{"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"}

{"sheet":"产品信息变更","index":0,"n_rows":17,"n_cols":25,"rows_kept":17}
["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"]
["00128806","硅凝胶疤痕修复贴",null,null,"罗敷康","SSS型（mm）：120x100、120x35、120x60、150x120、150x30、170x35、210x120、300x50、75x45；\nSSF型（mm）：120x100、120x60、150x120、150x30、170x35、170x76（乳房固定形）、210x120、250x100（锚形）、300x50、外径76（乳贴形）、外径76内径20（乳晕形）、76x38；\nSSP型（mm）：100x30、120x35、120x60、150x30、170x35、180x100、300x50、70x50","SSS型（cm）：12×10、12×3.5、12×6、15×12、15×3、17×3.5、21×12、30×5、7.5×4.5；SSF型（cm）：12×10、12×6、15×12、15×3、17×3.5、17×7.6（乳房固定形）、21×12、25×10（锚形）、30×5、外径7.6（乳贴形）、外径7.6内径2（乳晕形）、7.6×3.8；SSP型（cm）：10×3、12×3.5、12×6、15×3、17×3.5、18×10、30×5、7×5。","SSS型（mm）：120x100、120x35、120x60、150x120、150x30、170x35、210x120、300x50、75x45；\nSSF型（mm）：120x100、120x60、150x120、150x30、170x35、170x76（乳房固定形）、210x120、250x100（锚形）、300x50、外径76（乳贴形）、外径76内径20（乳晕形）、76x38；\nSSP型（mm）：100x30、120x35、120x60、150x30、170x35、180x100、300x50、70x50","SSS型（cm）：12×10、12×3.5、12×6、15×12、15×3、17×3.5、21×12、30×5、7.5×4.5；SSF型（cm）：12×10、12×6、15×12、15×3、17×3.5、17×7.6（乳房固定形）、21×12、25×10（锚形）、30×5、外径7.6（乳贴形）、外径7.6内径2（乳晕形）、7.6×3.8；SSP型（cm）：10×3、12×3.5、12×6、15×3、17×3.5、18×10、30×5、7×5。","硅凝胶",null,"粤械注准20202140543",null,"5年",null,"纸塑袋",null,"硅凝胶疤痕贴分为SSS型、SSF型及SSP型三种型号，均由保护层、粘胶层和离型层三部分组成，离型层在使用时需去除。其中SSS型保护层有硅橡胶膜组成，SSF型保护层由肤色织造布组成，而SSP型保护层由聚氨酯膜与含粘胶无纺布组成，粘胶层由硅凝胶（硅酮）组成，离型层由PE膜、PP膜或PET膜组成。所含成分不具有药理学作用。",null,"该产品适用于体表外伤、烧伤及手术愈合后的增生性疤痕的辅助治疗。不用于未愈合的伤口。",null,"1、 打开包装，取出敷料；\n2、 根据需要，裁剪成所需形状大小，确保敷料超出疤痕边缘1厘米；\n3、 使用时，确保敷用区域干燥。若与油膏和药膏合用时，保证敷料能覆盖住治疗区；\n4、 揭去背面离型膜，将有粘性的一面贴在疤痕上，在睡眠或大运动量时，可用胶布固定；\n5、 建议每天使用不少于12h，单片重复使用最长不超过4周；\n6、 若敷料受到污染，可用温和的清洗剂清洗干净，晾干或电吹风吹干后重复使用，直至粘性下降到不足以贴敷皮肤为止，更换新的敷料；\n7、 贴敷后用合适的弹力套进行加压使用，效果更佳。"]
["00323855","抗Mi-2抗体测定试剂盒（化学发光免疫分析法）","抗Mi-2抗体测定试剂盒（磁微粒化学发光法）",{"$nulls":3},"50人份/盒；2×50人份/盒；100人份/盒；2×100人份/盒；200人份/盒；500人份/盒；校准品（选配）；质控品（选配）。",null,null,"液体","液体、液体＋固体",{"$nulls":3},"18个月",null,"纸盒",null,"试剂盒由试剂组分、对照组分和质控组分组成。其中试剂组分包括R1、R2 和试剂盒信息卡；对照组分包括对照品、复溶液、对照品信息卡和对照品一维码；质控组分包括质控品、质控品信息卡和质控品一维码。具体内容详见附表。",null,"用于体外定性检测人血清中抗Mi-2抗体IgG，临床上主要用于皮肌炎（DM）的辅助诊断。",null,null,"2～8℃避光保存，有效期18个月"]
["00013303","中性电极",null,"美成",null,"MA2000","MA2000、 MA2000-R、 MA2000-H、MA2000-1、 MA2000- 1R、 MA2000-1H、 MA2000-B、 MA2000-BR、MA2000-BH、 MA2000- 1B、 MA2000- 1 BR、MA2000- 1BH、 MA2000-C、 MA2000-CR、MA2000-CH、 MA2000- 1C、MA2000- 1CR、MA2000- 1CH","MA2000","MA2000、 MA2000-R、 MA2000-H、MA2000-1、 MA2000- 1R、 MA2000-1H、 MA2000-B、 MA2000-BR、MA2000-BH、 MA2000- 1B、 MA2000- 1 BR、MA2000- 1BH、 MA2000-C、 MA2000-CR、MA2000-CH、 MA2000- 1C、MA2000- 1CR、MA2000- 1CH","凝胶",null,"YZB／粤1115-2011《中性电极》",null,"24个月",null,"铝箔袋",null,"主要由电极导线、极板和夹具组成。","主要由电极导线、回路负极板和夹具组成。其中型号MA2000、MA2000-1、MA2000- -B、MA2000- 1B、MA2000-C、 MA2000-1C导线\n(MA-1) 可选配。","与高频手术器配合使用，在外科手术中作切割或凝血之用。",null,"1．选择距离病人手术部位较近的血管丰富和肌肉平坦的位置；\n2．清洗消毒使用位置，并且完全擦干；\n3. 使用前先确认所选的产品规格是否和主机配套(兼容)；\n4．粘牢到皮肤上，理顺边缘防止流体进入接触区；\n5．接好导线夹具（带线产品忽略）；连接电缆到高频手术设备的相应插座上；\n6．除去时从边角慢慢揭起，揭离过快容易损伤皮肤。"]
["00296761","抑制素A（INH A）测定试剂盒（化学发光免疫分析法）","抑制素A（INH A）测定试剂盒（磁微粒化学发光法）",{"$nulls":3},"50人份/盒；2×50人份/盒；100人份/盒；2×100人份/盒；200人份/盒；500人份/盒；校准品（选配）；质控品（选配）。",null,null,"液体＋固体","液体、液体＋固体",{"$nulls":3},"18个月",null,"纸盒",null,"试剂盒由试剂组分、校准组分和质控组分组成。其中试剂组分包括R1、R2、R3、R4和试剂盒信息卡；校准组分包括校准品、复溶液、校准品信息卡和校准品一维码；质控组分包括质控品、质控品信息卡和质控品一维码。具体内容详见附表。",null,"用于体外定量检测人血清中的抑制素A (INH A)的含量。",null,null,"2-8℃避光保存，有效期18个月。"]
["00125775","软聚硅酮伤口敷贴",null,"罗敷康",null,"90x60(45x30)mm、100x90(60x45)mm、150x90(100x45)mm、100x100(60x60)mm、150x100(100x60)mm、200x100(145x45)mm、250x100(190x45)mm、300x100(240x45)mm、350x100(290x45)mm、175x150(125x100)mm、250x200(190x140)mm","9×6cm、10×9cm、 15×9cm、 10×10cm、 15×10cm、 20×10cm、 25×10cm、 30×10cm、 35×10cm、 17.5×15cm、 25×20cm","90x60(45x30)mm、100x90(60x45)mm、150x90(100x45)mm、100x100(60x60)mm、150x100(100x60)mm、200x100(145x45)mm、250x100(190x45)mm、300x100(240x45)mm、350x100(290x45)mm、175x150(125x100)mm、250x200(190x140)mm","9×6cm、10×9cm、 15×9cm、 10×10cm、 15×10cm、 20×10cm、 25×10cm、 30×10cm、 35×10cm、 17.5×15cm、 25×20cm","由涂覆压敏胶的透明聚氨酯膜，聚酯纤维、聚丙烯酸钠纤维及粘胶纤维组成的吸水垫，打孔的薄层软聚硅酮组成粘贴层",null,"粤械注准20202140816",null,"3年",null,"纸塑袋",null,"本产品是由背衬膜、吸液层、粘贴层及离型膜构成。背衬膜层由涂覆压敏胶的透明聚氨酯膜组成，吸液层由聚酯纤维、聚丙烯酸钠纤维及粘胶纤维组成的吸水垫构成，粘贴层由打孔的薄层软聚硅酮组成，离型膜层由聚乙烯离型膜组成。",null,"适用于急性浅表性伤口的护理。","用于体表非慢性创面的护理，如浅表性创面、手术后缝合创面、机械创伤、擦伤、切割伤、I度或浅II度的烧烫伤创面","1、按照正常程序清洗伤口，彻底干燥周围的皮肤；\n2、根据伤口大小选择合适大小的敷贴，敷贴应至少比伤口边缘大1-2cm；\n3、使用时先去掉离型膜，再将敷贴的粘性面贴敷于伤口上；\n4、当渗液接近敷芯边缘2cm处时应及时更换或遵医嘱；\n5、本产品在伤口上的贴敷时间由伤口及周围皮肤状况而定，最长累积使用时间不得超过30天。"]
["00330279","抗Sp100抗体测定试剂盒（化学发光免疫分析法）","抗Sp100抗体测定试剂盒（磁微粒化学发光法）",null,"康润",null,"50人份/盒；2×50人份/盒；100人份/盒；2×100人份/盒；200人份/盒；500人份/盒；校准品（选配）；质控品（选配）",null,null,"液体","液体、液体＋固体",{"$nulls":3},"18个月",null,"纸盒",null,"试剂盒由试剂组分、对照组分和质控组分组成。其中试剂组分包括R1、R2和试剂盒信息卡；对照组分包括对照品、复溶液、对照品信息卡和对照品一维码；质控组分包括质控品、质控品信息卡和质控品一维码。试剂组分包括Sp100磁珠包被物（R1）：含包被Sp100（重组抗原）的磁珠包被物的PBS缓冲液、表面活性剂、蛋白（牛白蛋白）、Proclin300；Sp100吖啶酯标记物（R2）：含吖啶酯标记的抗人IgG抗体（羊多抗）结合物的PBS缓冲液、表面活性剂、蛋白（牛白蛋白）、Proclin300；试剂盒信息卡：含配套对照品信息，如对照品批号、有效期和对照品各浓度水平的信息。对照组分包括Sp100对照品C1-C2：含不同浓度Sp100抗体（人源）的冻干粉，牛血清白蛋白，Proclin300；复溶液：含活性剂，Proclin300；对照品信息卡：含对照品批号、有效期和对照品各浓度水平的信息；对照品一维码：含对照品批号、检测项目、水平相关信息。质控组分包括Sp100质控品QC1-QC2：含不同浓度Sp100抗体（人源）的冻干粉，牛血清白蛋白，Proclin300；质控品信息卡：含质控品批号、检测项目相关信息；质控品一维码：含质控品批号、检测项目、水平相关信息",null,"用于体外定性检测人血清中抗Sp100 IgG抗体，临床上主要用于原发性胆汁性肝硬化（PBC）的辅助诊断。",null,null,"2～8℃避光保存，有效期18个月"]
["00336366","尿酸试条（电化学法）",{"$nulls":7},"/",{"$nulls":13},"\"储存条件：试条应在4℃～37℃环境温度下干燥密封保存，请勿储存在温度及湿度过高的场所。避免阳光直射和高温，请勿冷冻、折叠或重压试条。储存不当、包装不严、试条受潮可能会导致测试不准确。取出的试条应在3分钟内完成测试，桶装试条开封后应立刻将桶"]
