颗粒、试剂1、试剂2、质控品、校准品1、校准品2（具体内容详见说明书）",null,"本试剂盒用于体外定量检测血清或血浆中的乙型肝炎病毒e抗体（Anti-HBe）的浓度。","3"]
["豫械注准20202140476",null,"一次性医用垫",{"$nulls":9},"2020-07-07","2025-07-07","2025-07-06","2030-07-06",{"$nulls":12},"2"]
["豫械注准20192140805",null,"一次性使用中单",{"$nulls":9},"2019-10-16","2024-10-16","2024-10-15","2029-10-15",{"$nulls":12},"2"]
["苏械注准20182250570","苏械注准20182010570","一次性使用高频手术电极",null,null,"张家港市凤凰镇长江路16号",{"$nulls":6},"2018-03-09","2023-03-09","2023-03-08","2028-03-08",{"$nulls":9},"一次性使用高频手术电极由刀头、柄部、手控开关（DB-S型）和电缆线组成。按控制方式不同分为手控型和脚控型两种规格，该产品以无菌状态提供，经辐照灭菌，一次性使用。",null,"与高频电刀配套使用，供手术时对组织进行电切、电凝用。","2"]
["豫械注准20162660602","豫械注准20202142093","一次性使用胃管",{"$nulls":9},"2016-09-13","2020-12-17","2021-09-12","2025-12-16",{"$nulls":12},"2"]
["苏械注准20192020474",null,"一次性使用管型吻合器",{"$nulls":5},"2023-10-11",{"$nulls":3},"2024-05-23",null,"2029-05-22",{"$nulls":9},"一次性使用管型吻合器由抵钉座总成、吻切组件、器体、固定手柄、活动手柄、保险、调节螺母、环形刀、吻合钉、垫刀圈、附件（荷包接杆、穿刺头、套管）组成。产品根据吻切组件外径的不同分为21、24、26、29、32、34 六种规格。产品以无菌状态提供，经环氧乙烷灭菌，一次性使用。",{"$nulls":3},"2"]
["湘械注准20152400189",null,"降钙素原测定试剂盒（胶乳增强免疫比浊法）",{"$nulls":9},"2020-12-08","2025-12-08","2025-12-07","2030-12-07",{"$nulls":12},"2"]
["湘械注准20152400185",null,"胃蛋白酶原I测定试剂盒（胶乳增强免疫比浊法）",{"$nulls":9},"2020-12-09","2025-12-09","2025-12-08","2030-12-08",{"$nulls":12},"2"]
["湘械注准20152400194",null,"肌酸激酶测定试剂盒（磷酸肌酸底物法）",{"$nulls":9},"2020-12-08","2025-12-08","2025-12-07","2030-12-07",{"$nulls":12},"2"]
["苏械注准20152401398",null,"细菌性阴道病检测试剂盒（干化学酶法）",{"$nulls":9},"2020-05-28","2025-05-28","2025-05-27","2030-05-27",{"$nulls":12},"2"]
["国械注准20153101782",null,"血液透析粉",{"$nulls":9},"2020-07-08","2025-07-08","2025-07-07","2030-07-07",{"$nulls":12},"3"]
["国械注准20153401475",null,"复合前列腺特异性抗原测定试剂盒（化学发光免疫分析法）",{"$nulls":5},"2023-11-24","2024-11-25",null,null,"2020-08-19","2025-08-19","2025-08-18","2030-08-18",{"$nulls":9},"试剂1、试剂2、磁颗粒、校准品1、校准品2、校准品3（具体内容详见说明书）",null,"本试剂盒用于体外定量检测人血清中复合前列腺特异性抗原（PSA-ACT）的浓度。主要用于对恶性肿瘤患者进行动态监测，以辅助判断疾病进程或者治疗效果，不能作为恶性肿瘤早期诊断或确诊的依据，不能用于普通人群的肿瘤筛查。","3"]
["豫长械备20150051号",null,"检查手套","医用检查手套",{"$nulls":8},"2015-07-02",null,"2099-12-31",{"$nulls":13},"1"]
["粤械注准20162400461",null,"血清降钙素（CT）测定试剂盒（化学发光法）","血清降钙素测定试剂盒（化学发光法）",{"$nulls":8},"2020-07-02","2025-07-02","2025-07-01","2030-07-01",{"$nulls":12},"2"]
["国械注进20163102348",null,"血液滤过管路 Haemofiltration Line",{"$nulls":9},"2020-07-28","2025-07-28","2025-07-27","2030-07-27",{"$nulls":12},"3"]
["国械注进20163101837",null,"透析附件——连接件Dialysis Accessory",{"$nulls":9},"2020-09-07","2025-09-07","2025-09-06","2030-09-06",{"$nulls":12},"3"]
["豫械注准20202172064",null,"一次性使用口腔包",{"$nulls":9},"2020-11-19","2025-11-19","2025-11-18","2030-11-18",{"$nulls":12},"2"]
["国械注准20153102392",null,"血液透析浓缩液",{"$nulls":9},"2021-07-06","2025-07-06","2025-07-05","2030-07-05",{"$nulls":12},"3"]
["国械注准20153402067",null,"淋病奈瑟球菌抗原检测试剂盒（乳胶法）",{"$nulls":9},"2020-11-27",null,"2025-11-26","2030-11-26",{"$nulls":12},"3"]
["国械注准20153131847",null,"室间隔缺损封堵器",{"$nulls":9},"2020-11-12","2025-11-12","2025-11-11","2030-11-11",{"$nulls":12},"3"]
["鄂械注准20152142162",null,"纱布球",{"$nulls":9},"2020-07-22","2025-07-24","2025-07-21","2030-07-23",{"$nulls":12},"2"]
["国械注准20163130130",null,"金属骨针",null,null,"北京市平谷区中关村科技园区平谷园兴谷A区平和街39 号院6号楼；山东省泰安市岱岳区大汶口工业园南留",{"$nulls":6},"2020-08-04","2025-08-04","2025-08-03","2030-08-03",{"$nulls":12},"3"]
["国械注准20173134462",null,"骨修复材料",null,"中国.杭州",null,"杭州九源基因工程有限公司","杭州九源基因生物医药股份有限公司","2021-12-01",{"$nulls":3},"2022-09-28",null,"2027-09-27",{"$nulls":3},"杭州九源基因工程有限公司","杭州九源基因生物医药股份有限公司",{"$nulls":4},"该产品以重组人骨形态发生蛋白-2（rhBMP-2)为原料，以药用明胶，大豆卵磷脂及羟基磷灰石为载体材料复合而成。灭菌包装。",null,"用于骨缺损、骨不连、骨延迟愈合或不愈合的填充修复，以及脊柱融合、关节融合及矫形植骨修复。",null,"3"]
["国械注准20163400156",null,"高尔基体蛋白73（GP73）测定试剂盒（上转发光法）",{"$nulls":9},"2020-11-15","2025-10-15","2025-11-14","2030-10-14",{"$nulls":12},"3"]
["渝械注准20202200270",null,"艾灸装置",{"$nulls":9},"2021-10-10","2025-10-10","2025-10-09","2030-10-09",{"$nulls":9},"艾灸装置分A型、B型、C型、D型、E型和F型六种型号。A型艾灸装置由灸盖、磁铁、定位纸片、灸柱、透气胶贴、筒身组成。其中灸盖、磁铁、定位纸片和筒身组成灸筒，灸柱主要是由艾绒柱组成。B型艾灸装置由灸盖、定位金属片、灸柱、透气胶贴、筒身组成。其中灸盖、定位金属片和筒身组成灸筒，灸柱主要是由艾绒柱组成。C型艾灸装置由灸盖、定位金属支架、灸柱、透气胶贴、筒身组成。其中灸盖、定位金属支架和筒身组成灸筒，灸柱主要是由艾绒柱组成。D型艾灸装置由灸盖、磁铁、定位纸片、调节环、灸柱、透气胶贴、筒身组成。其中灸盖、磁铁、定位纸片、调节环和筒身组成灸筒，灸柱主要是由艾绒柱组成。E型艾灸装置由灸盖（顶部为无纺布过滤棉）、磁铁、定位纸片、灸柱、透气胶贴、筒身组成。其中灸盖、磁铁、定位纸片和筒身组成灸筒，灸柱主要是由艾绒柱组成。F型艾灸装置由灸盖、上滤片、侧面滤片、磁铁、定位纸片、灸柱、透气胶贴、筒身组成。其中灸盖、磁铁、定位纸片、上滤片、侧面滤片和筒身组成灸筒，灸柱主要是由艾绒柱组成。",null,"适用于灸疗（包括温灸、雷火灸、隔物灸等）","2"]
["国械注准20153132350",null,"空心接骨螺钉（非锁定）",{"$nulls":9},"2020-07-10","2025-07-10","2025-07-09","2030-07-09",{"$nulls":12},"3"]
["国械注准20163401690",null,"肺炎衣原体IgM抗体检测试剂盒（乳胶法）",{"$nulls":9},"2021-05-19",null,"2026-05-18","2031-05-18",{"$nulls":12},"3"]
["国械注准20153100511",null,"血液停跳液灌注装置",{"$nulls":9},"2020-09-27","2025-09-27","2025-09-26","2030-09-26",{"$nulls":12},"3"]
["国械注进20152143786",null,"软组织活检针Soft Tissue Biopsy Needles",null,null,"美国",null,"爱琅（上海）医疗器械有限公司",null,"2024-03-18",null,null,"2020-06-23","2025-06-23","2025-06-22","2030-06-22",{"$nulls":3},"爱琅（上海）医疗器械有限公司",null,"Argon Medical Devices, Inc.",{"$nulls":3},"产品由针座、标记弹簧、针管、针芯接头、针芯组成。针座材料为K-树脂（苯乙烯—丁二烯共聚物）、标记弹簧材料为302不锈钢、针管材料为304不锈钢、针芯接头材料为聚丙烯、针芯材料为302不锈钢。产品经环氧乙烷灭菌，为一次性使用。",null,"适用于经皮对软组织进行活体检查。","2"]
["国械注进20152023785",null,"乳腺定位针Accura Needle",null,null,"美国",null,"爱琅（上海）医疗器械有限公司",null,"2024-05-24",null,null,"2020-06-15","2025-06-15","2025-06-14","2030-06-14",{"$nulls":3},"爱琅（上海）医疗器械有限公司",null,"Argon Medical Devices, Inc.",{"$nulls":3},"乳腺定位针由穿刺针、定位导丝、固定夹和加硬针管（仅Accura II）组成。穿刺针、定位导丝为304不锈钢；穿刺针针座材料为树脂（KR03 K-Resin）；固定夹材料为聚碳酸酯；加硬针管的针管手柄材料为聚氨酯（Pellethane），加硬针管的针管材料为304不锈钢。产品经环氧乙烷灭菌，为一次性使用。",null,"适用于手术中乳腺活组织检查定位。","2"]
["冀械注准20212400167",null,"骨钙素测定试剂盒（磁微粒化学发光免疫分析法）",{"$nulls":9},"2021-04-13","2026-04-13","2026-04-12","2031-04-12",{"$nulls":12},"2"]
["湘械注准20162140160",null,"一次性使用无菌加药器带针",{"$nulls":9},"2020-10-26","2025-10-26","2025-10-25","2030-10-25",{"$nulls":12},"3"]
["国械注准20153402295","京械注准20242400307","α-L-岩藻糖苷酶测定试剂盒(CNPF底物法)",{"$nulls":6},"2024-06-06",null,null,"2020-10-26","2025-10-26","2025-10-25","2030-10-25",{"$nulls":11},"本产品用于体外定量测定人血清中α-L-岩藻糖苷酶的含量。","3","2"]
["国械注准20163401691",null,"肺炎支原体IgM抗体检测试剂盒（乳胶法）",{"$nulls":9},"2021-05-31",null,"2026-05-30","2031-05-30",{"$nulls":12},"3"]
["苏械注准20222400788",null,"层粘蛋白检测试剂盒（化学发光免疫分析法）","层粘连蛋白测定试剂盒（化学发光免疫分析法）",{"$nulls":4},"2022-02-24",{"$nulls":3},"2022-02-24",null,"2027-02-23",{"$nulls":3},"基蛋生物科技股份有限公司",{"$nulls":5},"L1：链霉亲和素包被的磁性微粒；2.50mg/mL;含0.1%普乐净PC-300防腐剂（25人份/盒 1X0.40mL；50人份/盒 1X0.6mL；75人份/盒 1X0.8mL；100人份/盒：1X1.10mL；150人份/盒 1X1.6mL；200人份/盒 1X2.10mL)。L：校准品L（64.00-96.00ng/mL,大肠杆菌表达重组抗原，含2%牛血清蛋白BSA和0.1%普乐净PC-300防腐剂的20mM磷酸盐缓冲液,（PH=7.4±0.2）(25人份/盒 1X1.00mL；50人份/盒：1X2.00mL；75人份/盒 1X2.00mL；100人份/盒 1X2.00mL；150人份/盒 1X2.00mL；200人份/盒：1X2.00mL）；H：校准品H（400.00-600.00ng/mL,大肠杆菌表达重组抗原，含2%牛血清蛋白BSA和0.1%普乐净PC-300防腐剂的20mM磷酸盐缓冲液,（PH=7.4±0.2）(25人份/盒 1X1.00mL；50人份/盒：1X2.00mL；75人份/盒 1X2.00mL；100人份/盒 1X2.00mL；150人份/盒 1X2.00mL",null,"用于体外定量人血清、血浆和全血中层黏蛋白（LN）的浓度，临床上主要用于肝纤维化的辅助诊断。",null,"2"]
["国械注准20203130761",null,"可解脱栓塞弹簧圈",{"$nulls":9},"2020-09-23","2025-09-23","2025-09-22","2030-09-22",{"$nulls":12},"3"]
["苏械注准20202400927",null,"血清淀粉样蛋白A检测试剂盒（胶体金法）",{"$nulls":9},"2020-08-05","2025-08-05","2025-08-04","2030-08-04",{"$nulls":12},"2"]
["国械注准20163142108",null,"一次性使用连接管",{"$nulls":9},"2020-11-02","2025-11-02","2025-10-01","2030-11-01",{"$nulls":9},"产品分为直型连接管、三通连接管和T型连接管。产品由外圆锥接头防护帽、卡式螺帽、外圆锥接头、管体、移动夹或片夹、内圆锥接头、内圆锥接头防护帽、三通阀(三通连接管含有)、T型接头(T型连接含有)组成。连接管管体采用含有增塑剂TOTM(偏苯三酸三辛酯)的软聚氯乙烯(PVC)塑料制成，三通阀、T型接头和内、外圆锥接头采用聚碳酸酯(PC)材料制成。环乙灭菌、无菌、无热原。",null,"本产品用于延长输、注药液管道及多次注射药液时使用。","3"]
["沪械注准20202180457",null,"输卵管导管",{"$nulls":6},"2025-03-05",null,null,"2020-09-23","2025-09-23","2025-09-22","2030-09-22",{"$nulls":12},"2"]
["豫械注准20202081298",null,"一次性使用气管插管包",{"$nulls":9},"2020-10-16","2025-10-16","2025-10-15","2030-10-15",{"$nulls":12},"2"]
["国械注准20203130409",null,"自稳定型颈椎融合器",null,"浙江嘉兴",{"$nulls":3},"2020-04-17","2025-05-26",null,null,"2020-04-17","2025-05-26","2025-04-16","2030-04-17",null,null,"浙江德康医疗器械有限公司",{"$nulls":5},"该产品是由固定板、融合器、螺钉组成，融合器内含显影针，融合器由符合YY/T 0660标准要求的PEEK OPTIMA LT1聚醚醚酮材料制成，固定板和螺钉由符合GB/T 13810标准要求的TC4钛合金材料制成，显影针由符合YY/T 0966标准要求的纯钽材料制成。固定板及螺钉表面经阳极氧化处理，辐照灭菌或非灭菌包装，无菌有效期5年。",null,"该产品适用于颈椎椎间融合。",null,"3"]
["苏械注准20202400926",null,"血清淀粉样蛋白A/C反应蛋白二合一检测试剂盒（胶体金法）",{"$nulls":9},"2020-08-05","2025-08-05","2025-08-04","2030-08-04",{"$nulls":12},"2"]
["国械注准20163140673",null,"密闭式防针刺伤静脉留置针",{"$nulls":9},"2020-12-29","2025-12-29","2025-12-28","2030-12-28",{"$nulls":12},"3"]
["沪械注准20202040468",null,"关节镜用腕管松解手术器械",null,"中国",null,"上海瑛泰医疗器械股份有限公司",{"$nulls":5},"2020-09-25","2025-09-25","2025-09-24","2030-09-24",null,null,"上海瑛泰医疗器械股份有限公司",{"$nulls":5},"产品由扩张器、带撑芯套管、剥离器、勾刀和铲刀组成，塑料部分采用丙烯腈-丁二烯-苯乙烯共聚物(ABS)PA-747制成，金属部分采用420J2不锈钢制成。",null,"用于在关节镜下作腕管松解手术。",null,"2"]
["赣械注准20202140587",null,"医用外科口罩",{"$nulls":9},"2020-10-09","2025-10-09","2025-10-08","2029-10-08",{"$nulls":9},"本产品以灭菌及非无菌两种形式提供，由口罩体、鼻夹和口罩带组成。本产品为三层，内外层主要原材料为PP无纺布复合材料，中间层为聚丙烯熔喷布，鼻梁条为可塑性金属材质，耳带为弹性带，灭菌后产品经环氧乙烷灭菌，产品无菌。",null,null,"2"]
["浙械注准20202040725",null,"椎体成形器系列-一次性使用弯角骨填充器",{"$nulls":9},"2020-08-07","2025-08-07","2025-08-06","2030-08-06",{"$nulls":12},"2"]
["豫械注准20202140576",null,"医用无菌敷贴",{"$nulls":9},"2020-09-14","2025-09-14","2025-09-13","2030-09-13",{"$nulls":12},"2"]
["浙械注准20202060683",null,"一次性使用无菌关节镜入路套管",{"$nulls":9},"2020-07-14","2025-07-14","2025-07-13","2030-07-13",{"$nulls":12},"2"]
["国械注准20203130609",null,"丙烯酸树脂骨水泥",{"$nulls":9},"2020-07-01","2025-07-01","2025-06-30","2030-06-30",{"$nulls":12},"3"]
["国械注准20163400147","京械注准20242400308","癌抗原CA15-3测定试剂盒（磁微粒化学发光法）",{"$nulls":6},"2024-06-06",null,null,"2020-10-26","2025-10-26","2025-10-25","2030-10-25",{"$nulls":11},"本产品用于体外定量测定人血清中癌抗原CA15-3含量。","3","2"]
["国械注准20163400146","京械注准20242400309","肿瘤相关抗原CA125测定试剂盒（磁微粒化学发光法）",{"$nulls":6},"2024-06-06",null,null,"2020-10-30","2025-10-30","2025-10-29","2030-10-29",{"$nulls":11},"本产品用于体外定量测定人血清中肿瘤相关抗原CA125的含量。","3","2"]
["浙械注准20162400749",null,"甘胆酸测定试剂盒(胶乳增强免疫比浊法)",{"$nulls":9},"2016-09-26","2021-08-27","2021-09-25","2026-08-26",{"$nulls":12},"2"]
["京械注准20152401142",null,"游离人绒毛膜促性腺激素β亚单位（F-hCGβ）测定试剂盒（磁微粒化学发光法）",{"$nulls":6},"2025-02-11",null,null,"2020-10-28","2025-10-28","2025-10-27","2030-10-27",{"$nulls":11},"本产品用于体外定量测定人血清中游离人绒毛膜促性腺激素β亚单位（F-hCGβ）含量。","2"]
["浙械注准20162400752",null,"髓过氧化物酶测定试剂盒(酶法)",{"$nulls":9},"2016-09-26","2021-08-27","2021-09-25","2026-08-26",{"$nulls":12},"2"]
["鲁械注准20152400075",null,"γ-谷氨酰基转移酶测定试剂盒（GCANA底物法）",{"$nulls":9},"2019-12-31","2024-12-31","2024-12-30","2029-12-30",{"$nulls":12},"2"]
["国械注进20153173909",null,"种植体","种植体系统",{"$nulls":5},"2024-11-04",null,"2025-06-30","2020-09-14","2025-09-14","2025-09-13","2030-09-13",{"$nulls":12},"3"]
["国械注准20153142367",null,"一次性使用输注泵",{"$nulls":9},"2020-07-21","2025-07-21","2025-07-20","2030-07-20",{"$nulls":12},"3"]
["国械注准20163130572",null,"脊柱后路内固定系统",{"$nulls":9},"2020-07-28","2025-07-28","2025-07-27","2030-07-27",{"$nulls":12},"3"]
["国械注进20163100744",null,"置换液管",{"$nulls":9},"2020-07-15","2025-07-15","2025-07-14","2030-07-14",{"$nulls":12},"3"]
["京械注准20162400010",null,"α-淀粉酶测定试剂盒(EPS底物法)",{"$nulls":9},"2020-12-17","2025-12-17","2025-12-16","2030-12-16",{"$nulls":9},"试剂1：HEPES缓冲液(pH 7.25) 50 mmol/L\n       氯化钠 50 mmol/L\n       a-葡糖苷酶 ＞4500 U/L\n试剂2：HEPES缓冲液(pH 7.15) 50 mmol/L\n       4,6-亚乙基-对硝基G7 5mmol/L",null,"用于体外定量测定人血清或尿液中α-淀粉酶的活性。","2"]
["浙械注准20162400748",null,"载脂蛋白E测定试剂盒(胶乳增强免疫比浊法)",{"$nulls":9},"2016-09-26","2021-08-24","2021-09-25","2026-08-23",{"$nulls":12},"2"]
["苏械注准20202141556",null,"一次性使用防返流引流袋",{"$nulls":9},"2020-10-10","2025-10-10","2025-10-09","2030-10-09",{"$nulls":9},"一次性使用防返流引流袋由护帽、接头（蓝色接头\n、白色接头、采样口接头、螺旋接头、红色接头）\n、导管、挂钩(带)或绑带、袋体、防返流止回膜、\n排液管、排液阀（十字阀、螺旋阀、折叠阀、拉阀\n、夹阀等）组成，可选配绑绳、排液阀护帽、带防\n返流止回膜滴瓶、非乳胶橡筋、床单夹、夹片（或\n夹子）、空气膜、进液座、贮液盒（1 腔、2 腔、3腔）。该产品以无菌状态提供，经环氧乙烷灭菌。\n一次性使用。",null,"临床收集尿液用。","2"]
["国械注准20153401967","闽械注准20152401967","糖类抗原125（CA 125）测定试剂盒（磁微粒化学发光法）","糖类抗原125（CA125）测定试剂盒（磁微粒化学发光法）",{"$nulls":8},"2020-08-24","2025-08-24","2025-08-23","2030-08-23",null,null,"厦门万泰凯瑞生物技术有限公司",{"$nulls":5},"试剂1：1瓶（50人份：2.5mL；100人份：5mL；200人份：10mL；300人份：15mL；500人份：25mL），CA125 抗体包被的磁微粒。\n试剂2：1瓶（50人份：2.5mL；100人份：5mL；200人份：10mL；300人份：15mL；500人份：25mL），吖啶酯标记的CA125抗体。\n校准品1：0.5mL×1瓶，30U/mL的糖类抗原125，含牛血清的磷酸盐缓冲液，含有ProClin300防腐剂。\n校准品2：0.5mL×1 瓶，600U/mL的糖类抗原125，含牛血清的磷酸盐缓冲液，含有ProClin300防腐剂。",null,"本产品用于定量检测人血清或血浆中的糖类抗原125(CA125)。主要用于对恶性肿瘤患者进行动态监测以辅助判断疾病进程或治疗效果，不能作为恶性肿瘤早期诊断或确诊的依据，不能用于普通人群的肿瘤筛查。",null,"2"]
["京械注准20152401145",null,"纤维蛋白（原）降解产物（FDP）测定试剂盒（胶乳免疫比浊法）",{"$nulls":6},"2025-02-13",null,null,"2020-10-28","2025-10-28","2025-10-27","2030-10-27",{"$nulls":11},"本产品用于体外定量检测人血浆中纤维蛋白（原）降解产物的含量。","2"]
["京械注准20152401146",null,"游离脂肪酸（NEFA）测定试剂盒(ACS-ACOD酶法)",{"$nulls":6},"2025-01-16",null,null,"2020-10-28","2025-10-28","2025-10-27","2030-10-27",{"$nulls":11},"本产品用于体外定量测定人血清中游离脂肪酸的含量。","2"]
["粤械注准20162400463",null,"黄体生成素（LH）测定试剂盒（化学发光法）","黄体生成素测定试剂盒（化学发光法）",{"$nulls":8},"2020-07-17","2025-07-17","2025-07-16","2030-07-16",{"$nulls":12},"2"]
["浙械注准20162400381","浙温械备20250028","淋球菌培养基","TM（Thayer-Martin）淋球菌培养基",{"$nulls":8},"2021-01-18","2025-04-09","2026-01-17","2029-12-31",{"$nulls":12},"2"]
["鲁械注准20152400421",null,"肌酸激酶同工酶检测试剂盒（免疫抑制法）",{"$nulls":9},"2020-03-28","2025-03-28","2025-03-27","2030-03-27",{"$nulls":12},"2"]
["渝械注准20212020020",null,"一次性使用无菌包皮套扎器",{"$nulls":9},"2021-01-29","2026-01-29","2025-01-28","2031-01-28",{"$nulls":12},"2"]
["豫械注准20192140276",null,"一次性使用护脐包",{"$nulls":9},"2019-06-06","2024-06-06","2024-06-05","2029-06-05",{"$nulls":12},"2"]
["国械注进20173035073","国械注进20172035073","血管鞘组Introducer for PTCA Guiding Catheters",null,null,"美国",null,"爱琅（上海）医疗器械有限公司",null,"2024-05-24",null,null,"2020-10-26","2025-10-26","2025-10-25","2030-10-25",{"$nulls":3},"爱琅（上海）医疗器械有限公司",null,"Argon Medical Devices, Inc.",{"$nulls":3},"该产品由穿刺针、导管鞘、扩张器和导丝组成。穿刺针具有针和座结构。导管鞘具有鞘、座、止血阀和鲁尔接头结构。扩张器具有扩张器、座和端帽结构。导丝具有芯丝、绕丝和安全丝结构。环氧乙烷灭菌，一次性使用。有效期五年。",null,"该产品用于临床介入治疗中导引球囊导管、血管造影导管进入血管内。","3","2"]
["国械注准20163400689",null,"乙型肝炎病毒核心抗体测定试剂盒（磁微粒化学发光法）","乙型肝炎病毒核心抗体检测试剂盒（磁微粒化学发光法）",{"$nulls":8},"2021-02-23",null,"2026-02-22",{"$nulls":13},"3"]
["国械注准20163400784",null,"乙型肝炎病毒e抗体校准品",{"$nulls":9},"2020-11-02","2025-11-02","2025-11-01","2030-11-01",{"$nulls":12},"3"]
["国械注进20193130493",null,"髋关节假体-金属球头",{"$nulls":9},"2019-09-29","2024-09-29","2024-09-28","2029-09-28",{"$nulls":12},"3"]
["国械注准20153401438",null,"幽门螺杆菌抗体分型检测试剂盒（免疫印迹法）",{"$nulls":6},"2025-01-14",null,null,"2020-07-20","2025-07-20","2025-07-19","2030-07-19",{"$nulls":9},"含浓缩洗涤液、酶联试剂、显色剂、印迹膜、阳性对照、阴性对照、标准带。（具体内容详见说明书）",null,"本试剂盒用于体外定性检测人血清中多种幽门螺杆菌（HP）IgG抗体，包括细胞毒（CagA）、空泡毒（VacA）和尿素酶亚单位A和B抗体。","3"]
["浙械注准20162400751",null,"N-乙酰-β-D-氨基葡萄糖苷酶测定试剂盒(MPT底物法)",{"$nulls":9},"2016-09-26","2021-08-24","2021-09-25","2026-08-23",{"$nulls":12},"2"]
["浙械注准20162400750",null,"尿微量白蛋白测定试剂盒(免疫比浊法)",{"$nulls":9},"2016-09-26","2021-08-24","2021-09-25","2026-08-23",{"$nulls":12},"2"]
["国械注准20153401399",null,"人类免疫缺陷病毒抗体检测试剂盒(胶体金法)",{"$nulls":6},"2024-06-05",null,null,"2020-07-06","2025-07-06","2025-07-05","2030-07-05",{"$nulls":9},"1.抗HIV抗体检测试剂；2.试验记录纸。（具体内容详见说明书）",null,"该产品用于定性检测人血清或血浆样本中的人类免疫缺陷病毒抗体。","3"]
["国械注准20163140672",null,"密闭式防针刺伤静脉留置针",{"$nulls":9},"2020-12-27","2025-11-27","2025-12-26","2030-11-26",{"$nulls":12},"3"]
["国械注准20153142327",null,"一次性使用输液器 带针",{"$nulls":9},"2020-08-20","2025-08-20","2025-08-19","2030-08-19",{"$nulls":12},"3"]
["国械注进20172040153",null,"骨科手术用锯片 Saw Blades",{"$nulls":9},"2020-07-13","2025-07-13","2025-07-12","2030-07-12",{"$nulls":9},"产品为骨科手术用锯片。产品由胸骨锯片、摆动锯片、胸骨锯保护套、植骨取出锯片、摆锯锯片、往复锯片、矢状锯片、小骨弧形锯片、垂直截骨锯片、小骨髓内锯片、小骨ACL锯片、摆锯替换锯片组成。γ射线灭菌，一次性使用。",null,"该产品与动力系统联用，用于矫形（骨科）手术中切割、移除软组织或骨组织。","2"]
["湘械注准20162140167",null,"一次性使用护理包",{"$nulls":9},"2020-11-13","2025-11-13","2025-11-12","2030-11-12",{"$nulls":9},"本产品由治疗巾、医用胶贴、创口贴、橡胶检查手套、医用棉球、医用纱布、碘伏棉签、止血带、棉卷、污物袋、医用无纺布、医用棉签、纱布卷、医用输液贴、碘伏棉球、碘伏纱布、酒精棉球、酒精纱布、母针基盖、医用敷贴、镊子、锐器盒、防护手套、托盘组合而成，其中治疗巾和医用胶贴为基本配置，其余配件为可选配置。产品应无菌（碘伏棉签、碘伏棉球、碘伏纱布、酒精棉球、酒精纱布除外），本产品使用环氧乙烷灭菌。",null,"本品供医疗部门对患者护理时一次性使用。","2"]
["粤械注准20152401081",null,"糖尿病自身抗体免疫印迹试剂盒（免疫印迹法）",{"$nulls":6},"2024-12-18",null,null,"2020-08-25","2025-08-25","2025-08-24","2030-08-24",{"$nulls":9},"a）浓缩洗涤液：含8%吐温的磷酸盐缓冲液，25ml*1瓶；b）酶联试剂：辣根过氧化物酶标记抗人IgG（效价1：50），1ml*1瓶；c）显色剂A液：0.7‰3,3-二氨基联苯胺，25ml*1瓶；d）显色剂B液：0.1％过氧化氢，25ml*1瓶；e）终止液：2M硫酸，25ml*1瓶；f）样品稀释液：含0.4%吐温的磷酸盐缓冲液，100ml*1瓶；g）印迹薄膜：胰岛细胞抗原印迹膜（2*100mm），40人份；h）标准带：1份；i）说明书：1份。",null,"可供临床实验室对糖尿病患者自身抗体测定，用于体外定性检测人血清中的胰岛细胞抗体（ICA）、胰岛素抗体（IAA）、谷氨酸脱羧酶抗体（GADA）、蛋白酪氨酸磷酸酶抗体（IA-2A）和锌转运体8抗体（ZnT8A）。临床上用于Ⅰ型糖尿病的辅助诊断。","2"]
["浙械注准20162400459","浙温械备20250033","弧菌培养基","硫柠胆蔗琼脂培养基（TCBS琼脂培养基）",{"$nulls":8},"2021-01-15","2025-04-09","2026-01-14","2099-12-31",{"$nulls":12},"2","1"]
["浙械注准20162400753",null,"氯离子测定试剂盒(硫氰酸汞终点法)",{"$nulls":9},"2016-09-26","2021-08-27","2021-09-25","2026-08-26",{"$nulls":12},"2"]
["国械注准20153132159",null,"金属骨针",{"$nulls":9},"2020-09-21","2025-09-21","2025-09-20","2030-09-21",{"$nulls":9},"产品由符合GB 4234.1标准的牌号为00Cr18Ni14Mo3不锈钢材料制造，产品分灭菌包装和非灭菌包装，无菌产品采用辐照灭菌，灭菌有效期为5年。",null,"适用于骨科手术时作为牵引辅助器械、复位固定、导向。","3"]