["00321972","胰岛素（INS）测定试剂盒（化学发光免疫分析法）","胰岛素（INS）测定试剂盒（磁微粒化学发光法）",null,"康润",null,"50人份/盒；2×50人份/盒；100人份/盒；2×100人份/盒；200人份/盒；500人份/盒；校准品（选配）；质控品（选配）。",null,null,"液体","液体、液体＋固体",{"$nulls":3},"18个月",null,"纸盒",null,"试剂盒由试剂组分、校准组分和质控组分组成。其中试剂组分包括R1、R2、R3和试剂盒信息卡；校准组分包括校准品、复溶液、校准品信息卡和校准品一维码；质控组分包括质控品、质控品信息卡和质控品一维码。试剂组分：INS磁珠包被物(R1)含包被INS抗体（鼠单抗）的磁珠包被物的PBS缓冲液、表面活性剂、蛋白（牛白蛋白）、Proclin300。INS吖啶酯标记物(R2)含吖啶酯标记的INS抗体（鼠单抗）结合物的PBS缓冲液、表面活性剂、蛋白（牛白蛋白）、Proclin300。INS反应缓冲液(R3)含PBS缓冲液、表面活性剂、蛋白（牛白蛋白）、Proclin300。试剂盒信息卡含配套校准品信息，如校准品批号、有效期和校准品各浓度水平的信息。校准组分：INS校准品C0-C2含不同浓度INS（重组抗原）的冻干粉，牛血清白蛋白， Proclin300。复溶液含活性剂，Proclin300。校准品信息卡含校准品批号、有效期和校准品各浓度水平的信息。校准品一维码含校准品批号、检测项目、水平相关信息。质控组分：INS质控品QC1-QC2含不同浓度INS（重组抗原）的冻干粉，牛血清白蛋白， Proclin300。质控品信息卡含质控品批号、检测项目相关信息。质控品一维码含质控品批号、检测项目、水平相关信息。",null,"用于体外定量检测人血清或血浆中胰岛素的含量。临床上主要用于评价胰岛功能。",null,null,"2-8℃避光保存，有效期18个月"]
["00137545","沙保罗琼脂培养基（平板）","沙保弱（罗）琼脂培养基",null,null,"平板：5个/包（7cm）、10个/包（7cm）、20个/盒（7cm）、5个/包（9cm）、10个/包（9cm）、20个/盒(9cm)、5个/包（9cm分隔）、10个/包（9cm分隔）、20个/盒(9cm分隔)。管装：10支/盒（9ml斜面）。",null,"平板：5个/包（7cm）、10个/包（7cm）、20个/盒（7cm）、5个/包（9cm）、10个/包（9cm）、20个/盒(9cm)、5个/包（9cm分隔）、10个/包（9cm分隔）、20个/盒(9cm分隔)。管装：10支/盒（9ml斜面）。",null,"琼脂",null,"浙械注准20162400355",null,"6个月",null,"塑料平皿和纸盒",null,"蛋白胨、葡萄糖、琼脂粉、氯霉素。",null,"用于体外标本中真菌的分离、培养。",null,"培养法"]
["00143388","人类HLA-B27核酸检测试剂盒（荧光PCR法）","人类白细胞抗原B27核酸检测试剂盒（荧光PCR法）","天隆科技",null,"32测试/盒",null,"32测试/盒",null,"纸质",null,"国械注准20163400302",null,"12个月",null,"纸质",null,"核酸提取液，红细胞裂解液，B27反应混合液，TAP酶，阳性对照，阴性对照。","核酸提取液、10×红细胞裂解液、B27反应混合液、Taq酶、B27阳性对照、阴性对照。","用于定性检测人全血样本中HLA-B27基因","本试剂盒用于定性检测人全血样本中人类白细胞抗原B27基因（包括B2702、B2704、B2705亚型）。","PCR法"]
["00137326","肠道菌培养基","麦康凯琼脂培养基",null,null,"\"中国蓝琼脂、伊红美蓝琼脂、麦康凯琼脂、SS 琼脂：7cm（5 个/包、10 个/包、20 个/盒），9cm（5 个/包、10 个/包、20 个/盒），9cm(分隔)（5 个/包、10 个/包、20 个/盒）。\n干粉：250g/瓶、500g/瓶。\"",null,"\"中国蓝琼脂、伊红美蓝琼脂、麦康凯琼脂、SS 琼脂：7cm（5 个/包、10 个/包、20 个/盒），9cm（5 个/包、10 个/包、20 个/盒），9cm(分隔)（5 个/包、10 个/包、20 个/盒）。\n干粉：250g/瓶、500g/瓶。\"",null,"琼脂",null,"浙械注准 20162400462",null,"3个月",null,"塑料平皿和纸盒",null,"\"中国蓝琼脂：中国蓝琼脂干粉（牛肉浸粉、 蛋白胨、氯化钠、乳糖、玫瑰红酸、中国蓝）；\n伊红美蓝琼脂： 伊红美蓝琼脂干粉（牛肉浸粉、 蛋白胨、氯化钠、乳糖、伊红、美蓝）；\n麦康凯琼脂： 麦康凯琼脂干粉（牛肉浸粉、乳糖、 蛋白胨、氯化钠、中性红）；\nSS 琼脂： SS 琼脂干粉（牛肉浸粉、 蛋白胨、氯化钠、乳糖、中性红、煌绿）。\"",null,"中国蓝琼脂，用于常见革兰阴性细菌的分离培养；伊红美蓝琼脂，用于肠道致病菌及大肠菌群的分离麦康凯琼脂，用于肠道致病菌的分离培养以及非发酵细菌的鉴别；SS 琼脂，用于沙门氏菌和志贺菌的分离培养。",null,"培养法"]
["00146498","一次性使用无菌输尿管支架套件",{"$nulls":3},"DJ-D04-L260-P01、DJ-D4.8-L260-P01、DJ-D05-L260-P01、DJ-D06-L260-P01、DJ-D07-L260-P01\nDJ-D08-L260-P01、DJ-D04-L280-P01、DJ-D4.8-L280-P01、DJ-D05-L280-P01、DJ-D06-L280-P01\nDJ-D07-L280-P01、DJ-D08-L280-P01、DJ-D04-L300-P01、DJ-D4.8-L300-P01、DJ-D05-L300-P01\nDJ-D06-L300-P01、DJ-D07-L300-P01、DJ-D08-L300-P01\nDJ-D04-L260-P02、DJ-D4.8-L260-P02、DJ-D05-L260-P02、DJ-D06-L260-P02、DJ-D07-L260-P02\nDJ-D08-L260-P02、DJ-D04-L280-P02、DJ-D4.8-L280-P02、DJ-D05-L280-P02、DJ-D06-L280-P02\nDJ-D07-L280-P02、DJ-D08-L280-P02、DJ-D04-L300-P02、DJ-D4.8-L300-P02、DJ-D05-L300-P02\nDJ-D06-L300-P02、DJ-D07-L300-P02、DJ-D08-L300-P02","DJ-D04-L260-P01\nDJ-D4.8-L260-P01\nDJ-D05-L260-P01\nDJ-D06-L260-P01\nDJ-D07-L260-P01\nDJ-D08-L260-P01\nDJ-D04-L280-P01\nDJ-D4.8-L280-P01\nDJ-D05-L280-P01\nDJ-D06-L280-P01\nDJ-D07-L280-P01\nDJ-D08-L280-P01\nDJ-D04-L300-P01\nDJ-D4.8-L300-P01\nDJ-D05-L300-P01\nDJ-D06-L300-P01\nDJ-D07-L300-P01\nDJ-D08-L300-P01\nDJ-D04-L260-P02\nDJ-D4.8-L260-P02\nDJ-D05-L260-P02\nDJ-D06-L260-P02\nDJ-D07-L260-P02\nDJ-D08-L260-P02\nDJ-D04-L280-P02\nDJ-D4.8-L280-P02\nDJ-D05-L280-P02\nDJ-D06-L280-P02\nDJ-D07-L280-P02\nDJ-D08-L280-P02\nDJ-D04-L300-P02\nDJ-D4.8-L300-P02\nDJ-D05-L300-P02\nDJ-D06-L300-P02\nDJ-D07-L300-P02\nDJ-D08-L300-P02\nDJ-D04-L270-P01\nDJ-D4.8-L270-P01\nDJ-D05-L270-P01\nDJ-D06-L270-P01\nDJ-D07-L270-P01\nDJ-D08-L270-P01\nDJ-D04-L290-P01\nDJ-D4.8-L290-P01\nDJ-D05-L290-P01\nDJ-D06-L290-P01\nDJ-D07-L290-P01\nDJ-D08-L290-P01\nDJ-D04-L270-P02\nDJ-D4.8-L270-P02\nDJ-D05-L270-P02\nDJ-D06-L270-P02\nDJ-D07-L270-P02\nDJ-D08-L270-P02\nDJ-D04-L290-P02\nDJ-D4.8-L290-P02\nDJ-D05-L290-P02\nDJ-D06-L290-P02\nDJ-D07-L290-P02\nDJ-D08-L290-P02\nDJ-D04-L260-P03\nDJ-D4.8-L260-P03\nDJ-D05-L260-P03\nDJ-D06-L260-P03\nDJ-D07-L260-P03\nDJ-D08-L260-P03\nDJ-D04-L270-P03\nDJ-D4.8-L270-P03\nDJ-D05-L270-P03\nDJ-D06-L270-P03\nDJ-D07-L270-P03\nDJ-D08-L270-P03\nDJ-D04-L280-P03\nDJ-D4.8-L280-P03\nDJ-D05-L280-P03\nDJ-D06-L280-P03\nDJ-D07-L280-P03\nDJ-D08-L280-P03\nDJ-D04-L290-P03\nDJ-D4.8-L290-P03\nDJ-D05-L290-P03\nDJ-D06-L290-P03\nDJ-D07-L290-P03\nDJ-D08-L290-P03\nDJ-D04-L300-P03\nDJ-D4.8-L300-P03\nDJ-D05-L300-P03\nDJ-D06-L300-P03\nDJ-D07-L300-P03\nDJ-D08-L300-P03\nDJS-D04-L260-P01\nDJS-D4.8-L260-P01\nDJS-D05-L260-P01\nDJS-D06-L260-P01\nDJS-D07-L260-P01\nDJS-D08-L260-P01\nDJS-D04-L270-P01\nDJS-D4.8-L270-P01\nDJS-D05-L270-P01\nDJS-D06-L270-P01\nDJS-D07-L270-P01\nDJS-D08-L270-P01\nDJS-D04-L280-P01\nDJS-D4.8-L280-P01\nDJS-D05-L280-P01\nDJS-D06-L280-P01\nDJS-D07-L280-P01\nDJS-D08-L280-P01\nDJS-D04-L290-P01\nDJS-D4.8-L290-P01\nDJS-D05-L290-P01\nDJS-D06-L290-P01\nDJS-D07-L290-P01\nDJS-D08-L290-P01\nDJS-D04-L300-P01\nDJS-D4.8-L300-P01\nDJS-D05-L300-P01\nDJS-D06-L300-P01\nDJS-D07-L300-P01\nDJS-D08-L300-P01\nDJS-D04-L260-P02\nDJS-D4.8-L260-P02\nDJS-D05-L260-P02\nDJS-D06-L260-P02\nDJS-D07-L260-P02\nDJS-D08-L260-P02\nDJS-D04-L270-P02\nDJS-D4.8-L270-P02\nDJS-D05-L270-P02\nDJS-D06-L270-P02\nDJS-D07-L270-P02\nDJS-D08-L270-P02\nDJS-D04-L280-P02\nDJS-D4.8-L280-P02\nDJS-D05-L280-P02\nDJS-D06-L280-P02\nDJS-D07-L280-P02\nDJS-D08-L280-P02\nDJS-D04-L290-P02\nDJS-D4.8-L290-P02\nDJS-D05-L290-P02\nDJS-D06-L290-P02\nDJS-D07-L290-P02\nDJS-D08-L290-P02\nDJS-D04-L300-P02\nDJS-D4.8-L300-P02\nDJS-D05-L300-P02\nDJS-D06-L300-P02\nDJS-D07-L300-P02\nDJS-D08-L300-P02\nDJS-D04-L260-P03\nDJS-D4.8-L260-P03\nDJS-D05-L260-P03\nDJS-D06-L260-P03\nDJS-D07-L260-P03\nDJS-D08-L260-P03\nDJS-D04-L270-P03\nDJS-D4.8-L270-P03\nDJS-D05-L270-P03\nDJS-D06-L270-P03\nDJS-D07-L270-P03\nDJS-D08-L270-P03\nDJS-D04-L280-P03\nDJS-D4.8-L280-P03\nDJS-D05-L280-P03\nDJS-D06-L280-P03\nDJS-D07-L280-P03\nDJS-D08-L280-P03\nDJS-D04-L290-P03\nDJS-D4.8-L290-P03\nDJS-D05-L290-P03\nDJS-D06-L290-P03\nDJS-D07-L290-P03\nDJS-D08-L290-P03\nDJS-D04-L300-P03\nDJS-D4.8-L300-P03\nDJS-D05-L300-P03\nDJS-D06-L300-P03\nDJS-D07-L300-P03\nDJS-