["国械注进20163102349",null,"血液过滤管路及附件Haemofiltration Line",{"$nulls":9},"2020-08-20","2025-08-21","2025-08-20","2030-08-20",{"$nulls":12},"3"]
["豫械注准20202140571",null,"一次性使用孔巾",{"$nulls":9},"2020-09-14","2025-09-25","2025-09-13","2030-09-24",{"$nulls":12},"2"]
["豫械注准20202140530",null,"一次性使用中单",{"$nulls":9},"2020-08-21","2025-08-21","2025-08-20","2030-08-20",{"$nulls":12},"2"]
["豫械注准20202140531",null,"一次性使用换药缝合包",{"$nulls":9},"2020-08-21","2025-08-21","2025-08-20","2030-08-20",{"$nulls":12},"2"]
["国械注准20203030023",null,"一次性使用无菌导管鞘组",{"$nulls":9},"2020-01-08",null,"2025-01-07","2030-06-04",{"$nulls":12},"3"]
["鄂咸械备20160015号",null,"弹性绷带",{"$nulls":9},"2019-06-05","2025-09-23","2099-12-31","2099-12-31",{"$nulls":9},"由纺织布、无纺布加工而成的片状、卷状、管状的材料。纺织布型为经弹布、人造丝布或弹力丝布喷涂压敏胶复合离型材料制成。无纺布型由弹性无纺布喷涂压敏胶复合制成；可以通过绑扎的形式对创面敷料进行固定或限制肢体活动，以对创面愈合起到间接的辅助作用。具有弹力和自粘特性。非无菌提供，一次性使用。不与创面直接接触。粘贴部位为完好皮肤。",null,"用于对创面敷料或肢体提供束缚力，以起到包扎、固定作用。","1","1"]
["京械注准20152401137",null,"凝血酶时间（TT）测定试剂盒（凝固法）",{"$nulls":9},"2025-05-25",null,"2025-05-24","2030-05-24",{"$nulls":12},"2"]
["国械注准20153400753",null,"腺病毒IgG抗体检测试剂盒（酶免渗滤法）",{"$nulls":9},"2020-06-04","2025-06-04","2025-06-03","2030-06-03",{"$nulls":12},"3"]
["国械注进20163030584",null,"血栓清除系统Cleaner Rotational Thrombectomy System",null,null,"美国",null,"爱琅（上海）医疗器械有限公司",null,"2024-04-17",null,null,"2020-07-20","2025-07-20","2025-07-19","2030-07-19",{"$nulls":3},"爱琅（上海）医疗器械有限公司",null,"Argon Medical Devices, Inc.",{"$nulls":3},"本产品由手持主体、滑动钮、冲洗导管、三通、旋切导管、旋切导丝、旋切头组成。具体信息见附页。产品为一次性使用。",null,"本产品通过手持电池控制仪来旋转导丝和旋切头，以机械方式去除封闭的固有的血管透析瘘和人工透析通路移植物中的血栓凝块。","3"]
["国械注准20153400752",null,"腺病毒IgM抗体检测试剂盒（酶免渗滤法）",{"$nulls":9},"2020-06-08","2025-06-08","2025-06-07","2030-06-07",{"$nulls":12},"3"]
["鲁械注准20152140394",null,"一次性使用护理包",{"$nulls":9},"2020-08-28","2025-08-28","2025-08-27","2030-08-27",{"$nulls":9},"换药护理包基本配置为：垫巾、纱布块、镊子、托盘；选配配置为：包巾、洞巾、碘伏消毒棉球、酒精消毒棉球、医用棉球、一次性使用聚乙烯（PE）手套、一次性使用医用橡胶检查手套、弯盘、换药碗、手术刀片。拆线护理包基本配置为：垫巾、普通手术剪、纱布块、托盘、镊子；选配配置为：包巾、洞巾、手术刀片、碘伏消毒棉球、酒精消毒棉球、医用棉球、一次性使用聚乙烯（PE）手套、一次性使用医用橡胶检查手套、医用无菌敷贴。清创缝合护理包基本配置为：洞巾、纱布块、带线缝合针、托盘、镊子；选配配置为：包巾、垫巾、普通手术剪、手术刀、持针钳、碘伏消毒棉球、医用棉球、一次性使用医用橡胶检查手套、酒精消毒棉球、一次性使用聚乙烯（PE）手套、医用无菌敷贴。会阴护理包基本配置为：垫巾、托盘、碘伏消毒棉球；选配配置为：包巾、洞巾、纱布块、医用棉球、一次性使用医用橡胶检查手套、阴道扩张器、一次性使用拭子、一次性使用聚乙烯（PE）手套、镊子。透析护理包基本配置为：垫巾、纱布块、医用无菌敷贴、医用碘伏棉签、托盘；选配配置为：包巾、洞巾、普通手术剪、医用棉球、酒精消毒棉球、碘伏消毒棉球、碘伏消毒纱布、酒精消毒纱布、擦机水刺布、一次性使用医用橡胶检查手套、一次性使用聚乙烯（PE）手套、镊子、创口贴、脱脂棉、储存袋、弯盘、止血带、酒精棉片、弹性绷带、冲洗器、保护套。胃镜检查护理包基本配置为：垫巾、托盘、一次性使用聚乙烯（PE）手套、口垫；选配配置为：洞巾、包巾、纱布块、普通手术剪、酒精消毒棉球、碘伏消毒棉球、医用棉球、一次性使用医用橡胶检查手套、镊子。气切护理包基本配置为：垫巾、镊子、碘伏消毒棉球、托盘；选配配置为：洞巾、包巾、纱布块、手术刀片、医用棉球、普通手术剪、酒精消毒棉球、一次性使用聚乙烯（PE）手套、一次性使用医用橡胶检查手套、医用无菌敷贴、冲洗器、换药碗。内瘘护理包基本配置为：纱布块、医用无菌敷贴、医用碘伏棉签，托盘；",null,"换药包适用于医疗机构外科换药；拆线包适用于临床拆线；清创护理包适用于临床清创缝合；会阴护理包适用于临床会阴部护理；透析护理包适用于血液透析治疗中的护理用；胃镜检查包适用于医疗机构对患者进行胃镜检查时使用；气切护理包适用于气切手术时的护理用；内瘘护理包适用于透析内瘘治疗使用；置管护理包适用于临床透析时护理使用；上机护理包适用于血液透析治疗中的上机前的护理用；下机护理包适用于血液透析治疗中的下机后的护理用。","2"]
["国械注进20153033809",null,"心内膜心肌活检钳 Endomyocardial Biopsy Forceps",null,null,"美国",null,"爱琅（上海）医疗器械有限公司",null,"2024-01-30",null,null,"2020-06-02","2025-06-02","2025-06-01","2030-06-01",{"$nulls":3},"爱琅（上海）医疗器械有限公司",null,"Argon Medical Devices, Inc.",{"$nulls":3},"本产品由咬切器、钳体线圈、外套、手柄组成。产品无菌，一次性使用，货架有效期5年。",null,"本产品经皮肤导入，通过股骨静脉（长度105cm）或颈静脉（长度50cm）途径进入心室，采集心内膜心肌的组织样品，供病理分析使用。","3"]
["赣械注准20192070358",null,"一次性脑电传感器",{"$nulls":9},"2019-12-30","2024-12-30","2024-12-29","2029-12-29",{"$nulls":12},"2"]
["国械注准20193030937",null,"一次性使用非顺应性冠状动脉球囊扩张导管",{"$nulls":9},"2019-12-04",null,"2024-12-03","2030-06-08",{"$nulls":12},"3"]
["豫械注准20202140533",null,"医用棉签",{"$nulls":9},"2020-08-20","2025-08-21","2025-08-20","2030-08-20",{"$nulls":12},"2"]
["豫械注准20202140551",null,"一次性使用医用垫",{"$nulls":9},"2020-08-31","2025-08-31","2025-08-30","2030-08-30",{"$nulls":12},"2"]
["国械注准20193131021",null,"足踝锁定接骨板系统",null,"浙江嘉兴",{"$nulls":3},"2019-12-12","2024-08-26",null,null,"2019-12-12","2024-12-12","2024-12-11","2029-12-11",null,null,"浙江德康医疗器械有限公司",{"$nulls":5},"该产品是由足踝接骨螺钉和足踝锁定接骨板（包括足踝锁定板以及足踝万向板）组成。其中足踝接骨螺钉由TC4钛合金材料制造，符合GB/T13810标准；足踝锁定接骨板是由TA3G纯钛材料制造，符合GB/T13810标准。产品表面经着色阳极氧化，交付状态为非灭菌状态。","该产品是由足踝接骨螺钉和足踝锁定接骨板（包括足踝锁定板以及足踝万向板）组成。其中足踝接骨螺钉是由TC4钛合金材料制造，符合GB/T 13810标准。足踝锁定接骨板是由TA3G纯钛材料制造，符合GB/T 13810标准。产品表面经着色阳极氧化，交付状态为灭菌状态或非灭菌状态。","适用于足踝骨折内固定。",null,"3"]
["豫械注准20202140552",null,"一次性使用治疗巾",{"$nulls":9},"2020-08-31","2025-08-31","2025-08-30","2030-08-30",{"$nulls":12},"2"]
["国械注准20153401872",null,"人乳头瘤病毒分型检测试剂盒（基因芯片法）",{"$nulls":9},"2020-07-14","2025-08-07","2025-07-13","2030-08-06",{"$nulls":12},"3"]
["京械注准20202400159",null,"血糖试条（葡萄糖脱氢酶法）（型号：H1）",{"$nulls":9},"2020-04-16","2025-04-16","2025-04-15","2030-04-15",{"$nulls":12},"2"]
["粤械注准20152081317",null,"一次性使用呼吸机管路",{"$nulls":9},"2020-06-08","2025-06-08","2025-06-07","2030-06-07",{"$nulls":9},"一次性使用呼吸机管路是由基础配置和选用配置I组和/或选用配置II组组成。\n产品型号基础配置：普通回路型由波纹管、Y形件、盖帽、接水杯、转换接头、单管、测压管、监控过滤器和连接器等部件组成。\n内壁光滑型由内壁光滑管、Y形件、盖帽、接水杯、转换接头、单管、测压管、监控过滤器和连接器等部件组成。\n吸痰接头型由波纹管/仲缩管/内壁光滑管、吸痰接头和转换接头组成。\n无创呼吸型由内壁光滑管/EVA管、带测/泄压口连接器、盖帽、接水杯、转换接头、单管、测压管、监控过滤器和连接器附件组成\n普通回路A型由波纹管、Y形件、盖帽、22M/22M(15F)连接器、可选部件组成。\n内壁光滑A型由内壁光滑管、Y形件、盖帽、22M/22M(15F)连接器、可选部件组成。\n无创呼吸A型由内壁光滑管/EVA管/波纹管、22M/22M(15F)连接器、可选部件组成。\nY型件，连接器、普通呼吸面罩/免充气呼吸面罩(可选配)组成，其中呼吸面罩由呼吸面罩主体、套环、松紧带组成。\n无创面罩型由波纹管、Y型件，连接器、普通呼吸面罩/免充气呼吸面罩(可选配)组成，其中呼吸面罩由呼吸面罩主体、套环、松紧带组成。\n无创型出EVA管、EVA管端口接头、无创型接头、测压管、22mm漏气接头(可选配)组成。\n基本型的基础配置出单管(波纹管/内壁光滑管/伸编管/EVA管)、接头等组成。\n辅助型的基础配置由单管(波纹管/内壁光滑管/伸缩管/EVA管)、PFEP呼气阀、测压管和接头组成。",null,null,"2"]
["鲁械注准20202400188",null,"C反应蛋白与血清淀粉样蛋白A检测试剂盒（免疫荧光法）",{"$nulls":9},"2020-02-21","2025-02-21","2025-02-20","2030-02-20",{"$nulls":12},"2"]
["国械注准20203400384",null,"新型冠状病毒2019-nCoV核酸检测试剂盒（荧光PCR法）",{"$nulls":9},"2020-11-20","2025-11-20","2025-11-19","2030-11-19",{"$nulls":12},"3"]
["鲁械注准20202400189",null,"糖化血红蛋白检测试剂盒（免疫荧光法）","糖化血红蛋白检测试剂盒（干式免疫荧光发光法）",{"$nulls":8},"2020-02-21","2025-02-21","2025-02-20","2030-02-20",{"$nulls":12},"2"]
["国械注准20203400336",null,"总前列腺特异性抗原（t-PSA）检测试剂盒（免疫荧光法）",{"$nulls":9},"2020-03-30","2025-03-30","2025-03-29","2030-03-29",{"$nulls":12},"3"]
["浙械注准20202080062",null,"一次性使用可视气管插管",{"$nulls":9},"2020-01-27","2025-01-26","2025-01-26","2030-01-25",{"$nulls":12},"2"]
["鲁械注准20192400907",null,"甘胆酸测定试剂盒（乳胶免疫比浊法）","甘胆酸测定试剂盒（胶乳免疫比浊法）",{"$nulls":8},"2019-12-26","2024-12-26","2024-12-25","2029-12-25",{"$nulls":12},"2"]
["鲁械注准20192400908",null,"乳酸脱氢酶同工酶1测定试剂盒（乳酸底物法）",{"$nulls":9},"2019-12-26","2024-12-26","2024-12-25","2029-12-25",{"$nulls":12},"2"]
["国械注准20193101972",null,"一次性体外循环用配套血管路",{"$nulls":9},"2019-08-26","2024-08-26","2024-08-25","2029-08-27",{"$nulls":12},"3"]
["津械注准20192140174",null,"便携式手动引流瓶",{"$nulls":9},"2019-11-04","2024-11-04","2024-11-03","2029-11-03",{"$nulls":12},"2"]
["津械注准20192080080",null,"一次性使用喉罩",{"$nulls":9},"2019-05-31","2024-05-31","2024-05-30","2029-05-30",{"$nulls":12},"2"]
["鲁械注准20202400002",null,"唾液酸检测试剂盒（酶法）",{"$nulls":9},"2020-01-01","2025-01-01","2024-12-31","2029-12-31",{"$nulls":12},"2"]
["国械注准20193131014",null,"颈椎前路固定系统",{"$nulls":9},"2019-12-12","2024-12-12","2024-12-11","2029-12-11",{"$nulls":12},"3"]
["鲁械注准20152400083",null,"尿微量白蛋白检测试剂盒（免疫透射比浊法）",{"$nulls":9},"2019-12-05","2024-12-05","2024-12-04","2029-12-04",{"$nulls":12},"2"]
["鲁械注准20202400190",null,"心肌肌钙蛋白I/肌酸激酶同工酶/肌红蛋白联合检测试剂盒（免疫荧光法）",{"$nulls":9},"2020-02-21","2025-02-21","2025-02-20","2030-02-20",{"$nulls":12},"2"]
["鲁械注准20152400095",null,"天门冬氨酸氨基转移酶测定试剂盒（天门冬氨酸底物法）",{"$nulls":9},"2020-01-13","2025-01-13","2025-01-12","2030-01-12",{"$nulls":12},"2"]
["鲁械注准20152400089",null,"甘油三酯检测试剂盒（酶法）",{"$nulls":9},"2019-12-31","2024-12-31","2024-12-30","2029-12-30",{"$nulls":12},"2"]
["鲁械注准20152400088",null,"丙氨酸氨基转移酶测定试剂盒（丙氨酸底物法））","丙氨酸氨基转移酶测定试剂盒（丙氨酸底物法）",{"$nulls":8},"2019-12-31","2024-12-31","2024-12-30","2029-12-30",{"$nulls":12},"2"]
["鲁械注准20152400077",null,"白蛋白检测试剂盒（溴甲酚绿法）",{"$nulls":9},"2019-12-31","2024-12-31","2024-12-30","2029-12-30",{"$nulls":12},"2"]
["鲁械注准20152400084",null,"乳酸脱氢酶测定试剂盒（乳酸底物法）",{"$nulls":9},"2020-01-13","2025-01-13","2025-01-12","2030-01-12",{"$nulls":12},"2"]
["鲁械注准20152400082",null,"肌酸激酶测定试剂盒（磷酸肌酸底物法）",{"$nulls":9},"2019-12-31","2024-12-31","2024-12-30","2029-12-30",{"$nulls":12},"2"]
["鲁械注准20152400078",null,"高密度脂蛋白胆固醇检测试剂盒（直接法）",{"$nulls":9},"2019-12-02","2024-12-02","2024-12-01","2029-12-01",{"$nulls":12},"2"]
["鲁械注准20152400071",null,"载脂蛋白A1检测试剂盒（免疫透射比浊法）",{"$nulls":9},"2019-12-02","2024-12-02","2024-12-01","2029-12-01",{"$nulls":12},"2"]
["国械注进20193130459",null,"膝关节假体",{"$nulls":9},"2019-09-23","2024-09-23","2024-09-22","2029-09-22",{"$nulls":12},"3"]
["国械注准20153131057",null,"脊柱内固定系统",null,null,"北京市平谷区中关村科技园区平谷园兴谷A区平和街39号院6号楼；委托地址：山东省泰安市岱岳区大汶口",{"$nulls":6},"2020-03-19","2025-03-20","2025-03-18","2030-03-19",{"$nulls":12},"3"]
["国械注准20153140874",null,"一次性医用压力延长管",{"$nulls":9},"2020-02-28","2025-02-28","2025-02-27","2030-02-27",{"$nulls":12},"3"]
["国械注准20203400325",null,"甲胎蛋白(AFP)检测试剂盒（免疫荧光法）",{"$nulls":9},"2020-03-30","2025-03-30","2025-03-29","2030-03-29",{"$nulls":12},"3"]
["国械注准20203400329","鲁械注准20242400787","癌胚抗原（CEA）检测试剂盒（免疫荧光法）",{"$nulls":9},"2020-03-30","2025-03-30","2025-03-29","2030-03-29",{"$nulls":12},"3"]
["吉械注准20192140056",null,"雾化含漱冲洗液功能性敷料",{"$nulls":9},"2019-09-24","2024-09-24","2024-09-23","2029-09-23",{"$nulls":9},"本品由储液瓶、溶液组成,溶液由聚氨基葡萄糖、十三肽、氯化钠、去离子水混合物组成的液体。",null,"用于缓解鼻、咽、喉、上呼吸道的局部炎症、疼痛、咳嗽、粘膜充血症状,减少分泌物、湿润呼吸道、湿化痰液;预防和消除口腔炎症、缩小溃疡面、减轻疼痛,清洁口腔,去除口腔异味;浅Ⅱ度烧伤、压力性损伤、溃疡、外伤小创口等非慢性创面的清创冲洗,护创,阻止病原微生物定植、促进伤口愈合作用。","2"]
["国械注准20153032227",null,"非顺应性PTCA球囊扩张导管",{"$nulls":6},"2024-11-14",null,null,"2020-07-06","2025-07-06","2025-07-05","2030-07-05",{"$nulls":9},"该产品由外管、球囊、内管、手柄、标记环组成，涂有聚乙烯吡咯烷酮涂层，球囊的材料为聚醚嵌段酰胺。环氧乙烷灭菌，一次性使用。货架有效期2年。",null,"该产品用于冠状动脉或者冠状动脉搭桥中的狭窄部分进行球囊扩张，以改善心肌灌注。","3"]
["国械注准20153401477",null,"人类免疫缺陷病毒抗体测定试剂盒（化学发光免疫分析法）",{"$nulls":6},"2024-11-25",null,null,"2020-07-20","2025-07-20","2025-07-19","2030-07-19",{"$nulls":9},"磁颗粒、试剂1、试剂2、质控品1、质控品2、校准品1、校准品2（具体内容详见说明书）",null,"本试剂盒用于体外定性检测人血清（浆）中的人类免疫缺陷病毒抗体，包括HIV-1和HIV-2型抗体。","3"]
["闽械注准20152400166",null,"甲胎蛋白(AFP)测定试剂盒(胶体金法)",{"$nulls":6},"2024-12-16",null,null,"2020-08-28","2025-08-28","2025-08-27","2030-08-27",{"$nulls":9},"质控线:硝酸纤维素膜包被羊抗鼠IgG抗体\n检测线:硝酸纤维素膜包被鼠抗AFP单克隆抗体\n结合垫:玻璃纤维包被胶体金标记鼠抗AFP单克隆抗体",null,"用于体外定量测定孕中期(14-22周) 孕妇血清(血浆)中的甲胎蛋白，检测结果与唐氏综合征产前筛查软件配合使用，用于唐氏综合征的产前筛查。","2"]
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["国械注准20203010675","沪械注准20252010132","弹簧圈解脱控制器",{"$nulls":6},"2025-04-01",null,null,"2020-07-31","2025-07-31","2025-07-30","2030-07-30",{"$nulls":9},"该产品由外壳、电路板、电池组成。",null,"该产品临床用于颅内动脉瘤栓塞手术过程中，为微创神通医疗科技（上海）有限公司适配的弹簧圈产品提供电量，解脱弹簧圈。","3","2"]
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["国械注准20203130489",null,"髋关节假体组件",{"$nulls":9},"2020-05-09","2025-05-09","2025-05-08","2030-05-08",{"$nulls":12},"3"]
["粤械注准20202401146",null,"抗组蛋白抗体IgG测定试剂盒（化学发光免疫分析法）","抗组蛋白抗体IgG测定试剂盒（磁微粒化学发光法）",{"$nulls":8},"2020-08-04","2025-08-04","2025-08-03","2030-08-03",{"$nulls":12},"2"]
["粤械注准20202401186",null,"抗核糖体核蛋白抗体IgG测定试剂盒（化学发光免疫分析法）","抗核糖体核蛋白抗体IgG测定试剂盒（磁微粒化学发光法）",{"$nulls":8},"2020-08-10","2025-08-14","2025-08-09","2030-08-13",{"$nulls":12},"2"]
["鲁械注准20152400096",null,"总胆固醇检测试剂盒（氧化酶法）","总胆固醇检测试剂盒（CHOD-PAP法）",{"$nulls":8},"2020-01-13","2025-01-13","2025-01-12","2030-01-12",{"$nulls":12},"2"]
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["鲁械注准20152400091",null,"尿素测定试剂盒（尿素酶-谷氨酸脱氢酶法）",{"$nulls":9},"2020-01-06","2025-01-06","2025-01-05","2030-01-05",{"$nulls":12},"2"]
["鲁械注准20152400081",null,"肌酐检测试剂盒（酶法）",{"$nulls":9},"2019-12-31","2024-12-31","2024-12-30","2029-12-30",{"$nulls":12},"2"]
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["国械注准20153021687",null,"α-氰基丙烯酸异丁酯医用胶",{"$nulls":9},"2020-09-15","2025-09-15","2025-09-14","2030-09-14",{"$nulls":12},"3"]
["皖械注准20202400386",null,"N末端B型钠尿肽前体测定试剂盒（荧光免疫层析法",{"$nulls":9},"2020-07-30","2025-07-30","2025-07-29","2030-07-29",{"$nulls":12},"2"]
["浙械注准20152080689",null,"YYX型一次性使用吸氧管",{"$nulls":9},"2020-08-05","2025-08-05","2025-08-04","2030-08-04",{"$nulls":12},"2"]
["鄂械注准20202143028",null,"医用外科口罩",{"$nulls":9},"2020-07-22","2025-07-22","2025-07-21","2030-07-21",{"$nulls":9},"口罩由面罩、鼻夹和口罩带组成，面罩分为面层、中间层和底层三层结构，内外两层为聚丙烯（PP）纺粘无纺布，中间层过滤材料为聚丙烯熔喷布。鼻夹由金属裹塑材料制成，口罩带由氨纶弹性带制成。灭菌级产品经环氧乙烷灭菌。",null,"用于戴在手术室医务人员口鼻部位，以防止皮屑、呼吸道微生物传播到开放的手术创面，并阻止手术病人的体液向医务人员传播，起到双向生物防护的作用。普通级产品如需进入有无菌要求的区域应灭菌后使用。","2"]
["苏械注准20202401021",null,"B型钠尿肽检测试剂盒（干式免疫荧光法）",{"$nulls":9},"2020-09-03","2025-09-04","2025-09-03","2030-09-03",{"$nulls":12},"2"]
["鲁械注准20142400083",null,"载脂蛋白B检测试剂盒（免疫透射比浊法）",{"$nulls":9},"2019-12-02","2024-12-02","2024-12-01","2029-12-01",{"$nulls":12},"2"]
["国械注准20153401889",null,"人类免疫缺陷病毒抗原及抗体测定试剂盒（化学发光免疫分析法）",{"$nulls":5},"2022-12-05","2025-07-11",null,null,"2020-07-06","2025-07-11","2025-07-05","2030-07-10",{"$nulls":9},"磁颗粒、试剂1、试剂2、质控品1、质控品2、质控品3、校准品（具体内容详见说明书）",null,"本试剂盒用于体外定性检测人血清（浆）中的人类免疫缺陷病毒抗原或抗体的浓度，包括HIV-1、HIV-2亚型抗体和HIV-1 P24抗原。","3"]
["浙械注准20152400924",null,"胰淀粉酶检测试剂盒（免疫抑制法）",{"$nulls":9},"2020-07-06","2025-07-06","2025-07-05","2030-07-05",{"$nulls":12},"2"]
["苏械注准20162020314",null,"一次性使用细胞刷",{"$nulls":6},"2025-08-04",null,"2025-09-15","2020-08-21","2025-08-21","2025-08-20","2030-08-20",{"$nulls":9},"一次性使用细胞刷由刷头；塑料外管；不锈钢弹簧软管（钢丝绳）；手柄和滑块组成，按有无塑料外管分为两类，每类按刷头直径；工作长度不同各分为若干规格。该产品以无菌状态提供，经环氧乙烷灭菌，一次性使用。",null,null,"2"]
["鄂械注准20202023085",null,"一次性使用自断定量弹力线肛肠套扎吻合器",{"$nulls":9},"2020-10-05","2025-10-05","2025-10-04","2030-10-04",{"$nulls":12},"2"]
["国械注准20153101908",null,"一次性使用心脏停跳液灌注器",{"$nulls":9},"2020-02-21","2025-02-21","2025-02-20","2030-02-20",{"$nulls":12},"3"]
["国械注准20153130958",null,"疝修补补片",{"$nulls":9},"2020-08-18","2025-08-18","2025-08-17","2030-08-17",{"$nulls":9},"该产品由聚丙烯单丝经编而成，分为网片、花瓣网塞、腹膜前间隙修补网片、3D \n补片四类。网片呈平面网状结构，包括预裁网片、轻质网片、轻量网片。花瓣网塞由两层花瓣网片和一层圆形网片经定型后缝合连接成圆锥状。腹膜前间隙修补网片由塑形花瓣（椭圆形）网片与圆（椭圆）形网片，两层缝合连接。3D 补片呈弧形凸面结构。产品一次性使用，经环氧乙烷灭菌。货架有效期 3 年。",null,"该产品适用于腹腔外修补原发性成人腹股沟疝、切口疝。花瓣网塞仅用于Ⅰ、Ⅱ \n型腹股沟疝。","3"]
["国械注准20203130422",null,"钛网系统",null,"浙江嘉兴",{"$nulls":3},"2020-04-23","2024-05-07",null,null,"2020-04-23","2025-04-23","2025-04-22","2030-04-22",null,null,"浙江德康医疗器械有限公司",{"$nulls":5},"本产品由钛网和端盖组成。本产品均由纯钛材料制造，牌号为TA2，符合GB/T13810材料标准。产品表面经黑灰色阳极氧化或无着色。交付状态为非灭菌状态。",null,"产品须与内固定器械联合使用，适用于椎体全部切除或部分切除手术后的椎体替代。",null,"3"]
["滇械注准20202400120",null,"C肽( C-Peptide)检测试剂盒（免疫层析法）",{"$nulls":9},"2020-07-30","2025-07-30","2025-07-29","2030-07-29",{"$nulls":9},"本试剂盒主要由以下组成： 1、本品系由硝酸纤维膜（抗人C肽（ C-Peptide）抗体包被的硝酸纤维膜、抗鼠IgG抗体包被的硝酸纤维膜）、胶体金结合垫（胶体金标记的C肽金标记抗体）以及样本垫（玻璃纤维膜）、吸水纸和外壳组成。 2、其他组成：吸管、SD卡、干燥剂。",null,"配套昊戌品牌HX-201胶体金试纸分析仪、华科瑞HR-201免疫定量分析仪，用于定量检测人血清或血浆／全血中的C肽（ C-Peptide）的含量。临床上用于评价胰岛功能。","2"]
["粤械注准20152081467",null,"医用雾化器",{"$nulls":9},"2020-07-10","2025-07-10","2025-07-09","2030-07-09",{"$nulls":12},"2"]
["粤械注准20152021195",null,"一次性使用非血管腔道导丝",{"$nulls":9},"2020-09-29","2025-09-29","2025-09-28","2030-09-28",{"$nulls":12},"2"]
["津械注准20192100074",null,"阻隔式压力传导器",{"$nulls":9},"2019-05-27","2024-05-27","2024-05-26","2029-05-26",{"$nulls":12},"2"]
["滇械注准20202400121",null,"补体C1q测定试剂盒（免疫比浊法）",{"$nulls":9},"2020-07-30","2025-07-30","2025-07-29","2030-07-29",{"$nulls":9},"产品由R1（Tris 缓冲液 100mmol/L）、 R2（Tris缓冲液 100mmol/L 、乳胶包被C1q抗体 0.2%）、 补体C1q校准品：1×1ml（可选购） 补体C1q质控品：1×1ml（可选购）组成。",null,"用于体外定量测定人血清中补体C1q（C1q）的含量。临床上可用于肾炎、肾小球损伤的辅助诊断。","2"]
["滇械注准20202400123",null,"尿碘测定试剂盒（比色法）",{"$nulls":9},"2020-07-30","2025-07-30","2025-07-29","2030-07-29",{"$nulls":9},"产品是由R1（氯化钠 0.5mmol/L、氢氧化钠 1mmol/L）、 R2（碘酸钾 1mmol/L、硫酸铵 0.5mmol/L）、 尿碘校准品： 1×1ml（可选购） 尿碘质控品： 1×1ml（可选购）",null,"用于体外定量测定人尿液中碘（I）的含量。临床上用于甲状腺疾病的辅助诊断。","2"]
["国械注准20203400755","苏械注准20252400486","肿瘤相关抗原19-9（CA19-9）测定试剂盒（化学发光免疫分析法）","糖类抗原19-9测定试剂盒（化学发光免疫分析法）",{"$nulls":4},"2022-07-14","2025-03-25",null,null,"2020-09-21","2025-09-21","2025-09-20","2030-09-20",{"$nulls":9},"试剂1：内含生物素化抗肿瘤相关抗原19-9特异性单克隆抗体（小鼠），蛋白缓冲液，0.1%Proclin300防腐；\n试剂2：内含吖啶酯标记的抗肿瘤相关抗原19-9特异性单克隆抗体（小鼠），蛋白缓冲液，0.1%Proclin300防腐；\n磁颗粒：内含链霉亲和素包被的微粒，经防腐处理；\n校准品1、校准品2、校准品3：内含人源性的肿瘤相关抗原19-9抗原，蛋白缓冲液，0.1%Proclin300。（具体内容详见产品说明书）",null,"用于体外定量测定人血清中肿瘤相关抗原 19-9的浓度。临床上用于胰腺消化道恶性肿瘤的疗效监测，不能作为恶性肿瘤早期诊断或确诊的依据，不能用于普通人群的肿瘤筛查。","3","2"]
["浙械注准20152020662",null,"一次性使用消化道吻合器",{"$nulls":9},"2020-06-01","2025-06-01","2025-05-31","2030-05-31",{"$nulls":12},"2"]
["苏械注准20202141103",null,"弹力包扎敷料",{"$nulls":9},"2020-10-13","2025-10-13","2025-10-12","2030-10-12",{"$nulls":12},"2"]
["鲁械注准20142400085",null,"脂肪酶检测试剂盒（酶比色法）","脂肪酶检测试剂盒（甲基试卤灵底物法）",{"$nulls":8},"2019-12-02","2024-10-14","2024-12-01","2029-10-13",{"$nulls":12},"2"]
["鲁械注准20152400097",null,"总胆固醇检测试剂盒（氧化酶法）",{"$nulls":9},"2020-01-13","2025-01-13","2025-01-12","2030-01-12",{"$nulls":12},"2"]
["鲁械注准20152400074",null,"C-反应蛋白检测试剂盒（胶乳比浊法）",{"$nulls":9},"2019-12-10","2024-12-10","2024-12-09","2029-12-09",{"$nulls":12},"2"]
["鲁械注准20152400086",null,"纤维蛋白原检测试剂盒（免疫透射比浊法）",{"$nulls":9},"2019-12-02","2024-12-02","2024-12-01","2029-12-01",{"$nulls":12},"2"]
["浙械注准20202400776",null,"食物特异性抗体IgG检测试剂盒（蛋白芯片法）",{"$nulls":9},"2020-09-10","2025-09-17","2025-09-09","2030-09-16",{"$nulls":12},"2"]