D08-L300-P03","DJ-D04-L260-P01、DJ-D4.8-L260-P01、DJ-D05-L260-P01、DJ-D06-L260-P01、DJ-D07-L260-P01\nDJ-D08-L260-P01、DJ-D04-L280-P01、DJ-D4.8-L280-P01、DJ-D05-L280-P01、DJ-D06-L280-P01\nDJ-D07-L280-P01、DJ-D08-L280-P01、DJ-D04-L300-P01、DJ-D4.8-L300-P01、DJ-D05-L300-P01\nDJ-D06-L300-P01、DJ-D07-L300-P01、DJ-D08-L300-P01\nDJ-D04-L260-P02、DJ-D4.8-L260-P02、DJ-D05-L260-P02、DJ-D06-L260-P02、DJ-D07-L260-P02\nDJ-D08-L260-P02、DJ-D04-L280-P02、DJ-D4.8-L280-P02、DJ-D05-L280-P02、DJ-D06-L280-P02\nDJ-D07-L280-P02、DJ-D08-L280-P02、DJ-D04-L300-P02、DJ-D4.8-L300-P02、DJ-D05-L300-P02\nDJ-D06-L300-P02、DJ-D07-L300-P02、DJ-D08-L300-P02","DJ-D04-L260-P01\nDJ-D4.8-L260-P01\nDJ-D05-L260-P01\nDJ-D06-L260-P01\nDJ-D07-L260-P01\nDJ-D08-L260-P01\nDJ-D04-L280-P01\nDJ-D4.8-L280-P01\nDJ-D05-L280-P01\nDJ-D06-L280-P01\nDJ-D07-L280-P01\nDJ-D08-L280-P01\nDJ-D04-L300-P01\nDJ-D4.8-L300-P01\nDJ-D05-L300-P01\nDJ-D06-L300-P01\nDJ-D07-L300-P01\nDJ-D08-L300-P01\nDJ-D04-L260-P02\nDJ-D4.8-L260-P02\nDJ-D05-L260-P02\nDJ-D06-L260-P02\nDJ-D07-L260-P02\nDJ-D08-L260-P02\nDJ-D04-L280-P02\nDJ-D4.8-L280-P02\nDJ-D05-L280-P02\nDJ-D06-L280-P02\nDJ-D07-L280-P02\nDJ-D08-L280-P02\nDJ-D04-L300-P02\nDJ-D4.8-L300-P02\nDJ-D05-L300-P02\nDJ-D06-L300-P02\nDJ-D07-L300-P02\nDJ-D08-L300-P02\nDJ-D04-L270-P01\nDJ-D4.8-L270-P01\nDJ-D05-L270-P01\nDJ-D06-L270-P01\nDJ-D07-L270-P01\nDJ-D08-L270-P01\nDJ-D04-L290-P01\nDJ-D4.8-L290-P01\nDJ-D05-L290-P01\nDJ-D06-L290-P01\nDJ-D07-L290-P01\nDJ-D08-L290-P01\nDJ-D04-L270-P02\nDJ-D4.8-L270-P02\nDJ-D05-L270-P02\nDJ-D06-L270-P02\nDJ-D07-L270-P02\nDJ-D08-L270-P02\nDJ-D04-L290-P02\nDJ-D4.8-L290-P02\nDJ-D05-L290-P02\nDJ-D06-L290-P02\nDJ-D07-L290-P02\nDJ-D08-L290-P02\nDJ-D04-L260-P03\nDJ-D4.8-L260-P03\nDJ-D05-L260-P03\nDJ-D06-L260-P03\nDJ-D07-L260-P03\nDJ-D08-L260-P03\nDJ-D04-L270-P03\nDJ-D4.8-L270-P03\nDJ-D05-L270-P03\nDJ-D06-L270-P03\nDJ-D07-L270-P03\nDJ-D08-L270-P03\nDJ-D04-L280-P03\nDJ-D4.8-L280-P03\nDJ-D05-L280-P03\nDJ-D06-L280-P03\nDJ-D07-L280-P03\nDJ-D08-L280-P03\nDJ-D04-L290-P03\nDJ-D4.8-L290-P03\nDJ-D05-L290-P03\nDJ-D06-L290-P03\nDJ-D07-L290-P03\nDJ-D08-L290-P03\nDJ-D04-L300-P03\nDJ-D4.8-L300-P03\nDJ-D05-L300-P03\nDJ-D06-L300-P03\nDJ-D07-L300-P03\nDJ-D08-L300-P03\nDJS-D04-L260-P01\nDJS-D4.8-L260-P01\nDJS-D05-L260-P01\nDJS-D06-L260-P01\nDJS-D07-L260-P01\nDJS-D08-L260-P01\nDJS-D04-L270-P01\nDJS-D4.8-L270-P01\nDJS-D05-L270-P01\nDJS-D06-L270-P01\nDJS-D07-L270-P01\nDJS-D08-L270-P01\nDJS-D04-L280-P01\nDJS-D4.8-L280-P01\nDJS-D05-L280-P01\nDJS-D06-L280-P01\nDJS-D07-L280-P01\nDJS-D08-L280-P01\nDJS-D04-L290-P01\nDJS-D4.8-L290-P01\nDJS-D05-L290-P01\nDJS-D06-L290-P01\nDJS-D07-L290-P01\nDJS-D08-L290-P01\nDJS-D04-L300-P01\nDJS-D4.8-L300-P01\nDJS-D05-L300-P01\nDJS-D06-L300-P01\nDJS-D07-L300-P01\nDJS-D08-L300-P01\nDJS-D04-L260-P02\nDJS-D4.8-L260-P02\nDJS-D05-L260-P02\nDJS-D06-L260-P02\nDJS-D07-L260-P02\nDJS-D08-L260-P02\nDJS-D04-L270-P02\nDJS-D4.8-L270-P02\nDJS-D05-L270-P02\nDJS-D06-L270-P02\nDJS-D07-L270-P02\nDJS-D08-L270-P02\nDJS-D04-L280-P02\nDJS-D4.8-L280-P02\nDJS-D05-L280-P02\nDJS-D06-L280-P02\nDJS-D07-L280-P02\nDJS-D08-L280-P02\nDJS-D04-L290-P02\nDJS-D4.8-L290-P02\nDJS-D05-L290-P02\nDJS-D06-L290-P02\nDJS-D07-L290-P02\nDJS-D08-L290-P02\nDJS-D04-L300-P02\nDJS-D4.8-L300-P02\nDJS-D05-L300-P02\nDJS-D06-L300-P02\nDJS-D07-L300-P02\nDJS-D08-L300-P02\nDJS-D04-L260-P03\nDJS-D4.8-L260-P03\nDJS-D05-L260-P03\nDJS-D06-L260-P03\nDJS-D07-L260-P03\nDJS-D08-L260-P03\nDJS-D04-L270-P03\nDJS-D4.8-L270-P03\nDJS-D05-L270-P03\nDJS-D06-L270-P03\nDJS-D07-L270-P03\nDJS-D08-L270-P03\nDJS-D04-L280-P03\nDJS-D4.8-L280-P03\nDJS-D05-L280-P03\nDJS-D06-L280-P03\nDJS-D07-L280-P03\nDJS-D08-L280-P03\nDJS-D04-L290-P03\nDJS-D4.8-L290-P03\nDJS-D05-L290-P03\nDJS-D06-L290-P03\nDJS-D07-L290-P03\nDJS-D08-L290-P03\nDJS-D04-L300-P03\nDJS-D4.8-L300-P03\nDJS-D05-L300-P03\nDJS-D06-L300-P03\nDJS-D07-L300-P03\nDJS-D08-L300-P03","TPU、PP",null,"闽械注准20202140405",null,"36个月",null,"纸塑袋",null,"该产品由输尿管支架、推进管、导丝（选配）组成；其中，导丝主要由软头、内芯和包塑层组成，并套入导丝保护套中进行防护。输尿管支架采用聚氨酯（TPU）制成，推进管、导丝保护套采用聚丙烯（PP）制成，软头采用O6Cr19Ni10牌号的奥氏体不锈钢制成，内芯采用镍钛合金制成，包塑层采用聚四氟乙烯（PTFE）制成。经环氧乙烷灭菌，产品应无菌。","该产品由输尿管支架、推进管、导丝(选配)组成;其中导丝为两端直型导丝和复合斑马导丝，均主要由软头、内芯和包塑层组成，并套入导丝保护套中进行防护。经环氧乙烷灭菌，产品应无菌。","该产品通过微创介入或开放手术置入肾盂与膀胱间，起支撑、引流作用。",null,"1、撕开包装，取出输尿管支架及推进管（若配有导丝，连同导丝一起取出）；\t\t\t\n建议：导丝先用无菌生理盐水清洗，有水附着于导丝表面，导丝亦会变得光滑，操作起来更为方便。\t\t\t\n2、经膀胱镜逆行放置时先将导丝经尿道、膀胱、输尿管送入肾盂肾盏位置；\t\t\t\n（若采用顺行置入输尿管支架时，应先进行经皮肾穿刺后留置可撕裂鞘，建立通道；在输尿管镜下将导丝经肾盏、输尿管、膀胱、置入尿道口。）\t\t\t\n3、选择合适的输尿管支架及推进管小心套入导丝，待输尿管支架完全展开后沿导丝方向推送至确定位置，握紧推进管，回抽导丝将输尿管支架留置输尿管内，撤出推进管，必要时可采用内腔镜镊子做最后调节；\t\t\t\n4、直接手术或其他方法留置输尿管支架；\t\t\t\n5、放置后，记录放置日期定期使用膀胱镜或X射线显影进行检查，到预定日期应及时取出。"]
["00069570","一次性使用无菌手术包",null,"春芽",null,"常规","规格型号：常规型手术包、辅助包、膝关节包、产包、介入手术包、剖宫包、无菌流产包、婴儿护脐包、医用会阴护理包、胃管包、换药包、导尿包、口腔种植包。","常规型","规格型号：常规型手术包、辅助包、膝关节包、产包、介入手术包、剖宫包、无菌流产包、婴儿护脐包、医用会阴护理包、胃管包、换药包、导尿包、口腔种植包。","无纺布",null,"鲁械注准20172640657",null,"24个月",null,"医用透析袋",null,"基本配置：手术衣、医生帽、一次性使用医用外科口罩、手术洞巾；辅助配置：检查垫、中单、医用垫单、鞋套、枕套、防护罩、被罩、防护机罩、一次性使用灭菌外科手套、包巾。其中一次性使用灭菌橡胶外科手套为外购件，应采购具有医疗器械注册证的产品。","结构组成：一次性使用无菌手术包由基本配置和辅助配置组成。常规型手术包：基本配置手术衣、一次性使用医用帽子、医用外科口罩、手术洞巾。选用配置：检查垫、中单、医用垫单、鞋套、枕套、防护罩、被罩、一次性使用灭菌橡胶外科手套。辅助包：基本配置：中单。选用配置：医用垫单，一次性使用医用帽子，医用外科口罩，医用棉签，医用棉球，一次性使用敷料镊，医用盆，医用碗，托盘，医用纱布块，无菌婴儿护脐，包布，一次性使用医用薄膜手套，医用纱布垫，脐带夹，脐带剪，洗耳球，医用手术薄膜，弯盘，擦手巾，备胶料，美亚袋，手术衣，纱布绷带，脐带线，一次性使用灭菌橡胶外科手套，防护罩，医用碘伏消毒棉球、片、签，试管（带塑料塞），阴道扩张器，裤套，套袖，手术洞巾，鞋套，消毒刷，粘合扣，手术刀片（含刀柄），药杯，自粘式伤口敷料，医用吸引管，医用滑移垫。\n膝关节包：基本配置：检查垫、手术衣。选用配置：一次性使用灭菌橡胶外科手套，医用垫单，一次性使用医用帽子，一次性使用敷料镊，医用盆，医用棉签，医用纱布块，医用碘伏消毒棉球、片、签，擦手巾，备胶料，美亚袋，包布，中单，医用外科口罩，纱布绷带，托盘，医用碗，医用棉球，自粘式伤口敷料，鞋套，粘合扣，消毒刷，医用滑移垫，手术洞巾。产包：基本配置：中单。选用配置：一次性使用医用帽子，一次性使用灭菌橡胶外科手套，医用垫单，纱布绷带，裤套，脐带剪，手术洞巾，医用盆，脐带夹，医用外科口罩，手术衣，医用棉签，无菌婴儿护脐，医用纱布块，脐带线，托盘，医用纱布垫，检查垫，防护罩，医用碘伏消毒棉球、片、签，消毒刷，医用滑移垫，包布。介入手术包：基本配置：手术衣、一次性使用灭菌橡胶外科手套。选用配置：一次性使用医用帽子、医用外科口罩、包布、一次性使用敷料镊、医用盆、托盘、手术刀片（含刀柄）、药杯、医用碗、医用垫单、中单、检查垫、医用纱布块、纱布绷带、手术洞巾、防护罩、弯盘、备胶料、美亚袋、医用滑移垫。剖宫包：基本配置：检查垫、手术衣。选用配置：无菌婴儿护脐、医用垫单、备胶料、美亚袋、擦手巾、脐带线、脐带夹、医用吸引管、包布、中单、纱布绷带、医用纱布块、一次性使用灭菌橡胶外科手套、医用纱布垫、医用盆、洗耳球、手术刀片（含刀柄）、医用滑移垫。无菌流产包：基本配置：手术洞巾。选用配置：一次性使用灭菌橡胶外科手套，医用棉球，医用外科口罩，裤套，套袖，医用碘伏消毒棉球、片、签，医用纱布块，中单，医用棉签，一次性使用医用帽子，医用垫单。婴儿护脐包：基本配置：无菌婴儿护脐。选用配置：医用棉签、医用纱布块、脐带线。医用会阴护理包：基本配置：医用纱布块、中单、检查垫。选用配置：一次性使用医用薄膜手套，包布，手术洞巾，医用垫单，一次性使用敷料镊，医用棉签，医用棉球，医用碘伏消毒棉球、片、签，酒精棉球，擦手巾，药杯，消毒刷，妇科刮板。胃管包：基本配置：一次性使用胃管。选用配置：一次性使用医用薄膜手套、中单、口垫、医用棉签、包布、托盘、一次性使用敷料镊、压舌板、围巾。换药包：基本配置：手术洞巾。选用配置：医用碗，一次性使用敷料镊，医用棉球，医用棉签，医用碘伏消毒棉球、片、签，托盘，包布，医用纱布垫，一次性使用医用薄膜手套，自粘式伤口敷料，备胶料，创口贴，输液贴。导尿包：基本配置：一次性使用导尿管。选用配置：弯盘，包布，引流袋，一次性使用敷料镊，医用碘伏消毒棉球、片、签，手术洞巾，托盘，医用纱布块，检查垫，一次性使用无菌溶药注射器，试管（带塑料塞），石蜡棉球。口腔种植包：基本配置：手术洞巾。选用配置：中单、手术衣、检查垫。","用于临床手术、护理时使用",null,"1、撕开外包装，检查本包内物件是否完好无损；\n     2、然后按无菌操作要求依次使用手术包内配置物品"]
["00139314","超声隔离透声膜",null,"众德康",null,"A型  A2型  B型  C2型","A A2 B C2","A型  A2型  B型  C2型",null,"A型：由O形固定套和胶乳透声薄膜组成；A2型：由C形固定套和胶乳透声薄膜组成；B型：由乳胶透声薄膜组成；C2型：由聚乙烯保护套和乳胶材质透声薄膜组成",null,"冀械注准20182090220",null,"二年",null,"A型/A2型：铝箔 ；B型：复合纸；C2型：纸塑",null,"A型：由O形固定套和胶乳透声薄膜组成； A2型：由C形固定套和胶乳透声薄膜组成； B型：由乳胶透声薄膜组成； C2型：由聚乙烯保护套和乳胶材质透声薄膜组成；",null,"供临床B超检查时对探头的隔离保护及防止交叉感染。",null,"1、根据需要选择相应的型号，确认在灭菌有效期内和包装完好后，撕开启封口，取出超声隔离透声膜\n2、将超声隔离透声膜套在治疗枪透声窗上，按常规操作即可\n3、按无菌操作规程进行，使用完毕，集中销毁。"]
["00183171","抗Scl-70抗体测定试剂盒（化学发光免疫分析法）","抗Scl-70抗体测定试剂盒（磁微粒化学发光法）",null,"康润","100人份/盒","50人份/盒；2×50人份/盒；100人份/盒；2×100人份/盒；200人份/盒；500人份/盒；校准品（选配）；质控品（选配）","/",null,"液体","液体、液体＋固体","粤械注准20212400910",null,"18 个月",null,"纸盒",null,"Scl-70 磁珠包被物（R1）：含包被 Scl-70（牛源）的磁珠包被物的 PBS 缓冲液、表面活性剂、蛋白（牛白蛋\n白）、Proclin300。 ；\n抗人 IgG 抗体吖啶酯标记物（R2）：含吖啶酯标记的抗人 IgG 抗体（羊多抗）结合物的 PBS 缓冲液、表面活性剂、蛋白（牛白\n蛋白）、Proclin300。 ；\nScl-70 反应缓冲液（R3）：PBS 缓冲液、表面活性剂、蛋白（牛白蛋白）、Proclin300。 ；\nScl-70 校准品 C1：抗 Scl-70 抗体（人源）的冻干粉，牛血清白蛋白(BSA)，Proclin300。 ；\nScl-70 校准品 C2：抗 Scl-70 抗体（人源）的冻干粉，牛血清白蛋白(BSA)，Proclin300。 ；\n校准品复融液：含活性剂，Proclin300。","试剂盒由试剂组分、校准组分和质控组分组成。其中试剂组分包括Scl-70磁珠包被物（R1）、Scl-70吖啶酯标记物（R2）、 Scl-70反应缓冲液（R3）和试剂盒信息卡；校准组分包括Scl-70校准品C1-C2、复溶液、校准品信息卡和校准品一维码；质控组分包括Scl-70质控品、质控品信息卡和质控品一维码。试剂组分：Scl-70磁珠包被物（R1）含包被Scl-70（牛源）的磁珠包被物的PBS缓冲液、表面活性剂、蛋白（牛白蛋白）、Proclin300。Scl-70吖啶酯标记物（R2）含吖啶酯标记的抗人IgG抗体（羊多抗）结合物的PBS缓冲液、表面活性剂、蛋白（牛白蛋白）、Proclin300。Scl-70反应缓冲液（R3）含PBS缓冲液、表面活性剂、蛋白（牛白蛋白）、Proclin300。试剂盒信息卡含配套校准品信息，如校准品批号、有效期和校准品各浓度水平的信息。校准组分：Scl-70校准品C1-C2含不同浓度抗Scl-70抗体（人源）的冻干粉，牛血清白蛋白(BSA)，Proclin300。复溶液含活性剂，Proclin300。校准品信息卡含校准品批号、有效期和校准品各浓度水平的信息。校准品一维码含校准品批号、检测项目、水平相关信息。质控组分：Scl-70质控品QC1-QC2含不同浓度抗Scl-70抗体（人源）的冻干粉，牛血清白蛋白(BSA)，Proclin300。质控品信息卡含质控品批号、检测项目相关信息。质控品一维码含质控品批号、检测项目、水平相关信息。","本试剂用于体外定量检测人血清或血浆中抗 Scl-70 抗体 IgG 的含量。临床上主要用于系统性硬化（SSc）的辅助诊断。",null,"化学发光免疫分析法","磁微粒化学发光法"]
["00069716","一次性使用麻醉穿刺包",null,"春芽",null,"AS-E、AS-N、AS-S、AS-E/S","AS-E（硬膜外麻醉包）、AS-N（神经阻滞包）、AS-S（腰椎麻醉包）、Ⅰ型AS-E/SⅡ（硬膜外和腰椎联合麻醉包）、Ⅱ型AS-E/SⅡ（硬膜外和腰椎联合麻醉包）","AS-E、AS-N、AS-S、AS-E/S","AS-E（硬膜外麻醉包）、AS-N（神经阻滞包）、AS-S（腰椎麻醉包）、Ⅰ型AS-E/SⅡ（硬膜外和腰椎联合麻醉包）、Ⅱ型AS-E/SⅡ（硬膜外和腰椎联合麻醉包）","PVC、无纺布、玻璃注射器",null,"国械注准20183661608","国械注准20183141608","24个月",null,"铝箔",null,"基本配置：一次性使用麻醉穿刺针、一次性使用硬膜外麻醉导管、一次性使用药液过滤器、导管接头；选用配置：全玻璃注射器、一次性使用无菌注射器、破皮针、一次性使用灭菌橡胶外科手套、一次性使用无菌注射针、无纺布复合洞巾、医用纱布块、消毒刷、负压管、一次性使用创可贴、胶条、PVC托盘、无纺布复合方巾、无纺布复合包巾。\n含润滑剂：二甲基硅氧烷、增塑剂：邻苯二甲酸二辛脂（DOP）和粘合剂：环氧树脂胶，不含药和图层。一次性使用，环氧乙烷灭菌。","结构组成：一次性使用麻醉穿刺包由基本配置和选用配置组成，基本配置：一次性使用麻醉穿刺针、一次性使用硬膜外麻醉导管、一次性使用硬膜外麻醉导管加强型、一次性使用药液过滤器、导管接头；选用配置：全玻璃注射器、一次性使用无菌注射器、破皮针、一次性使用灭菌橡胶外科手套、一次性使用无菌注射针、无纺布复合洞巾、医用纱布块、消毒刷、负压管、一次性使用创可贴、胶条、托盘、无纺布复合方巾、无纺布复合包巾、自粘式伤口敷料、低阻力注射器、镊子、医用棉球。含润滑剂：二甲基硅氧烷、粘合剂：环氧树脂胶，不含药或涂层。一次性使用，环氧乙烷灭菌。","硬膜外麻醉、 腰椎麻醉、 神经阻滞麻醉、 硬膜外及腰椎联合麻醉穿刺及麻醉药液的注入",null,"1、撕开外包装，检查本包内物件是否完好无损；\n 2、然后按无菌操作要求依次使用包内配置物品"]

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["湘械注准20242181001",null,"低聚异麦芽糖阴道阻菌凝胶","阴道凝胶敷料","--",null,"--",null,"2024-10-23",null,"2025-02-28",null,"2024-10-23",null,"2029-10-22",{"$nulls":3},"--",{"$nulls":5},"低聚异麦芽糖阴道阻菌凝胶由溶液和给药器组成。溶液由低聚异麦芽糖、羟丙甲纤维素、丙二醇、卡波姆、羟苯乙酯、三乙醇胺和纯化水制成。给药器采用药用聚乙烯/乙烯-乙烯醇共聚物/聚乙烯复合软管。本品为一次性使用。",null,"通过在阴道壁形成一层保护性凝胶膜，将阴道壁与外界细菌物理隔离，从而阻止病原微生物定植。",null,"2"]
["浙械注准20162400770",null,"镁离子测定试剂盒(偶氮胂Ⅰ法)",{"$nulls":9},"2016-09-27","2021-09-08","2021-09-26","2026-09-07",{"$nulls":12},"2"]
["浙械注准20162400772",null,"腺苷脱氨酶测定试剂盒(过氧化物酶法)",{"$nulls":9},"2016-09-27","2021-09-09","2021-09-26","2026-09-08",{"$nulls":12},"2"]
["浙械注准20162400775",null,"胃蛋白酶原Ⅱ测定试剂盒(胶乳增强免疫比浊法)",{"$nulls":9},"2016-09-27","2021-09-09","2021-09-26","2026-09-08",{"$nulls":12},"2"]
["国械注进20152173960",null,"牙科膜片Thermoforming foils and discs",{"$nulls":9},"2020-06-04","2025-06-04","2025-06-03","2030-06-03",{"$nulls":12},"2"]
["浙械注准20162400823",null,"B因子测定试剂盒(胶乳增强免疫比浊法)",{"$nulls":9},"2016-10-17","2021-09-26","2021-10-16","2026-09-25",{"$nulls":12},"2"]
["浙械注准20162400824",null,"游离脂肪酸测定试剂盒(ACS-ACOD法)",{"$nulls":9},"2016-10-17","2021-09-26","2021-10-16","2026-09-25",{"$nulls":12},"2"]
["国械注准20153400537",null,"巨细胞病毒IgM抗体检测试剂盒（酶联免疫法）",{"$nulls":9},"2019-12-11","2024-12-11","2024-12-10","2029-12-10",{"$nulls":12},"3"]
["浙械注准20162400771",null,"脂肪酶测定试剂盒(酶比色法)",{"$nulls":9},"2016-09-27","2021-09-09","2021-09-26","2026-09-08",{"$nulls":12},"2"]
["浙械注准20162400773",null,"钠离子测定试剂盒(半乳糖苷酶法)",{"$nulls":9},"2016-09-27","2021-09-09","2021-09-26","2026-09-08",{"$nulls":12},"2"]
["渝械注准20202140103",null,"一次性使用乳房旋切活检针",{"$nulls":9},"2020-04-29",null,"2025-04-28","2025-12-31",{"$nulls":12},"2"]
["豫械注准20222140476",null,"一次性使用无菌配药注射器","一次性使用无菌配药溶药注射器",{"$nulls":4},"2022-01-22",{"$nulls":3},"2022-07-03",null,"2027-07-02",{"$nulls":9},"本产品由外套、配药针、芯杆、活塞、护帽（选配）、配药针（选配）组成。",null,"供抽取和配制药液用",null,"2"]
["粤械注准20162010076",null,"双极消融电极（多功能手术解剖器）",{"$nulls":9},"2020-11-05","2024-11-05","2025-11-04","2030-11-04",{"$nulls":12},"2"]
["国械注进20162401521",null,"单克隆免疫球蛋白检测试剂盒（毛细管电泳法）Immunodisplacement Kit",{"$nulls":9},"2020-11-02","2025-11-02","2025-11-01","2030-11-01",{"$nulls":12},"2"]
["国械注进20142225661",null,"凝血分析仪Actalyke Mini II ACT Analyzer",{"$nulls":9},"2020-02-21","2025-02-21","2025-02-20","2030-02-20",{"$nulls":12},"2"]