["国械注进20152142902",null,"活检针Biopsy Needles",null,null,"美国",null,"爱琅（上海）医疗器械有限公司",null,"2024-02-01",null,null,"2020-06-03","2025-06-03","2025-06-02","2030-06-02",{"$nulls":3},"爱琅（上海）医疗器械有限公司",null,"Argon Medical Devices, Inc.",{"$nulls":3},"活检针由针管、针芯、针柄组成。针管和针芯材料均为304不锈钢，针柄材料为聚碳酸酯。产品经环氧乙烷灭菌，一次性使用。",null,"与Bard Magnum活检装置或其他兼容可用的活检装置合并使用，适用于实体组织活组织检查。","2"]
["国械注准20153131024",null,"解剖型金属锁定接骨板钉系统",{"$nulls":9},"2020-06-24","2025-06-24","2025-06-23","2030-06-23",{"$nulls":12},"3"]
["国械注准20203130392",null,"不可吸收带线锚钉",{"$nulls":9},"2020-04-17","2025-04-17","2025-04-16","2030-04-16",{"$nulls":12},"3"]
["京械注准20202400298",null,"抗缪勒管激素测定试剂盒（上转发光法）",{"$nulls":9},"2020-08-05","2025-08-05","2025-08-04","2030-08-04",{"$nulls":12},"2"]
["湘械注准20152220045",null,"一次性使用人体静脉血样采集容器",{"$nulls":9},"2020-07-07","2025-06-29","2025-06-28","2030-06-28",{"$nulls":12},"2"]
["皖械注准20202400401",null,"肌酸激酶同工酶测定试剂盒（荧光免疫层析法）",{"$nulls":9},"2020-07-31","2025-07-30","2025-07-30","2030-07-29",{"$nulls":12},"2"]
["粤械注准20152401077",null,"脑自然肽N端前体蛋白测定试剂盒（化学发光法）","N末端B型利钠肽前体测定试剂盒（化学发光法）",{"$nulls":8},"2025-05-12",null,"2030-05-11",{"$nulls":13},"2"]
["国械注进20153033297",null,"PTCA扩张导管PTCA Dilatation Catheter","PTCA球囊扩张导管PTCA Dilatation Catheter",{"$nulls":8},"2020-07-20","2025-07-20","2025-07-19","2030-07-19",{"$nulls":12},"3"]
["国械注准20153141150",null,"一次性使用吊瓶式输液器 带针",{"$nulls":9},"2020-06-24","2025-06-24","2025-06-23","2030-06-23",{"$nulls":12},"3"]
["国械注准20203140664",null,"可吸收复合多聚糖止血粉",{"$nulls":9},"2020-07-27","2025-07-27","2025-07-26","2030-07-26",{"$nulls":12},"3"]
["苏械注准20152020805",null,"一次性使用直线切割吻（缝）合器","一次性使用直线切割吻合器及组件",{"$nulls":8},"2020-06-19","2025-06-19","2025-06-18","2030-06-18",{"$nulls":9},"一次性使用直线切割吻合器及组件由吻合器和组件组成。吻合器根据匹配的组件不同分为通用型吻合器和可拆换钉匣型组件专用吻合器。通用型吻合器按外观不同分为HJQ型和LC型可拆换钉匣型组件专用吻合器为HJQ60HY型号。HJQ 型吻合器由抵钉座、活动手柄、手柄、按钮、击发座、和组件(含缝钉)组成;LC型吻合器由抵钉座、钉座架、活动手柄、手柄、击发座和组件(含缝钉)组成。可拆换钉匣型组件专用吻合器由外管、旋转钮、转头扳手、击发手柄、释放钮、手柄和释放拉手组成。组件根据搭配的吻合器不同分为通用型组件和可拆换钉匣型组件。通用型组件由定位钉、钉仓、门栓、缝钉和推钉片组成;可拆换钉匣型组件由可拆换钉匣、抵钉座保护板、金属壳、连接杆、缝钉和切割刀组成。通用吻合器及组件按缝合长度分为60、80和100三种规格，按合厚度分为薄组织正常组织、稍厚组织和厚组织四种规格可拆换钉匣型组件专用吻合器只有一种规格，其组件按缝合长度分为45和60两种规格，按缝钉高度分为2.5、3.8和4.5三种规格。该产品以无菌状态提供，经辐照灭菌，一次性使用。",null,"适用于消化道重建及其它脏器切除手术中的吻合口创建及残端或切口的闭合。","2"]
["国械注准20153401719",null,"甲胎蛋白(AFP)测定试剂盒(上转发光法)",{"$nulls":9},"2020-08-20","2025-08-20","2025-08-19","2030-08-19",{"$nulls":12},"3"]
["川械注准20202400093",null,"综合Ⅱ生化测定试剂盘（微流控干化学法）",{"$nulls":9},"2020-06-30","2025-06-30","2025-06-29","2030-06-29",{"$nulls":12},"2"]
["国械注准20153031338",null,"网篮导丝",{"$nulls":9},"2020-07-10","2025-07-10","2025-07-09","2030-07-09",{"$nulls":12},"3"]
["国械注准20153401651",null,"甲胎蛋白检测试剂盒(化学发光法)",{"$nulls":6},"2024-10-24",null,null,"2020-08-21","2025-08-21","2025-08-20","2030-08-20",{"$nulls":9},"AFP预包被板(包被有鼠抗AFP单抗)、抗AFP-ALP标记物(含碱性磷酸酶标记羊抗AFP多抗)、AFP校准品(含不同浓度的AFP抗原，以牛血清配制而成)、AFP质控物(含一定量浓度的AFP抗原，以人血清配制而成)、浓缩清洗液(20X) (含表面活性剂、防腐剂)、发光底物液(含发光剂及增强剂)、样品稀释液(新生牛血清)、自封袋。(具体内容详见说明书)",null,"本产品用于体外定量检测人血清或肝素抗凝血浆样本中甲胎蛋白(AFP)的浓度。主要用于对恶性肿瘤患者进行动态监测以辅助判断疾病进程或治疗效果，不能作为恶性肿瘤早期诊断或确诊的依据，不能用于普通人群的肿瘤筛查。","3"]
["浙械注准20152400914",null,"糖化白蛋白检测试剂盒（酶法）",{"$nulls":9},"2020-07-02","2025-07-02","2025-07-01","2030-07-01",{"$nulls":12},"2"]
["浙械注准20152400909",null,"类风湿因子检测试剂盒（胶乳增强免疫比浊法）",{"$nulls":9},"2020-07-06","2025-07-06","2025-07-05","2030-07-05",{"$nulls":12},"2"]
["国械注进20143165890",null,"硅油 Silicone Oil",{"$nulls":6},"2025-04-27",null,null,"2020-05-20","2025-05-20","2025-05-19","2030-05-19",{"$nulls":12},"3"]
["粤械注准20152141448",null,"一次性使用护创材料",{"$nulls":9},"2020-10-29","2025-10-29","2025-10-28","2030-10-28",{"$nulls":12},"2"]
["鲁械注准20152400079",null,"胱氨酸蛋白酶抑制剂C检测试剂盒（免疫比浊法）",{"$nulls":9},"2019-12-10","2024-12-10","2024-12-09","2029-12-09",{"$nulls":12},"2"]
["浙械注准20202020713",null,"推结剪线器",{"$nulls":9},"2020-07-27","2025-07-27","2025-07-26","2030-07-26",{"$nulls":12},"2"]
["国械注准20203130528",null,"枕颈胸后路钉棒系统",null,"浙江嘉兴",{"$nulls":3},"2020-05-27","2025-02-17",null,null,"2020-05-27","2025-05-27","2025-05-26","2030-05-26",null,null,"浙江德康医疗器械有限公司",{"$nulls":5},"枕颈胸后路钉棒系统由椎弓根钉、钛棒、侧连、连接器（包括轴向连接器、多米诺连接器）、横连、枕骨螺钉、枕骨螺钉连接器、枕骨钛板、椎板钩、锁紧螺塞等组成。该产品由符合GB/T13810标准的TC4钛合金材料制造。产品表面经着色阳极氧化处理、黑灰色阳极氧化处理或表面无着色状态。非灭菌包装。",null,"该产品用于枕颈、颈椎、颈胸后路固定融合。",null,"3"]
["苏械注准20152021213",null,"一次性使用腹腔镜穿刺器","一次性使用腹腔镜穿刺器及套装",{"$nulls":8},"2020-07-01","2025-07-01","2025-06-30","2030-06-30",null,null,"芜湖华云创展医疗器械有限公司",{"$nulls":6},"一次性使用腹腔镜穿刺器及套装单支包 装：由穿刺芯、穿刺套管、弹簧和注气阀  组成，为一次性使用无菌产品。套装：由  穿刺器和选配附件气腹针、取物袋组成。\n穿刺器套装根据配置组合，为一次性使用无菌产品。一次性使用腹腔镜穿刺器根据  产品外观形状可分为：S 款、M 款、L 款三种款式。S款、M款根据穿刺套管内径分为 5.5、10.5、12.5 和 15.5 四种规格；L 款根据穿刺套管内径分为 3.5、5.5 二种规格 ；S 款和 M 款根据穿刺套管长度分为 A:60m m、B:100mm、C:120mm、D：150mm 四种规格。L 款根据穿刺套管长度分为 A:55mm、B:75mm、C:95mm、D:125mm 四种规格。穿刺器套装根据配置组合，可分为：T01-T18、T22-T39,共 36 种套装配置。该产品以无菌状态提供，经环氧乙烷灭菌。一次性使用。",null,null,"2"]
["国械注准20203010804",null,"超声软组织手术设备",{"$nulls":9},"2020-10-15",null,"2025-10-14","2030-10-14",{"$nulls":12},"3"]
["沪械注准20202020146",null,"输尿管导引鞘",{"$nulls":9},"2025-03-26",null,"2030-03-25",{"$nulls":10},"产品由导引鞘和扩张器组成。其中，导引鞘由导引鞘管和导引鞘接头组成，扩张器由扩张器导管和扩张器接头组成。导引鞘管由聚酰胺弹性体、304不锈钢和聚四氟乙烯制成，扩张器管由聚乙烯制成，导引鞘和扩张器的表面有亲水润滑涂层（聚乙烯吡咯烷酮），导引鞘接头（单腔型）由聚碳酸酯、硅胶制成，导引鞘接头（双腔型、三腔型）由聚酰胺弹性体制成，扩张器接头由聚丙烯制成。",null,null,"2"]
["国械注准20153141545",null,"密闭式静脉留置针",{"$nulls":9},"2020-07-13","2025-07-13","2025-07-12","2030-07-12",{"$nulls":12},"3"]
["国械注准20203140719",null,"预充式导管冲洗器",{"$nulls":9},"2020-08-31","2025-08-31","2025-08-30","2030-08-30",{"$nulls":12},"3"]
["国械注进20153172564",null,"氢氧化钙糊剂",{"$nulls":9},"2020-04-16","2025-04-16","2025-04-15","2030-04-15",{"$nulls":12},"3"]
["国械注准20153402066",null,"白色念珠菌、加德纳杆菌抗原联合检测试剂盒 （乳胶法）",{"$nulls":9},"2020-08-31","2025-08-31","2025-08-30","2030-08-30",{"$nulls":12},"3"]
["国械注准20203400674",null,"前列腺特异性抗原（PSA）测定试剂盒（化学发光免疫分析法）",{"$nulls":5},"2022-07-14","2024-11-25",null,null,"2020-07-31","2025-07-31","2025-07-30","2030-07-30",{"$nulls":9},"试剂1、试剂2、磁颗粒、校准品1、校准品2、校准品3（具体内容详见说明书）",null,"本试剂盒用于体外定量测定人血清中前列腺特异性抗原的浓度。主要用于对恶性肿瘤患者进行动态监测，以辅助判断疾病进程或者治疗效果，不能作为恶心肿瘤早期诊断或者确诊的依据，不能用于普通人群的肿瘤筛查。","3"]
["国械注准20193101981",null,"一次性使用动脉血液微栓过滤器",{"$nulls":9},"2019-09-12","2024-09-12","2024-09-11","2029-09-11",{"$nulls":12},"3"]
["湘械注准20202140225",null,"一次性使用医用口罩",{"$nulls":9},"2020-09-02","2025-09-02","2025-09-01","2030-09-01",{"$nulls":12},"2"]
["鲁械注准20142400081",null,"碱性磷酸酶测定试剂盒（NPP底物-AMP缓冲液法）",{"$nulls":9},"2019-12-02","2024-12-02","2024-12-01","2029-12-01",{"$nulls":12},"2"]
["鲁械注准20152400087",null,"总蛋白检测试剂盒（双缩脲法）",{"$nulls":9},"2019-12-31","2024-12-31","2024-12-30","2029-12-30",{"$nulls":12},"2"]
["国械注进20153172393",null,"牙本质牙釉质粘接剂",{"$nulls":9},"2020-06-18","2025-06-18","2025-06-17","2030-06-17",{"$nulls":12},"3"]
["苏械注准20152021083",null,"一次性使用自动荷包缝合器",{"$nulls":9},"2020-07-30","2025-07-07","2025-07-06","2030-07-06",{"$nulls":9},"一次性使用自动荷包缝合器（简称荷包器）由钉仓组件（PC）、荷包线(尼龙)、上下夹座（PPS）、保险杆（PC）、推钉片（PC）和钉（SUS）组成。荷包器有两排钉仓，钉仓内放置钉。根据荷包缝合长度不同分为APS45和APS65两种规格。该产品以无菌状态提供，经辐照灭菌或环氧乙烷灭菌。一次性使用。产品有效期为5年。",null,"供临床外科做荷包缝合用。","2"]
["国械注准20203130692",null,"锁定接骨板系统",null,"浙江嘉兴",{"$nulls":3},"2020-08-18","2025-01-26",null,null,"2020-08-18","2025-08-18","2025-08-17","2030-08-17",null,null,"浙江德康医疗器械有限公司",{"$nulls":5},"该产品由接骨螺钉和接骨板组成。接骨螺钉由符合GB/T 13810标准要求的TC4钛合金材料制成，接骨板由GB/T 13810标准要求的TA3G纯钛材料制成。产品表面经着色阳极氧化，非灭菌包装。","该产品由接骨螺钉和接骨板组成。接骨螺钉由符合GB/T 13810标准要求的TC4钛合金材料制成，接骨板由符合GB/T 13810标准要求的TA3G纯钛材料制成。产品表面经着色阳极氧化，非灭菌包装或灭菌包装。","该产品适用于骨科手术时四肢、锁骨、骨盆骨折内固定。",null,"3"]
["浙械注准20152400916",null,"亮氨酸氨基肽酶检测试剂盒（连续监测法）",{"$nulls":9},"2020-07-03","2025-07-03","2025-07-02","2030-07-02",{"$nulls":12},"2"]
["浙械注准20152400915",null,"乳酸脱氢酶同工酶1检测试剂盒（连续监测法）",{"$nulls":9},"2020-07-03","2025-07-03","2025-07-02","2030-07-02",{"$nulls":12},"2"]
["浙械注准20152400912",null,"甘氨酰脯氨酸二肽氨基肽酶检测试剂盒（连续监测法）",{"$nulls":9},"2020-07-03","2025-07-03","2025-07-02","2030-07-02",{"$nulls":12},"2"]
["浙械注准20152400911",null,"胃蛋白酶原Ⅱ 检测试剂盒（胶乳增强免疫比浊法）",{"$nulls":9},"2020-07-03","2025-07-03","2025-07-02","2030-07-02",{"$nulls":12},"2"]
["浙械注准20152400907",null,"抗链球菌溶血素“O” 检测试剂盒（胶乳增强免疫比浊法）",{"$nulls":9},"2020-07-06","2025-07-06","2025-07-05","2030-07-05",{"$nulls":12},"2"]
["国械注准20203130721",null,"半月板缝合系统",{"$nulls":9},"2020-08-31","2025-08-31","2025-08-30","2030-08-30",{"$nulls":12},"3"]
["川械注准20202400094",null,"综合Ⅲ生化测定试剂盘（微流控干化学法）",{"$nulls":9},"2020-06-30","2025-06-30","2025-06-29","2030-06-29",{"$nulls":12},"2"]
["国械注准20203130505",null,"氧化膜单铆房间隔缺损封堵器",{"$nulls":9},"2020-05-19","2025-05-19","2025-05-18","2030-05-18",{"$nulls":12},"3"]
["国械注准20203130560",null,"左心耳封堵器系统",{"$nulls":9},"2020-06-09","2025-06-09","2025-06-08","2030-06-08",{"$nulls":12},"3"]
["苏械注准20202400928",null,"血清淀粉样蛋白A/C反应蛋白二合一检测试剂盒（干式免疫荧光法）",{"$nulls":9},"2020-08-05","2025-08-05","2025-08-04","2030-08-04",{"$nulls":12},"2"]
["苏械注准20162020313",null,"一次性使用活体取样钳",{"$nulls":6},"2025-08-06",null,null,"2020-08-21","2025-08-21","2025-08-20","2030-08-20",{"$nulls":9},"一次性使用活体取样钳由钳头；不锈钢弹簧软管；手柄；滑块；针尖（部分型号适用）；包塑层（部分型号适用）组成。该产品以无菌状态提供，经环氧乙烷灭菌，一次性使用。",null,null,"2"]
["国械注准20203100791",null,"一次性使用补液管路",{"$nulls":9},"2020-10-09","2025-10-09","2025-10-08","2030-10-08",{"$nulls":8},"由主管、泵管、母针基、旋转接头、泵管直通接头，部分型号有支管、母针基盖、泵管T接头、大止血夹、小止血夹、冲洗接头、补液管螺纹接头、补液管螺纹接头盖、补液管T接头、补液管螺纹T接头、三通、硅胶圈、硅胶片、采样接头、补液管接头、单向阀、传感器保护器、气泡捕获器、气泡捕获器上盖、直管、锥套帽组成。环氧乙烷灭菌，一次性使用。",null,"用于血液透析滤过、血液滤过时作为补充置换液的管路，只适用于成人。",null,"3"]
["国械注准20153100871",null,"一次性使用腔静脉插管",{"$nulls":9},"2020-07-02","2025-07-02","2025-07-01","2030-07-01",{"$nulls":12},"3"]
["国械注准20203130289",null,"交锁髓内钉系统",null,"浙江嘉兴",{"$nulls":3},"2020-03-20","2024-07-09",null,null,"2020-03-20","2025-03-20","2025-03-19","2030-03-19",null,null,"浙江德康医疗器械有限公司",{"$nulls":5},"交锁髓内钉系统按使用部位可分为股骨粗隆髓内钉系统、股骨重建髓内钉系统、股骨倒置髓内钉系统、胫骨髓内钉系统和肱骨髓内钉系统，按部件可分为髓内钉主钉、锁钉、拉力钉以及配套使用的尾帽。所有组件均由TC4钛合金材料制造，符合GB/T13810 标准。产品表现经着色阳极氧化，交付状态为非灭菌状态。","交锁髓内钉系统按使用部位可分为股骨粗隆髓内钉系统、股骨重建髓内钉系统、股骨倒置髓内钉系统、胫骨髓内钉系统和肱骨髓内钉系统，按部件可分为髓内钉主钉、锁钉、拉力钉以及配套使用的尾帽。所有组件均由TC4钛合金材料制造，符合GB/T 13810 标准。产品表面经着色阳极氧化，交付状态为非灭菌状态。","交锁髓内钉系统主要适用于四肢骨折内固定。",null,"3"]
["国械注准20153401186",null,"戊型肝炎病毒IgM抗体测定试剂盒（化学发光免疫分析法）",{"$nulls":6},"2024-12-24",null,null,"2020-06-04","2025-06-04","2025-06-03","2030-06-03",{"$nulls":9},"磁颗粒、试剂1、试剂2、质控品、校准品1、校准品（具体内容详见说明书）",null,"本试剂盒用于体外定性检测人血清（浆）中的戊型肝炎病毒IgM抗体。","3"]
["渝械注准20202020170",null,"一次性使用包皮套扎器",{"$nulls":9},"2020-07-01","2025-07-01","2025-06-30","2030-06-30",{"$nulls":12},"2"]
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["京械注准20202400297",null,"胃泌素17测定试剂盒（磁微粒化学发光免疫分析法）",{"$nulls":9},"2020-08-05","2025-08-05","2025-08-04","2030-08-04",{"$nulls":12},"2"]
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["苏械注准20202140883",null,"一次性使用吸引连接管",{"$nulls":4},"苏州中天医疗器械科技有限公司",null,"2025-02-19",null,null,"2020-07-21","2025-07-21","2025-07-20","2030-07-20",{"$nulls":9},"一次性使用吸引连接管由压力延长管、直通接头、开关阀、连接套管和母鲁尔接头或鲁尔转接头组成，该产品以无菌状态提供，经环氧乙烷灭菌，一次性使用。",null,"用于体外连接负压吸引装置和吸引导管，供临床吸引用","2"]
["湘械注准20202140106",null,"活性因子生物敷料","高分子液体敷料",{"$nulls":8},"2020-08-31","2025-08-31","2025-08-30","2030-08-30",{"$nulls":11},"适用于Ⅰ度或浅Ⅱ度的烧烫伤创面；手术缝合创面；微整形术后创面；机械创伤、小创口、擦伤、切割伤创面及阴道炎、宫颈炎的护理。也可用于浅表性创面及周围皮肤清洗和防护。","2"]
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["皖械注准20202400399",null,"心肌肌钙蛋白I/肌酸肌酶同工酶/肌红蛋白三合一测定试剂盒（荧光免疫层析法）","心肌肌钙蛋白I/肌酸激酶同工酶/肌红蛋白三合一测定试剂盒（荧光免疫层析法）",{"$nulls":8},"2020-07-31","2025-07-30","2025-07-30","2030-07-29",{"$nulls":12},"2"]
["国械注准20203130645",null,"雷帕霉素药物洗脱椎动脉支架系统",{"$nulls":9},"2020-07-17","2025-09-16","2025-07-16","2030-09-15",{"$nulls":12},"3"]
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["粤械注准20202401187",null,"抗线粒体M2抗体IgG测定试剂盒（化学发光免疫分析法）","抗线粒体M2抗体IgG测定试剂盒（磁微粒化学发光法）",{"$nulls":8},"2020-08-10","2025-08-14","2025-08-09","2030-08-13",{"$nulls":12},"2"]
["粤械注准20202401188",null,"抗着丝点抗体IgG测定试剂盒（化学发光免疫分析法）","抗着丝点抗体IgG测定试剂盒（磁微粒化学发光法）",{"$nulls":8},"2020-08-10","2025-08-14","2025-08-09","2030-08-13",{"$nulls":12},"2"]
["京械注准20202400391",null,"泌乳素测定试剂盒（荧光免疫层析法）",{"$nulls":6},"2025-02-20",null,null,"2020-10-19","2025-10-19","2025-10-18","2030-10-18",{"$nulls":12},"2"]
["京械注准20202400386",null,"微量白蛋白测定试剂盒（荧光免疫层析法）",{"$nulls":6},"2025-02-27",null,null,"2020-10-19","2025-10-19","2025-10-18","2030-10-18",{"$nulls":12},"2"]
["京械注准20202400385",null,"睾酮测定试剂盒（荧光免疫层析法）",{"$nulls":6},"2025-04-23",null,null,"2020-10-19","2025-10-19","2025-10-18","2030-10-18",{"$nulls":12},"2"]
["苏械注准20152020377",null,"一次性使用痔吻合器及附件",{"$nulls":9},"2020-04-14",null,"2025-04-13",{"$nulls":13},"2"]
["滇械注准20202400122",null,"透明质酸测定试剂盒（比色法）",{"$nulls":9},"2020-07-30","2025-07-30","2025-07-29","2030-07-29",{"$nulls":9},"产品是由R1（Tris缓冲液 100mmol/L）、 R2（Tris缓冲液 100mmol/L、乳胶包被HA抗体 0.2%）、透明质酸校准品： 1×1ml（可选购） 透明质酸质控品： 1×1ml（可选购）组成。",null,"用于体外定量测定人血清中透明质酸（HA）的含量。临床上用于肝纤维化的辅助诊断。","2"]
["京械注准20202400389",null,"促卵泡生成素测定试剂盒（荧光免疫层析法）",{"$nulls":6},"2025-03-07",null,null,"2020-10-19","2025-10-19","2025-10-18","2030-10-18",{"$nulls":12},"2"]
["国械注准20203400585",null,"甲型/乙型流感病毒抗原检测试剂（免疫层析法）",{"$nulls":9},"2020-06-19","2025-06-19","2025-06-18","2030-06-18",{"$nulls":9},"甲型/乙型流感病毒抗原检测试剂条，裂解液，裂解管，裂解管滴头，工作台。（具体内容详见产品说明书）",null,"本产品用于体外定性检测人鼻腔拭子、口咽拭子样本中甲型/乙型流感病毒抗原。","3"]
["苏械注准20202021558",null,"一次性使用管型消化道吻合器",{"$nulls":6},"2025-05-09",null,null,"2020-10-10","2025-10-10","2025-10-09","2030-10-09",{"$nulls":9},"一次性使用管型消化道吻合器由抵钉座总成、吻切组件、器体（弯铝管）、固定手柄、活动手柄、保险、调节螺母、环形刀、吻合钉、 垫刀圈、附件（荷包接杆、穿刺头、套管）组成。产品根据吻切组件外径的不同分为 21、24、26、29、32 五种规格。该产品以无菌状态提供，经环氧乙烷灭菌，一次性使用。",null,null,"2"]
["国械注准20203030698",null,"非顺应性外周动脉血管球囊扩张导管",{"$nulls":9},"2020-08-18","2025-08-18","2025-08-17","2030-08-17",{"$nulls":12},"3"]
["皖械注准20202400400",null,"血清淀粉样蛋白A测定试剂盒（荧光免疫层析法）",{"$nulls":9},"2020-07-31","2025-07-30","2025-07-30","2030-07-29",{"$nulls":12},"2"]
["苏械注准20152020368",null,"镍钛记忆合金缝合线",{"$nulls":9},"2020-04-27","2025-06-17","2025-04-26","2030-06-16",{"$nulls":12},"2"]
["粤械注准20202080242",null,"婴儿呼吸管路套件",{"$nulls":9},"2020-03-06","2025-03-06","2025-03-05","2030-03-05",{"$nulls":9},"有创婴儿管路由Y型接头、管路、接水杯、端口接头、加热导丝、电源专用接头、湿化罐、单管、气阻短管、测压管、转接头、可选配件、 带氧气管和接头组成。无创婴儿管路由婴儿发生器(鼻塞/鼻罩)、鼻导管、帽子、管路、接水杯、端口接头、加热导丝、电源专用接头、湿化罐、单管、气阻短管、呼气延长管、测压管、转接头、可选配件、带氧气管和接头组成。T型管路由管路、T型主体、PEEP阀、盖帽和端口接头组成。所有型号规格可根据临床需求选配一个或多个或不选，可选配件包括单管、呼气延长管、气阻短管、Y型件、22M/22M(15F)连接器、 15M/22F连接器、15M/15M连接器、22F/15F转接头、90度15M/22M(15F)连接器、90度22F/22M(15F)连接器、软接头、12M11M接头、11M15M(12F)接头、7.8mm接头、15F12m接头、T型接头、带接管吸痰接头、测压接头、测温接头、管路连接器、22F/6M连接器、延长短管、延长短管A、接水杯、接水杯A、接水杯B、婴儿发生器（鼻塞）、婴儿发生器（鼻罩）、帽子、鼻导管、测压管、测压管（带阻水器）、氧气管、雾化器、普通型过滤器、皱纸型过滤器、复合型过滤器、温湿型过滤器、婴儿面罩、方型过滤盖帽、螺旋盖帽。",null,"用于与呼吸辅助设备配套一次性使用，为婴儿建立一个呼吸连接通道。","2"]
["京械注准20202400296",null,"抗缪勒管激素测定试剂盒（磁微粒化学发光免疫分析法）",{"$nulls":9},"2020-08-05","2025-08-05","2025-08-04","2030-08-04",{"$nulls":12},"2"]
["粤械注准20162080019",null,"一次性使用呼吸过滤器包",{"$nulls":9},"2020-09-28","2025-09-28","2025-09-27","2030-09-27",{"$nulls":12},"2"]
["冀械注准20202400638",null,"肾素测定试剂盒（磁微粒化学发光免疫分析法）",{"$nulls":9},"2020-11-03","2025-11-03","2025-11-02","2030-11-02",{"$nulls":12},"2"]
["苏械注准20152021219",null,"一次性使用冲洗引流管",{"$nulls":9},"2020-09-03","2025-09-03","2025-09-02","2030-09-02",{"$nulls":12},"2"]
["赣械注准20202140589",null,"一次性使用医用口罩",{"$nulls":9},"2020-10-09","2025-10-09","2025-10-08","2029-10-08",{"$nulls":9},"由口罩体、鼻夹和口罩带组成。本产品为三层，内外层主要原材料为PP无纺布复合材料，中间层为聚丙烯熔喷布，鼻梁条为可塑性金属材质，耳带为弹性带。产品经环氧乙烷灭菌，产品无菌。",null,null,"2"]
["赣械注准20202140586",null,"一次性使用手术衣",{"$nulls":9},"2020-10-09","2025-10-09","2025-10-08","2029-10-08",{"$nulls":9},"产品由非织造布或淋膜非织造布及胸部位置覆盖一层聚乙烯膜组成。分前身、后身、袖子、系带等部分。其中加强型在灭菌型的基础上，在袖口位置覆盖了一层聚乙烯膜。",null,null,"2"]
["沪普械备20190001号","沪宝械备20250027","胸部固定板",{"$nulls":6},"2025-04-29",null,null,"2019-01-16","2025-04-29","2099-12-31",{"$nulls":13},"1"]
["苏械注准20152020376",null,"一次性使用组织闭合夹",{"$nulls":9},"2025-04-14","2025-04-14","2030-04-13","2030-04-13",{"$nulls":8},"一次性使用组织闭合夹由结扎锁、固定盖和底座组成，根据尺寸不同分为大、中、小三种型号。产品以无菌状态提供，经环氧乙烷灭菌，一次性使用。",{"$nulls":3},"2"]
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["京械注准20172400105",null,"肌红蛋白（MYO）测定试剂盒（磁微粒化学发光法）",{"$nulls":6},"2025-02-13",null,null,"2020-10-28","2025-10-28","2025-10-27","2030-10-27",{"$nulls":11},"本产品用于体外定量测定人血清或血浆中的肌红蛋白（MYO）含量。","2"]
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["国械注准20153142012",null,"输液用肝素帽",{"$nulls":9},"2020-07-23","2025-07-13","2025-07-22","2030-07-12",{"$nulls":12},"3"]
["国械注准20203030699",null,"非顺应性外周球囊扩张导管",{"$nulls":6},"2024-11-28",null,null,"2020-08-18","2025-08-18","2025-08-17","2030-08-17",{"$nulls":9},"该产品主要由球囊、外管、内管、管座、缓冲管和显影标记等组成，涂有聚乙烯吡咯烷酮亲水涂层。球囊、外管、内管及管座材料均为尼龙12，缓冲管材料为PVC，显影标记材料为铂铱合金(90％铂10％铱)。一次性使用，环氧乙烷灭菌。货架有效期三年。",null,"该产品适用于髂动脉、股动脉、腘动脉、胫动脉、腓动脉以及肾动脉等外周动静脉血管的经皮腔内血管成形术(PTA),并适用于治疗天然或人造透析用动静脉瘘的狭窄或堵塞病变。","3"]
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["京械注准20202400388",null,"雌二醇测定试剂盒（荧光免疫层析法）",{"$nulls":6},"2025-03-25",null,null,"2020-10-19","2025-10-19","2025-10-18","2030-10-18",{"$nulls":12},"2"]
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["国械注进20153033916",null,"微导管 Trevo Pro 18 Microcatheter",{"$nulls":9},"2020-10-13","2025-10-13","2025-10-12","2030-10-12",{"$nulls":12},"3"]