["京械注准20152400928",null,"血管炎自身抗体谱检测试剂盒（条带免疫印迹法）",{"$nulls":9},"2020-08-03","2025-08-03","2025-08-02","2030-08-02",{"$nulls":12},"2"]
["京械注准20152400927",null,"抗核抗体谱检测试剂盒（条带免疫印迹法）",{"$nulls":9},"2020-08-03","2025-08-03","2025-08-02","2030-08-02",{"$nulls":12},"2"]
["京械注准20152400931",null,"自身免疫肝病抗体谱检测试剂盒（条带免疫印迹法）",{"$nulls":9},"2020-08-03","2025-08-03","2025-08-02","2030-08-02",{"$nulls":12},"2"]
["国械注进20152171456",null,"临时冠桥树脂",{"$nulls":9},"2019-11-04","2024-11-04","2024-11-03","2029-11-03",{"$nulls":12},"2"]
["粤械注准20212400910",null,"抗Scl-70抗体测定试剂盒（化学发光免疫分析法）","抗Scl-70抗体测定试剂盒（磁微粒化学发光法）",null,"国产",{"$nulls":6},"2021-06-25",null,"2026-06-24",{"$nulls":4},"广州市康润生物科技有限公司",{"$nulls":5},"试剂盒由试剂组分、校准组分和质控组分组成。其中试剂组分包括Scl-70磁珠包被物（R1）、Scl-70吖啶酯标记物（R2）、 Scl-70反应缓冲液（R3）和试剂盒信息卡；校准组分包括Scl-70校准品C1-C2、复溶液、校准品信息卡和校准品一维码；质控组分包括Scl-70质控品、质控品信息卡和质控品一维码。试剂组分：Scl-70磁珠包被物（R1）含包被Scl-70（牛源）的磁珠包被物的PBS缓冲液、表面活性剂、蛋白（牛白蛋白）、Proclin300。Scl-70吖啶酯标记物（R2）含吖啶酯标记的抗人IgG抗体（羊多抗）结合物的PBS缓冲液、表面活性剂、蛋白（牛白蛋白）、Proclin300。Scl-70反应缓冲液（R3）含PBS缓冲液、表面活性剂、蛋白（牛白蛋白）、Proclin300。试剂盒信息卡含配套校准品信息，如校准品批号、有效期和校准品各浓度水平的信息。校准组分：Scl-70校准品C1-C2含不同浓度抗Scl-70抗体（人源）的冻干粉，牛血清白蛋白(BSA)，Proclin300。复溶液含活性剂，Proclin300。校准品信息卡含校准品批号、有效期和校准品各浓度水平的信息。校准品一维码含校准品批号、检测项目、水平相关信息。质控组分：Scl-70质控品QC1-QC2含不同浓度抗Scl-70抗体（人源）的冻干粉，牛血清白蛋白(BSA)，Proclin300。质控品信息卡含质控品批号、检测项目相关信息。质控品一维码含质控品批号、检测项目、水平相关信息。",null,"本试剂用于体外定量检测人血清或血浆中抗Scl-70抗体IgG的含量。临床上主要用于系统性硬化症（SSc）的辅助诊断。","2"]
["粤械注准20202400226",null,"总甲状腺素（TT4）测定试剂盒（磁微粒化学发光法）",null,"国产",{"$nulls":7},"2020-03-01","2025-05-21","2025-02-28","2030-05-20",null,null,"广州市康润生物科技有限公司",{"$nulls":5},"试剂盒由 R1、R2、R3、试剂盒信息卡；校准品、复溶液、校准品信息卡、校准品一维码；质控品、质控品靶值表、质控品信息卡、质控品一维码组成。",null,"用于体外定量检测人血清或血浆中总甲状腺素（TT4）的含量；临床上主要用于辅助评价甲状腺功能。",null,"2"]
["湘械注准20212401702",null,"抑制素A（INH A）测定试剂盒（化学发光免疫分析法）","抑制素A（INH A）测定试剂盒（磁微粒化学发光法）",null,"国产",null,null,"2021-09-09",{"$nulls":3},"2021-09-09",null,"2026-09-08",{"$nulls":3},"湖南康晴生物科技有限公司",{"$nulls":5},"试剂盒由R1R2R3R4校准品(如有)复融液(如有)说明书试剂盒信息卡和校准品信息卡(如有)组成。INHA抗体磁珠包被物(R1)含包被INHA抗体(鼠单抗)的磁珠包被物的50mMPBS缓冲液(pH 7.0±0.1)0.05%表面活性剂蛋白牛白蛋白0.05% Proclin300。INHA抗体吖啶酯标记物(R2)含吖啶酯标记的INHA抗体鼠单抗结合物的50mMPBS缓冲液(pH7.0±0.1)0.05%表面活性剂蛋白(牛白蛋白)0.05% Proclin300。反应缓冲液A(R3)10mMMES缓冲液(pH6.0±0.1)0.05%表面活性剂0.05%Proclin300。反应缓冲液B(R4)50mMTBS缓冲液(pH7.4±0.1)0.05%表面活性剂蛋白(牛白蛋白)0.05% Proclin300。复融液含0.05%活性剂，0.05% Proclin300。INHA校准品C1-C2含不同浓度INHA重组抗原的冻干粉牛血清白蛋白0.05%Proclin300。试剂盒信息卡含配套校准品信息，如校准品批号有效期和校准品各浓度水平的信息。校准品信息卡含校准品批号有效期和校准品各浓度水平的信息","试剂盒由试剂组分、校准组分和质控组分组成。其中试剂组分包括R1、R2、R3、R4和试剂盒信息卡；校准组分包括校准品、复溶液、校准品信息卡和校准品一维码；质控组分包括质控品、质控品信息卡和质控品一维码。具体内容详见附表。","用于体外定量检测人血清中的抑制素A (INH A)的含量。",null,"2"]
["国械注准20203100891",null,"血液透析干粉",null,"中国",null,"广州骐骥生物科技有限公司",null,"2023-07-11","2025-04-30","2023-07-11",null,"2020-11-09","2025-11-09","2025-11-08","2030-11-08",{"$nulls":8},"血液透析干粉包括血液透析干粉A、血液透析干粉B(联机用和血液透析于粉B。血液透析干粉A干粉由氯化钠、氯化钾、氯化镁、氯化钙、冰醋酸组成，其中冰醋酸独立包装;血液透析干粉B(联机用)和血液透析干粉B由碳酸氢钠组成。",null,"适用于急性肾衰竭、慢性肾衰竭（尿素症）的血液透析治疗。",null,"3"]
["国械注准20163131472",null,"肠道支架",{"$nulls":9},"2020-10-27","2025-10-27","2025-10-26","2030-10-26",{"$nulls":12},"3"]
["津械注准20202140813",null,"一次性医用外科口罩",null,"中国天津",null,"天津市蓝航医疗科技有限公司",null,"2020-11-27","2025-09-26","2023-03-31",null,"2020-11-27","2025-11-27","2025-11-26","2030-11-26",null,null,"天津市蓝航医疗科技有限公司",{"$nulls":5},"该产品主要由面罩部分、鼻夹和口罩带组成。",null,"用于戴在手术室医务人员口鼻部位，以防止皮屑、呼吸道微生物传播到开放的手术创面，并阻止手术病人的体液向医务人员传播，起到双向生物防护的作用。",null,"2"]
["苏泰械备20230142",null,"弹性绷带",{"$nulls":5},"2023-11-07",null,"2023-08-22","2025-06-03","2023-11-07",null,"2099-12-31",{"$nulls":3},"江苏艾博得医疗器械有限公司",{"$nulls":5},"弹力绷带由魔术贴、束带组成。间接作用于创面，非无菌提供。",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。",null,"1"]
["鲁械注准20152400709",null,"胃蛋白酶原Ⅱ（PGⅡ）测定试剂盒（胶乳免疫比浊法）",{"$nulls":9},"2020-11-16","2025-11-16","2025-11-15","2030-11-15",{"$nulls":12},"2"]
["鲁械注准20152400713",null,"超氧化物歧化酶（SOD）测定试剂盒（邻苯三酚比色法）",{"$nulls":9},"2020-11-16","2025-11-16","2025-11-15","2030-11-15",{"$nulls":12},"2"]
["湘械注准20162400061",null,"β2-微量球蛋白测定试剂盒（胶乳增强免疫比浊法）",{"$nulls":9},"2021-02-02","2026-02-02","2026-02-01","2031-02-01",{"$nulls":12},"2"]
["湘械注准20162400062",null,"视黄醇结合蛋白测定试剂盒（胶乳增强免疫比浊法）",{"$nulls":9},"2021-02-02","2026-02-02","2026-02-01","2031-02-01",{"$nulls":12},"2"]
["鲁械注准20172140657",null,"一次性使用无菌手术包",{"$nulls":5},"2022-08-10",null,"2022-08-18",null,"2022-08-18",null,"2027-08-17",null,"鲁械注准20172140657",{"$nulls":8},"规格型号：常规型手术包、辅助包、膝关节包、产包、介入手术包、剖宫包、无菌流产包、婴儿护脐包、医用会阴护理包、胃管包、换药包、导尿包、口腔种植包。\n结构组成：一次性使用无菌手术包由基本配置和辅助配置组成。常规型手术包：基本配置手术衣、一次性使用医用帽子、医用外科口罩、手术洞巾。选用配置：检查垫、中单、医用垫单、鞋套、枕套、防护罩、被罩、一次性使用灭菌橡胶外科手套。辅助包：基本配置：中单。选用配置：医用垫单，一次性使用医用帽子，医用外科口罩，医用棉签，医用棉球，一次性使用敷料镊，医用盆，医用碗，托盘，医用纱布块，无菌婴儿护脐，包布，一次性使用医用薄膜手套，医用纱布垫，脐带夹，脐带剪，洗耳球，医用手术薄膜，弯盘，擦手巾，备胶料，美亚袋，手术衣，纱布绷带，脐带线，一次性使用灭菌橡胶外科手套，防护罩，医用碘伏消毒棉球、片、签，试管（带塑料塞），阴道扩张器，裤套，套袖，手术洞巾，鞋套，消毒刷，粘合扣，手术刀片（含刀柄），药杯，自粘式伤口敷料，医用吸引管，医用滑移垫。\n膝关节包：基本配置：检查垫、手术衣。选用配置：一次性使用灭菌橡胶外科手套，医用垫单，一次性使用医用帽子，一次性使用敷料镊，医用盆，医用棉签，医用纱布块，医用碘伏消毒棉球、片、签，擦手巾，备胶料，美亚袋，包布，中单，医用外科口罩，纱布绷带，托盘，医用碗，医用棉球，自粘式伤口敷料，鞋套，粘合扣，消毒刷，医用滑移垫，手术洞巾。产包：基本配置：中单。选用配置：一次性使用医用帽子，一次性使用灭菌橡胶外科手套，医用垫单，纱布绷带，裤套，脐带剪，手术洞巾，医用盆，脐带夹，医用外科口罩，手术衣，医用棉签，无菌婴儿护脐，医用纱布块，脐带线，托盘，医用纱布垫，检查垫，防护罩，医用碘伏消毒棉球、片、签，消毒刷，医用滑移垫，包布。介入手术包：基本配置：手术衣、一次性使用灭菌橡胶外科手套。选用配置：一次性使用医用帽子、医用外科口罩、包布、一次性使用",null,null,"2"]
["粤深械备20160237号",null,"巴氏染色液",{"$nulls":9},"2016-06-16","2025-01-26","2099-12-31",{"$nulls":10},"由苏木素染液(苏木素、硫酸铝铵、乙醇、纯化水)、橙黄G染液\n纯化水)、EA50染液(伊红、俾斯麦棕、亮绿、磷钨酸、碳酸锂、乙醇、纯化水)组成。",null,"用于人体细胞样本的常规染色,适用于妇科细胞学涂片染色、细胞脱落标本染色。","1"]
["国械注准20163130336",null,"房间隔缺损封堵器",{"$nulls":9},"2020-12-15","2025-12-15","2025-12-14","2030-12-14",{"$nulls":12},"3"]
["浙械注准20162400835",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)",{"$nulls":9},"2016-10-25","2021-10-22","2021-10-24","2026-10-24",{"$nulls":12},"2"]
["浙械注准20162400844",null,"心型脂肪酸结合蛋白测定试剂盒(胶乳增强免疫比浊法)",{"$nulls":9},"2016-10-31","2021-11-03","2021-10-30","2026-11-02",{"$nulls":12},"2"]
["浙械注准20162400845",null,"直接胆红素测定试剂盒(酶法)",{"$nulls":9},"2016-10-31","2021-11-03","2021-10-30","2026-11-02",{"$nulls":12},"2"]
["浙械注准20162400860",null,"甘氨酰脯氨酸二肽氨基肽酶测定试剂盒(连续监测法)",{"$nulls":9},"2016-11-03","2021-11-03","2021-11-02","2026-11-02",{"$nulls":12},"2"]
["浙械注准20162400861",null,"5'-核苷酸酶(5'-NT)测定试剂盒(过氧化物酶法)",{"$nulls":9},"2016-11-03","2021-11-03","2021-11-02","2026-11-02",{"$nulls":12},"2"]
["浙械注准20172400780",null,"载脂蛋白A2测定试剂盒(免疫比浊法)",{"$nulls":9},"2017-07-13","2022-02-28","2022-07-12","2027-07-12",{"$nulls":12},"2"]
["国械注准20153401409",null,"弓形虫IgG抗体检测试剂盒（酶联免疫法）",{"$nulls":9},"2020-06-12","2025-06-12","2025-06-11","2030-06-11",{"$nulls":12},"3"]
["国械注准20153401403",null,"单纯疱疹病毒II型IgG抗体检测试剂盒（酶联免疫法）",{"$nulls":9},"2020-07-08","2025-07-08","2025-07-07","2030-07-07",{"$nulls":12},"3"]
["国械注准20153401408",null,"风疹病毒IgG抗体检测试剂盒（酶联免疫法）",{"$nulls":9},"2020-07-20","2025-07-20","2025-07-19","2030-07-19",{"$nulls":12},"3"]
["浙械注准20172400777",null,"纤维蛋白溶酶原测定试剂盒(免疫比浊法)",{"$nulls":9},"2017-07-13","2022-02-28","2022-07-12","2027-07-12",{"$nulls":12},"2"]
["国械注准20193100129",null,"一次性使用胆红素血浆吸附器",{"$nulls":9},"2019-03-06","2024-03-06","2024-03-05","2029-03-05",{"$nulls":12},"3"]
["国械注进20163180172",null,"精子梯度分离液",{"$nulls":9},"2020-08-05","2025-08-05","2025-08-04","2030-08-04",{"$nulls":3},"瑞利芙（北京）医疗器械有限公司",null,"瑞利芙瑞典有限公司Vitrolife Sweden AB",{"$nulls":3},"产品为含有硅烷包裹的胶体二氧化硅颗粒的悬浮性缓冲溶液。组成成分为：氯化钙、葡萄糖、HEPES、硫酸镁、氯化钾、磷酸二氢钾、丙酮酸钠、硅烷包裹的胶体二氧化硅、碳酸氢钠、氯化钠、乳酸钠、注射用水。该产品一次性使用，过滤除菌。有效期38周。",null,"该产品适用于体外生殖过程，作为密度梯度分离介质用于精子的收集和准备。","3"]
["鲁械注准20152400706",null,"唾液酸（SA）测定试剂盒（神经氨酸苷酶法）",{"$nulls":9},"2020-11-16","2025-11-16","2025-11-15","2030-11-15",{"$nulls":12},"2"]
["豫械注准20202080631",null,"一次性使用鼻氧管",{"$nulls":9},"2020-10-30","2025-10-30","2025-10-29","2030-10-29",{"$nulls":12},"2"]
["豫械注准20202140598",null,"一次性使用负压引流袋",{"$nulls":9},"2020-10-23","2025-10-23","2025-10-22","2030-10-22",{"$nulls":12},"2"]
["津械注准20202140250",null,"一次性使用直肠导管",{"$nulls":5},"2020-11-11","2025-09-26","2023-03-31",null,"2020-11-11","2025-11-11","2025-11-10","2030-11-10",null,null,"天津市蓝航医疗科技有限公司",{"$nulls":5},"产品由注液管、软体头部（或乳胶帽）、废液管、套囊、充气组件、连接器组成。注液管、软体头部、废液管、套囊、充气管的材料为医用聚氯乙烯（PVC）,乳胶帽（如有）采用天然乳胶，连接器为医用聚碳酸酯（PC）材料。",null,"临床上用于直肠清洗、灌注和排空。",null,"2"]
["国械注准20163030279","沪械注准20252030040","血管造影导丝",{"$nulls":9},"2020-09-24","2025-09-24","2025-09-23","2030-09-23",{"$nulls":12},"3"]
["粤械注准20162400488",null,"糖化血红蛋白（HbAlc）质控品",{"$nulls":9},"2020-09-29","2025-09-29","2025-09-28","2030-09-28",{"$nulls":12},"2"]
["粤械注准20162400487",null,"糖化血红蛋白（HbAlc）校准品",{"$nulls":9},"2020-09-29","2025-09-29","2025-09-28","2030-09-28",{"$nulls":12},"2"]
["川械注准20172140065",null,"直肠测压导管",{"$nulls":9},"2021-07-14",null,"2026-07-13",{"$nulls":13},"2"]
["浙械注准20202400859",null,"β-羟丁酸检测试剂盒（酶法）",{"$nulls":7},"2025-11-25",null,"2030-11-24","2025-11-25","2024-11-24","2030-11-24",{"$nulls":12},"2"]
["湘械注准20162400016",null,"天门冬氨酸氨基转移酶测定试剂盒（速率法）",{"$nulls":9},"2021-01-14","2026-01-13","2026-01-13","2031-01-13",{"$nulls":12},"2"]
["湘械注准20162400019",null,"载脂蛋白E测定试剂盒（免疫比浊法）",{"$nulls":9},"2021-01-14","2026-01-14","2026-01-13","2031-01-13",{"$nulls":12},"2"]
["粤械注准20202140543",null,"硅凝胶疤痕修复贴","软聚硅酮疤痕修复数料",{"$nulls":8},"2025-04-30",null,"2030-04-29",{"$nulls":13},"2"]
["国械注准20203030651","豫械注准20242030858","一次性使用导丝",{"$nulls":9},"2020-07-17","2025-07-17","2025-07-16","2030-07-16",{"$nulls":12},"3"]
["国械注准20203080574",null,"一次性使用麻醉穿刺套件",{"$nulls":9},"2020-06-19","2025-06-19","2025-06-18","2030-06-18",{"$nulls":12},"3"]
["国械注准20153141546",null,"一次性使用留置针",{"$nulls":9},"2020-08-06","2025-08-06","2025-08-05","2030-08-05",{"$nulls":12},"3"]
["苏械注准20202141053",null,"封闭式负压引流套装",{"$nulls":5},"2020-09-16","2025-09-05",null,null,"2020-09-16","2025-09-16","2025-09-15","2030-09-15",{"$nulls":8},"封闭式负压引流套装由非功能性多孔海绵、封闭贴膜、管路系 统组成。其中管路系统由吸盘［附吸盘贴膜，吸盘管路］、管夹、 管路［吸盘管路］、连接头、小管路［吸盘管路］、小连接头、 封帽［吸盘管路］、直通、三通组成。 非功能性多孔海绵的材 质为聚氨酯。所有配件封闭贴膜与吸盘贴膜材质为聚氨酯薄膜 涂布医用压敏胶，其中管路系统中吸盘管路、延长管路、小管 路、连接头、小连接头、材质为聚氯乙烯，管夹、封帽、直通、 三通的材质为 ABS.本产品的灭菌形式为辐照灭菌，一次性使用。",null,"用于对非慢性创面（如手术后缝合创面、机械创伤、切割伤创面、浅II度的烧烫伤创面）进行引流。",null,"2"]
["浙械注准20172400769",null,"丙酮酸测定试剂盒(酶法)",{"$nulls":9},"2017-07-13","2022-02-28","2022-07-12","2027-07-12",{"$nulls":12},"2"]
["浙械注准20172400763",null,"α2-巨球蛋白测定试剂盒(免疫比浊法)",{"$nulls":9},"2017-07-13","2022-02-28","2022-07-12","2027-07-12",{"$nulls":12},"2"]
["浙械注准20172400762",null,"髓过氧化物酶测定试剂盒(胶乳增强免疫比浊法)",{"$nulls":9},"2017-07-13","2022-03-03","2022-07-12","2027-07-12",{"$nulls":12},"2"]
["浙械注准20172400764",null,"载脂蛋白C2测定试剂盒(免疫比浊法)",{"$nulls":9},"2017-07-13","2022-02-28","2022-07-12","2027-07-12",{"$nulls":12},"2"]
["浙械注准20172400775",null,"抗环瓜氨酸肽抗体测定试剂盒(胶乳增强免疫比浊法)",{"$nulls":9},"2017-07-13","2022-02-28","2022-07-12","2027-07-12",{"$nulls":12},"2"]
["国械注准20163400754",null,"ALDH2基因突变检测试剂盒（PCR-荧光探针法）",{"$nulls":9},"2020-11-13","2025-11-13","2025-11-12","2030-11-12",{"$nulls":12},"3"]
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["浙械注准20172400767",null,"α1-酸性糖蛋白测定试剂盒(免疫比浊法)",{"$nulls":9},"2017-07-13","2022-02-28","2022-07-12","2027-07-12",{"$nulls":12},"2"]
["浙械注准20172400771",null,"抗凝血酶Ⅲ测定试剂盒(免疫比浊法)",{"$nulls":9},"2017-07-13","2022-02-28","2022-07-12","2027-07-12",{"$nulls":12},"2"]
["鲁械注准20152400721",null,"血氨（AMM）测定试剂盒（谷氨酸脱氢酶法）",{"$nulls":9},"2020-11-16","2025-11-16","2025-11-15","2030-11-15",{"$nulls":12},"2"]
["鲁械注准20152400718",null,"铜（Cu）测定试剂盒（PAESA显色剂法）",{"$nulls":9},"2020-11-16","2025-11-16","2025-11-15","2030-11-15",{"$nulls":12},"2"]
["鲁械注准20152400704",null,"缺血性修饰白蛋白（IMA）测定试剂盒（白蛋白钴结合法）",{"$nulls":9},"2020-11-16","2025-11-16","2025-11-15","2030-11-15",{"$nulls":12},"2"]
["鲁械注准20152400696",null,"轻链λ（Lambda）测定试剂盒（免疫比浊法）",{"$nulls":9},"2020-11-17","2025-11-17","2025-11-16","2030-11-16",{"$nulls":12},"2"]