["国械注准20203130548",null,"金属骨针",{"$nulls":9},"2020-06-09","2025-06-09","2025-06-08","2030-06-08",{"$nulls":9},"金属骨针由符合GB/T 13810中规定的TC4钛合金材料制造，表面有未经阳极氧化和经着色阳极氧化处理两种。产品以灭菌和非灭菌两种状态交付，以灭菌状态交付的产品采用辐照灭菌，灭菌有效期5年。",null,"单独使用或与外固定支架配合使用，适用于四肢骨折复位时部分植入人体做牵引或四肢骨折内固定。","3"]
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["国械注准20163220454",null,"一次性使用静脉采血针",{"$nulls":9},"2020-10-23","2025-10-23","2025-10-22","2030-10-22",{"$nulls":12},"3"]
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["国械注准20203130790",null,"不可吸收带线锚钉",{"$nulls":9},"2020-10-09","2025-10-09","2025-10-08","2030-10-08",{"$nulls":9},"不可吸收带线锚钉由锚钉（带钉翼或不带钉翼）、插入器和缝线（带缝合针或不带缝合针）组成。锚钉由符合GB/T 13810标准规定的TC4（Ti6Al4V）钛合金材料制成，表面经黑灰色阳极氧化处理。锚钉钉翼由符合GB 24627标准规定的镍钛记忆合金材料制成，表面未经阳极氧化处理。缝线有两种单股编织缝线：白线和蓝白线。其中白线由超高分子量聚乙烯材料制成；蓝白线由超高分子量聚乙烯和聚丙烯材料制成，并含有符合USP要求的酞菁铜蓝色染料（CAS ：147-14-8）。缝合针由符合GB/T 4240标准规定的12Cr18Ni9不锈钢材料制成。该产品预装插入器，插入器与人体接触部分由符合ASTM F899规定的316或630不锈钢制成。产品采用环氧乙烷灭菌，灭菌有效期5年。",null,"该产品用于软组织从骨性结构撕脱或撕裂的修复手术，适用于骨与软组织的连接固定。","3"]
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["浙械注准20162010109",null,"一次性使用中性电极板",{"$nulls":9},"2020-09-29","2025-09-29","2025-09-28","2030-09-28",{"$nulls":12},"2"]
["苏械注准20162400416",null,"绒毛膜促性腺激素及β亚单位检测试剂盒（干式免疫荧光法）",{"$nulls":9},"2020-10-12","2025-10-12","2025-10-11","2030-10-11",{"$nulls":12},"2"]
["国械注准20153402109","闽械注准20152402109","肿瘤相关抗原CA125检测试剂盒(化学发光法)",{"$nulls":6},"2025-04-01",null,null,"2020-10-29","2025-10-29","2025-10-28","2030-10-28",{"$nulls":12},"2"]
["浙械注准20202140762",null,"水胶体敷料",{"$nulls":9},"2020-09-02","2025-09-02","2025-09-01","2030-09-01",{"$nulls":12},"2"]
["国械注准20153141739",null,"创伤负压引流套装",{"$nulls":9},"2020-09-27","2025-09-27","2025-09-26","2030-09-26",{"$nulls":12},"3","3"]
["国械注进20153141034",null,"引流导管",{"$nulls":9},"2020-05-26","2025-05-26","2025-05-25","2030-05-25",{"$nulls":12},"3"]
["苏械注准20162400415",null,"人绒毛膜促性腺激素检测试剂盒（胶体金法）",{"$nulls":9},"2020-10-10","2025-10-10","2025-10-09","2030-10-09",{"$nulls":12},"2"]
["苏械注准20202011080",null,"射频消融用针状电极",{"$nulls":9},"2020-09-28","2025-09-28","2025-09-27","2030-09-27",{"$nulls":11},"该产品与工作频率在200kHz~750kHz的射频手术设备配合使用，供临床用于非内窥镜外科手术中，对肝、肺、肾、胆、脾、甲状腺、乳腺、子宫附件、下肢静脉部位组织的消融、凝血治疗。","2"]
["国械注准20203010799",null,"一次性使用旋转型乳头括约肌切开刀",{"$nulls":9},"2020-10-16","2025-10-16","2025-10-15","2030-10-15",{"$nulls":12},"3"]
["国械注准20163400077",null,"耐万古霉素肠球菌基因(vanA,vanB)检测试剂盒（荧光 PCR 法）",{"$nulls":9},"2020-07-03","2025-07-03","2025-07-02","2030-07-02",{"$nulls":12},"3"]
["国械注进20162400911",null,"C-反应蛋白检测试剂盒(免疫比浊法)",{"$nulls":9},"2020-10-27","2025-10-27","2025-10-26","2030-10-26",{"$nulls":12},"2"]
["粤械注准20162061066",null,"微创外科专用切除组织取出器",{"$nulls":6},"2025-03-20",null,null,"2020-11-09","2025-11-09","2025-11-08","2030-11-08",{"$nulls":9},"标准型由外鞘管、内鞘管、前手柄、后手柄、张开装置和纳物袋组成；A型由收口线和纳物袋组成；C型由外鞘管、中鞘管、内鞘管、前手柄、后手柄、张开装置、收口线和纳物袋组成；S型由外鞘管、内鞘管、前手柄、后手柄、张开装置和纳物袋组成；D型由纳物袋、张开装置、外鞘管、前手柄、后手柄、牵引带、收口线组成；F型有下侧耳、纳物袋、收口线、上侧耳组成。",null,"适用于微创外科手术时将切除的体内病变组织取出体外。","2"]
["粤械注准20162400789",null,"肌酸激酶同工酶（CK-MB）测定试剂盒（化学发光免疫分析法）",{"$nulls":6},"2024-08-02",null,null,"2020-10-22","2025-10-22","2025-10-21","2025-10-21",{"$nulls":12},"2"]
["粤械注准20162400749",null,"特定蛋白复合质控品",{"$nulls":6},"2024-11-29",null,null,"2020-10-22","2025-08-14","2025-10-21","2030-08-13",{"$nulls":12},"2"]
["粤械注准20162400747",null,"特定蛋白复合校准品",{"$nulls":6},"2024-11-29",null,null,"2020-08-14","2025-08-14","2025-08-13","2030-08-13",{"$nulls":12},"2"]
["豫械注准20202171259",null,"医用口腔包",{"$nulls":9},"2020-09-28","2025-09-28","2025-09-27","2030-09-27",{"$nulls":12},"2"]
["苏械注准20162400419",null,"肌酸激酶同工酶检测试剂盒（化学发光免疫分析法）",{"$nulls":9},"2020-10-12","2025-10-12","2025-10-11","2030-10-11",{"$nulls":12},"2"]
["国械注进20162400907",null,"免疫球蛋白A测定试剂(免疫比浊法)",{"$nulls":9},"2020-09-28","2025-09-28","2025-09-27","2030-09-27",{"$nulls":12},"2"]
["湘械注准20202401407",null,"花生F013过敏原特异性IgE抗体检测试剂盒(荧光免疫法)",{"$nulls":7},"2022-11-10",null,"2020-08-18","2025-08-18","2025-08-17","2030-08-17",{"$nulls":12},"2"]
["国械注进20162400908",null,"免疫球蛋白M测定试剂盒(免疫比浊法)",{"$nulls":9},"2020-09-28","2025-09-28","2025-09-27","2030-09-27",{"$nulls":12},"2"]
["湘械注准20202401728",null,"百慕达草G002过敏原特异性IgE抗体检测试剂盒(荧光免疫法)",{"$nulls":7},"2022-11-09",null,"2020-12-03","2025-12-03","2025-12-02","2030-12-02",{"$nulls":12},"2"]
["湘械注准20162400066",null,"二氧化碳测定试剂盒（PEP-C法）",{"$nulls":9},"2020-12-11","2025-12-11","2025-12-10","2030-12-10",{"$nulls":12},"2"]
["苏械注准20202141101",null,"一次性使用髂骨穿刺针",{"$nulls":9},"2020-10-13","2025-10-13","2025-10-12","2030-10-12",{"$nulls":12},"2"]
["京械注准20202400517",null,"血清淀粉样蛋白A（SAA）质控品",{"$nulls":6},"2025-04-10",null,null,"2020-12-17","2025-12-17","2025-12-16","2030-12-16",{"$nulls":11},"与本公司生产的血清淀粉样蛋白A（SAA）测定试剂盒（胶乳增强免疫比浊法）配套使用，用于室内质量控制。","2"]
["国械注进20162221890",null,"糖化血红蛋白层析柱COLUMN UNIT",{"$nulls":9},"2020-08-06","2025-08-06","2025-08-05","2030-08-05",{"$nulls":12},"2"]
["国械注准20163400799",null,"呼吸道合胞病毒A型和B型核酸检测试剂盒（荧光PCR法）",{"$nulls":9},"2020-11-02","2025-11-02","2025-11-01","2030-11-01",{"$nulls":12},"3"]
["国械注准20203030870",null,"冠脉药物释放球囊扩张导管",{"$nulls":9},"2020-11-09",null,"2025-11-08","2030-11-08",{"$nulls":12},"3"]
["国械注进20162180714",null,"胎头真空吸引器（Kiwi Vacuum Delivery System)",{"$nulls":9},"2020-11-23","2025-11-23","2025-11-22","2030-11-22",{"$nulls":12},"2"]
["国械注准20203400849",null,"游离前列腺特异性抗原（fPSA）测定试剂盒（化学发光免疫分析法）",{"$nulls":5},"2022-10-10","2025-01-07",null,null,"2020-11-09","2025-11-09","2025-11-08","2030-11-08",{"$nulls":12},"3"]
["京械注准20202400522",null,"免疫七项校准品",{"$nulls":9},"2020-12-17","2025-12-17","2025-12-16","2030-12-16",{"$nulls":9},"校准品（冻干粉）：在血清基质中，添加表1中的物质。\n表 1  组成及目标浓度范围\n序号 项目名称（缩写） 检测方法 生物学来源 目标浓度范围 单位\n1 免疫球蛋白A(IgA) 免疫比浊法 人源 4.8-6.0 g/L\n2 免疫球蛋白G(IgG) 免疫比浊法 人源 26-30 g/L\n3 免疫球蛋白M(IgM) 免疫比浊法 人源 2.1-3.1 g/L\n4 补体C3(C3) 免疫比浊法 人源 2.5-4.0 g/L\n5 补体C4(C4) 免疫比浊法 人源 0.5-0.9 g/L\n6 前白蛋白(PALB) 免疫比浊法 重组 700-1050 mg/L\n7 转铁蛋白(TRF) 免疫比浊法 重组 4.6-7.8 g/L",null,"本产品与本公司生化项目测定试剂盒配套使用，用于临床检验系统的校准。本产品包含以下 7 个项目：免疫球蛋白 A(IgA)、免疫球蛋白 G(IgG)、免疫球蛋白 M(IgM)、补体 C3(C3)、补体 C4(C4)、前白蛋白(PALB)、转铁蛋白(TRF)。","2"]
["苏械注准20162400418",null,"N-端脑利钠肽前体检测试剂盒（化学发光免疫分析法）",{"$nulls":9},"2023-06-01","2025-09-25","2025-09-24","2030-09-24",{"$nulls":12},"2"]
["湘械注准20202401489",null,"大豆F014过敏原特异性IgE抗体检测试剂盒(荧光免疫法)",{"$nulls":7},"2022-11-10",null,"2020-09-14","2025-09-14","2025-09-13","2030-09-13",{"$nulls":12},"2"]
["湘械注准20202401536",null,"IgE质控品",{"$nulls":7},"2022-11-10",null,"2020-09-22","2025-09-22","2025-09-21","2030-09-21",{"$nulls":12},"2"]
["苏械注准20202071701",null,"穿戴式心电传感器",{"$nulls":9},"2020-12-08","2025-12-08","2025-12-07","2030-12-07",{"$nulls":12},"2"]
["湘械注准20202011694",null,"射频消融用针状电极",{"$nulls":9},"2020-11-16",null,"2025-11-15","2030-11-15",{"$nulls":12},"2"]
["冀械注准20162400141",null,"人绒毛膜促性腺激素检测试剂盒(免疫荧光法)",{"$nulls":6},"2025-06-08",null,null,"2020-12-18","2025-12-18","2025-12-17","2030-12-17",{"$nulls":9},"由试剂1和试剂2两部分组成。试剂1（反应杯）（主要组成部分：三羟基甲基氨基甲烷缓冲液1mol/L；抗人绒毛膜促性腺激素抗体，＞70mg/L；脱氧核糖核酸（DNA）多聚酶，＞10U；三磷酸脱氧核糖核酸（dNTP），10mmol/L；DNA染料）；试剂2（主要组成成分：三羟甲基氨基甲烷缓冲液，1mol/L；单克隆抗体特异性结合抗原决定簇-DNA欧联模板，＞70mg/L）",null,"用于体外定量检测人体血清中人绒毛膜促性腺激素（HCG）的含量。","2"]
["湘械注准20202401681",null,"涎液化糖链抗原（KL-6）检测试剂盒（磁微粒化学发光法）",{"$nulls":9},"2020-11-10",null,"2025-11-09","2030-11-09",{"$nulls":12},"2"]
["浙械注准20202400858",null,"游离脂肪酸检测试剂盒（酶法）",{"$nulls":9},"2020-11-25","2025-11-25","2025-11-24","2030-11-24",{"$nulls":12},"2"]
["浙械注准20202400859",null,"β-羟丁酸检测试剂盒（酶法）",{"$nulls":8},"2025-11-25","2020-11-25","2030-11-24","2024-11-24",{"$nulls":13},"2"]
["浙械注准20202400886",null,"天门冬氨酸氨基转移酶线粒体同工酶检测试剂盒（免疫抑制法）",{"$nulls":9},"2020-12-10","2025-12-10","2025-12-09","2030-12-09",{"$nulls":12},"2"]
["国械注准20203400855","苏械注准20252400490","糖类抗原242（CA242）测定试剂盒（化学发光免疫分析法）","糖类抗原242测定试剂盒（化学发光免疫分析法）",{"$nulls":4},"2023-09-25","2025-03-25",null,null,"2020-11-03","2025-11-03","2025-11-02","2030-11-02",{"$nulls":9},"试剂 1：内含有生物素标记抗糖类抗原 242 单克隆抗体（小鼠），蛋白缓冲液，0.1%Proclin300；\n试剂 2：内含有吖啶酯标记抗糖类抗原 242 单克隆抗体（小鼠），蛋白缓冲液，0.1%Proclin300；\n磁颗粒：内含链霉亲和素标记的磁颗粒，经防腐处理；\n校准品 1：内含人源性的糖类抗原 242 抗原（约20.0U/mL±20%），蛋白缓冲液，0.1%Proclin300\n校准品 2：内含人源性的糖类抗原 242 抗原（约100.0U/mL±20%），蛋白缓冲液，0.1%Proclin300\n校准品 3：内含人源性的糖类抗原 242 抗原（约50.0U/mL±20%），蛋白缓冲液，0.1%Proclin300。\n（溯源性：溯源至企业内部校准品）",null,"用于体外定量检测人血清样本中糖类抗原242（CA242）的含量，临床上用于胰腺癌、结直肠癌消化道恶性肿瘤的疗效监测。不能作为恶性肿瘤早期诊断或确诊的依据，不能用于普通人群的肿瘤筛查。","2","2"]
["湘械注准20202401496",null,"车前草W009过敏原特异性IgE抗体检测试剂盒(荧光免疫法)",{"$nulls":7},"2022-11-09",null,"2020-09-14","2025-09-14","2025-09-13","2030-09-13",{"$nulls":12},"2"]
["粤械注准20162400934",null,"N端前体脑钠肽（NT-ProBNP）测定试剂盒（化学发光免疫分析法）",{"$nulls":6},"2024-07-05",null,null,"2020-10-22","2025-10-22","2025-10-21","2030-10-21",{"$nulls":12},"2"]
["冀械注准20162400135",null,"N端脑钠肽前体检测试剂盒（免疫荧光法）",{"$nulls":6},"2025-01-09",null,null,"2020-11-25","2025-11-25","2025-11-24","2030-11-24",{"$nulls":9},"由试剂1和试剂2两部分组成。试剂1（反应杯）（主要组成成分：三羟甲基氨基甲烷缓冲液，1mol/L；抗N端脑钠肽前体抗体，＞70mg/L；脱氧核糖核酸（DNA）多聚酶，＞10U；三磷酸脱氧核糖核酸（dNTP），10mmol/L；DNA染料）；试剂2（主要组成成分：三羟甲基氨基甲烷缓冲液，1mol/L；单克隆抗体特异性结合抗原决定簇-DNA偶联模板，＞70mg/L)。",null,"用于体外定量检测人体血清或全血中N端脑钠肽前体（NT-Pro BNP）的含量。","2"]
["国械注进20162140665",null,"一次性使用活检针Biopsy Needle",null,null,"美国",null,"爱琅（上海）医疗器械有限公司",null,"2023-04-13",null,null,"2020-10-26","2025-10-26","2025-10-25","2030-10-25",{"$nulls":3},"爱琅（上海）医疗器械有限公司",null,"Argon Medical Devices, Inc",{"$nulls":3},"一次性使用活检针含活检针、引导针； 活检针由针管、针芯、上膛扳机、手柄、安全锁、激发按钮组成。配套的引导针由针管、针芯、针管座、针芯座组成。活检针： 针管和针芯的材料均为304不锈钢； 上膛扳机材料为聚碳酸酯； 安全锁、激发按钮材料均为ABS工程塑料， 01型活检针的手柄材料为ABS工程塑料； 02、03型活检针的手柄材料为聚碳酸酯。引导针： 针管及针芯的材料为304不锈钢； 针管座材料为K-Resin； 针芯座材料ABS工程塑料。产品经环氧乙烷灭菌。",null,"活检针适用于人体肝、肾、肺、腹部包块等软组织的样本获取。","2"]
["国械注准20203030935",null,"切割球囊系统",{"$nulls":6},"2025-06-09",null,null,"2020-12-01","2025-12-01","2025-11-30","2030-11-30",{"$nulls":9},"该产品为快速交换型球囊扩张导管，主要由球囊、外管、内管、加强丝、管座、显影标记、尖端管、缓冲管等组成，涂有聚乙烯吡咯烷酮亲水涂层。球囊材料为嵌段聚醚酰胺弹性体，球囊上有3组或4组不锈钢刀片纵向安装在球囊上，外管、内管及管座材料为尼龙11、聚乙烯、不锈钢管和聚碳酸酯，显影标记材料为铂铱合金。环氧乙烷灭菌，一次性使用，货架有效期三年。",null,"切割球囊系统适用于患有冠状动脉血管存在粥样硬化斑块需要切割处理的患者，在紧急情况下可接受冠状动脉旁路移植（CABG）手术的患者。此外靶病变还应具有以下特征：病变长度≤20mm的局限性病变；参考血管直径(RVD）为2.00mm-4.00mm；器械容易进入；近侧血管段弯曲度为轻度或中度；病变段非成角（＜45°）；血管造影轮廓平滑；不存在血管造影可以看见的血栓。","3"]
["豫械注准20192020277",null,"一次性使用备皮包",{"$nulls":9},"2019-06-06","2024-06-06","2024-06-05","2029-06-05",{"$nulls":12},"2"]
["湘械注准20202401535",null,"牛奶F002过敏原特异性IgE抗体检测试剂盒(荧光免疫法)",{"$nulls":7},"2022-11-09",null,"2020-09-22","2025-09-22","2025-09-21","2030-09-21",{"$nulls":12},"2"]
["湘械注准20202401497",null,"鱼（鳕鱼）F003过敏原特异性IgE抗体检测试剂盒(荧光免疫法)",{"$nulls":7},"2022-11-09",null,"2020-09-14","2025-09-14","2025-09-13","2030-09-13",{"$nulls":12},"2"]
["国械注进20163170171",null,"通用型自粘接树脂水门汀",{"$nulls":9},"2020-08-18","2025-08-18","2025-08-17","2030-08-17",{"$nulls":12},"3"]
["冀械注准20162400151",null,"免疫球蛋白E检测试剂盒（速率散射比浊法）",{"$nulls":6},"2025-01-24",null,null,"2020-11-25","2025-11-25","2025-11-24","2030-11-24",{"$nulls":9},"由试剂1和试剂2两部分组成。试剂1（反应杯）（主要组成成分：磷酸盐缓冲液（pH7.0），50mmol/L；聚乙二醇6000，5%）；试剂2（主要组成成分：羊抗人免疫球蛋白E抗体胶乳颗粒，＞50mg/L).",null,"用于体外定量检测人体血清中免疫球蛋白E（IgE）的含量。","2"]
["渝械注准20202020120",null,"皮肤创口闭合器",{"$nulls":9},"2020-05-12","2025-05-12","2025-05-11","2030-05-11",{"$nulls":12},"2"]
["冀械注准20162400149",null,"免疫球蛋白M检测试剂盒（速率散射比浊法）",{"$nulls":6},"2025-01-24",null,null,"2020-11-24","2025-11-24","2025-11-23","2030-11-23",{"$nulls":9},"由试剂1和试剂2两部分组成。试剂1（反应杯）（主要组成成分：磷酸盐缓冲液（pH7.2），200mmol/L；聚乙二醇6000，6%）；试剂2（主要组成成分：羊抗人免疫球蛋白M抗体，50mg/L).",null,"用于体外定量检测人体血清中免疫球蛋白M（IgM）的含量。","2"]
["冀械注准20162400131",null,"C反应蛋白(hsCRP+常规CRP)检测试剂盒 （速率散射比浊法）",{"$nulls":6},"2025-01-22",null,null,"2020-11-25","2025-11-25","2025-11-24","2030-11-24",{"$nulls":9},"由试剂1和试剂2两部分组成。试剂1（反应杯）（主要组成成分：磷酸盐缓冲液（pH7.0），0.1mol/L；聚乙二醇6000，5%）；试剂2（主要组成成分：抗C反应蛋白抗体胶乳颗粒，150mol/L；磷酸盐缓冲液（pH8.0）,0.1mol/L).",null,"用于体外定量检测人体全血中C反应蛋白（CRP）的含量。","2"]
["国械注准20203060646",null,"胃肠X射线检查标记的胶囊",{"$nulls":9},"2020-07-17","2025-09-29","2025-07-16","2030-09-28",{"$nulls":12},"3"]
["豫械注准20202141293",null,"一次性使用手术衣",{"$nulls":9},"2020-10-16","2025-10-16","2025-10-15","2030-10-15",{"$nulls":12},"2"]
["豫械注准20202141270",null,"一次性使用医用帽",{"$nulls":9},"2020-09-30","2025-09-30","2025-09-29","2030-09-29",{"$nulls":12},"2"]
["京械注准20202400518",null,"血清淀粉样蛋白A（SAA）测定试剂盒（胶乳增强免疫比浊法）",{"$nulls":6},"2025-03-27",null,null,"2020-12-17","2025-12-17","2025-12-16","2030-12-16",{"$nulls":11},"本产品用于体外定量测定人血清样本中血清淀粉样蛋白A（SAA）的含量。","2"]
["京械注准20202400514",null,"25羟基维生素D（25-OH VD）质控品",{"$nulls":6},"2025-04-23",null,null,"2020-12-17","2025-12-17","2025-12-16","2030-12-16",{"$nulls":11},"与本公司生产的25羟基维生素D（25-OH VD）测定试剂盒（胶乳增强免疫比浊法）配套使用，用于室内质量控制。","2"]
["国械注进20163100675",null,"一次性使用血液透析滤过器及配套管路oXiris Set",{"$nulls":9},"2020-10-15","2025-10-15","2025-10-14","2030-10-14",{"$nulls":12},"3"]
["国械注进20163101045",null,"一次性使用血液透析滤过器及配套管路",{"$nulls":9},"2020-11-02","2025-11-02","2025-11-01","2030-11-01",{"$nulls":12},"3"]
["苏械注准20202141099",null,"一次性使用骨髓穿刺针",{"$nulls":9},"2020-10-13","2025-10-13","2025-10-12","2030-10-12",{"$nulls":9},"一次性使用骨髓穿刺针由管心针座（辅助钕磁片）、导管座、导管、管心针、安全帽组成。该产品以无菌状态提供，经环氧乙烷灭菌。一次性使用。",null,"供临床配合电动骨钻或手动使用，用于对胫骨近端及远端、肱骨近端、股骨远端建立药物输注通道。","2"]
["苏械注准20202021158",null,"一次性腔镜直线型切割吻合器及组件",{"$nulls":6},"2025-08-13",null,null,"2020-10-23","2025-10-23","2025-10-22","2030-10-22",{"$nulls":9},"一次性腔镜直线型切割吻合器及组件包括一次性腔镜直线型切割吻合器和一次性腔镜直线型切割组件，吻合器器身的型号为KHQJ型，组件的型号为KHQJR型；吻合器器身根据器身套管长度不同分为60、160和260三种规格。组件根据有效缝合长度分为30、45、60三种规格；根据吻合钉高度不同分为四种，分别用字母G、T、P、B表示。一次性腔镜直线型切割吻合器及组件由抵钉座、钉仓、钉仓支架、组件套管、器身套管、转向手柄、转动把手、固定手柄、击发手柄、复位块、复位把手、吻合钉和切割刀组成。组件为独立包装。该产品以无菌状态提供，经环氧乙烷灭菌，一次性使用。",null,null,"2"]
["冀械注准20162400153",null,"脂蛋白磷脂酶A2检测试剂盒（速率散射比浊法）",{"$nulls":6},"2025-01-22",null,null,"2020-11-25","2025-11-25","2025-11-24","2030-11-24",{"$nulls":9},"由试剂1和试剂2两部分组成。试剂1（反应杯）（主要组成成分：磷酸盐缓冲液（pH7.2），0.1mol/L；聚乙二醇6000，5.8%）；试剂2（主要组成成分：抗脂蛋白磷脂酶A2抗体胶乳颗粒，＞1mg/L)。",null,"用于体外定量检测人体血清中脂蛋白磷脂酶A2（Lp-PLA2）的含量。","2"]
["冀械注准20162400152",null,"脂蛋白(a) 检测试剂盒（速率散射比浊法）",{"$nulls":6},"2025-01-22",null,null,"2020-11-24","2025-11-24","2025-11-23","2030-11-23",{"$nulls":9},"由试剂1和试剂2两部分组成。试剂1（反应杯）（主要组成成分：磷酸盐缓冲液（pH7.2）,0.1mol/L；聚乙二醇6000,1.8%）；试剂2（主要组成成分：抗人脂蛋白（a）抗体胶乳颗粒，30ml/L).",null,"用于体外定量检测人体血清中脂蛋白（a）的含量。","2"]
["苏械注准20202071679",null,"穿戴式心电传感器",{"$nulls":9},"2020-11-27","2025-11-27","2025-11-26","2030-11-26",{"$nulls":12},"2"]
["苏械注准20202071702",null,"穿戴式心电传感器",{"$nulls":9},"2020-12-08","2025-12-08","2025-12-07","2030-12-07",{"$nulls":12},"2"]
["豫械注准20202081297",null,"医用喉罩",{"$nulls":9},"2020-10-16","2025-10-16","2025-10-15","2030-10-15",{"$nulls":12},"2"]
["豫械注准20202140574",null,"一次性使用脐带保护包",{"$nulls":9},"2020-09-14","2025-09-14","2025-09-13","2030-09-13",{"$nulls":12},"2"]
["国械注准20163400148","京械注准20242400302","糖类抗原CA19-9测定试剂盒（磁微粒化学发光法）",{"$nulls":6},"2024-06-06",null,null,"2020-10-26","2025-10-26","2025-10-25","2030-10-25",{"$nulls":11},"本产品用于体外定量测定人血清中糖类抗原CA19-9含量。","3","2"]
["鲁械注准20152400443",null,"纤维连接蛋白测定试剂盒（免疫透射比浊法）",{"$nulls":9},"2020-08-07","2025-08-07","2025-08-06","2030-08-06",{"$nulls":12},"2"]
["豫械注准20202141227",null,"一次性使用胃镜检查包",{"$nulls":9},"2020-09-21","2025-09-21","2025-09-20","2030-09-20",{"$nulls":12},"2"]
["浙械注准20202400782",null,"抗环瓜氨酸肽抗体检测试剂盒（胶乳增强免疫比浊法）",{"$nulls":9},"2020-09-22","2025-09-22","2025-09-21","2030-09-21",{"$nulls":12},"2"]
["冀械注准20162400132",null,"血清淀粉样蛋白A检测试剂盒（速率散射比浊法）",{"$nulls":6},"2025-01-22",null,null,"2020-11-25","2025-11-25","2025-11-24","2030-11-24",{"$nulls":9},"由试剂1和试剂2两部分组成。试剂1（反应杯）（主要组成成分：磷酸盐缓冲液（pH7.4),0.1mol/L；氯化钠0.9%；聚乙二醇6000，适量）；试剂2（主要组成成分：羊抗人血清淀粉样蛋白A抗体胶乳颗粒，0.35mg/L）。",null,"用于体外定量检测人体血清、血浆或全血中血清淀粉样蛋白A（SAA）的含量。","2"]
["冀械注准20162400140",null,"α1-微球蛋白检测试剂盒（速率散射比浊法）",{"$nulls":6},"2025-01-22",null,null,"2020-11-25","2025-11-25","2025-11-24","2030-11-24",{"$nulls":9},"由试剂1和试剂2两部分组成。试剂1（反应杯）（主要组成成分：磷酸盐缓冲液（pH7.5）,50mmol/L；聚乙二醇6000，5.8%）；试剂2（主要组成成分：抗人α1-微球蛋白抗体胶乳颗粒，5g/L）。",null,"用于体外定量检测人体尿液中α1-微球蛋白（α1-MG）的含量。","2"]
["冀械注准20162400137",null,"同型半胱氨酸检测试剂盒（酶法）",{"$nulls":6},"2025-02-09",null,null,"2020-11-25","2025-11-25","2025-11-24","2030-11-24",{"$nulls":9},"由试剂1和试剂2两部分组成。试剂1（反应杯）（主要组成成分：二硫苏糖醇，2%；裂解酶，10%；乙二胺四乙酸，2mmol/L);试剂2（主要组成成分：硫酸，0.1mol/L；氧化铁，50mmol/L；三羟甲基氨基甲烷缓冲液，100mmol/L;2,2-二羟甲基丙酸，15%）",null,"用于体外定量检测人体血清中同型半胱氨酸(Hcy)的含量。","2"]
["国械注进20162142162",null,"同轴引导活检针Co-Axial Introducer Needles",null,null,"美国",null,"爱琅（上海）医疗器械有限公司",null,"2024-04-22",null,null,"2020-10-29","2025-10-29","2025-10-28","2030-10-28",{"$nulls":3},"爱琅（上海）医疗器械有限公司",null,"Argon Medical Devices, Inc",{"$nulls":3},"活检针由带内圆锥锁定接头的针管、带外圆锥锁定接头的针芯、定位器三部分组成。针管材料为304不锈钢、针芯材料为304不锈钢、定位器材料为302不锈钢。产品经环氧乙烷灭菌，为一次性使用。",null,"活检针用于人体软组织活体检查的引导取样。","2"]
["国械注进20162400913",null,"补体C3测定试剂盒(免疫比浊法)",{"$nulls":9},"2020-09-28","2025-09-28","2025-09-27","2030-09-27",{"$nulls":12},"2"]
["豫械注准20202141283",null,"一次性护理包",{"$nulls":9},"2020-10-21","2025-10-21","2025-10-20","2030-10-20",{"$nulls":12},"2"]
["京械注准20202400401",null,"单胺氧化酶（MAO）测定试剂盒（谷氨酸脱氢酶法）",{"$nulls":6},"2025-03-25",null,null,"2020-11-04","2025-11-04","2025-11-03","2030-11-03",{"$nulls":11},"本产品用于体外定量测定人体血清中单胺氧化酶（MAO）的含量。","2"]
["国械注进20162400912",null,"免疫球蛋白G测定试剂(免疫比浊法)",{"$nulls":9},"2020-10-26","2025-10-26","2025-10-25","2030-10-25",{"$nulls":12},"2"]