["鄂械注准20242025114",null,"一次性内窥镜手术用穿刺器套件",null,"中国",null,"--",null,"2024-08-02",null,"2024-10-24","2025-05-12","2024-08-02",null,"2029-08-01",{"$nulls":3},"武汉半边天医疗技术发展有限公司","微尔创（武汉）医疗科技有限 公司",{"$nulls":4},"一次性内窥镜手术用穿刺器套件由带导丝双动抓取钳头（包含无创抓钳、肺钳、输卵管钳、马里兰钳、\n胆囊钳、胃钳）、带导丝双动弯剪、主穿刺杆、穿刺针、密封帽、手柄、蝴蝶螺钉和球形锁线器组成。\n密封帽材质为医用硅胶，球形锁线器材质为铜镀镍，钳头、剪刀、导丝、主穿刺杆、穿刺针、蝴蝶螺钉\n材质均为SUS304不锈钢（06Cr19Ni10）。手柄分为有锁手柄和无锁手柄两种型号，有锁手柄有锁合结\n构。手柄材质为高性能聚酰胺(MXD6)（玻璃纤维增强）。产品经环氧乙烷灭菌，无菌提供，一次性使\n用。",null,"与胸腹腔镜配合，在临床上供胸腹腔手术使用。",null,"2"]
["国械注进20202020491",null,"不可吸收性外科缝线",null,"韩国",null,"北京圣杰鑫科技有限公司",null,"2020-11-30","2025-07-02",null,null,"2020-11-30","2025-11-30","2025-11-29","2030-11-29",null,null,"AILEE CO.,LTD. 韩国爱丽有限公司",{"$nulls":5},"该产品是带针或不带针的单股缝合线，其中针的材料是医用不锈钢SUS304；不可吸收性外科缝线是由尼龙6/6制成的人工合成 不可吸收外科缝线，无涂层，缝线颜色为黑色（苏木精）、蓝色（FD&C Blue #2）和白色（未染色）。环氧乙烷灭菌，一次性使用。",null,"产品适用于一般软组织的缝合或结扎，不适用于神经外科或心血管手术。",null,"2"]
["渝械注准20202040212",null,"一次性无菌变向磨头",{"$nulls":9},"2020-08-20",null,"2025-08-19",{"$nulls":13},"2"]
["浙甬械备20200259号",null,"CD45RO检测试剂","CD45RO抗体试剂",{"$nulls":4},"2020-05-14",{"$nulls":3},"2020-05-14",null,"2099-12-31",{"$nulls":3},"泛肽生物科技（浙江）有限公司",{"$nulls":5},"主要包括磷酸盐缓冲液、蛋白稳定剂、防腐剂、荧光标记的鼠抗人CD45RO单克隆抗体","由磷酸盐缓冲液、蛋白稳定剂、防腐剂、荧光标记的鼠抗人CD45R0 单克隆抗体组成。","检测人体生物标本中CD45RO的表达，为医师提供诊断的辅助信息","用于辅助人体样本中CD45R0的检测，临床上用于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。","2","1"]
["苏械注准20202020825",null,"一次性肠管提拉固定器",{"$nulls":9},"2020-07-10","2025-07-07","2025-07-06","2030-07-06",{"$nulls":9},"一次性肠管提拉固定器根据结构和外形分为 KZTLQ、KZTLQA、KZTLQB 三种型号。其中每种型号按照扎带长度和宽度又各分为 3 种规格。KZTLQ型、KZTLQA型由捆扎带和提拉带组成。KZTLQB型由捆扎带、提拉带和套管组成。其中捆扎带可被预制成不规则环形状。该产品以无菌状态提供，经环氧乙烷灭菌。一次性使用 。",null,"开放手术或腔镜手术中，用于肠管的捆扎和提拉。","2"]
["浙甬械备20200260号",null,"CD45RA检测试剂","CD45RA抗体试剂",{"$nulls":4},"2020-05-14",null,null,"2025-09-05","2020-05-14",null,"2099-12-31",{"$nulls":3},"泛肽生物科技（浙江）有限公司",{"$nulls":5},"主要包括磷酸盐缓冲液、蛋白稳定剂、防腐剂、荧光标记的鼠抗人CD45RA单克隆抗体","由磷酸盐缓冲液、蛋白稳定剂、防腐剂、荧光标记的鼠抗人CD45RA单克隆抗体组成","检测人体生物标本中CD45RA的表达，为医师提供诊断的辅助信息","用于辅助人体样本中CD45RA的检测，临床上用于为医师提供诊断的辅助信息，不得用于指导临床用药或伴随诊断。","1"]
["京械注准20152400933",null,"糖尿病自身抗体谱检测试剂盒（条带免疫印迹法）",{"$nulls":9},"2020-08-03","2025-08-03","2025-08-02","2030-08-02",{"$nulls":12},"2"]
["国械注进20152170230",null,"酸蚀剂",{"$nulls":9},"2019-07-31","2024-07-31","2024-07-30","2029-07-30",{"$nulls":12},"2"]
["国械注进20153171367",null,"后牙充填玻璃离子",{"$nulls":9},"2020-04-27","2025-04-27","2025-04-26","2030-04-26",{"$nulls":12},"3"]
["国械注进20162160973",null,"一次性使用眼科手术刀",{"$nulls":9},"2020-12-07","2025-12-07","2025-12-06","2030-12-06",{"$nulls":5},"美国爱尔康公司Alcon Laboratories, Incorporated",{"$nulls":6},"2"]
["苏械注准20152401437",null,"胰岛素样生长因子结合蛋白-1检测试剂盒（胶体金法）",{"$nulls":9},"2020-10-26",null,"2025-10-25","2030-10-25",{"$nulls":12},"2"]
["粤械注准20202140816",null,"软聚硅酮伤口敷贴",{"$nulls":9},"2020-06-12","2025-06-12","2025-06-11","2030-06-11",{"$nulls":11},"用于体表非慢性创面的护理，如浅表性创面、手术后缝合创面、机械创伤、擦伤、切割伤、I度或浅II度的烧烫伤创面","2"]
["粤械注准20222401288",null,"胰岛素（INS）测定试剂盒（化学发光免疫分析法）","胰岛素（INS）测定试剂盒（磁微粒化学发光法）",null,"国产",null,null,"2022-08-31",{"$nulls":3},"2022-08-31",null,"2027-08-30",{"$nulls":3},"广州市康润生物科技有限公司",{"$nulls":5},"试剂盒由R1、R2、R3、说明书、校准品、复融液、试剂盒信息卡和校准品信息卡组成。其中：INS抗体磁珠包被物(R1)：含包被INS抗体（鼠单抗）的磁珠包被物的PBS缓冲液、表面活性剂、蛋白（牛白蛋白）、Proclin300。INS抗体吖啶酯标记物(R2)：含吖啶酯标记的INS抗体（鼠单抗）结合物的PBS缓冲液、表面活性剂、蛋白（牛白蛋白）、Proclin300。INS反应缓冲液(R3)：PBS缓冲液、表面活性剂、蛋白（牛白蛋白）、Proclin300。复融液：含活性剂，Proclin300。INS校准品C0-C2：含不同浓度INS（重组抗原）的冻干粉，牛血清白蛋白， Proclin300。","试剂盒由试剂组分、校准组分和质控组分组成。其中试剂组分包括R1、R2、R3和试剂盒信息卡；校准组分包括校准品、复溶液、校准品信息卡和校准品一维码；质控组分包括质控品、质控品信息卡和质控品一维码。试剂组分：INS磁珠包被物(R1)含包被INS抗体（鼠单抗）的磁珠包被物的PBS缓冲液、表面活性剂、蛋白（牛白蛋白）、Proclin300。INS吖啶酯标记物(R2)含吖啶酯标记的INS抗体（鼠单抗）结合物的PBS缓冲液、表面活性剂、蛋白（牛白蛋白）、Proclin300。INS反应缓冲液(R3)含PBS缓冲液、表面活性剂、蛋白（牛白蛋白）、Proclin300。试剂盒信息卡含配套校准品信息，如校准品批号、有效期和校准品各浓度水平的信息。校准组分：INS校准品C0-C2含不同浓度INS（重组抗原）的冻干粉，牛血清白蛋白， Proclin300。复溶液含活性剂，Proclin300。校准品信息卡含校准品批号、有效期和校准品各浓度水平的信息。校准品一维码含校准品批号、检测项目、水平相关信息。质控组分：INS质控品QC1-QC2含不同浓度INS（重组抗原）的冻干粉，牛血清白蛋白， Proclin300。质控品信息卡含质控品批号、检测项目相关信息。质控品一维码含质控品批号、检测项目、水平相关信息。","用于体外定量检测人血清或血浆中胰岛素的含量。临床上主要用于评价胰岛功能。",null,"2"]
["冀石械备20220180",null,"一次性使用口腔器械盒",{"$nulls":5},"2022-04-13",{"$nulls":3},"2022-04-13",null,"2099-12-31",{"$nulls":3},"河北振德医疗器械有限公司",{"$nulls":5},"一次性使用口腔器械盒是组合包，均有I类医疗器械组成。由口镜、牙探针、一次性使用牙科镊、脱脂棉球、医用橡胶检查手套、吸唾管、医用检查垫、水枪头八种医疗器械按型号要求不同而组成。 口镜：由柄、带有连接杆或不带有连接杆的镜子组成。镜面采用玻璃制成。非无菌提供。使用前由使用机构根据说明书进行灭菌或消毒。牙探针：由手持部分和细长工作端组成，手持部分材料是聚氯乙烯，工作端采用不锈钢材料制成，根据用途的差异有不同的形状和表面。非无菌提供。使用前由使用机构根据说明书进行灭菌或消毒。一次性使用牙科镊：由一对尾部叠合的叶片组成，由冷轧钢材料制成。非无菌提供。使用前由使用机构根据说明书进行灭菌或消毒。脱脂棉球：吸水性材料，不含消毒剂。非无菌提供。一次性使用。医用橡胶检查手套:采用橡胶材料制造，有足够的强度和阻隔性能。非无菌提供，一次性使用。吸唾管：采用塑料材料制成，与牙科治疗机的抽吸装置一起使用。非无菌提供。使用前由使用机构根据说明书进行灭菌或消毒。医用检查垫:由纸巾和塑料膜复合或缝制而成。非无菌提供，一次性使用。水枪头采用塑料材料制成，使用时安装在牙科综合治疗台的喷枪前端，为喷枪气流、液体的出口端。非无菌",null,"供口腔临床检查、治疗时一次性使用",null,"1"]
["鄂械注准20182012381",null,"微型钨针消融电极",{"$nulls":9},"2018-08-06","2023-08-06","2023-08-05","2028-08-05",{"$nulls":12},"2"]
["湘械注准20162400008",null,"类风湿因子测定试剂盒（胶乳增强免疫比浊法）",{"$nulls":9},"2021-01-14","2026-01-14","2026-01-13","2031-01-13",{"$nulls":12},"2"]
["湘械注准20162400020",null,"脂肪酶测定试剂盒（酶速率法）",{"$nulls":9},"2021-01-14",null,"2026-01-13",{"$nulls":13},"2"]
["鲁械注准20162400045",null,"补体C4（C4）测定试剂盒（免疫比浊法）",{"$nulls":9},"2020-11-16","2025-11-16","2025-11-15","2030-11-15",{"$nulls":12},"2"]
["国械注准20203400714","鲁械注准20252400444","α-L-岩藻糖苷酶（AFU）测定试剂盒（CNPF底物法）",{"$nulls":9},"2020-08-25","2025-08-25","2025-08-24","2030-08-24",{"$nulls":12},"3","2"]
["国械注准20163130337",null,"陶瓷膜室间隔缺损封堵器",{"$nulls":9},"2020-12-15","2025-12-15","2025-12-14","2030-12-14",{"$nulls":12},"3"]
["湘械注准20162400064",null,"N-乙酰-β-D-氨基葡萄糖苷酶测定试剂盒（比色法）",{"$nulls":9},"2021-02-02","2026-02-02","2026-02-01","2031-02-01",{"$nulls":12},"2"]
["湘械注准20162400055",null,"脂蛋白a测定试剂盒（胶乳增强免疫比浊法）",{"$nulls":9},"2021-02-02","2026-02-02","2026-02-01","2031-02-01",{"$nulls":12},"2"]
["浙械注准20172400479",null,"总胆红素测定试剂盒(胆红素氧化酶法)",{"$nulls":9},"2017-05-10","2022-04-22","2022-05-09","2027-05-09",{"$nulls":12},"2"]