["国械注准20163400788",null,"乙型肝炎病毒核心抗体IgM校准品",{"$nulls":9},"2020-11-02","2025-11-02","2025-11-01","2030-11-01",{"$nulls":12},"3"]
["国械注进20163130124",null,"腔静脉过滤器Option Retrievable Vena Cava Filter System",null,null,"美国",null,"爱琅（上海）医疗器械有限公司",null,"2024-04-22",null,null,"2020-10-26","2025-10-26","2025-10-25","2030-10-25",{"$nulls":3},"爱琅（上海）医疗器械有限公司",null,"Argon Medical Devices, Inc.",{"$nulls":3},"本产品由过滤装置（过滤器、过滤器储存管内管、过滤器储存管）、导管鞘（导管鞘导管、止血阀、座、侧支管路、三通阀）、血管造影扩张器（扩张器、标示带、座）、推进器（导丝、导管、座）和鞘帽组成。制造材料：过滤器：镍钛合金；过滤器储存管内管：不锈钢；过滤器储存管：丙烯腈-丁二烯-苯乙烯；导管鞘导管：聚醚嵌段酰胺；止血阀：硅胶；导管鞘座：聚碳酸酯；侧支管路：聚乙烯；三通阀主体：聚碳酸酯；三通阀手柄：聚甲醛树脂；扩张器：高密度聚乙烯；标示带：铂铱合金；血管造影扩张器座：聚丙烯；导丝：聚四氟乙烯涂层的不锈钢；推进器导管和座：尼龙；鞘帽：聚丙烯。产品经环氧乙烷灭菌，一次性使用。货架有效期3年。",null,"预期在以下情况下经皮放置于下腔静脉用于防止复发性肺栓塞：1）当抗凝剂治疗禁忌使用时的肺血栓栓塞；2）血栓栓塞疾病抗凝剂治疗失败；3）大量肺栓塞在常规治疗疗效下降时的紧急处理；4）当抗凝剂治疗失败或禁忌使用的慢性、复发性肺栓塞。","3"]
["苏械注准20202071675",null,"穿戴式心电传感器",{"$nulls":9},"2020-11-27","2025-11-27","2025-11-26","2030-11-26",{"$nulls":12},"2"]
["粤械注准20152401083",null,"风湿病自身抗体检测试剂盒（斑点印迹法）",{"$nulls":6},"2025-01-26",null,null,"2020-08-25","2025-08-25","2025-08-24","2030-08-24",{"$nulls":9},"1、浓缩洗涤液（20x）2、酶联试剂3、显色剂4、样品稀释液5、印迹膜条6、标准带7、说明书",null,"可供临床实验室对风湿病患者自身抗体测定，用于体外定性检测人血清中的抗核糖核蛋白的U1片段（U1-RNP）抗体、抗小核糖蛋白（Sm）抗体、抗细胞浆可溶性物质A-60kd（SSA-60）抗体、抗细胞浆可溶性物质A-52kd（SSA-52）抗体、抗细胞核可溶性物质B（SSB）抗体、抗脱氧核糖核酸拓扑异构酶（SCL-70）抗体、抗细胞浆组酰-转运核糖核酸合成酶（J0-1）抗体、抗着丝粒（CENP-B）抗体、抗双链脱氧核糖核酸（DS-DNA）抗体、抗核小体（ANUA）抗体、抗组蛋白（HIS）和核糖体P蛋白（Rib）抗体。","2"]
["苏械注准20162400414",null,"肌红蛋白检测试剂盒（化学发光免疫分析法）",{"$nulls":9},"2023-06-21","2025-09-29","2025-09-28","2030-09-28",{"$nulls":12},"2"]
["京械注准20202400400",null,"触珠蛋白(HPT)测定试剂盒(免疫比浊法)",{"$nulls":6},"2025-03-25",null,null,"2020-11-04","2025-11-04","2025-11-03","2030-11-03",{"$nulls":11},"本产品用于体外定量测定人血清中触珠蛋白(HPT)的含量。","2"]
["豫械注准20202080573",null,"一次性使用气管插管",{"$nulls":9},"2020-09-14","2025-09-14","2025-09-13","2030-09-13",{"$nulls":12},"2"]
["粤械注准20202020733",null,"一次性使用腹腔镜用穿刺器",{"$nulls":6},"2024-06-07",null,null,"2020-06-02","2025-06-02","2025-06-01","2030-06-01",{"$nulls":3},"广州保瑞医疗技术有限公司",{"$nulls":5},"穿刺器包括套管和穿刺针两部分。套管主要由穿刺器套管、阻气阀、注气阀、密封帽、密封圈组成；穿刺针主要由穿刺针管、穿刺锥头、穿刺针座、穿刺针盖组成。",null,"供腹腔镜检查和手术过程中，对人体腹壁组织穿刺，建立腹腔手术的工作通道。","2"]
["湘械注准20202401408",null,"户尘螨D001过敏原特异性IgE抗体检测试剂盒(荧光免疫法)",{"$nulls":7},"2022-11-09",null,"2020-08-18","2025-08-18","2025-08-17","2030-08-17",{"$nulls":12},"2"]
["国械注准20163100249",null,"生理氯化钠溶液",{"$nulls":9},"2021-01-14",null,"2026-01-13",{"$nulls":4},"广州万益特医疗用品有限公司",{"$nulls":8},"3"]
["浙械注准20202400887",null,"降钙素原检测试剂盒（胶乳增强免疫比浊法）",{"$nulls":9},"2020-11-25","2025-12-10","2024-11-24","2030-12-09",{"$nulls":12},"2"]
["浙械注准20202400885",null,"多项生化校准品",{"$nulls":9},"2020-12-10","2025-12-10","2025-12-09","2030-12-09",{"$nulls":12},"2"]
["国械注准20153402108",null,"铜蓝蛋白测定试剂盒（免疫比浊法）",{"$nulls":6},"2025-02-14",null,null,"2020-10-26","2025-10-26","2025-10-25","2030-10-25",{"$nulls":11},"本产品临床上用于体外定量测定人血清中铜蓝蛋白的含量。","3"]
["湘械注准20202401500",null,"粉尘螨D002过敏原特异性IgE抗体检测试剂盒(荧光免疫法)",{"$nulls":7},"2022-11-10",null,"2020-09-14","2025-09-14","2025-09-13","2030-09-13",{"$nulls":12},"2"]
["湘械注准20202401531",null,"猫皮屑E001过敏原特异性IgE抗体检测试剂盒(荧光免疫法)",{"$nulls":7},"2022-11-09",null,"2020-09-22","2025-09-22","2025-09-21","2030-09-21",{"$nulls":12},"2"]
["湘械注准20202401733",null,"牛皮屑E004过敏原特异性IgE抗体检测试剂盒(荧光免疫法)",{"$nulls":7},"2022-11-10",null,"2020-12-03","2025-12-03","2025-12-02","2030-12-02",{"$nulls":12},"2"]
["鲁械注准20152400435",null,"载脂蛋白AII测定试剂盒（免疫透射比浊法）",{"$nulls":9},"2020-08-07","2025-08-07","2025-08-06","2030-08-06",{"$nulls":12},"2"]
["湘械注准20202401530",null,"狗皮屑E005过敏原特异性IgE抗体检测试剂盒(荧光免疫法)",{"$nulls":7},"2022-11-10",null,"2020-09-22","2025-09-22","2025-09-21","2030-09-21",{"$nulls":12},"2"]
["湘械注准20202401533",null,"蛋白F001过敏原特异性IgE抗体检测试剂盒(荧光免疫法)",{"$nulls":7},"2022-11-10",null,"2020-09-22","2025-09-22","2025-09-21","2030-09-21",{"$nulls":12},"2"]
["桂械注准20202400335",null,"D-二聚体检测试剂盒（乳胶增强免疫比浊法）",{"$nulls":9},"2020-07-17","2025-03-17","2025-07-16","2030-07-16",{"$nulls":12},"2"]
["冀械注准20162400148",null,"免疫球蛋白A检测试剂盒（速率散射比浊法）",{"$nulls":6},"2025-01-24",null,null,"2020-11-25","2025-11-25","2025-11-24","2030-11-24",{"$nulls":9},"由试剂1和试剂2两部分组成。试剂1（反应杯）（主要组成成分：磷酸盐缓冲液（pH7.0），200mmol/L；聚乙二醇6000，3%）；试剂2（主要组成成分：羊抗人免疫球蛋白A抗体，＞5mg/mL).",null,"用于体外定量检测人体血清中免疫球蛋白A（IgA）的含量。","2"]
["粤械注准20202071320",null,"一次性无创脑电传感器",{"$nulls":9},"2020-08-25","2025-08-25","2025-08-24","2030-08-24",{"$nulls":12},"2"]
["豫械注准20202141273",null,"医用外科口罩",{"$nulls":9},"2020-09-30","2025-09-30","2025-09-29","2030-09-29",{"$nulls":12},"2"]
["鲁械注准20152400439",null,"κ轻链测定试剂盒（免疫透射比浊法）",{"$nulls":9},"2020-08-07","2025-08-07","2025-08-06","2030-08-06",{"$nulls":12},"2"]
["冀械注准20162400143",null,"25-羟基维生素D检测试剂盒（免疫荧光法）",{"$nulls":6},"2025-06-08",null,null,"2020-11-25","2025-11-25","2025-11-24","2030-11-24",{"$nulls":9},"由试剂1和试剂2两部分组成。试剂1（反应杯）（主要组成部分：三羟基甲基氨基甲烷缓冲液1mol/L；抗人25-羟基维生素D抗体，＞60mg/L；脱氧核糖核酸（DNA）多聚酶，＞10U；三磷酸脱氢核糖核酸（dNTP）,10mmol/L；DNA染料）；试剂2（主要组成成分：三羟甲基氨基甲烷缓冲液，1mol/L；单克隆抗体特异性结合抗原决定簇-DNA偶联模板，＞60mg/L）。",null,"用于体外定量检测人体血清或全血中25-羟基维生素D（25-OH-VD）的含量。","2"]
["苏械注准20162400413",null,"降钙素原检测试剂盒（化学发光免疫分析法）",{"$nulls":9},"2023-06-21","2025-10-10","2025-10-09","2030-10-09",{"$nulls":12},"2"]
["国械注进20162400910",null,"转铁蛋白测定试剂盒(免疫比浊法)",{"$nulls":9},"2020-10-29","2025-10-29","2025-10-28","2030-10-28",{"$nulls":12},"2"]
["豫械注准20202141282",null,"一次性使用会阴护理包",{"$nulls":9},"2020-10-21","2025-10-21","2025-10-20","2030-10-20",{"$nulls":12},"2"]
["京械注准20202400519",null,"25羟基维生素D（25-OH VD）测定试剂盒 （胶乳增强免疫比浊法）",{"$nulls":6},"2025-06-19",null,null,"2020-12-17","2025-12-17","2025-12-16","2030-12-16",{"$nulls":11},"\"本产品用于体外定量测定人血清中25 羟基维生素D\n（25-OHVD）的含量。\"","2"]
["沪械注准20202400493",null,"转铁蛋白测定试剂盒(胶乳免疫比浊法)",{"$nulls":9},"2020-10-26","2025-10-26","2025-10-25","2030-10-25",{"$nulls":12},"2"]
["湘械注准20202401376",null,"IgE校准品",{"$nulls":7},"2022-11-10",null,"2020-08-07","2025-08-07","2025-08-06","2030-08-06",{"$nulls":12},"2"]
["湘械注准20202401378",null,"总IgE检测试剂盒(荧光免疫法)",{"$nulls":7},"2022-11-10",null,"2020-08-07","2025-08-13","2025-08-06","2030-08-12",{"$nulls":12},"2"]
["冀械注准20162400146",null,"胃蛋白酶原II检测试剂盒（速率散射比浊法）",{"$nulls":6},"2025-03-13",null,null,"2020-11-25","2025-11-25","2025-11-24","2030-11-24",{"$nulls":9},"由试剂1和试剂2两部分组成。试剂1（反应杯）（主要组成成分：磷酸盐缓冲液（pH7.4），50mmol/L；聚乙二醇6000，2%）；试剂2（主要组成成分：抗人胃蛋白酶原II抗体胶乳颗粒，1.0%).",null,"用于体外定量检测人体血清中胃蛋白酶原II（PGII）的含量。","2"]
["湘械注准20202401494",null,"小麦F004过敏原特异性IgE抗体检测试剂盒(荧光免疫法)",{"$nulls":7},"2022-11-11",null,"2020-09-14","2025-09-14","2025-09-13","2030-09-13",{"$nulls":12},"2"]
["湘械注准20202401492",null,"牛肉F027过敏原特异性IgE抗体检测试剂盒(荧光免疫法)",{"$nulls":7},"2022-11-11",null,"2020-09-14","2025-09-14","2025-09-13","2030-09-13",{"$nulls":12},"2"]
["豫械注准20202140014",null,"一次性使用医用外科口罩",{"$nulls":9},"2020-02-03","2025-02-03","2025-02-02","2030-02-02",{"$nulls":12},"2"]
["鲁械注准20152400429",null,"α1-抗胰蛋白酶测定试剂盒（免疫透射比浊法）",{"$nulls":9},"2020-08-07","2025-08-07","2025-08-06","2030-08-06",{"$nulls":12},"2"]
["湘械注准20202401485",null,"梯牧草G006过敏原特异性IgE抗体检测试剂盒(荧光免疫法)",{"$nulls":7},"2022-11-10",null,"2020-09-14","2025-09-14","2025-09-13","2030-09-13",{"$nulls":12},"2"]
["湘械注准20202401730",null,"屋尘H001过敏原特异性IgE抗体检测试剂盒(荧光免疫法)",{"$nulls":7},"2022-11-10",null,"2020-12-03","2025-12-03","2025-12-02","2030-12-02",{"$nulls":12},"2"]
["国械注准20163400078","国械注准20253401053","耐甲氧西林金黄色葡萄球菌耐药性基因检测试剂盒（荧光 PCR 法）",{"$nulls":9},"2020-04-09","2025-05-29","2025-04-08","2030-05-28",{"$nulls":12},"3"]
["苏械注准20212020549",null,"一次性使用直线型切割吻合器及组件",{"$nulls":6},"2025-05-16",null,null,"2021-01-19","2026-01-19","2026-01-18","2031-01-18",{"$nulls":9},"一次性使用直线型切割吻合器及组件根据切割刀的装配位置分为 DZQ 型（器身带刀、推柄单推）和 SZQ 型（组件带刀、推柄双推）两种型式，其中 DZQ型号根据吻合长度不同分为 55、75、100 三种规格，SZQ 型号根据吻合长度不同分为 60、80、100 三种规格。组件根据外型不同分为 DZ、SZ 两种型号，其中 DZ 型号根据吻合长度不同分为 55、75、100三种规格，SZ 型号根据吻合长度不同分为 60、80、100 三种规格；根据吻合钉高度，DZ75 分为 3.8、4.2 、4.5 三种规格，DZ55、DZ100 分为 3.8、4.5 两种规格，SZ 型分为 3.8、4.6 两种规格。DZQ 型直线型切割吻合器及组件由组件、抵钉座、切割组件架、外壳、锁定杆外壳、推扭、吻合钉、切割刀、组件保护盖组成；SZQ 型直线型切割吻合器及组件由组件、抵钉座、锁定杆、外壳、击发推钮、锁定杆外壳、切割组件架、吻合钉、组件保护盖、切割刀组件、快速释放按钮组成。该产品以无菌状态提供，经环氧乙烷灭菌，一次性使用。",null,null,"2"]
["苏械注准20192220059",null,"一次性使用游离DNA保存管",{"$nulls":9},"2020-12-04","2024-01-26","2024-01-22","2029-01-22",{"$nulls":12},"2"]
["湘械注准20202401501",null,"艾蒿W006过敏原特异性IgE抗体检测试剂盒(荧光免疫法)",{"$nulls":7},"2022-11-09",null,"2020-09-14","2025-09-14","2025-09-13","2030-09-13",{"$nulls":12},"2"]
["湘械注准20202401680",null,"抗磷脂酶A2受体（PLA2R）抗体IgG检测试剂盒（磁微粒化学发光法）",{"$nulls":9},"2020-11-10",null,"2025-11-09","2030-11-09",{"$nulls":12},"2"]
["豫械注准20202180511",null,"一次性无菌妇科检查包",{"$nulls":9},"2020-08-03","2025-08-03","2025-08-02","2030-08-02",{"$nulls":12},"2"]
["苏械注准20202071709",null,"穿戴式心电传感器",{"$nulls":9},"2020-12-09","2025-12-09","2025-12-08","2030-12-08",{"$nulls":12},"2"]
["湘械注准20202401539",null,"芝麻F010过敏原特异性IgE抗体检测试剂盒(荧光免疫法)",{"$nulls":7},"2022-11-09",null,"2020-09-25","2025-09-25","2025-09-24","2030-09-24",{"$nulls":12},"2"]
["京械注准20202400516",null,"25羟基维生素D（25-OH VD）校准品",{"$nulls":6},"2025-04-08",null,null,"2020-12-17","2025-12-17","2025-12-16","2030-12-16",{"$nulls":11},"与本公司生产的25羟基维生素D（25-OH VD）测定试剂盒（胶乳增强免疫比浊法）配套使用，用于建立校准曲线。","2"]
["国械注准20163400464",null,"柯萨奇病毒A6型和A10型核酸检测试剂盒（荧光PCR法）",{"$nulls":9},"2020-09-04","2025-09-04","2025-09-03","2030-09-03",{"$nulls":12},"3"]
["冀械注准20162400138",null,"前白蛋白检测试剂盒（速率散射比浊法）",{"$nulls":6},"2025-01-22",null,null,"2020-11-25","2025-11-25","2025-11-24","2030-11-24",{"$nulls":9},"由试剂1和试剂2两部分组成。试剂1（反应杯）（主要组成成分：磷酸盐缓冲液（pH7.0），50mmol/L；聚乙二醇6000，4%）；试剂2（主要组成成分：抗人前白蛋白抗体，＞20mg/L).",null,"用于体外定量检测人血清中前白蛋白（PA）的含量。","2"]
["冀械注准20162400136",null,"肌酸激酶同工酶MB检测试剂盒（免疫抑制法）",{"$nulls":6},"2025-02-04",null,null,"2020-11-25","2025-11-25","2025-11-24","2030-11-24",{"$nulls":9},"由试剂1和试剂2两部分组成。试剂1（反应杯）（主要组成部分：咪唑缓冲液，100mmol/L；肌酸激酶-M型羊抗人抑制抗体，300mg/L；葡萄糖，20mmol/L；醋酸镁，10mmol/L；乙二胺四乙酸，2mmol/L)；试剂2（主要组成成分：腺苷二磷酸，2mmol/L；腺苷单磷酸，5mmol/L；N-乙酰半胱氨酸，20mmol/L；6-磷酸葡萄糖脱氢酶，≥1.5KU/L；已糖激酶，≥2.5KU/L；磷酸激酶，30mmol/L；氧化性辅酶II,2mmol/L）",null,"用于体外定量检测人体血清中肌酸激酶同工酶MB的活性。","2"]
["国械注准20163400045",null,"乙型肝炎病毒表面抗原检测试剂（胶体金法）",{"$nulls":9},"2020-10-26","2025-10-26","2025-10-25","2030-10-25",{"$nulls":9},"试剂盒包含乙型肝炎病毒表面抗原检测试剂（条型/板型）、缓冲液、一次性塑料吸管、记录卡。试剂条组成包含：硝酸纤维素膜上T线包被抗HBsAg多克隆抗体、C线包被羊抗鼠多克隆抗体，聚酯纤维素膜包被标记后抗HBsAg单克隆抗体，玻璃纤维素膜。缓冲液主要成分：磷酸盐缓冲液，0.02%叠氮化钠，0.025%卡那霉素。（具体内容详见产品说明书）",null,"本产品用于体外定性检测人血清、血浆、全血样本中的乙型肝炎病毒表面抗原（HBsAg）。","3"]
["湘械注准20202401534",null,"普通白桦树T003过敏原特异性IgE抗体检测试剂盒(荧光免疫法)",{"$nulls":7},"2022-11-10",null,"2020-09-22","2025-09-22","2025-09-21","2030-09-21",{"$nulls":12},"2"]
["湘械注准20202401637",null,"抗突变型瓜氨酸波形蛋白（MCV）抗体检测试剂盒（磁微粒化学发光法）",{"$nulls":9},"2020-11-10","2020-10-28","2025-11-09","2030-10-27",{"$nulls":12},"2"]
["湘械注准20202401634",null,"基质金属蛋白酶3（MMP-3）检测试剂盒（磁微粒化学发光法）",{"$nulls":9},"2020-11-10","2020-10-28","2025-11-09","2030-10-27",{"$nulls":12},"2"]
["黑械注准20202070072",null,"一次性无创脑电传感器",{"$nulls":9},"2020-11-06","2025-07-11","2025-11-05","2030-07-10",{"$nulls":12},"2"]
["苏械注准20202021358",null,"一次性使用腔镜切割吻合器及阶梯组件",{"$nulls":6},"2025-03-19",null,null,"2020-12-17","2025-12-17","2025-12-16","2030-12-16",{"$nulls":12},"2"]
["冀械注准20162400142",null,"促黄体生成素检测试剂盒（免疫荧光法）",{"$nulls":6},"2025-06-09",null,null,"2020-11-25","2025-11-25","2025-11-24","2030-11-24",{"$nulls":9},"由试剂1和试剂2两部分组成。试剂1（反应杯）（主要组成部分：三羟甲基氨基甲烷缓冲液1mol/L；抗促黄体生成素抗体，＞70mg/L；脱氧核糖核酸（DAN）多聚酶，＞10U；三磷酸脱氧核糖核酸（dNTP），10mmol/L；DNA染料）；试剂2（主要组成成分：三羟甲基氨基甲烷缓冲液，1mol/L；单克隆抗体特异性结合抗原决定簇-DNA偶联模板，＞70mg/L）。",null,"用于检测人体血清中促黄体生成素（LH）的含量。","2"]
["湘械注准20202401490",null,"马皮屑E003过敏原特异性IgE抗体检测试剂盒(荧光免疫法)",{"$nulls":7},"2022-11-10",null,"2020-09-14","2025-09-14","2025-09-13","2030-09-13",{"$nulls":12},"2"]
["国械注准20203030835",null,"滤器回收系统",{"$nulls":9},"2020-11-02","2025-11-02","2025-11-01","2030-11-01",{"$nulls":12},"3"]
["豫械注准20202140578",null,"一次性无菌透析护理包",{"$nulls":9},"2020-09-13","2025-09-14","2025-09-13","2030-09-13",{"$nulls":12},"2"]
["冀械注准20162400130",null,"视黄醇结合蛋白检测试剂盒（速率散射比浊法）",{"$nulls":6},"2025-02-11",null,null,"2020-11-25","2025-11-25","2025-11-24","2030-11-24",{"$nulls":9},"由试剂1和试剂2两部分组成。试剂1（反应杯）（主要组成成分：磷酸盐缓冲液（pH7.0），0.1mol/L；聚乙二醇6000，6g/L）；试剂2（主要组成成分：抗视黄醇结合蛋白抗体胶乳颗粒。6%；磷酸盐缓冲液（pH8.0）,0.1mol/L).",null,"用于体外定量检测人体血清中视黄醇结合蛋白（RBP）的含量。","2"]
["浙械注准20202400860",null,"果糖胺检测试剂盒（四氮唑蓝法）",{"$nulls":9},"2020-11-25","2025-11-25","2024-11-24","2030-11-24",{"$nulls":12},"2"]
["苏械注准20162400417",null,"超敏肌钙蛋白I检测试剂盒（化学发光免疫分析法）",{"$nulls":9},"2023-06-21","2025-10-10","2025-10-09","2030-10-09",{"$nulls":12},"2"]
["冀械注准20162400150",null,"免疫球蛋白G检测试剂盒（速率散射比浊法）",{"$nulls":6},"2025-01-24",null,null,"2020-11-25","2025-11-25","2025-11-24","2030-11-24",{"$nulls":9},"由试剂1和试剂2两部分组成。试剂1（反应杯）（主要组成成分：磷酸盐缓冲液（pH7.2），50mmol/L；聚乙二醇6000，5%）；试剂2（主要组成成分：羊抗人免疫球蛋白G抗体，＞15mg/mL).",null,"用于体外定量检测人体血清中免疫球蛋白G（IgG）的含量。","2"]
["鲁械注准20152400440",null,"λ轻链测定试剂盒（免疫透射比浊法）",{"$nulls":9},"2020-08-07","2025-08-07","2025-08-06","2030-08-06",{"$nulls":12},"2"]
["湘械注准20202401486",null,"杏仁F020过敏原特异性IgE抗体检测试剂盒(荧光免疫法)",{"$nulls":7},"2022-11-09",null,"2020-09-14","2025-09-14","2025-09-13","2030-09-13",{"$nulls":12},"2"]
["湘械注准20202401498",null,"榛子F017过敏原特异性IgE抗体检测试剂盒(荧光免疫法)",{"$nulls":7},"2022-11-11",null,"2020-09-14","2025-09-14","2025-09-13","2030-09-13",{"$nulls":12},"2"]
["湘械注准20202401493",null,"椰子F036过敏原特异性IgE抗体检测试剂盒(荧光免疫法)",{"$nulls":7},"2022-11-10",null,"2020-09-14","2025-09-14","2025-09-13","2030-09-13",{"$nulls":12},"2"]
["湘械注准20202401731",null,"烟曲霉M003过敏原特异性IgE抗体检测试剂盒(荧光免疫法)",{"$nulls":7},"2022-11-11",null,"2020-12-03","2025-12-03","2025-12-02","2030-12-02",{"$nulls":12},"2"]
["冀械注准20162400134",null,"降钙素原检测试剂盒（免疫荧光法）",{"$nulls":6},"2025-01-22",null,null,"2020-11-25","2025-11-25","2025-11-24","2030-11-24",{"$nulls":9},"由试剂1和试剂2两部分组成。试剂1（反应杯）（主要组成成分：三羟甲基氨基甲烷缓冲液，1mol/L；抗降钙素原抗体，＞2g/L；脱氧核糖核酸（DNA）多聚酶，＞10U，三磷酸脱氧核糖核酸(dNTP),10mmol/L；DNA染料）；试剂2（主要组成成分：三羟甲基氨基甲烷缓冲液，1mol/L；单克隆抗体特异性结合抗原决定簇-DNA偶联模板，＞2g/L)。",null,"用于体外定量检测人体血清、血浆、全血中的降钙素原（PCT）的含量。","2"]
["国械注准20163032020",null,"PTCA球囊扩张导管",{"$nulls":6},"2025-04-15",null,null,"2020-12-18","2025-12-18","2025-12-17","2030-12-17",{"$nulls":9},"该产品为快速交换型经皮腔内冠状动脉成型术用球囊扩张导管，带有铂铱合金可视标记。主要由手柄座、导管的外管、导管的内管和球囊组成。外管远端材料为尼龙11、聚醚嵌段酰胺，其远端表面涂覆亲水涂层，近端材料为尼龙12、不锈钢管；内管材料为尼龙11、低密度聚乙烯和高密度聚乙烯；球囊材料为改性尼龙12；手柄材料为聚碳酸酯。该产品经环氧乙烷灭菌；一次性使用，有效期两年。",null,"用于冠心病微创介入治疗手术：1.冠状动脉或旁路移植狭窄部分的球囊扩张；2.球囊扩张支架的植入后后扩张。","3"]
["苏械注准20202400411",null,"尿液分析试纸条（干化学法）",{"$nulls":9},"2020-04-14","2025-04-14","2025-04-13","2030-04-13",{"$nulls":12},"2"]
["冀械注准20162400144",null,"触珠蛋白检测试剂盒（速率散射比浊法）",{"$nulls":6},"2025-01-22",null,null,"2020-11-25","2025-11-25","2025-11-24","2030-11-24",{"$nulls":9},"由试剂1和试剂2两部分组成。试剂1（反应杯）（主要组成成分：磷酸盐缓冲液（pH7.2），50mmol/L；聚乙二醇6000,5.8%）；试剂2（主要组成成分：抗触珠蛋白抗体，3g/L)。",null,"用于检测人体血清中触珠蛋白（HPT）的含量。","2"]
["湘械注准20202401495",null,"蒲公英W008过敏原特异性IgE抗体检测试剂盒(荧光免疫法)",{"$nulls":7},"2022-11-09",null,"2020-09-14","2025-09-14","2025-09-13","2030-09-13",{"$nulls":12},"2"]
["浙械注准20202400857",null,"胆碱酯酶检测试剂盒（丁酰硫代胆碱底物法）",{"$nulls":9},"2020-11-25","2025-11-25","2025-11-24","2030-11-24",{"$nulls":12},"2"]
["赣械注准20202200449",null,"灸疗装置",{"$nulls":9},"2020-07-09","2025-07-09","2025-07-08","2030-07-08",{"$nulls":12},"2"]
["国械注准20163401240",null,"乙型肝炎病毒e抗原测定试剂盒（磁微粒化学发光法）","乙型肝炎病毒e抗原检测试剂盒（磁微粒化学发光法）",{"$nulls":8},"2021-03-25",null,"2026-03-24",{"$nulls":13},"3"]
["冀械注准20162400139",null,"β2-微球蛋白检测试剂盒（速率散射比浊法）",{"$nulls":6},"2025-02-04",null,null,"2020-11-25","2025-11-25","2025-11-24","2030-11-24",{"$nulls":9},"由试剂1和试剂2两部分组成。试剂1（反应杯）（主要组成成分：磷酸盐缓冲液（pH7.0），0.1mol/L；聚乙二醇6000，2.5%；氯化钠，0.9%）；试剂2（主要组成成分：羊抗人β2-微球蛋白抗体胶乳颗粒，0.2g/L；磷酸盐缓冲液（pH8.0），0.1mol/L",null,"用于体外定量检测人体血清中β2-微球蛋白（β2-MG）的含量。","2"]
["冀械注准20162400133",null,"转铁蛋白检测试剂盒（速率散射比浊法）",{"$nulls":6},"2025-01-22",null,null,"2020-11-24","2025-11-24","2025-11-23","2030-11-23",{"$nulls":9},"由试剂1和试剂2两部分组成。试剂1（反应杯）（主要组成部分：三羟基甲基氨基甲烷缓冲液（pH7.6）,50mmol/L；聚乙二醇6000，,10g/L)；试剂2（主要组成成分：羊抗人转铁蛋白抗体胶乳颗粒，12ml/L）",null,"用于体外定量检测人体血清中转铁蛋白（TRF）的含量。","2"]
["国械注进20203100308",null,"一次性使用带滤器的补液装置Accessory for ULTRA Therapies for Hemodialysis",{"$nulls":9},"2020-06-09","2025-06-09","2025-06-08","2030-06-08",{"$nulls":12},"3"]
["湘械注准20202401679",null,"抗gp210抗体IgG检测试剂盒（磁微粒化学发光法）",{"$nulls":9},"2020-11-10",null,"2025-11-09","2030-11-09",{"$nulls":12},"2"]
["京械注准20202400515",null,"血清淀粉样蛋白A（SAA）校准品",{"$nulls":6},"2025-03-25",null,null,"2020-12-17","2025-12-17","2025-12-16","2030-12-16",{"$nulls":11},"与本公司生产的的血清淀粉样蛋白A（SAA）测定试剂盒（胶乳增强免疫比浊法）配套使用，用于建立校准曲线。","2"]
["鲁械注准20152400431",null,"α2-巨球蛋白测定试剂盒（免疫透射比浊法）",{"$nulls":9},"2020-08-07","2025-08-07","2025-08-06","2030-08-06",{"$nulls":12},"2"]
["湘械注准20202401491",null,"热带螨D201过敏原特异性IgE抗体检测试剂盒(荧光免疫法)",{"$nulls":7},"2022-11-09",null,"2020-09-14","2025-09-14","2025-09-13","2030-09-13",{"$nulls":12},"2"]
["国械注准20163400076",null,"鲍曼不动杆菌耐碳青霉烯类抗生素基因（OXA23）检测试剂盒（荧光PCR法）",{"$nulls":9},"2020-08-07","2025-08-07","2025-08-06","2030-08-06",{"$nulls":12},"3"]
["湘械注准20202401729",null,"IgE校准品配套检测试剂",{"$nulls":7},"2022-11-11",null,"2020-12-03","2025-12-03","2025-12-02","2030-12-02",{"$nulls":12},"2"]
["京械注准20202400402",null,"缺血修饰白蛋白（IMA）测定试剂盒（游离钴比色法）",{"$nulls":6},"2025-04-10",null,null,"2020-11-04","2025-11-04","2025-11-03","2030-11-03",{"$nulls":11},"本产品用于体外定量测定人血清中缺血修饰白蛋白（IMA）的含量。","2"]
["赣械注准20152020265",null,"皮肤扩张器",{"$nulls":9},"2020-10-09","2025-10-09","2025-10-08","2030-10-08",{"$nulls":12},"2"]
["冀械注准20162400145",null,"胃蛋白酶原I检测试剂盒（速率散射比浊法）",{"$nulls":6},"2025-03-13",null,null,"2020-11-25","2025-11-25","2025-11-24","2030-11-24",{"$nulls":9},"由试剂1和试剂2两部分组成。试剂1（反应杯）（主要组成成分：磷酸盐缓冲液（pH6.5），50mmol/L；聚乙二醇6000，2%）；试剂2（主要组成成分：鼠抗人胃蛋白酶原I抗体胶乳颗粒，1.2%）。",null,"用于体外定量检测人体血清中胃蛋白酶原I（PGI）的含量。","2"]
["湘械注准20202401636",null,"抗缪勒氏管激素（AMH）检测试剂盒（磁微粒化学发光法）",{"$nulls":9},"2020-11-10","2020-10-28","2025-11-09","2030-10-27",{"$nulls":12},"2"]
["湘械注准20202401487",null,"巴西坚果F018过敏原特异性IgE抗体检测试剂盒(荧光免疫法)",{"$nulls":7},"2022-11-11",null,"2020-09-14","2025-09-14","2025-09-13","2030-09-13",{"$nulls":12},"2"]
["湘械注准20202401532",null,"蟹F023过敏原特异性IgE抗体检测试剂盒(荧光免疫法)",{"$nulls":7},"2022-11-09",null,"2020-09-22","2025-09-22","2025-09-21","2030-09-21",{"$nulls":12},"2"]
["湘械注准20202401488",null,"虾F024过敏原特异性IgE抗体检测试剂盒(荧光免疫法)",{"$nulls":7},"2022-11-09",null,"2020-09-14","2025-09-14","2025-09-13","2030-09-13",{"$nulls":12},"2"]
["湘械注准20202401499",null,"雏菊W007过敏原特异性IgE抗体检测试剂盒(荧光免疫法)",{"$nulls":7},"2022-11-11",null,"2020-09-14","2025-09-14","2025-09-13","2030-09-13",{"$nulls":12},"2"]
["国械注进20162141057",null,"活检针Biopsy Needle",null,null,"美国",null,"爱琅（上海）医疗器械有限公司",null,"2024-05-11",null,null,"2020-10-29","2025-10-29","2025-10-28","2030-10-28",{"$nulls":3},"爱琅（上海）医疗器械有限公司",null,"Argon Medical Devices, Inc",{"$nulls":3},"活检针由手柄和活检针（针芯、针管）组成，手柄材料为ABS工程塑料，针管和针芯均由304不锈钢材料制成；部分型号带有同轴套管针和适配器，套管针由带内圆锥锁定接头的针管、带外圆锥锁定接头的针芯、定位器三部分组成，针管座材料为树脂（SBC）K-Resin KR-03,针芯座材料为塑料（ABS）Cycolac MG47MD,针管和针芯均由304不锈钢材料制成，定位器材料为302不锈钢，适配器的材料为聚碳酸酯。产品经环氧乙烷灭菌，一次性使用。",null,"适用于人体软组织，如肝脏、脾脏、肾脏、肺、淋巴、乳房及前列腺的检查取样。","2"]
["苏械注准20202071693",null,"穿戴式心电传感器",{"$nulls":9},"2020-12-07","2025-12-07","2025-12-06","2030-12-06",{"$nulls":12},"2"]
["湘械注准20202401502",null,"德国小蠊I006过敏原特异性IgE抗体检测试剂盒(荧光免疫法)",{"$nulls":7},"2022-11-09",null,"2020-09-14","2025-09-14","2025-09-13","2030-09-13",{"$nulls":12},"2"]
["湘械注准20202401732",null,"链格孢M006过敏原特异性IgE抗体检测试剂盒(荧光免疫法)",{"$nulls":7},"2022-11-11",null,"2020-12-03","2025-12-03","2025-12-02","2030-12-02",{"$nulls":12},"2"]
["豫械注准20202140455",null,"一次性孔巾",{"$nulls":9},"2020-06-19","2025-06-19","2025-06-18","2030-06-18",{"$nulls":12},"2"]
["湘械注准20202401018",null,"阴道炎联合检测试剂盒（干化学酶法）",{"$nulls":9},"2020-05-26","2025-09-23","2025-05-25","2030-09-22",{"$nulls":12},"2"]
["豫械注准20202082110",null,"一次性使用麻醉面罩",{"$nulls":9},"2020-12-31","2025-12-31","2025-12-30","2030-12-30",{"$nulls":12},"2"]
["浙械注准20202040726",null,"一次性使用刨削刀头",{"$nulls":9},"2020-08-07","2025-08-07","2025-08-06","2030-08-06",{"$nulls":12},"2"]
["湘械注准20212141484",null,"一次性冲洗吸引器","一次性冲洗吸引器及引流导管",{"$nulls":7},"2025-07-28","2021-07-29",null,"2026-07-28",{"$nulls":10},"产品由液流控制器、穿刺器、吸引管、冲洗管、鲁尔连接件、冲洗头（可选）、及备用导管（可选）组成，其中备用导管由管体和鲁尔连接件构成，冲洗头由手柄和喷管组件组成。产品为无菌提供，经环氧乙烷灭菌。",null,null,"2"]
["粤械注准20162400317",null,"高密度脂蛋白胆固醇测定试剂（盒）（直接法-过氧化氢酶消除法）",{"$nulls":9},"2020-07-06","2025-07-06","2025-07-05","2030-07-05",{"$nulls":12},"2"]
["粤械注准20162400306",null,"总胆汁酸测定试剂(盒)(酶循环法)",{"$nulls":9},"2020-07-06","2025-07-06","2025-07-05","2030-07-05",{"$nulls":12},"2"]
["粤械注准20162400319",null,"天门冬氨酸氨基转移酶测定试剂（盒）（天门冬氨酸底物法）",{"$nulls":9},"2020-07-02","2025-07-02","2025-07-01","2030-07-01",{"$nulls":12},"2"]
["粤械注准20162400310",null,"α-羟丁酸脱氢酶测定试剂（盒）（α-酮丁酸底物法）",{"$nulls":9},"2020-07-02","2025-07-02","2025-07-01","2030-07-01",{"$nulls":12},"2"]
["粤械注准20162400296",null,"乳酸脱氢酶测定试剂（盒）（乳酸底物法）",{"$nulls":9},"2020-07-02","2025-07-02","2025-07-01","2030-07-01",{"$nulls":12},"2"]
["粤械注准20162400297",null,"低密度脂蛋白胆固醇测定试剂(盒)(直接消除法)",{"$nulls":9},"2020-07-06","2025-07-06","2025-07-05","2030-07-05",{"$nulls":12},"2"]
["浙械注准20162400380","浙温械备20250035","L型细菌培养基","L型细菌增菌培养基",{"$nulls":8},"2021-01-18","2025-04-09","2026-01-17","2099-12-31",{"$nulls":12},"2","1"]
["粤械注准20162400308",null,"总胆固醇测定试剂(盒)(CHOD-PAP法)",{"$nulls":9},"2020-07-06","2025-07-06","2025-07-05","2030-07-05",{"$nulls":12},"2"]
["粤械注准20162400318",null,"载脂蛋白E测定试剂(盒)(免疫透射比浊法)",{"$nulls":9},"2020-07-06","2025-07-06","2025-07-05","2030-07-05",{"$nulls":12},"2"]
["鄂械注准20152142161",null,"不粘伤口敷料",{"$nulls":9},"2020-07-20","2025-07-20","2025-07-19","2030-07-19",{"$nulls":12},"2"]
["粤械注准20162400311",null,"肌酸激酶同工酶测定试剂(盒)(免疫抑制法)",{"$nulls":9},"2020-07-02","2025-07-02","2025-07-01","2030-07-01",{"$nulls":12},"2"]
["粤械注准20162400305",null,"α-淀粉酶测定试剂（盒）（EPS底物法）",{"$nulls":9},"2020-07-02","2025-07-02","2025-07-01","2030-07-01",{"$nulls":12},"2"]
["粤械注准20202401399",null,"C反应蛋白测定试剂盒（胶乳免疫透射比浊法）",{"$nulls":9},"2020-09-08","2025-09-08","2025-09-07","2030-09-07",{"$nulls":12},"2"]
["粤械注准20202400967",null,"镁测定试剂盒（二甲苯胺蓝法）",{"$nulls":9},"2020-07-10","2025-07-06","2025-07-09","2030-07-05",{"$nulls":12},"2"]
["粤械注准20202401401",null,"脂肪酶测定试剂盒（甲基试卤灵底物法）",{"$nulls":9},"2020-09-08","2025-09-08","2025-09-07","2030-09-07",{"$nulls":12},"2"]
["粤械注准20202400107",null,"β2-微球蛋白测定试剂盒（胶乳免疫比浊法）",{"$nulls":9},"2020-01-22","2025-01-22","2025-01-21","2030-01-21",{"$nulls":12},"2"]
["粤械注准20202400800",null,"乳酸脱氢酶同工酶1测定试剂盒（化学抑制法）",{"$nulls":9},"2020-06-10","2025-06-10","2025-06-09","2030-06-09",{"$nulls":12},"2"]
["粤械注准20202401875",null,"糖化血红蛋白测定试剂盒（胶乳免疫透射比浊法）",{"$nulls":9},"2020-11-17","2025-11-17","2025-11-16","2030-11-16",{"$nulls":12},"2"]
["粤械注准20202401402",null,"类风湿因子测定试剂盒（胶乳免疫透射比浊法）",{"$nulls":9},"2020-09-08","2025-09-08","2025-09-07","2030-09-07",{"$nulls":12},"2"]
["粤械注准20202401874",null,"结合珠蛋白测定试剂盒（免疫透射比浊法）",{"$nulls":9},"2020-11-17","2025-11-17","2025-11-16","2030-11-16",{"$nulls":12},"2"]
["粤械注准20202400123",null,"α1-微球蛋白测定试剂盒（胶乳免疫比浊法）",{"$nulls":9},"2020-01-22","2025-01-22","2025-01-21","2030-01-21",{"$nulls":12},"2"]
["粤械注准20202401900",null,"5’-核苷酸酶测定试剂盒（过氧化物酶法）",{"$nulls":9},"2020-11-18","2025-11-18","2025-11-17","2030-11-17",{"$nulls":12},"2"]
["粤械注准20162400312",null,"尿素测定试剂（盒）（尿素酶-谷氨酸脱氢酶法）",{"$nulls":9},"2020-08-25","2025-08-25","2025-08-24","2030-08-24",{"$nulls":12},"2"]
["京械注准20202400347",null,"多项脂类校准品",{"$nulls":6},"2025-01-14",null,null,"2020-09-18","2025-09-18","2025-09-17","2030-09-17",{"$nulls":11},"与本公司生产的试剂盒配套使用，用于载脂蛋白A2、载脂蛋白C2、载脂蛋白C3、载脂蛋白E4个项目建立系统校准曲线。","2"]
["国械注进20203130105",null,"热熔断三维弹簧圈MCS HyperSoft 3D",{"$nulls":9},"2020-03-11","2025-03-11","2025-03-10","2030-03-10",{"$nulls":12},"3"]
["京械注准20202400521",null,"免疫球蛋白IgE测定试剂盒（胶乳免疫比浊法）",{"$nulls":9},"2020-12-17","2025-12-17","2025-12-16","2030-12-16",{"$nulls":9},"试剂1：Tris-HCl缓冲液               20mmol/L  \n       氯化钠                       100mmol/L\n       EDTA                        50mmol/L\n试剂2：抗人IgE抗体结合胶乳         适量\n       Tris-HCl缓冲液                20mmol/L  \n       氯化钠                       100mmol/L\n校准品：Tris-HCl缓冲液、人血清（含量≥5%）、免疫球蛋白IgE，目标浓度：水平1：50IU/mL，水平2：100IU/mL，水平3：200IU/mL，水平4：500IU/mL，水平5：1000IU/mL；\n质控品：Tris-HCl缓冲液、人血清（含量≥5%）、免疫球蛋白IgE，质控品水平1靶值范围：50-86IU/mL；质控品水平2靶值范围：350-510IU/mL。\n校准品、质控品批特异，具体浓度见瓶签。",null,"用于体外定量测定人血清中免疫球蛋白E(IgE)的含量。","2"]
["浙械注准20162400355","浙温械备20250032","沙保罗琼脂培养基","沙保弱（罗）琼脂培养基",{"$nulls":8},"2021-01-18","2025-04-09","2026-01-17","2099-12-31",{"$nulls":12},"2","1"]
["浙械注准20162400338","浙温械备20250031","血琼脂培养基",{"$nulls":9},"2021-01-18","2025-04-27","2026-01-17","2099-12-31",{"$nulls":12},"2","1"]
["浙械注准20162400356","浙温械备20250036","嗜血杆菌巧克力琼脂选择培养基",{"$nulls":9},"2021-01-18","2025-04-09","2026-01-17","2099-12-31",{"$nulls":12},"2","1"]
["浙械注准20162400462","浙温械备20250029","肠道菌培养基","麦康凯琼脂培养基",{"$nulls":8},"2021-01-18","2025-04-09","2026-01-17","2099-12-31",{"$nulls":12},"2","1"]
["浙械注准20162400207",null,"结合胆红素测定试剂盒(胆红素氧化酶法)",{"$nulls":9},"2020-10-13","2025-10-13","2025-10-12","2030-10-12",{"$nulls":12},"2"]
["浙械注准20152140871",null,"一次性使用静脉穿刺辅助包",{"$nulls":9},"2020-10-30","2025-10-30","2025-10-29","2030-10-29",{"$nulls":12},"2"]
["浙械注准20152140622",null,"一次性使用无菌敷贴",{"$nulls":9},"2020-09-21","2025-09-21","2025-09-20","2030-09-20",{"$nulls":12},"2"]
["苏械注准20202021729",null,"一次性微创筋膜吻合器",{"$nulls":6},"2025-07-24",null,null,"2020-12-18","2025-12-18","2025-12-17","2030-12-17",{"$nulls":9},"一次性微创筋膜吻合器按照外形分为两种型式，型号为KH-JM-A和KH-JM-B。筋膜吻合器由闭合固件和缝线穿引器两部分组成（产品不含缝线，但需要与2-0和0缝线配合使用）。KH-JM-A型闭合固件由夹头、硅胶垫、外壳、拉杆组成，缝线穿引器由缝合针和手柄组成；KH-JM-B型闭合固件由夹线块、拉线架、导引孔、器身和推柄组成，缝线穿引器由按钮、按钮弹簧、手柄、穿刺针、带线钩组成。该产品以无菌状态提供，经环氧乙烷灭菌，一次性使用。",null,null,"2"]
["国械注进20162061625",null,"超声血管导引穿刺套件",{"$nulls":9},"2020-09-07","2025-09-04","2025-09-06","2030-09-07",{"$nulls":12},"2"]
["豫械注准20202140475",null,"一次性治疗巾",{"$nulls":9},"2020-07-07","2025-07-07","2025-07-06","2030-07-06",{"$nulls":12},"2"]
["国械注准20163401343",null,"A族链球菌抗原检测试剂盒（乳胶法）",{"$nulls":9},"2021-05-19",null,"2026-05-18","2031-05-18",{"$nulls":12},"3"]
["冀械注准20212040093",null,"骨科外固定支架（手部专用）","骨科外固定支架（手足专用）",{"$nulls":8},"2021-02-18",null,"2026-02-17",{"$nulls":10},"产品性能结构:\n由托板，储液盘、排水管、弹性紧固带、手掌挡板、手指挡板、组合拉钩、弹性拉钩组成。主要原料为医用ABS。",null,"【产品适用范围】:\n用于对手指、手掌、前臂及足部进行医疗操作（如手术，理疗）时的固定。","2"]
["豫械注准20202140572",null,"一次性使用胃镜检查辅助包",{"$nulls":9},"2020-09-14","2025-09-14","2025-09-13","2030-09-13",{"$nulls":12},"2"]
["国械注准20163401243",null,"乙型肝炎病毒e抗体测定试剂盒（磁微粒化学发光法）","乙型肝炎病毒e抗体检测试剂盒（磁微粒化学发光法）",{"$nulls":8},"2021-04-20",null,"2026-04-19",{"$nulls":13},"3"]
["粤械注准20202401408",null,"氨测定试剂盒（谷氨酸脱氢酶法）",{"$nulls":9},"2020-09-08","2025-09-08","2025-09-07","2030-09-07",{"$nulls":12},"2"]
["湘械注准20162400338",null,"尿液分析试纸条",{"$nulls":9},"2020-09-16","2025-09-16","2025-09-15","2030-09-15",{"$nulls":12},"2"]
["粤械注准20162400307",null,"碱性磷酸酶测定试剂（盒）（NPP底物-AMP缓冲液法）",{"$nulls":9},"2020-07-02","2025-07-02","2025-07-01","2030-07-01",{"$nulls":12},"2"]
["粤械注准20162400302",null,"肌酸激酶测定试剂（盒）（磷酸肌酸底物法）",{"$nulls":9},"2020-07-02","2025-07-02","2025-07-01","2030-07-01",{"$nulls":12},"2"]
["粤械注准20202400801",null,"不饱和铁结合力测定试剂盒（Ferene法）",{"$nulls":9},"2020-06-10","2025-06-10","2025-06-09","2030-06-09",{"$nulls":12},"2"]
["粤械注准20202401400",null,"β—羟丁酸测定试剂盒（β—羟丁酸脱氢酶法）",{"$nulls":9},"2020-09-08","2025-09-08","2025-09-07","2030-09-07",{"$nulls":12},"2"]
["国械注准20173100027",null,"一次性使用血液透析用中心静脉导管",{"$nulls":9},"2020-11-23","2025-11-23","2025-11-22","2030-11-22",{"$nulls":12},"3"]
["粤械注准20162400293",null,"甘油三酯测定试剂(盒)( GPO-PAP法)",{"$nulls":9},"2020-07-06","2025-07-06","2025-07-05","2030-07-05",{"$nulls":12},"2"]
["粤械注准20162400300",null,"脂蛋白a测定试剂(盒)(乳胶增强比浊法)",{"$nulls":9},"2020-07-06","2025-07-06","2025-07-05","2030-07-05",{"$nulls":12},"2"]
["粤械注准20162400301",null,"丙氨酸氨基转移酶测定试剂（盒）（丙氨酸底物法）",{"$nulls":9},"2020-07-06","2025-07-06","2025-07-05","2030-07-05",{"$nulls":12},"2"]
["粤械注准20162400309",null,"γ-谷氨酰基转移酶测定试剂（盒）（GCANA底物法）",{"$nulls":9},"2020-07-02","2025-07-02","2025-07-01","2030-07-01",{"$nulls":12},"2"]
["粤械注准20202401106",null,"微量白蛋白测定试剂盒（免疫透射比浊法）",{"$nulls":9},"2020-07-27","2025-07-27","2025-07-26","2030-07-26",{"$nulls":12},"2"]
["粤械注准20162400304",null,"葡萄糖测定试剂(盒)(己糖激酶法)",{"$nulls":9},"2020-07-02","2025-07-02","2025-07-01","2030-07-01",{"$nulls":12},"2"]
["粤械注准20202401105",null,"尿液/脑脊液总蛋白测定试剂盒（苄索氯铵法）",{"$nulls":9},"2020-07-27","2025-07-27","2025-07-26","2030-07-26",{"$nulls":12},"2"]
["国械注进20172140378",null,"活检穿剌针",{"$nulls":9},"2020-07-21","2025-07-21","2025-07-20","2030-07-20",{"$nulls":9},"活检穿刺针采用ABS、聚四氟乙烯和不锈钢材料制成，由穿刺针、鞘和接头组成。",null,"活检穿刺针用于刺破气管壁和抽出足够的组织和/或细胞样品检测支气管癌。","2"]
["粤械注准20162400314",null,"肌酐测定试剂(盒)(肌氨酸氧化酶法)",{"$nulls":9},"2020-07-02","2025-07-02","2025-07-01","2030-07-01",{"$nulls":12},"2"]
["粤械注准20202401898",null,"糖化血清蛋白测定试剂盒（NBT法）",{"$nulls":9},"2020-11-18","2025-11-18","2025-11-17","2030-11-17",{"$nulls":12},"2"]
["皖械注准20202020550",null,"一次性腹腔镜软器械鞘管","一次性多通道单孔腹腔镜穿刺器",{"$nulls":8},"2020-12-04",null,"2025-12-03",{"$nulls":13},"2"]
["粤械注准20162400298",null,"白蛋白测定试剂(盒)(溴甲酚绿法)",{"$nulls":9},"2020-07-02","2025-07-02","2025-07-01","2030-07-01",{"$nulls":12},"2"]
["国械注准20203400437",null,"人类CYP2C19*2*3*17基因多态性检测试剂盒（荧光探针熔解曲线法）",{"$nulls":6},"2025-06-17",null,null,"2020-04-24","2025-06-17","2025-04-23","2030-06-16",{"$nulls":12},"3"]
["国械注进20203030433",null,"微导管VIA Microcatheter",{"$nulls":9},"2020-09-23","2025-09-23","2025-09-22","2030-09-22",{"$nulls":12},"3"]
["粤械注准20162400303",null,"总胆红素测定试剂(盒)(钒酸盐氧化法)",{"$nulls":9},"2020-08-25","2025-08-25","2025-08-24","2030-08-24",{"$nulls":12},"2"]
["粤械注准20162400294",null,"直接胆红素测定试剂(盒)(钒酸盐氧化法)",{"$nulls":9},"2020-07-02","2025-07-02","2025-07-01","2030-07-01",{"$nulls":12},"2"]
["国械注进20172141230",null,"活检穿刺针",{"$nulls":9},"2020-07-31","2025-07-31","2025-07-30","2030-07-30",{"$nulls":9},"活检穿刺针由穿刺针、鞘和接头组成。穿刺针采用304不锈钢（牌号S30400）材料制成，鞘采用聚四氟乙烯材料制成，接头采用ABS材料制成。其中，W-220型号的Y型接头由含有邻苯二甲酸酯（DEHP）的PVC材料制成，但该Y型接头不与人体接触。一次性使用；环氧乙烷灭菌。",null,"活检穿刺针用于穿刺支气管壁，吸收足够的组织和/或细胞样本，以便为支气管癌分级。","2"]
["粤械注准20162400295",null,"总蛋白测定试剂(盒)(双缩脲法)",{"$nulls":9},"2020-08-25","2025-08-25","2025-08-24","2030-08-24",{"$nulls":12},"2"]
["粤械注准20162400299",null,"同型半胱氨酸测定试剂(盒)(酶循环法)",{"$nulls":9},"2020-07-06","2025-07-06","2025-07-05","2030-07-05",{"$nulls":12},"2"]
["粤械注准20202400968",null,"前白蛋白测定试剂盒（免疫透射比浊法）",{"$nulls":9},"2020-07-10","2025-07-06","2025-07-09","2030-07-05",{"$nulls":12},"2"]
["粤械注准20202401899",null,"糖化白蛋白测定试剂盒（过氧化物酶法）",{"$nulls":9},"2020-11-18","2025-11-18","2025-11-17","2030-11-17",{"$nulls":12},"2"]
["粤械注准20212400366",null,"降钙素原/C-反应蛋白/血清淀粉样蛋白A联合检测试剂盒（荧光免疫层析法）","降钙素原/全程C-反应蛋白/血清淀粉样蛋白A联合测定试剂盒（荧光免疫层析法）",{"$nulls":8},"2021-03-09",null,"2026-03-08",{"$nulls":13},"2"]
["粤械注准20172400487",null,"脂蛋白磷脂酶A2检测试剂盒（荧光免疫层析法）","脂蛋白相关磷脂酶A2测定试剂盒（荧光免疫层析法）",{"$nulls":8},"2021-06-23",null,"2026-06-22",{"$nulls":10},"试剂盒由测试卡、IC卡、稀释液以及说明书组成。\n包装规格、测试卡、IC卡、稀释液、说明书\n1人份/袋、1人份、1张、200μL、1份\n10人份/盒、10人份、1张、200μL*10支、1份\n25人份/盒、25人份、1张、200μL*25支、1份\n40人份/盒、40人份、1张、200μL*40支、1份\n50人份/盒、50人份、1张、200μL*50支、1份\n其中测试卡由试纸条、塑料盒组成，试纸条上的主要成分有：\na) Lp-PLA2单克隆抗体（固定在硝酸纤维素膜上）；\nb)羊抗鼠lgG多克隆抗体（固定在硝酸纤维素膜上）；\nc)荧光标记的Lp-PLA2单克隆抗体（固定在玻璃纤维上）；\nd)其他试纸条支持物。",null,"适用于体外定量检测人血清、血浆或全血样本中的脂蛋白磷脂酶A2（简称Lp-PLA2）浓度。","2"]
["国械注准20153141054",null,"一次性使用无菌自毁型固定剂量疫苗注射器  带针",{"$nulls":9},"2020-06-02","2025-06-02","2025-06-01","2030-06-01",{"$nulls":12},"3"]
["粤械注准20202021308",null,"微创筋膜闭合器",{"$nulls":6},"2024-12-30",null,null,"2020-08-24","2025-08-24","2025-08-23","2030-08-23",{"$nulls":3},"广州保瑞医疗技术有限公司",{"$nulls":5},"产品包括闭合固件和缝线穿引器两部分。闭合固件由器身、传动器、近端翼、手环、窗口组成，缝线穿引器由穿引针和手柄组成。",null,"用于腹腔镜手术中收拢组织、经皮缝合、以便闭合手术切口。","2"]
["闽械注准20202400430",null,"胱抑素C（Cys.C）检测试剂盒（量子点荧光免疫层析法）",{"$nulls":5},"2020-09-09","2025-05-29",null,null,"2020-09-09","2025-09-09","2025-09-08","2030-09-08",null,null,"厦门市波生生物技术有限公司",{"$nulls":5},"1. Cys.C检测卡: 1人份/袋\n检测线(T线):硝酸纤维素膜包被鼠抗Cys.C单克隆抗体\n质控线(C线):硝酸纤维素膜包被鼠抗兔IgG单克隆抗体\n结合垫:玻璃纤维包被含量子点标记的鼠抗Cys.C单克隆\n抗体及量子点标记的正常兔IgG\n2.稀释液(含表面活性剂的0.9%生理盐水): 1瓶/人份\n3.ID卡(内含试剂批次信息及校准曲线): 1个/盒","1.Cys.C检测卡: 1人份/袋\n检测线(T线):硝酸纤维素膜包被鼠抗Cys.C单克隆抗体\n质控线(C线):硝酸纤维素膜包被鼠抗兔IgG单克隆抗体\n结合垫:玻璃纤维包被含量子点标记的鼠抗Cys.C单克隆\n抗体及量子点标记的正常兔IgG\n2.稀释液(含表面活性剂的0.9%生理盐水): 1瓶/人份\n3.ID卡(内含试剂的批号信息及校准曲线): 1份/盒","本品用于体外定量检测人体血清、血浆及静脉全血中的\n胱抑素C(Cystatin C, Cys.C)， 主要作为反映肾小球滤过率的指标之一。",null,"2"]
["国械注准20203400987",null,"CYP2C19、CYP2C9和VKORC1基因检测试剂盒（荧光PCR-毛细管电泳法）",{"$nulls":5},"2020-12-17","2025-09-03",null,null,"2020-12-17","2025-12-17","2025-12-16","2030-12-16",null,null,"北京阅微基因技术股份有限公司",{"$nulls":5},"酶混合液，PCR反应液，CV-引物混合液,无核酸酶纯水,CV-质控品1,CV一质控品2，CV-质控品3， ROX500。",null,"本试剂盒用于体外定性检测人外周血样本中CYP2C19、CYP2C9和和VKORC1三个基因6个位点的基因型多态性(SNP），包括CYP2C19*2(681G>A)、*3（636G>A)、*17（-806C>T）；CYP2C 9*2(430C>T）、*3（1075A>C和VKORC1 (-1639G>A)的野生型、杂合型和纯合突变型。",null,"3"]
["粤械注准20202171630",null,"机用根管锉",null,"中国深圳市",{"$nulls":3},"2020-09-30","2024-09-27",null,null,"2020-09-30","2025-09-30","2025-09-29","2030-09-29","YY0803.2-2010",null,"深圳市葆丰医疗器械有限公司",null,"ShenzhenPerfectMedicalInstrumentsCo.,Ltd",{"$nulls":3},"由操作部分、杆部和橡胶限位块组成。操作部分上有带切削刃的工作部，操作部分由镍钛合金，杆部由不锈钢金属材料制成，橡胶限位块由硅胶材料制成。",null,"与有源医疗器械配合使用，用于齿科治疗中对牙骨、牙根管等的切削、平整、清洁和塑形等。",null,"2"]
["粤械注准20192061131",null,"超声探头导针架",null,"中国",{"$nulls":3},"2024-04-18",{"$nulls":3},"2024-10-22",null,"2029-10-21",{"$nulls":3},"经方精密医疗（深圳）有限公司",{"$nulls":5},"由针槽、架体、卡扣组成",null,"配合腔内或体外超声探头使用，用于固定超声探头或穿刺针用",null,"2"]
["冀械注准20202220473",null,"一次性使用真空采血管",null,"中国",{"$nulls":3},"2024-06-20",{"$nulls":3},"2020-06-24","2025-06-24","2025-06-23","2030-06-23","冀械注准20202220473",null,"河北康卫仕医疗科技有限公司",{"$nulls":5},"本产品由试管（玻璃试管或PET试管）、丁基胶塞、聚乙烯塑料帽盖、标签、添加剂（如有）及附加物（如有）组成。",null,"与采血针配套使用，分别用于临床人体静脉血液标本的采集、抗凝、促凝、分离、保存。",null,"2"]
["苏械注准20202091041",null,"医用静脉曲张压缩袜",null,"中国",null,"苏州恒星医用材料有限公司",null,"2020-09-10","2025-05-27",null,null,"2020-09-10","2025-09-10","2025-09-09","2030-09-09","苏械注准20202091041",null,"苏州恒星医用材料有限公司",{"$nulls":5},"医用静脉曲张压缩袜采用锦纶和氨纶纤维材料制成。医用静脉曲张压缩袜型号按照压缩力等级和型式分为：AD-I、AD-II，AD-III；AG-I、AG-II、AG-III；AT-I、AT-II、AT-III。每种型号按照脚踝的周长尺寸不同，分为S、M、L、XL、XXL。该产品以非无菌状态提供。",null,"用于促进静脉血液回流，预防深静脉血栓形成，缓解静脉曲张症状。",null,"2"]
["苏械注准20172041599",null,"椎体成形工具包","椎体成形术器械",{"$nulls":4},"2021-11-08",{"$nulls":3},"2022-08-22",null,"2027-08-21",{"$nulls":3},"苏州爱得科技发展股份有限公司",{"$nulls":5},"椎体成形工具包按用途分为ZT-Ⅰ、ZT-Ⅱ、ZT-Ⅲ 三种型号。其中，ZT-Ⅰ由组合式探针套管组成；ZT-Ⅱ由钻头、保护套管、扩张套管和引导丝组成；ZT-Ⅲ由骨水泥填充器组成。规格由（外径×长度）和头部形式组成。成套型工具包根据组配器械的不同分为B型、D型、G型、T1型、T11型、T2型、T21型七种型号规格。该产品以无菌状态提供，经环氧乙烷灭菌，一次性使用。","椎体成形术器械按用途分为ZT-Ⅰ、ZT-Ⅱ、ZT-Ⅲ三种型号。其中，ZT-Ⅰ由组合式探针套管组成；ZT-Ⅱ由钻头、钻头试模、保护套管、扩张套管和引导丝组成；ZT-Ⅲ由骨水泥填充器组成。规格由（外径×长度）和头部形式组成。成套型工具包根据组配器械的不同分为B型、D型、G型、T1型、T11型、T2型、T21型七种型号规格。该产品以无菌状态提供，经环氧乙烷灭菌，一次性使用。","供医疗单位经皮椎体成形术时做配套工具用。",null,"2"]
["粤械注准20222400678",null,"谷胱甘肽还原酶测定试剂盒（紫外酶法）",{"$nulls":5},"2022-06-01",{"$nulls":3},"2022-06-01",null,"2027-05-31",{"$nulls":3},"珠海鎏联生物技术有限公司",{"$nulls":5},"产品性能\n1.在 37℃、340nm 波长、1cm光径条件下，试剂空白吸光度≥0.500。用生理盐水作为样本加入试剂测试时，试剂空白吸光度变化率（ΔA/min）应≤0.004。\n2.分析灵敏度：用本试剂测试谷胱甘肽还原酶时，1 单位浓度引起的吸光度变化率（ΔA/min）不小于0.6×10-4。\n3.准确度：回收率（R）应在85%~115%。\n4.线性区间：试剂（盒）线性在4～300U/L区间内，理论浓度与实测浓度的线性相关系数r应不小于0.990；在[4～100]U/L区间内，实测浓度与估计值的线性绝对偏差的绝对值≤ 10U/L；（100～300]U/L区间内,实测浓度与估计值的线性相对偏差的绝对值≤10%。\n5.精密度：a）重复性：重复性CV≤10%；b）批间差：批间变异系数（CV）应≤15%。\n结构及组成\nR1：三羟甲基氨基甲烷（Tris）缓冲液：120mmol/L、还原型辅酶Ⅱ（NADPH）：0.20mmol/L；\nR2：三羟甲基氨基甲烷（Tris）缓冲液：120mmol/L、氧化型谷胱甘肽（GSSG）：2.5mmol/L；\n校准品（选配）：2*0.5mL/瓶；GR（含小牛血清的",{"$nulls":3},"2"]
["国械注进20203170456",null,"牙科树脂修复材料 Resin-based Dental RestorativeMateria",null,"日本",null,"山八齿材工业（常熟）有限公司",null,"2020-10-20","2025-01-07",null,null,"2020-10-20","2025-10-26","2025-10-25","2530-10-25",null,null,"山八齿材工业(常熟)有限公司",null,"TokuyamaDentalCorporation",{"$nulls":3},"牙科树脂修复材料是由有机复合填料。一氧化硅氧化锆填料 Bis-GMA，TEGDMA脑醒，自由基放大剂，4-羟基苯甲醚丁基轻基甲苯，紫外线吸收剂，荧光剂，颜料组成。",null,"本产品用于龋齿治疗后的前、后牙的充填修复。",null,"3"]
["桂械注准20202090293",null,"定向药透仪专用电极",{"$nulls":5},"2020-06-23","2025-04-30",null,null,"2020-06-23","2025-06-23","2025-06-22","2030-06-22",{"$nulls":8},"本产品由电极板(适用于WND-GD-A1、WND-GD-A2、WN- GD-A3、WND-GD-A4、WND-GD-A5、WND- GD-A6、WND-GD-A7、WND-GD-A8、WND-GD-A9、WND-GD-A10、WND-GD-A11、WND-GD-A12)、导电胶贴(适用于WND-ZN-A1、WND-ZN-A2、WND-ZN-A3、WND ZN-M4、WND-ZN-A5、WND-ZN-A6、WND-ZN-A7、WND-ZN-A8、WND-ZN-A9、WND-ZN-A10、WND-ZN-A11、WND-ZN-A12)、电极片、电极线(或电极转接线)组成，其中电极片由无纺布垫片、甘油、55%乙醇组成。垫片接触皮肤表面，将仪器输出的电刺激信号通过电极片传导到皮肤。产品中电极板、电极线(或电极转接线)可重复使用，根据实际使用配给。导电胶贴、电极片均为一次性使用。产品以非无菌形式提供。",null,"与桂林市威诺敦医疗器械有限公司生产的定向药透仪配套使用。",null,"2"]
["鄂械注准20152142155",null,"敷贴",null,"中国湖北枝江",{"$nulls":3},"2020-08-06","2025-05-08",null,null,"2020-08-06","2025-08-06","2025-08-05","2030-08-05","鄂械注准20152142155",null,"奥美医疗用品股份有限公司",{"$nulls":5},"采用隔离纸、吸水垫、粘胶层和无纺布组成。",null,"主要供清创后的外伤、术后创口隔离防护及各种输液针、管、敷料等的固定。",null,"2"]
["浙械注准20202400751",null,"N-乙酰-β-D-氨基葡萄糖苷酶测定试剂盒(MPT底物法)",{"$nulls":5},"2020-08-21",{"$nulls":3},"2020-08-21","2025-08-21","2025-08-20","2030-08-20",null,null,"宁波海尔施智造有限公司",{"$nulls":5},"试剂1：柠檬酸缓冲液、ProClin300；试剂2：6-甲基-2-吡啶基-1-硫-N-乙酰-B-D-氨基葡萄糖苷、磷酸盐缓冲液、ProClin300；校准品和质控品；含有N-乙酰-B-D-氨基葡萄糖苷酶的冻干品。（具体内容详见产品说明书）",null,"用于体外定量检测人尿液中的N-乙酰-B-D-氨基葡萄糖苷酶的活性。",null,"2"]
["浙械注准20202400744",null,"α1-微球蛋白测定试剂盒（胶乳免疫比浊法）",{"$nulls":5},"2020-08-18",{"$nulls":3},"2020-08-18","2025-08-18","2025-08-17","2030-08-17",null,null,"宁波海尔施智造有限公司",{"$nulls":5},"试剂1：4-羟乙基哌嗪乙磺酸缓冲液；试剂2：抗人α1-微球蛋白抗体、胶乳溶液；校准品和质控品：含有a1-微球蛋白的冻干品。（具体内容详见产品说明书）",null,"用于体外定量检测人血清或尿液中α1-微球蛋白的含量。",null,"2"]
["桂械注准20222400260",null,"超敏肌钙蛋白I检测试剂盒（磁微粒化学发光法）","高敏肌钙蛋白I检测试剂盒（磁微粒化学发光法）",{"$nulls":4},"2022-08-08",{"$nulls":3},"2022-08-08",null,"2027-08-07",{"$nulls":3},"巴迪泰（广西）生物科技有限公司",{"$nulls":5},"试剂一（R1）：磷酸盐缓冲液0.01M、牛血清白蛋白1.0%；\n磁微粒（M）：生物素化超敏肌钙蛋白I抗体偶联的磁微粒4%、磷酸氢二钠缓冲液0.01M、牛血清白蛋白1.0%；\n试剂二（R2）：碱性磷酸酶标记的超敏肌钙蛋白I抗体0.1%、吗啉乙磺酸缓冲液0.05M、牛血清白蛋白1.0%；\n校准品（选配）：超敏肌钙蛋白I抗原、三羟甲基氨基甲烷缓冲液0.05M；\n质控品（选配）：超敏肌钙蛋白I抗原、三羟甲基氨基甲烷缓冲液0.05M。","\"试剂一（R1）:磷酸盐缓冲液0.01M、牛血清白蛋白1.0%；\n磁微粒（M）：生物素化高敏肌钙蛋白I抗体偶联的磁微粒4%、磷酸氢二钠缓冲液0.01M、牛血清白蛋白1.0%；\n试剂二（R2）：碱性磷酸酶标记的高敏肌钙蛋白I抗体0.1%、吗啉乙磺酸缓冲液0.05M、牛血清白蛋白1.0%；\n校准品（选配）：高敏肌钙蛋白I抗原、三羟甲基氨基甲烷缓冲液0.05M；\n质控品（选配）：高敏肌钙蛋白I抗原、三羟甲基氨基甲烷缓冲液0.05M\"","本试剂盒用于体外定量检测人全血、血清、血浆样本超敏肌钙蛋白I (hs-cTnI)的浓度，临床上主要用于心肌梗死的辅助诊断。","本试剂盒用于体外定量检测人全血、血清、血浆样本高敏肌钙蛋白I（hs?cTnI)的浓度，临床上主要用于心肌梗死的辅助诊断。","2"]
["粤械注准20212400358",null,"抗链球菌溶血素\"O\"测定试剂盒（胶乳免疫透射比浊法）",{"$nulls":5},"2021-03-08",{"$nulls":3},"2021-03-08","2026-03-08","2026-03-07","2031-03-07",null,null,"深圳市新产业生物医学工程股份有限公司",{"$nulls":5},"R1:磷酸缓冲液;\nR2:磷酸缓冲液、包被有链球菌溶血素“O”的胶乳颗粒；\n校准品:抗链球菌溶血素“O”",null,"本试剂盒用于体外定量测定人血清中抗链球菌溶血素“O”(ASO)的含量。临床上主要用于急性风湿热的辅助诊断。",null,"2"]
["粤械注准20212400373",null,"视黄醇结合蛋白测定试剂盒（胶乳免疫透射比浊法）",{"$nulls":5},"2021-03-10",{"$nulls":3},"2021-03-10","2026-03-10","2026-03-09","2031-03-09",null,null,"深圳市新产业生物医学工程股份有限公司",{"$nulls":5},"R1:磷酸盐缓冲液;R2:磷酸盐缓冲液、包被有羊抗人RBP抗体的胶乳颗粒;校准品1*:重组人RBP蛋白;校准品2*:重组人RBP蛋白。",null,"用于体外定量测定人血清或尿液中视黄醇结合蛋白(RBP)的含量,临床上主要用于肝脏或肾小管损伤性疾病的辅助诊断。",null,"2"]
["粤械注准20202402103",null,"游离脂肪酸测定试剂盒（ACS-ACOD法）",{"$nulls":5},"2020-12-16",{"$nulls":3},"2020-12-16","2025-12-16","2025-12-15","2030-12-15",null,null,"深圳市新产业生物医学工程股份有限公司",{"$nulls":5},"R1:磷酸盐缓冲液,腺嘌呤核苷三磷酸（ATP）,辅酶A,4-氨基安替比林,酰基辅酶A合成酶; R2:磷酸盐缓冲液,过氧化物酶,酰基辅酶A氧化酶,N-乙基-N-（2-羟基-3-磺丙基）-3-甲基苯胺钠（TOOS）; 校准品:油酸钠。",null,"本试剂用于体外定量测定人血清或血浆中游离脂肪酸(NEFA)的含量。临床上主要用于高脂血症、冠心病和动脉粥样硬化的辅助诊断。",null,"2"]
["粤械注准20202402102",null,"N一乙酰一β—D一氨基葡萄糖苷酶测定试剂盒（MPT底物法）",{"$nulls":5},"2020-12-16",{"$nulls":3},"2020-12-16","2025-12-16","2025-12-15","2030-12-15",null,null,"深圳市新产业生物医学工程股份有限公司",{"$nulls":5},"R1：柠檬酸缓冲液； R2：柠檬酸缓冲液，6-甲基-2-硫代吡啶-N-乙酰-β-D-氨基葡萄糖苷（MPT-NAG）； 校准品：柠檬酸缓冲液，牛血清白蛋白（BSA），N-乙酰-β-D-氨基葡萄糖苷酶（NAG）。",null,"本试剂盒用于体外定量测定人尿液或血清中N-乙酰-β-D-氨基葡萄糖苷酶(NAG)的活性浓度,临床上主要用于辅助评价肾小管损害。",null,"2"]
["京械注准20222040343",null,"一次性使用无菌脊柱定位手术工具包","一次性使用无菌骨科定位手术工具包",{"$nulls":4},"2022-08-17",null,"2023-03-15",null,"2022-08-17",null,"2027-08-16",{"$nulls":9},"见附页","见附页","适用于配合计算机辅助骨科手术定位仪或脊柱外科手术导航定位设备在骨科手术中定位、导向以及建立工作通道。","适用于配合骨科钻孔调节定位器、脊柱外科手术导航定位设备或骨科手术导航定位系统在骨科手术中定位、导向以及建立工作通道。","2"]
["辽械注准20152020111",null,"一次性使用腔镜导管",null,"中国/大连",{"$nulls":3},"2020-06-12","2024-10-14","2023-03-31",null,"2020-06-12","2025-06-12","2025-06-11","2030-06-11",null,null,"鑫海合星科技（大连）有限公司",{"$nulls":5},"I型（380mm）和II型（1800mm）由双腔导管、连接管、锥形固定器和注射器连接锥头组成，III型（1650mm）和IV型（2300mm）由注药头和导管组成，V型（330mm）由注药头、小盖和导管组成，VI型（330mm）由导管注塑件、导管、推杆注塑件、推杆和推药头组成，其中I型（380 mm）和V型（330mm）可选配套管。",null,"用于内窥镜和腔镜外科手术中输送液体组分到创面。",null,"2"]
["苏械注准20182220731","苏械注准20182020731","一次性使用细胞刷",{"$nulls":9},"2023-04-10",null,"2028-04-09",{"$nulls":9},"一次性使用细胞刷（以下简称细胞刷）主要由\n刷头、外套管、拉索杆、滑环和手柄组成。刷\n头采用符合 GB/T21032-2007 要求的 PA 材料；\n外套管采用符合 QB/T 4877-2015 要求的 PTFE\n材料；拉索杆采用符合 GB/T 1220-2007 要求\n06Cr19Ni10 材料；滑环、手柄采用符合 GB/T\n12672-2009 要求的 ABS 材料。\n细胞刷根据刷头型式分为：直型刷头和 U 型刷头二种型号；根据外套管的直径不同分为：\nφ1.8 mm、φ2.3 mm 共二种规格；根据细胞刷\n工作长度的不同分为\n1050mm、1200mm、1600mm、1800mm、2300\nmm 共 5 种规格。\n外套管无损坏。刷毛排列分布应均匀。刷毛应\n无浮毛现象。刷头进出外套管应顺畅，且刷头\n能完全伸出外套管。\n产品经环氧乙烷灭菌后应无菌，一次性使用",null,"适用于临床刷取细胞样品用",null,"2"]
["鄂械注准20192172596",null,"定制式活动义齿","定制式活动义齿",{"$nulls":4},"2019-01-29","2023-08-30",null,null,"2019-01-29","2024-01-29","2024-01-28","2029-01-28",null,null,"湖北顺富医疗器械科技有限公司","湖北顺富医疗器械科技有限公司",{"$nulls":4},"定制式活动义齿结构为可摘局部义齿、全口义齿，可摘局部义齿由人工牙、基托、固位体和连接体组成；全口义齿由人工牙和基托组成。","定制式活动义齿结构为钴铬合金铸造支架可摘局部义齿、树脂基托可摘局部义齿由人工牙、基托、固位体和连接体组成；树脂基托全口义齿、钴铬合金铸造基托全口义齿由人工牙和基托组成。","定制式活动义齿用于牙列缺损、牙列缺失的活动修复。","定制式活动义齿用于牙列缺损、牙列缺失的活动修复。","2","2"]
["鄂械注准20192172595",null,"定制式固定义齿","定制式固定义齿",{"$nulls":4},"2019-01-29","2023-08-25",null,null,"2019-01-29","2024-01-29","2024-01-28","2029-01-28",null,null,"湖北顺富医疗器械科技有限公司","湖北顺富医疗器械科技有限公司",{"$nulls":4},"固定义齿结构冠桥由固位体、桥体、连接体三部分组成。","固定义齿结构冠桥由固位体、桥体、连接体三部分组成","适用于牙列缺损或牙体缺损的固定修复。","适用于牙列缺损或牙体缺损的固定修复。","2","2"]
["鲁械注准20232140108",null,"鼻腔填充海绵","膨胀止血海绵",{"$nulls":4},"2023-02-13",{"$nulls":3},"2023-02-13",null,"2028-02-12",{"$nulls":3},"诺一迈尔（山东）医学科技有限公司",{"$nulls":5},"本产品是由羟乙基纤维素制成的高分子海绵，经电子束辐照灭菌，一次性使用。",null,"用于手术、创伤及其他原因导致的鼻腔出血的填塞压迫止血。","用于手术、创伤及其他原因导致的鼻腔、中耳与外耳出血的填塞、压迫止血与支撑","2"]
["皖械注准20232140049","国械注准20253140731","可降解膨胀止血绵","可降解耳鼻止血绵","国产","国产","合肥启灏医疗科技有限公司","合肥启灏医疗科技有限公司","2023-03-20","2025-06-20","2023-05-12","2025-06-20","2023-03-20","2025-06-20","2028-03-19","2030-04-08",null,null,"合肥启灏医疗科技有限公司","合肥启灏医疗科技有限公司",null,"合肥启灏医疗科技有限公司",null,null,"产品为多聚醚型聚氨酯海绵，由(DL-丙交酯-co-ε- 己内酯)-氨酯共聚物组成,一次性使用。产品经辐照灭菌，应无菌。","产品为多聚醚型聚氨酯海绵，由（DL-丙交酯-co-ε-己内酯）-氨酯共聚物组成，本产品为一次性使用无菌产品，采用电子束辐照灭菌。","用于鼻腔、中耳与外耳术后的暂时压迫止血与支撑。","用于鼻腔、中耳与外耳术后的暂时压迫止血与支撑。","2","3"]
["闽械注准20202400429",null,"C反应蛋白（CRP）检测试剂盒（量子点荧光免疫层析法）",{"$nulls":5},"2020-09-09","2025-05-29",null,null,"2020-09-09","2025-09-09","2025-09-08","2030-09-08",null,null,"厦门市波生生物技术有限公司",{"$nulls":5},"1.C反应蛋白检测卡: 1人份/袋\n检测线(T线):硝酸纤维素膜包被鼠抗CRP单克隆抗体\n质控线(C线):硝酸纤维素膜包被鼠抗兔IgG单克隆抗体\n结合垫:玻璃纤维包被含量子点标记的鼠抗CRP单克隆抗\n体及量子点标记的正常兔IgG i\n2.稀释液(含表面活性剂的0.9%生理盐水): 1瓶/人份\n3. ID卡(内含试剂的批号信息及校准曲线): 1个/盒","1.C反应蛋白检测卡: 1人份/袋\n检测线(T线):硝酸纤维素膜包被鼠抗CRP单克隆抗体\n质控线(C线):硝酸纤维素膜包被鼠抗兔IgG单克隆抗体\n结合垫:玻璃纤维包被含量子点标记的鼠抗CRP单克隆抗\n体及量子点标记的正常兔IgG\n2.稀释液(含表面活性剂的0.9%生理盐水): 1瓶/人份\n3.ID卡(内含试剂的批号信息及校准曲线): 1份/盒","本品用于体外定量检测人血清/血浆/静脉全血中的C反\n应蛋白(C reactive protein, CRP)， 包括常规C反应蛋白\n(常规CRP)检测和超敏C反应蛋白(hsCRP)检测。",null,"2"]
["川械注准20222400148",null,"凝血测定试剂盘（透射比浊法）",{"$nulls":5},"2022-09-20",{"$nulls":3},"2022-09-20",null,"2027-09-19",{"$nulls":3},"成都普利泰生物科技有限公司",{"$nulls":5},"1、试剂盒内有独立包装的试剂盘和产品说明书；试剂盘中央有二维码，二维码中含有校准数据、项目参数、生产批次等信息。\n2、试剂盘中各检测项目主要成分、含量如下：\n项目   主要组成成分    含量\nFib  牛凝血酶 0.05 U～0.4 U\nTT  牛凝血酶 0.01 U～0.06 U\nPT  组织因子0.11 ng～1.6 ng\n氯化钙0.01 mg\nAPTT 磷脂1.6 μg～6.4 μg\n氯化钙0.008 mg\n高岭土1 %\nD-Dimer  小鼠抗-人D-Dimer单抗0.1 mg/mL～0.4 mg/mL\n胶乳0.2 %～0.8 %\nFDP    鼠抗人FDP单抗  0.2 mg/mL～0.8 mg/mL\n羧基微  球0. 4 %～0.9 %\n3、Fib项目溯源至NIBSC标准物质Fibrinogen Plasma(D)(3rd International Standard)，其他项目溯源至企业参考品。\n（因版面字数限制，其他内容详见“注册证或说明书”。）",null,"凝血测定试剂盘（透射比浊法）各规格的预期用途如下：\n凝血6项用于体外测定人全血或血浆中凝血酶时间、凝血酶原时间、活化部分凝血活酶时间和纤维蛋白原、纤维蛋白（原）降解产物、D-二聚体的含量；\n凝血5项用于体外测定人全血或血浆中凝血酶时间、凝血酶原时间、活化部分凝血活酶时间和纤维蛋白原、D-二聚体的含量；\n凝血4项用于体外测定人全血或血浆中凝血酶时间、凝血酶原时间、活化部分凝血活酶时间和纤维蛋白原的含量。","凝血测定试剂盘（透射比浊法）各规格的预期用途如下：\n凝血6项用于体外测定人全血或血浆中凝血酶时间、凝血酶原时间、活化部分凝血活酶时间和纤维蛋白原、纤维蛋白（原）降解产物、D-二聚体的含量；\n凝血5项用于体外测定人全血或血浆中凝血酶时间、凝血酶原时间、活化部分凝血活酶时间和纤维蛋白原、D-二聚体的含量；\n凝血4项用于体外测定人全血或血浆中凝血酶时间、凝血酶原时间、活化部分凝血活酶时间和纤维蛋白原的含量；\n凝血2项用于体外测定人全血或血浆中凝血酶原时间和活化部分凝血活酶时间的含量。","2"]
["川械注准20222400225",null,"综合Ⅳ生化测定试剂盘（微流控干化学法）",{"$nulls":5},"2022-11-29",{"$nulls":3},"2022-11-29",null,"2027-11-28",{"$nulls":3},"成都普利泰生物科技有限公司",{"$nulls":5},"试剂盒内有独立包装的试剂盘，试剂盘中央有二维码。二维码中含有校准数据、项目参数、生产批次信息等。其主要组成成分、含量如下：项目主要成分含量TP：五水合硫酸铜4～10 g/L、四水合酒石酸钾钠20～50 g/L、氢氧化钠6～36 g/L；TG：β-烟酰胺腺嘌呤二核苷酸4～16 g/L、脂蛋白脂肪酶20～35 KU/L、甘油脱氢酶8～32 KU/L；GLU：腺苷-5'-三磷酸二钠盐4.50～11.25 g/L、β-烟酰胺腺嘌呤二核苷酸6～20 g/L；UREA：α-酮戊二酸二钠盐合二水13～40 g/L、谷氨酸脱氢酶450～900 U/L、尿素酶35～50 KU/L；TC：胆固醇酯酶69～82 KU/L、胆固醇脱氢酶28.2～40.0 KU/L；β-烟酰胺腺嘌呤二核苷酸7.0～8.5 g/L；ALT：L-丙氨酸40～70 g/L、α-酮戊二酸二钠盐合二水1.5～4.5 g/L、D-乳酸脱氢酶10～25 KU/L、还原型β-烟酰胺腺嘌呤二核苷酸二钠盐0.5～1.4 g/L。（因版面字数限制，其他内容详见“注册证或说明书”。）",null,"综合Ⅳ生化测定试剂盘（微流控干化学法）各规格的预期用途如下：\n综合17项B用于体外定量检测人末梢血和静脉全血、血浆或血清中甘油三酯、总胆固醇、高密度脂蛋白胆固醇、同型半胱氨酸、脂蛋白(a)、胱抑素C、肌酐、尿素、尿酸、葡萄糖、果糖胺、总蛋白、白蛋白、天门冬氨酸氨基转移酶、丙氨酸氨基转移酶、总胆红素、直接胆红素的浓度；\n综合14项C用于体外定量检测人末梢血和静脉全血、血浆或血清中甘油三酯、总胆固醇、高密度脂蛋白胆固醇、同型半胱氨酸、肌酐、尿素、尿酸、葡萄糖、总蛋白、白蛋白、天门冬氨酸氨基转移酶、丙氨酸氨基转移酶、总胆红素、直接胆红素的浓度；\n慢病检测13项用于体外定量检测人末梢血和静脉全血、血浆或血清中甘油三酯、总胆固醇、高密度脂蛋白胆固醇、同型半胱氨酸、脂蛋白(a)、胱抑素C、肌酐、尿素、尿酸、葡萄糖、果糖胺、总蛋白、白蛋白的浓度；\n肝肾功10项用于体外定量检测人末梢血和静脉全血、血浆或血清中胱抑素C、肌酐、尿素、尿酸、总蛋白、白蛋白、天门冬氨酸氨基转移酶、丙氨酸氨基转移酶、总胆红素、直接胆红素的浓度。（因版面字数限制，其他内容详见“注册证或说明书”。）",null,"2"]
["京械注准20232010221",null,"手术电极（多功能手术解剖器）","电凝切割器（多功能手术解剖器）","北京市",null,"北京鸿鹄高翔科技开发有限公司",null,"2023-04-11",{"$nulls":3},"2023-04-11",null,"2028-04-10",null,"京械注准20232010221",null,"北京鸿鹄高翔科技开发有限公司",{"$nulls":5},"产品组成：HQ01-X型主要由刀头、塑料手柄、手控按钮开关、导线、吸引管、功能管等组成。HQ02-X型由头部、手柄、塑料压块、导线组成。","产品组成：HQ01-X型主要由刀头、塑料手柄、手控按钮开关、导线、吸引管、功能管等组成。HQ02-X型由头部、手柄、塑料压块、导线组成。HQ03-X型由头部、手柄、导线组成。","与高频手术设备配合使用，在外科手术中进行切割或凝血。",null,"2"]
["川械注准20222400231",null,"综合Ⅴ生化测定试剂盘（微流控干化学法）",{"$nulls":5},"2022-12-12",{"$nulls":3},"2022-12-12",null,"2027-12-11",{"$nulls":3},"成都普利泰生物科技有限公司",{"$nulls":5},"试剂盒内有独立包装的试剂盘，试剂盘中央有二维码。二维码中含有校准数据、项目参数、生产批次信息等。其主要组成成分、含量如下：项目 主要成分 含量 AST：还原型β-烟酰胺腺嘌呤二核苷酸二钠盐0.535～0.730 g/L、苹果酸脱氢酶  10～20 KU/L；LDH：乳酸锂25.0～88.4 g/L、β-烟酰胺腺嘌呤二核苷酸4.0～25.2 g/L；CK-MB：葡萄糖3.20～9.20 g/L、辅酶Ⅱ，二钠盐 6.10～9.10 g/L、磷酸肌酸，二钠盐 40.00～70.00 g/L、二磷酸腺苷3.10～6.10 g/L；CKMM：单克隆抗体8.00～14.00 ml/L；CK：二磷酸腺苷3.00～4.00 g/L、磷酸肌酸，二钠盐40.00～54.00 g/L；HBDH：2-酮丁酸钠盐水合物1.5～3.0 g/L、还原型β-烟酰胺腺嘌呤二核苷酸二钠盐1.50～2.25 g/L。（因版面字数限制，其他内容详见“注册证或说明书”。）",null,"综合Ⅴ生化测定试剂盘（微流控干化学法）各规格的预期用途如下：\n综合19项B用于体外定量检测人末梢血和静脉全血、血浆或血清中天门冬氨酸氨基转移酶、乳酸脱氢酶、肌酸激酶、肌酸激酶同工酶、α-羟丁酸脱氢酶、钾、钠、氯、总二氧化碳、钙、镁、无机磷、淀粉酶、肌酐、尿素、尿酸、脂肪酶、葡萄糖、C-反应蛋白的浓度；\n综合17项C用于体外定量检测人末梢血和静脉全血、血浆或血清中天门冬氨酸氨基转移酶、乳酸脱氢酶、肌酸激酶、肌酸激酶同工酶、α-羟丁酸脱氢酶、钾、钠、氯、总二氧化碳、钙、淀粉酶、肌酐、尿素、尿酸、脂肪酶、葡萄糖、C-反应蛋白的浓度；\n心肌电解质12项用于体外定量检测人末梢血和静脉全血、血浆或血清中天门冬氨酸氨基转移酶、乳酸脱氢酶、肌酸激酶、肌酸激酶同工酶、α-羟丁酸脱氢酶、钾、钠、氯、总二氧化碳、钙、镁、无机磷的浓度；\n电解质肾功11项用于体外定量检测人末梢血和静脉全血、血浆或血清中钾、钠、氯、总二氧化碳、钙、镁、无机磷、肌酐、尿素、尿酸、葡萄糖的浓度。\n（因版面字数限制，其他内容详见“注册证或说明书”。）",null,"2"]
["豫械注准20202140487",null,"一次性使用采血输液辅助包",{"$nulls":3},"新乡市金世康医疗器械有限公司",null,"2020-07-07",null,"2023-07-13",null,"2020-07-07","2025-07-07","2025-07-06","2030-07-06",null,null,"新乡市金世康医疗器械有限公司",{"$nulls":5},"采血型由基本配置医用棉签、包布，和选用配置一次性使用输液贴、碘伏棉签、透气胶带、止血带和一次性使用聚乙烯检查手套组成。输液型由基本配置医用棉签、包布，和选用配置一次性使用输液贴、碘伏棉签、酒精棉签、止血带和一次性使用聚乙烯检查手套组成。",null,"供医疗机构为患者采血或输液护理时使用。",null,"2"]
["国械注准20163100455",null,"一次性使用动静脉穿刺针",{"$nulls":9},"2021-01-22","2026-01-22","2026-01-21","2031-01-21",{"$nulls":8},"固定的一次性使用动静脉穿刺针：由穿刺针（针头）、针柄（蝴蝶柱和固定蝴蝶翼）、软管（管路）、止流夹（止血夹）、内圆锥接头（母针基）、接头保护套（母针基盖）、穿刺针保护套（穿刺针护套）组成。\n旋转的一次性使用动静脉穿刺针：由穿刺针（针头）、针柄（蝴蝶柱和旋转蝴蝶翼）、软管（管路）、止流夹（止血夹）、内圆锥接头（母针基）、接头保护套（母针基盖）、穿刺针保护套（穿刺针护套）组成。",null,null,"本产品用于血液透析治疗中进行动静脉穿刺。","3"]
["闽械注准20232400090",null,"脑利钠肽测定试剂盒（磁微粒化学发光法）","B型钠尿肽（BNP）测定试剂盒（磁微粒化学发光法）",{"$nulls":4},"2023-07-06",{"$nulls":3},"2023-07-06",null,"2028-07-05",null,"闽械注准20232400090",null,"厦门万泰凯瑞生物技术有限公司",{"$nulls":5},"试剂 1：1瓶（50人份：2.5mL；100人份：5mL；200人份：10mL），BNP单克隆抗体（鼠源）包被的磁微粒。\n试剂 2：1瓶（50人份：2.5mL；100人份：5mL；200人份：10mL），吖啶酯标记的BNP单克隆抗体（鼠源）。\n试剂 3：1瓶（50人份：2.5mL；100人份：5mL；200人份：10mL），含有表面活性剂溶液。\n校准品 1：0.5mL×1瓶，35.00pg/mL-65.00pg/mL 的BNP。\n校准品 2：0.5mL×1瓶，1600.00pg/mL-2400.00pg/mL 的BNP。",null,"本试剂盒用于定量检测人血浆中的脑利钠肽（BNP），临床上主要用于心力衰竭的辅助诊断。","本试剂盒用于定量检测人血浆中的B型钠尿肽（BNP），临床上主要用于心力衰竭的辅助诊断。","2"]
["国械注准20153401966",null,"总前列腺特异性抗原测定试剂盒（磁微粒化学发光法）",{"$nulls":9},"2020-08-19","2025-08-19","2025-08-18","2030-08-18",null,null,"厦门万泰凯瑞生物技术有限公司",{"$nulls":5},"试剂1：1 瓶（50人份：2.5mL；100人份：5 mL；200人份：10mL；300人份：15mL；500人份：25mL），T-PSA 抗体包被的磁微粒。\n试剂2：1 瓶（50人份：5mL；100人份：5 mL；200人份：10mL；300人份：15mL；500人份：25mL），吖啶酯标记的T-PSA 抗体。\n校准品1：1mL×1 瓶，0.8ng/mL 的总前列腺特异性抗原，含牛血清的磷酸盐缓冲液，含有ProClin 300 防腐剂。\n校准品2：1mL×1 瓶，20ng/mL 的总前列腺特异性抗原，含牛血清的磷酸盐缓冲液，含有ProClin 300 防腐剂。",null,"本试剂盒定量检测人血清或血浆样品中总前列腺特异性抗原(T-PSA) 。对临床诊断前列腺疾病有重要辅助作用。主要用于对恶性肿瘤患者进行动态监测以辅助判断疾病进程或治疗效果，不能作为恶性肿瘤早期诊断或确诊的依据，不宜用于普通人群的肿瘤筛查。","本试剂盒定量检测人血清或血浆样本中总前列腺特异性抗原（T-PSA）。对临床诊断前列腺疾病有重要辅助作用。主要用于对恶性肿瘤患者进行动态监测以辅助判断疾病进程或治疗效果，不能作为恶性肿瘤早期诊断或确诊的依据，不宜用于普通人群的肿瘤筛查。","3"]
["国械注准20163401356",null,"甲型肝炎病毒抗体测定试剂盒（磁微粒化学发光法）","甲型肝炎病毒抗体检测试剂盒（磁微粒化学发光法）",{"$nulls":8},"2021-08-03",null,"2026-08-02",{"$nulls":3},"厦门万泰凯瑞生物技术有限公司",{"$nulls":5},"试剂1：1瓶（50 人份：2.5mL；100人份：5mL；200人份：10mL；300人份：15mL；500人份：25mL），HAV单抗和HAV抗原包被的磁微粒，置于含表面活性剂和防腐剂ProClin300的缓冲液中。\n试剂2：1瓶（50 人份：1.25mL；100人份：2.5mL；200人份：5mL；300人份：7.5mL；500人份：12.5mL），吖啶酯标记的HAV单抗，置于含蛋白保护剂、表面活性剂和防腐剂ProClin300的缓冲液中。\n试剂3：1瓶（50 人份：1mL；100人份：2mL；200人份：4mL；300人份：6mL；500人份：10mL），含蛋白保护剂、表面活性剂和防腐剂ProClin300的缓冲液。\n校准品1：1mL×1瓶，淡黄色，灭活的HAV Ab检测为阳性的人血清或血浆，防腐剂：ProClin300。\n校准品2：1mL×1瓶，淡黄色，灭活的HAV Ab检测为阴性的人血清或血浆，防腐剂：ProClin300。",null,"本产品用于体外定性检测人血清或血浆中的甲型肝炎病毒总抗体。",null,"3"]
["国械注准20153401962","闽械注准20152401962","癌胚抗原测定试剂盒（磁微粒化学发光法）",{"$nulls":9},"2020-08-24","2025-08-24","2025-08-23","2030-08-23",null,null,"厦门万泰凯瑞生物技术有限公司",{"$nulls":5},"试剂1：1瓶（50人份：2.5mL；100人份：5mL；200人份：10mL；300人份：15mL；500人份：25mL），CEA抗体包被的磁微粒。\n试剂2：1瓶（50人份：2.5mL；100人份：5ml；200人份：10mL；300人份：15mL；500人份：25mL），吖啶酯标记CEA抗体。\n试剂3：1瓶（50人份：2.5mL；100人份：5mL；200 人份：10mL；300人份：15mL；500人份：25mL），反应稀释液。\n校准品1: 1mL×1 瓶，10.00ng/mL 的癌胚抗原，含牛血清的磷酸盐缓冲液，含有ProClin300防腐剂。\n校准品2: 1mL×1 瓶，100.00ng/mL 的癌胚抗原，含牛血清的磷酸盐缓冲液，含有ProClin300防腐剂。",null,"本产品用于定量检测人血清或血浆中的癌胚抗原。主要用于对恶性肿瘤患者进行动态监测以辅助判断疾病进程或治疗效果，不能作为恶性肿瘤早期诊断或确诊的依据，不能用于普通人群的肿瘤筛查。",null,"2"]
["浙械注准20152400980",null,"γ-谷氨酰基转移酶测定试剂盒(GCANA底物法)",{"$nulls":9},"2015-12-09","2021-01-06","2020-12-08","2026-01-05",{"$nulls":12},"2"]
["辽械注准20232060067",null,"一次性使用胰胆成像导管","一次性使用成像导管",{"$nulls":4},"2023-08-02",{"$nulls":3},"2023-08-02",null,"2028-08-01",{"$nulls":3},"鑫海合星科技（大连）有限公司",{"$nulls":5},"产品由头端部、弯曲部、插入部、操作部、和连接部组成，绑带和Y型接口连接器为产品的选配件。头端部是PC和SUS316材质，弯曲部和插入部外包材是Pebax材质。产品以无菌状态提供，经环氧乙烷灭菌，一次性使用。","产品由头端部、弯曲部、插入部、操作部和连接部组成，绑带和接口连接器为产品的选配件。其中XH-YDDG-01～XH-YDDG-06、XH-YDDG-10～XH-YDDG-14、XH-YDDG-16～XH-YDDG-38、XH-YDDG-48、XH-YDDG-49型号操作部包含锁止键、按键、转向轮，连接部包含电源插头、吸引管路、冲洗管路、电源线。头端部是PC和SUS316材质，弯曲部和插入部外包材是Pebax材质。产品以无菌状态提供，经环氧乙烷灭菌，一次性使用。","产品与配套的医用内窥镜图像处理器连接使用，专为胰胆系统的内镜手术过程的诊疗应用提供显像，并为其他诊疗附件提供工作通道。","产品与配套的医用内窥镜图像处理器连接使用，专为胰胆系统、阑尾腔的内镜手术过程的诊疗应用提供显像，并为其他诊疗附件提供工作通道，亦可用于术中注射造影剂。","2"]
["湘械注准20222400472",null,"血糖试条（电化学法）","血糖试纸（葡萄糖脱氢酶法)",{"$nulls":4},"2022-03-14",{"$nulls":3},"2022-03-14",null,"2027-03-13",{"$nulls":9},"\"该产品由血糖试条与采血针（外购）组成。试条由PET基板、密码卡（电流、浓度）、碳电极、试剂、双面胶、亲水膜、盖膜组成。每片试剂包含葡萄糖脱氢酶、铁氰化钾、非反应性物质（缓冲剂、粘稠剂）。\n\"",null,"\"本品主要用于体外定量检测人体毛细血管全血或静脉全血中的葡萄糖浓度，不适用于血清或血浆标本的检测，同时也不适用于新生儿血液样本的检测。血糖试条只用于监测糖尿病人的血糖控制的效果，而不用于糖尿病的诊断和筛查，也不能作为治疗药物调整的依据。\n\"",null,"2"]
["浙械注准20152401045",null,"总胆固醇测定试剂盒(CHOD-PAP法)",{"$nulls":9},"2015-12-24","2021-01-13","2020-12-23","2026-01-12",{"$nulls":12},"2"]
["津械注准20192400145",null,"钙卫蛋白检测试剂盒（磁微粒化学发光法）",{"$nulls":5},"2019-09-27",{"$nulls":3},"2019-09-27",null,"2024-09-26","2029-09-26",null,null,"弗雷米德生物医药技术（天津）有限公司",{"$nulls":5},"名称\t数量\t规格\t主要成分\n\t\t50测试/盒\t100测试/盒\t\n免疫磁微粒试剂\t1瓶\t2mL/瓶\t4mL/瓶\t磁微粒与抗FITC抗体连接物、含BSA的缓\n冲液。\n抗试剂\t1瓶\t2mL/瓶\t4mL/瓶\t含有碱性磷酸酶（AP）标记的钙卫蛋白抗体、异硫氰酸荧光素（FITC）标记的钙卫蛋白抗体的BSA缓冲液\n校准品（A-F）\t6瓶\t0.2mL/瓶\t0.2mL/瓶\t分别添加了不同浓度钙卫蛋白抗原的BSA缓冲液。校准品抗原浓度分别为0ng/mL、4ng/mL、12ng/mL、40ng/mL、120ng/mL、240ng/mL.\n质控品（QCL、QCH）\t2瓶\t0.2mL/瓶\t0.2mL/瓶\t分别添加了低高浓度的钙卫蛋白抗原的BSA缓冲液。\n注：\n（1）不同批号试剂盒中各组分不可以互换。\n（2）校准品A-F的标准浓度为0、4、12、40、120、240ng/ml，考虑到样本的提取与稀释，稀释比例为1：2500，经过称量验证10ug样本相当于10ul样本，故1ng/ml的检测结果相当于原始样本浓度为2.5ug/g，所得测量样本的计算区间0、10、30、100、300、600ug/g。标曲线的设定采用此",null,"该产品用于体外定量检测人粪便中钙卫蛋白的含量",null,"2"]
["浙械注准20152401036",null,"碱性磷酸酶测定试剂盒(NPP底物-AMP缓冲液法)",{"$nulls":9},"2015-12-21","2021-01-12","2020-12-20","2026-01-11",{"$nulls":12},"2"]
["浙械注准20152401033",null,"胆碱酯酶测定试剂盒(丁酰硫代胆碱底物法)",{"$nulls":9},"2015-12-21","2021-01-12","2020-12-20","2026-01-11",{"$nulls":12},"2"]
["浙械注准20152401032",null,"低密度脂蛋白胆固醇测定试剂盒(直接法-表面活性剂清除法)",{"$nulls":9},"2015-12-21","2021-01-12","2020-12-20","2026-01-11",{"$nulls":12},"2"]
["粤械注准20232401322",null,"涎液化糖链抗原测定试剂盒（胶乳免疫透射比浊法）",{"$nulls":5},"2023-08-08",{"$nulls":3},"2023-08-08",null,"2028-08-07",{"$nulls":3},"珠海鎏联生物技术有限公司",{"$nulls":5},"【主要组成成分】R1：甘氨酸缓冲液（100mmol/L）、聚乙二醇6000（2%）、防腐剂Proclin300（0.2%）；R2：甘氨酸缓冲液（100mmol/L），包被有涎液化糖链抗体的胶乳微球（≥1.0mg/mL）；\n校准品（选配）：涎液化糖链抗原（磷酸盐缓冲液基质液体校准品），具体浓度见瓶签，校准品可溯源至本公司工作校准品。\n质控品（选配）：涎液化糖链抗原（磷酸盐缓冲液基质液体质控品），靶值具有批特异性，具体浓度见瓶签。",null,"用于体外定量测定人体血清中涎液化糖链抗原（KL-6）的含量。临床上主要用于反映间质性肺炎的病情发展。",null,"2"]
["国械注准20153401965","闽械注准20152401965","糖类抗原19-9（CA19-9）测定试剂盒（磁微粒化学发光法）",{"$nulls":9},"2020-08-21","2025-08-21","2025-08-20","2030-08-20",null,null,"厦门万泰凯瑞生物技术有限公司",{"$nulls":5},"试剂1：1 瓶（50人份：2.5mL；100人份：5mL；200人份：10mL；300人份：15mL；500人份：25mL），CA19-9 抗体包被的磁微粒，在磷酸盐缓冲液中配制，含ProClin300 防腐剂。\n试剂2：1 瓶（50人份：2.5mL；100人份：5mL；200人份：10mL；300人份：15mL；500人份：25mL），吖啶酯标记的CA19-9 抗体，在磷酸盐缓冲液中配制，含ProClin300 防腐剂。\n校准品1：0.5mL×1 瓶，10U/mL 的糖类抗原19-9，含磷酸盐缓冲液，含有ProClin 300 防腐剂。\n校准品2：0.5mL×1 瓶，100U/mL 的糖类抗原19-9，含磷酸盐缓冲液，含有ProClin 300 防腐剂。",null,"本试剂用于定量检测人血清或血浆中的糖类抗原19-9。主要用于对恶性肿瘤患者进行动态监测以辅助判断疾病进程或治疗效果，不能作为恶性肿瘤早期诊断或确诊的依据，不能用于普通人群的肿瘤筛查。",null,"2"]
["国械注准20203170795",null,"个性化基台",null,"深圳",{"$nulls":3},"2020-10-09",null,"2023-11-02",null,"2020-10-09","2025-10-09","2025-10-08","2030-10-08",null,null,"深圳康泰健医疗科技股份有限公司",{"$nulls":5},"“该产品由基台和螺钉组成。基台材质为钛合金TC4，螺钉材质为钛合金TC4ELI，均符合GB/T13810的要求。基台与种植体连接部位为十字锁和，六边形、圆锥形（螺丝)、梅花形、八边形。产品基于CAD/CAM技术的CNC数控机床加工而成。基台的直径D，穿龈GH，基台冠部高度AH，和基台的角度A为个性化加工。切削打磨抛光好的基台、螺钉表面未经任何其它处理。以非无菌状态提供。”",null,"该产品为牙缺失后颌骨内植入的牙种植体的配套用部件，用于连接、支持和固位修复体或种植体上部结构。",null,"3"]
["粤械注准20232401922",null,"特异性生长因子测定试剂盒（茚三酮显色法）",{"$nulls":5},"2023-11-17",{"$nulls":3},"2023-11-17",null,"2028-11-16",{"$nulls":3},"珠海鎏联生物技术有限公司",{"$nulls":5},"R1：4-羟乙基哌嗪丙磺酸(HEPPS)（50mmol/L）、乙二胺四乙酸二钠（EDTANa2)）（10mmol/L）、防腐剂；R2：4-羟乙基哌嗪丙磺酸(HEPPS)（50mmol/L）、茚三酮（10mmol/L）、曲拉通（1%）、防腐剂；校准品（选配）：特异性生长因子校准物；质控品（选配）：特异性生长因子校准物。",null,"用于体外定量测定人体血清、血浆中特异性生长因子的活性，可用于炎症指标的辅助诊断。",null,"2"]
["粤械注准20232401920",null,"基质金属蛋白酶3测定试剂盒（胶乳免疫比浊法）",{"$nulls":5},"2023-11-17",{"$nulls":3},"2023-11-17",null,"2028-11-16",{"$nulls":3},"珠海鎏联生物技术有限公司",{"$nulls":5},"R1：甘氨酸缓冲液（100mmol/L）、聚乙二醇6000（2%）、防腐剂Proclin300（0.2%）；R2：甘氨酸缓冲液（100mmol/L），包被有基质金属蛋白酶3抗体（鼠抗）的胶乳微球（≥1.0mg/mL）；校准品（选配）：基质金属蛋白酶3抗原（重组，Escherichia coli (E. coli)）（磷酸盐缓冲液基质液体校准品），具体浓度见瓶签。质控品（选配）：基质金属蛋白酶3抗原（重组，Escherichia coli (E. coli)）（磷酸盐缓冲液基质液体质控品），具体浓度见瓶签。",null,"本试剂盒用于体外定量测定人体血清、血浆中基质金属蛋白酶3的含量。用于类风湿关节炎的辅助诊断。",null,"2"]
["桂械注准20232200220",null,"电子灸治疗仪","电子铺灸治疗仪",{"$nulls":4},"2023-10-24",{"$nulls":3},"2023-10-24",null,"2028-10-23",{"$nulls":3},"桂林市威诺敦医疗器械有限公司",{"$nulls":5},"由主机、灸头、灸垫（不含药）、固定胶贴和嵌入式软件组成。",null,"通过灸头和灸垫对人体产生温热作用施灸于人体穴位，用于疾病的预防与治疗。",null,"2"]
["苏械注准20232400964",null,"肝素结合蛋白检测试剂盒（化学发光免疫分析法）","肝素结合蛋白测定试剂盒（化学发光免疫分析法）",{"$nulls":4},"2023-07-11",{"$nulls":3},"2023-07-11",null,"2028-07-10",{"$nulls":9},"A型：L1：链霉亲和素包被的磁性微粒，含0.1%普乐净PC-300防腐剂。L：校准品L（10.00-20.00ng/ml,肝素结合蛋白重组抗原（大肠杆菌表达），20mM磷酸盐缓冲液，PH=7.4±0.2，含防腐剂0.1%普乐净PC-300）。H：校准品H（150.00-250.00ng/mL，肝素结合蛋白重组抗原（大肠杆菌表达），20mM磷酸盐缓冲液，PH=7.4±0.2，含防腐剂0.1%普乐净PC-300）。L3：吖啶酯标记的肝素结合蛋白小鼠单克隆抗体①；0.038~0.375ug/ml；100mmol/L柠檬酸缓冲液，含0.1%普乐净PC-300防腐剂。L4：生物素标记的肝素结合蛋白小鼠单克隆抗体②；0.469~3.750ug/ml；100mmol/L柠檬酸缓冲液，含0.1%普乐净PC-300防腐剂。  B型：L1：链霉亲和素包被的磁性微粒，含0.1%普乐净PC-300防腐剂。L：校准品L（10.00-20.00ng/ml,肝素结合蛋白重组抗原（大肠杆菌表达），20mM磷酸盐缓冲液，PH=7.4±0.2，含防腐剂0.1%普乐净PC-300）。H：校准品H（150.00-250.00",null,"试剂盒用于临床体外定量检测人血清、血浆和全血中肝素结合蛋白（HBP）的浓度。",null,"2"]
["国械注准20233011285",null,"高频手术设备","等离子手术设备","中国",null,"/",null,"2023-09-06",null,"2024-01-08","2025-05-16","2023-09-06",null,"2028-09-05",{"$nulls":3},"北京科仪邦恩医疗器械科技有限公司",{"$nulls":5},"产品由主机控制器、脚踏开关、电源线和一次性使用高频手术电极组成。","产品由主机控制器、脚踏开关、电源线和一次性使用等离子手术电极组成。","本产品在医疗机构中使用，在生理盐水环境下，用于关节镜手术时，对关节软骨及周围软组织的汽化、凝血。","本产品在医疗机构中使用，在生理盐水环境下，用于关节镜手术中对软骨及周围软组织进行汽化、切割、凝血，以及用于椎间盘软组织的汽化、凝血。","3"]
["沪械注准20202140509",null,"一次性使用动脉压迫止血带",null,"中国",null,"上海瑛泰医疗器械股份有限公司",{"$nulls":5},"2020-10-27","2025-10-27","2025-10-26","2030-10-26",null,null,"上海瑛泰医疗器械股份有限公司",{"$nulls":5},"ZXDI型由压迫垫、压迫垫硅胶、螺母、固定板和固定带组成; ZXDII 型由方形压块、T型压块、浮动螺母、红色指示圈、止血带弹簧、旋转外套、压力螺柱、挂钩、带ZXDI型由压迫垫、压迫垫硅胶、螺母、固定板和固定带\n组成; ZXDII 型由方形压块、T型压块、浮动螺母、红色\n指示圈、止血带弹簧、旋转外套、压力螺柱、挂钩、带\n体和带子组成。",null,"产品供医务人员在动静脉穿刺手术中拔除穿刺针或留置针后辅助压迫止血用。",null,"2"]
["豫械注准20182140477",null,"一次性使用无菌巾",{"$nulls":5},"2023-03-29",null,"2024-02-22",null,"2023-03-29","2023-09-10","2028-09-09","2028-09-09",null,null,"河南省蓝天医疗器械有限公司",{"$nulls":5},"本产品由非织造布加工制成。",null,"临床用于防止交叉感染。",null,"2"]
["川械注准20232400375",null,"血气电解质生化测试卡（干式电化学法）",{"$nulls":5},"2023-11-09",{"$nulls":3},"2023-11-09",null,"2028-11-08",{"$nulls":3},"成都普利泰生物科技有限公司",{"$nulls":5},"1.试剂盒内有独立包装的测试卡、血气电解质生化复合质控品（选配）、红细胞压积（Hct）质控品（选配）和产品说明书；测试卡上有二维码，二维码中含有校准数据、项目参数、生产批次等信息。\n1）血气电解质生化测试卡(干式电化学法)\n组分\t主要成分\t含量\nCa2+\tN-（2-羟乙基）亚氨基二乙酸\t0.44%～0.49%\n\t钙离子载体Ⅱ\t0.87%～1.04%\nCl-\t氯化钾（KCl）\t0.68%～0.72%\n\t甲基三辛基氯化铵\t7.81%～13.60%\nGlu\t葡萄糖氧化酶\t0.05%～0.35%\nK+\t氯化钠（NaCl）\t0.60%～0.86%\n\t缬氨霉素\t0.41%～0.81%\n（因版面字数限制，其他内容详见：产品“注册证或说明书”。）",null,"血气电解质生化10项（BG10）用于体外定量检测人全血中的钾离子、钠离子、氯离子、钙离子、葡萄糖、乳酸的浓度，酸碱度、二氧化碳分压、氧分压和红细胞压积；\n血气电解质8项（BG8）用于体外定量检测人全血中的钾离子、钠离子、氯离子、钙离子的浓度，酸碱度、二氧化碳分压、氧分压和红细胞压积；\n血气电解质7项（BG7）用于体外定量检测人全血中的钾离子、钠离子、氯离子、钙离子的浓度，酸碱度、二氧化碳分压和氧分压；\n电解质5项（BE5）用于体外定量检测人全血中的钾离子、钠离子、氯离子、钙离子的浓度和酸碱度；\n电解质4项（BE4）用于体外定量检测人全血中的钾离子、钠离子、氯离子、钙离子的浓度；\n血气3项（BG3）用于体外定量检测人全血中的酸碱度、二氧化碳分压、氧分压；\n血气电解质生化复合质控品用于酸碱度、二氧化碳分压、氧分压、钾离子、钠离子、氯离子、钙离子、葡萄糖、乳酸项目检测时的质量控制；\n红细胞压积（Hct）质控品用于红细胞压积检测时的质量控制。","血气电解质生化10项用于体外定量检测人全血中的钾离子、钠离子、氯离子、钙离子、葡萄糖、乳酸的浓度，酸碱度、二氧化碳分压、氧分压和红细胞压积；\n血气电解质8项用于体外定量检测人全血中的钾离子、钠离子、氯离子、钙离子的浓度，酸碱度、二氧化碳分压、氧分压和红细胞压积；\n血气电解质7项用于体外定量检测人全血中的钾离子、钠离子、氯离子、钙离子的浓度，酸碱度、二氧化碳分压和氧分压；\n血气生化6项用于体外定量检测人全血中的葡萄糖、乳酸的浓度，酸碱度、二氧化碳分压、氧分压和红细胞压积；\n血气生化5项用于体外定量检测人全血中的葡萄糖、乳酸的浓度，酸碱度、二氧化碳分压和氧分压；\n血气生化4项用于体外定量检测人全血中的乳酸的浓度，酸碱度、二氧化碳分压和氧分压；\n电解质6项用于体外定量检测人全血中的钾离子、钠离子、氯离子、钙离子的浓度，酸碱度和红细胞压积；\n电解质5项用于体外定量检测人全血中的钾离子、钠离子、氯离子、钙离子的浓度和酸碱度；\n电解质4项用于体外定量检测人全血中的钾离子、钠离子、氯离子、钙离子的浓度；\n血气3项用于体外定量检测人全血中的酸碱度、二氧化碳分压、氧分压；\n血气电解质生化复合质控品用于酸碱度、二氧化碳分压、氧分压、钾离子、钠离子、氯离子、钙离子、葡萄糖、乳酸项目检测时的质量控制；\n红细胞压积（Hct）质控品用于红细胞压积检测时的质量控制。","2"]
["国械注准20153081288",null,"一次性使用麻醉穿刺包",{"$nulls":9},"2020-05-22","2025-05-22","2025-05-21","2030-05-21",{"$nulls":8},"本产品由一次性使用麻醉用针（硬膜外穿刺针、腰椎穿刺针Ⅰ型或Ⅱ型、神经阻滞穿刺针）、一次性使用硬膜外麻醉导管、导管接头、低阻力注射器（或全玻璃注射器）、一次性使用无菌注射器、一次性使用无菌注射针、一次性使用无菌溶药针、药液过滤器、空气过滤器、手术洞巾、一次性医用垫、一次性使用治疗巾、脱脂纱布块、消毒刷、医用棉球、一次性使用灭菌橡胶外科手套、医用胶带、自粘性无菌敷料、药液杯、负压管、导管固定垫组成。\n一次性使用麻醉用针（硬膜外穿刺针、腰椎穿刺针Ⅰ型或Ⅱ型、神经阻滞穿刺针）由304不锈钢和苯乙烯-丁二烯共聚物制成，一次性使用硬膜外麻醉导管由聚酰胺（即尼龙）（其中加强型导管内壁附有加强型不锈钢导丝）制成，导管接头由聚丙烯、聚碳酸酯和橡胶制成，药液过滤器及空气过滤器由丙烯腈-丁二烯-苯乙烯共聚物和过滤膜制成，药液过滤器滤膜孔径2μm，消毒刷柄由丙烯腈-丁二烯苯乙烯共聚物（ABS）制成，负压管由聚碳酸酯（PC）制成，药液杯由聚对苯二甲酸乙二醇酯（PET）制成，导管固定垫由EVA泡沫、医用压敏胶及离型纸制成。","本产品由一次性使用麻醉用针（硬膜外穿刺针、腰椎穿刺针Ⅰ型或Ⅱ型、神经阻滞穿刺针）、一次性使用硬膜外麻醉导管、导管接头、低阻力注射器（或全玻璃注射器）、一次性使用无菌注射器、一次性使用无菌注射针、一次性使用无菌溶药针、药液过滤器、空气过滤器、手术洞巾、一次性医用垫、一次性使用治疗巾、脱脂纱布块、消毒刷、医用棉球、一次性使用灭菌橡胶外科手套、医用胶带、自粘性无菌敷料、药液杯、负压管、导管固定垫组成。一次性使用麻醉用针（硬膜外穿刺针、腰椎穿刺针Ⅰ型或Ⅱ型、神经阻滞穿刺针）由304不锈钢和苯乙烯-丁二烯共聚物制成，一次性使用硬膜外麻醉导管由聚酰胺(即尼龙)（其中加强型导管内壁附有加强型不锈钢导丝）制成，导管接头由聚丙烯、聚碳酸酯和橡胶制成，药液过滤器及空气过滤器由丙烯腈-丁二烯-苯乙烯共聚物和过滤膜制成，药液过滤器滤膜孔径2μm，消毒刷柄由丙烯腈-丁二烯-苯乙烯共聚物（ABS）制成，负压管由聚碳酸酯（PC）制成，药液杯由聚对苯二甲酸乙二醇酯（PET）制成，导管固定垫由EVA泡沫、医用压敏胶及离型纸制成。","本产品用于人体硬脊膜外腔神经阻滞（简称硬膜外麻醉）、蛛网膜下腔阻滞（简称腰椎麻醉）、硬膜外和腰椎联合麻醉、神经阻滞局部麻醉。",null,"3"]
["湘长械备20240150号",null,"妇科分析用染色液","阴道分泌物染色液",{"$nulls":4},"2024-05-08","2025-06-19",null,null,"2024-05-08","2025-06-19","2099-12-31",{"$nulls":9},"由亚甲基蓝、蔗糖、吐温、聚乙烯呲咯烷酮、氢氧化钠、水组成。",null,"用于妇科分析物中的有形成分进行染色，从而观察其形态与结构。",null,"1"]
["苏苏械备20200272号","苏苏械备20200272","负压吸引用收集装置",null,"中国江苏省苏州市",null,"苏州中天医疗器械科技有限公司",null,"2020-03-30",null,"2024-05-15",null,"2020-03-30","2024-12-03","2099-12-31",null,"苏苏械备20200272号","苏苏械备20200272","苏州中天医疗器械科技有限公司",{"$nulls":5},"负压吸引用收集装置是由收集容器组件和中间管道组成。",null,"用于临床负压引流时，与插入体内的引流导管相连接，起到充当负压传导介质和/或引导、收集引流液的作用。",null,"1"]
["苏械注准20202141001",null,"医用负压吸引器",null,"中国江苏省苏州市",null,"苏州中天医疗器械科技有限公司",null,"2020-08-21","2025-04-21","2024-05-15",null,"2020-08-21","2025-08-21","2025-08-20","2030-08-20",null,null,"苏州中天医疗器械科技有限公司",{"$nulls":5},"产品由负压吸引泵、外壳、负压调节器、负压指示器、 一次性过滤器以及一次性收集容器组成。",null,"该产品适用于医院或诊所的普通吸引。",null,"2"]
["粤穗械备20230796",null,"HPV探针试剂（原位杂交法）","人乳头瘤病毒（HPV）探针试剂",{"$nulls":4},"2023-12-27",{"$nulls":3},"2023-12-27",null,"2099-12-31",{"$nulls":9},"产品描述：本试剂盒是由阴性对照探针杂交液(细菌DapB基因)、原位 杂交阳性探针(PPIB)、HPV HR18探针杂交液(8mL)、预处理液A(10mL)、100×消化液(120uL)、反应1(8mL)、反应2(8mL)、反应 3(8mL)、反应4(4mL)、反应5(4mL)、底物稀释液、底物1、底物2、50×洗液、25×预处理液B plus组成。","由HPV探针，探针杂交液（甲酰胺、氯化钠、十二烷基磺酸钠、柠檬酸钠、BSA），超纯水组成","预期用途：1、预期用途：在常规染色(如：HE染色)基础上进行原位杂交染色，为医师提供诊断的辅助信息。   2、适用人群：成人3、禁忌证：无4、产品检测指标的临床意义和临床用途：   1)外观检查：确保  产品没有出现变质问题；   2)阳性参考品符合率：反映产品检测的灵敏 度以及对不同型别被测物的检出能力；   3)阴性参考品符合率：反映产 品检测的特异性；   4)重复性：反应产品检测的稳定性","预期用途：在常规染色基础上进行原位杂交染色，为医师提供诊断的辅助信息，不得用于指导临床用药或伴随诊断。","1"]
["国械注进20153133936",null,"栓塞弹簧圈",{"$nulls":9},"2020-10-10","2025-10-10","2025-10-09","2030-10-09",{"$nulls":8},"该产品为电解脱弹簧圈，由线圈、导入鞘管、缩退锁和递送推杆组成。线圈丝体由铂钨合金制成，有抗解脱丝，含有亲水性聚丙烯酸共聚物凝胶芯。电子束灭菌，一次性使用。货架有效期5年。",null,"该产品用于对颅内动脉瘤、动静脉畸形和动静脉瘤实施血管内栓塞术。还可用于阻塞神经血管系统的血管，藉以永久性地阻断流向动脉瘤或其它血管畸形处的血流及对外周血管系统的动静脉实施栓塞术治疗。",null,"3"]
["苏械注准20242060472",null,"一次性电子关节内窥镜","一次性使用关节成像导管","中国",null,"--",null,"2024-04-16",{"$nulls":3},"2024-04-16",null,"2029-04-15",{"$nulls":3},"苏州智镜医疗科技有限公司",{"$nulls":5},"一次性电子关节内窥镜由镜管（内置物镜、CMOS 图像传感器及光纤）、手柄（内置水阀、LED 光源及线路板）、水管（进、出水管）、连接线缆和附件镜鞘(ZJ-C630060 和 ZJ-C630100 规格带有附件镜鞘)组成。产品以无菌状态提供，经环氧乙烷灭菌，一次性使用。","一次性使用关节成像导管由镜管(内置物镜、CMOS 图像传感器及光纤)、手柄(内置水阀、LED 光源及线路板)、水管(进出水管)、连接线缆和附件镜鞘(ZJ-C630060 和 ZJ-C630100规格带有附件镜鞘)组成产品以无菌状态提供，经环氧乙烷灭菌一次性使用。","本产品与本公司生产的电子内窥镜图像处理装置(ZJ-D1) 配合使用，通过视频监视器提供影像，用于关节部位的检查和手术中观察成像。","与本公司生产的电子内窥镜图像处理装置(ZJ-D1)配合使用，通过视频监视器提供影像用于关节部位的检查和手术中观察成像","2"]
["津械注准20242140139",null,"抗黏附润滑体外引流系统","抗黏附润滑体外引流装置","--",null,"--",null,"2024-05-27",null,"2024-07-03",null,"2024-05-27",null,"2029-05-26",{"$nulls":3},"--",{"$nulls":5},"见附页",null,"用于脑积水和颅内出血患者的脑脊液或血肿引流。",null,"2"]
["浙械注准20152401041",null,"尿酸测定试剂盒(尿酸酶法)",{"$nulls":9},"2015-12-21","2021-01-12","2020-12-20","2026-01-11",{"$nulls":12},"2"]
["浙械注准20152400981",null,"肌酸激酶测定试剂盒(连续监测法)",{"$nulls":9},"2015-12-09","2021-01-06","2020-12-08","2026-01-05",{"$nulls":12},"2"]
["浙械注准20152400982",null,"肌酐测定试剂盒(肌氨酸氧化酶法)",{"$nulls":9},"2015-12-09","2021-01-06","2020-12-08","2026-01-05",{"$nulls":12},"2"]
["浙械注准20152400972",null,"α-羟丁酸脱氢酶测定试剂盒(a-酮丁酸底物法)",{"$nulls":9},"2015-12-29","2021-01-06","2020-12-08","2026-01-05",{"$nulls":12},"2"]
["川械注准20232400405",null,"慢性病测定试剂盘（微流控干化学法）",{"$nulls":5},"2023-11-28",{"$nulls":3},"2023-11-28",null,"2028-11-27",{"$nulls":3},"成都普利泰生物科技有限公司",{"$nulls":5},"详见“产品注册证”。",null,"详见“产品注册证”。",null,"2"]
["浙械注准20152401034",null,"同型半胱氨酸测定试剂盒(酶循环法)",{"$nulls":9},"2015-12-21","2021-01-12","2020-12-20","2026-01-11",{"$nulls":12},"2"]
["豫郑械备20240438",null,"沙门志贺(SS)琼脂培养基",{"$nulls":5},"2024-12-06",{"$nulls":3},"2024-12-06",null,"2099-12-31",{"$nulls":3},"郑州博赛生物技术股份有限公司",{"$nulls":5},"产品由蛋白胨、牛肉粉、三号胆盐、乳糖、柠檬酸钠、柠檬酸铁、硫代硫酸钠、中性红、煌绿、琼脂及一次性培养皿组成。",null,"用于沙门菌和志贺菌的分离培养，不具有微生物鉴别和药敏鉴别的作用。",null,"1"]
["豫郑械备20240432",null,"四号琼脂培养基",{"$nulls":5},"2024-12-06",{"$nulls":3},"2024-12-06",null,"2099-12-31",{"$nulls":3},"郑州博赛生物技术股份有限公司",{"$nulls":5},"产品由蛋白胨、牛肉膏粉、氯化钠、无水亚硫酸钠、十二烷基硫酸钠、胆汁粉、雷佛奴尔、庆大霉素、琼脂、亚碲酸钾及一次性培养皿组成。",null,"用于人体粪便样本中肠道致病性弧菌、霍乱弧菌的分离培养，不具有微生物鉴别和药敏鉴别的作用。。",null,"1"]
["苏苏械备20232017","苏苏械备20232107","一次性使用口腔器械盒",{"$nulls":5},"2024-10-15",{"$nulls":3},"2024-10-15",null,"2099-12-31",{"$nulls":3},"苏州卓奥生物医疗科技有限公司",{"$nulls":5},"一次性使用口腔器械盒由口镜、牙探针、牙科用镊、医用垫巾、棉球组成。包内各组成器械均属于第一类医疗器械。详见产品技术要求。非无菌提供。不在内窥镜下使用。使用前由使用机构根据说明书进行消毒。",null,"供医疗机构口腔检查、诊疗用。",null,"1"]
["湘械注准20242140724",null,"鼻腔冲洗器","鼻腔液体敷料","--",null,"--",null,"2024-08-09",null,"2025-02-28",null,"2024-08-09",null,"2029-08-08",{"$nulls":3},"--",{"$nulls":5},"鼻腔冲洗器 I 型和 II 型均由喷雾器和喷雾液组成。喷雾器由高密度聚乙烯瓶与聚丙烯喷雾剂泵组成。喷雾液由氯化钠、羟丙甲纤维素、木糖醇和纯化水制成。该产品以非无菌状态提供。",null,"用于急慢性鼻炎、过敏性鼻炎、鼻息肉、鼻窦炎等鼻腔疾病患者的鼻腔清洗，也用于鼻炎手术后的鼻腔清洗。",null,"2"]
["粵械注准20252060253","粤械注准20252060253","一次性使用电子胆道内窥镜导管",{"$nulls":5},"2025-02-20",{"$nulls":3},"2025-02-20",null,"2030-02-19",{"$nulls":3},"广州瑞派医疗器械有限责任公司",{"$nulls":5},"由手柄、导管组件（插入部）和配件组成，含内置光源。配件包括一次性内窥镜用三通阀、一次性换向三通阀。",null,"本产品与本公司生产的医用内窥镜图像处理器配合使用，用于胆道胆管的观察、诊断、摄影或治疗中成像。",null,"2"]
["国械注准20253400074",null,"游离前列腺特异抗原检测试剂盒（化学发光法）",{"$nulls":5},"2025-01-10",{"$nulls":3},"2025-01-10",null,"2025-04-07","2030-01-09",{"$nulls":8},"\"本试剂盒由磁珠试剂、吖啶酯标记试剂、质控品、校准\n品组成。（具体内容详见说明书）\"",null,"\"本试剂盒用于体外定量检测人体血清中的游离前列腺特异抗\n原（fPSA）的含量。主要用于对恶性肿瘤患者进行动态监测\n以辅助判断疾病进程或治疗效果，不能作为恶性肿瘤早期诊\n断或确诊的依据，不能用于普通人群的肿瘤筛查。\"",null,"3"]
["豫郑械备20250038",null,"医用无敏透气胶布",null,"--",null,"--",null,"2025-03-11",null,"2025-05-26","2099-12-31","2025-03-11",null,"2025-05-26","2099-12-31",null,null,"--",{"$nulls":5},"由背材上涂有具有自粘特性的胶黏剂的胶带和防渗圈、离型纸组成。部分胶带涂胶面有保护层，非无菌提供，一次性使用。不与创面直接接触。粘贴部位为完好皮肤。",null,"用于将敷料粘贴固定于创面或将其他医疗器械固定到人体的特定部位。",null,"1"]
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["浙械注准20152401040",null,"α-淀粉酶测定试剂盒(EPS底物法)",{"$nulls":9},"2015-12-21","2021-01-12","2020-12-20","2026-01-11",{"$nulls":12},"2"]
["浙械注准20152400977",null,"葡萄糖测定试剂盒(葡萄糖氧化酶法)",{"$nulls":9},"2015-12-09","2021-01-06","2020-12-08","2026-01-05",{"$nulls":12},"2"]
["粤械注准20162400320",null,"生化分析仪电解质模块用试剂包（离子选择电极法）",{"$nulls":5},"2020-08-25",{"$nulls":3},"2020-08-25","2025-08-25","2025-08-24","2030-08-24",null,null,"深圳市新产业生物医学工程股份有限公司",{"$nulls":5},"由定标液A、定标液B和质控品组成。定标液A：Na+ 140.0 mmol/L、K+ 4.0 mmol/L、Cl- 100.0 mmol/L、Ca2+ 1.0 mmol/L；定标液B：Na+ 100.0 mmol/L、K+8.0 mmol/L、Cl- 70.0 mmol/L、Ca2+ 2.0 mmol/L；质控品:Na+ 145.0 mmol/L、K+4.65 mmol/L、Cl- 100.0 mmol/L、Ca2+ 1.25 mmol/L。",null,"用于体外定量测定人血清中K+、Na+、Cl-、Ca2+的浓度。",null,"2"]
["粤械注准20202402118",null,"脂蛋白（a）校准品",{"$nulls":5},"2020-12-27",null,"2020-12-27",null,"2020-12-27","2025-12-27","2025-12-26","2030-12-26",{"$nulls":8},"本校准品主要成分为脂蛋白（a），牛血清，防腐剂。",null,"与本公司生产的试剂盒配套使用，用于脂蛋白（a）检测系统的校准。",null,"2"]
["粤械注准20212400096",null,"生化多项校准品",{"$nulls":5},"2021-01-20",{"$nulls":3},"2021-01-20","2026-01-20","2026-01-19","2031-01-19",{"$nulls":8},"为冻干状态，主要成分为人血清、胆固醇、Intralipid、谷丙转氨酶、谷草转氨酶、碱性磷酸酶、γ-谷氨酰转肽酶、胆红素、缀合胆红素、肌酐、尿酸、尿素、肌酸激酶、肌酸激酶同工酶、L-乳酸脱氢酶、葡萄糖、α-淀粉酶、磷酸二氢钾、氯化钙、硫酸亚铁、脂肪酶、丁酰胆碱酯酶、六水合硝酸镁和防腐剂等。\n本产品中人血清为人源性材料；α-淀粉酶为细菌培养；肌酸激酶同工酶为重组表达；胆固醇、谷丙转氨酶、谷草转氨酶、碱性磷酸酶、γ-谷氨酰转肽酶、胆红素、肌酸激酶、L-乳酸脱氢酶、脂肪酶和丁酰胆碱酯酶为动物源性材料；其余原料均为化学合成而来。",null,"本产品用于总胆固醇（TC）、甘油三酯（TG）、丙氨酸氨基转移酶（ALT）、天门冬氨酸氨基转移酶（AST）、碱性磷酸酶（ALP）、γ-谷氨酰基转移酶（GGT）、总胆红素（TBIL）、直接胆红素（DBIL）、总蛋白（TP）、白蛋白（ALB）、肌酐（Cr）、尿酸（UA）、尿素（Urea）、肌酸激酶（CK）、肌酸激酶同工酶（CK-MB）、α-羟丁酸脱氢酶（α-HBDH）、乳酸脱氢酶（LDH）、葡萄糖（GLU）、α-淀粉酶（α-AMY）、脂肪酶（LIP）、胆碱酯酶（CHE）、无机磷（P）、钙（Ca）、铁（Fe）、镁（Mg）生化项目检验的校准。",null,"2"]
["粤械注准20202401936",null,"同型半胱氨酸多水平校准品",{"$nulls":5},"2020-11-20",{"$nulls":3},"2020-11-20","2025-11-20","2025-11-19","2030-11-19",{"$nulls":8},"DL-高半胱氨酸；Tris-Hcl缓冲液。",null,"本产品用于同型半胱氨酸（Hcy）项目检验的校准。",null,"2"]
["粤械注准20202402104",null,"高/低密度脂蛋白胆固醇校准品",{"$nulls":5},"2020-12-16",{"$nulls":3},"2020-12-16","2025-12-16","2025-12-15","2030-12-15",{"$nulls":8},"为冻干状态，主要成分为人血清，防腐剂。",null,"本产品用于高/低密度脂蛋白胆固醇（HDL-C/LDL-C）生化项目检验的校准",null,"2"]

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["国械注进20163143010","带流量调节器的延长输液管路 Control-A-Flo Ex","J2280","百特医疗用品贸易(上海)有限公司","J11411","百特医疗仪器设备(上海)有限公司"]
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["国械注进20163142264","一次性使用输注装置 Infusor LV","J2280","百特医疗用品贸易(上海)有限公司","J11411","百特医疗仪器设备(上海)有限公司"]
["国械注进20222140116","双腔冲洗管Y-Type Irrigation Set","J2280","百特医疗用品贸易(上海)有限公司","J11411","百特医疗仪器设备(上海)有限公司"]
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["国械注进20173141288","一次性使用无菌胰岛素注射器","J3608","碧迪医疗器械（上海）有限公司","J12555","英佰达医疗器械（上海）有限公司"]
["国械注进20183142688","一次性使用注射笔用针头","J3608","碧迪医疗器械（上海）有限公司","J12555","英佰达医疗器械（上海）有限公司"]
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["国械注进20143036178","冠状动脉分流栓","J2280","百特医疗用品贸易(上海)有限公司","J11411","百特医疗仪器设备(上海)有限公司"]
["国械注进20173130449","自膨式颅内支架","J5596","北京宝格医疗器械有限公司","J1173","华瑭大昌商业（上海）有限公司"]
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