["浙械注准20172400482",null,"补体C4测定试剂盒(免疫比浊法)",{"$nulls":9},"2017-05-10","2021-12-27","2022-05-09","2027-05-09",{"$nulls":12},"2"]
["浙械注准20172400766",null,"胰淀粉酶测定试剂盒(免疫抑制-EPS底物法)",{"$nulls":9},"2017-07-13","2022-02-28","2022-07-12","2027-07-12",{"$nulls":12},"2"]
["浙械注准20172400783",null,"血清淀粉样蛋白A测定试剂盒(胶乳增强免疫比浊法)",{"$nulls":9},"2017-07-13","2022-02-28","2022-07-12","2027-07-12",{"$nulls":12},"2"]
["浙械注准20172400779",null,"载脂蛋白C3测定试剂盒(免疫比浊法)",{"$nulls":9},"2017-07-13","2022-02-28","2022-07-12","2027-07-12",{"$nulls":12},"2"]
["浙械注准20172400782",null,"甘胆酸测定试剂盒(均相酶免疫法)",{"$nulls":9},"2017-07-13","2022-02-28","2022-07-12","2027-07-12",{"$nulls":12},"2"]
["浙械注准20172400770",null,"25-羟基维生素D测定试剂盒(胶乳增强免疫比浊法)",{"$nulls":9},"2017-07-13","2022-03-02","2022-07-12","2027-07-12",{"$nulls":12},"2"]
["国械注准20163131470",null,"胆道支架",{"$nulls":9},"2020-10-26","2025-10-26","2025-12-25","2030-10-25",{"$nulls":12},"3"]
["国械注准20163130433",null,"非粘附性液体栓塞剂",{"$nulls":9},"2020-10-22","2025-10-23","2025-10-21","2030-10-22",{"$nulls":9},"该产品主要由EVAL聚合物溶液及显影剂组成。EVAL聚合物溶液主要成分为乙烯—乙烯醇共聚物（EVAL）、二甲亚砜（DMSO）和无水乙醇共混溶液，显影剂成分为钽粉。并配有1ml注射器（无针头）3支及1.5mlDMSO一瓶，分别用于栓塞剂输入及微导管预充。注射器筒身材质为聚丙烯。货架有效期两年。",null,"该产品用于脑血管畸形的血管内栓塞治疗。","3"]
["苏械注准20162080103",null,"一次性使用鼻氧管",null,"--",null,"--",null,"2024-08-21","2025-04-29","2024-12-11",null,"2024-08-21","2026-01-15","2026-01-14","2031-01-14",null,null,"江苏宏鑫医疗科技有限公司",{"$nulls":5},"一次性使用鼻氧管由加湿通路、湿化液、鼻氧管（输氧管导管、鼻氧管导管、气源接头、鼻塞、 调节套（选配）、二/三通接头）、\n吸氧记录标签（选配）。根据型式分为 01 型单套单鼻、02 型双套单 鼻、03 型双套双鼻三种系列。产品以无菌状态提供，\n经环氧乙烷灭菌。一次性使用。","一次性使用鼻氧管由湿化瓶（含湿化液）、鼻氧管\n（输氧管导管、鼻氧管导管、气源接头、鼻塞、调\n节套（选配）、二/三通接头）、吸氧记录标签（\n选配）。根据型式分为 01 型单套单鼻、02 型双套单鼻、03 型双套双鼻三种系列。产品以无菌状态提供，一次性使用。其中鼻氧管经环氧乙烷灭菌，湿化液经湿热灭菌。","本产品与输氧系统连接供人体吸入氧气用。","用于与输氧系统连接供人体吸入氧气用。","2"]
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["皖械注准20202400438",null,"子痫前期检测试剂盒（斑点扩散法）",{"$nulls":9},"2020-09-17","2025-09-17","2025-09-16","2030-09-16",{"$nulls":12},"2"]
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["川械注准20202140038",null,"一次性使用输尿管引流管",{"$nulls":9},"2020-03-31","2025-03-31","2025-03-30","2030-03-30",{"$nulls":12},"2"]
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["湘械注准20162400100",null,"糖化血红蛋白测定试剂盒（胶乳增强免疫比浊法）",{"$nulls":9},"2021-02-05","2026-02-07","2026-02-04","2031-02-06",{"$nulls":12},"2"]
["湘械注准20162400072",null,"总胆红素测定试剂盒（钒酸盐氧化法）",{"$nulls":9},"2021-02-08","2026-02-08","2026-02-07","2031-02-07",{"$nulls":12},"2"]
["赣械注准20162140016",null,"一次性使用引流袋",{"$nulls":9},"2020-12-23","2025-12-23","2025-12-22","2030-12-22",{"$nulls":9},"本产品以聚氯乙烯为主要原材料制成，由保护套、锥形接头、止水夹、悬挂装置、软管、袋体、出液接头和护塞组成。经环氧乙烷灭菌，产品无菌。",null,"供医疗单位引流贮存液体用。","2"]
["湘械注准20162400074",null,"α-淀粉酶测定试剂盒（EPS-G7底物法）",{"$nulls":9},"2021-02-08","2026-02-08","2026-02-07","2031-02-07",{"$nulls":12},"2"]
["国械注准20203030606",null,"一次性使用无菌导管鞘组",{"$nulls":9},"2020-07-01","2025-07-01","2025-06-30","2030-07-30",{"$nulls":12},"3"]
["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）","β-人绒毛膜促性腺激素测定试剂盒（干式免疫荧光法）",{"$nulls":8},"2025-10-12",null,"2030-10-11",{"$nulls":13},"2"]
["鲁械注准20152400614",null,"抗心磷脂抗体检测试剂（酶联免疫法）",{"$nulls":9},"2020-10-10","2025-10-10","2025-10-09","2030-10-09",{"$nulls":12},"2"]
["鲁械注准20202400848",null,"肌酸激酶同工酶（CK-MB）测定试剂盒（磁微粒化学发光法）",{"$nulls":9},"2020-08-12","2025-08-12","2025-08-11","2030-08-11",{"$nulls":12},"2"]
["鲁械注准20202400565",null,"N末端B型脑钠肽前体（NT proBNP）测定试剂盒（磁微粒化学发光法）",{"$nulls":9},"2020-05-27","2025-05-27","2025-05-26","2030-05-26",{"$nulls":12},"2"]
["鲁械注准20202400566",null,"肌红蛋白（MYO）测定试剂盒（磁微粒化学发光法）",{"$nulls":9},"2020-05-27","2025-05-27","2025-05-26","2030-05-26",{"$nulls":12},"2"]
["鲁械注准20192400902",null,"降钙素原检测试剂盒（磁微粒化学发光法）",{"$nulls":9},"2019-12-24","2024-12-24","2024-12-23","2029-12-23",{"$nulls":12},"2"]
["国械注准20153400937",null,"乙型肝炎病毒核心抗体检测试剂盒（化学发光法）",{"$nulls":9},"2020-05-18","2025-05-18","2025-05-17","2030-05-17",{"$nulls":12},"3"]
["国械注准20153400939",null,"乙型肝炎病毒e抗原检测试剂盒（化学发光法）",{"$nulls":9},"2020-05-13","2025-05-13","2025-05-12","2030-05-12",{"$nulls":12},"3"]
["鲁械注准20152400619",null,"天门冬氨酸氨基转移酶测定试剂盒（天门冬氨酸底物法）",{"$nulls":9},"2020-09-27","2025-09-27","2025-09-26","2030-09-26",{"$nulls":12},"2"]
["鲁械注准20152400468",null,"胆碱酯酶检测试纸（干化学法）",{"$nulls":9},"2020-04-21","2025-04-21","2025-04-20","2030-04-20",{"$nulls":12},"2"]
["浙械注准20162400767",null,"锌离子测定试剂盒(络合比色法)",{"$nulls":9},"2016-09-27","2021-09-08","2021-09-26","2026-09-07",{"$nulls":12},"2"]
["国械注准20203030701",null,"球囊扩张导管",{"$nulls":9},"2020-08-12","2025-08-12","2025-08-11","2030-08-11",{"$nulls":12},"3"]
["沪械注准20162400448",null,"免疫球蛋白E测定试剂盒（免疫比浊法）",{"$nulls":9},"2020-12-18","2025-12-18","2025-12-17","2030-12-17",{"$nulls":12},"2"]
["沪械注准20162400347",null,"可溶性转铁蛋白受体测定试剂盒（免疫比浊法）",{"$nulls":9},"2020-12-14","2025-12-14","2025-12-13","2030-12-13",{"$nulls":12},"2"]
["国械注准20203030933","湘械注准20252030452","涂层导丝",{"$nulls":9},"2020-12-01","2025-12-01","2025-11-30","2030-11-30",{"$nulls":12},"3","2"]
["湘械注准20152400169",null,"丙氨酸氨基转移酶测定试剂盒（速率法）",{"$nulls":9},"2020-12-09","2025-12-09","2025-12-08","2030-12-08",{"$nulls":12},"2"]
["国械注准20203031014","沪械注准20252030306","一次性使用亲水涂层导管鞘",{"$nulls":9},"2020-12-31","2025-12-31","2025-12-30","2030-12-30",{"$nulls":3},"上海瑛泰医疗器械股份有限公司",{"$nulls":5},"该产品由导管鞘、扩张器、导引导丝和穿刺针、导引套\n管构成。",null,"该产品用于介入手术中扩大桡动脉经皮切口， 建立导管\n导入血管的通道。","3"]
["国械注准20203030874",null,"外周球囊扩张导管",{"$nulls":9},"2020-11-09","2025-11-09","2025-11-08","2030-11-08",{"$nulls":12},"3"]
["湘械注准20162400012",null,"胱抑素C测定试剂盒（胶乳增强免疫比浊法）",{"$nulls":9},"2021-01-14","2026-01-14","2026-01-13","2031-01-13",{"$nulls":12},"2"]
["鲁械注准20162400046",null,"免疫球蛋白G（IgG）测定试剂盒（免疫比浊法）",{"$nulls":9},"2020-11-16","2025-11-16","2025-11-15","2030-11-15",{"$nulls":12},"2"]
["国械注准20163130335",null,"陶瓷膜动脉导管未闭封堵器",{"$nulls":9},"2020-12-15","2025-12-15","2025-12-14","2030-12-14",{"$nulls":12},"3"]
["鲁械注准20152400720",null,"甘胆酸（CG）测定试剂盒（胶乳免疫比浊法）",{"$nulls":9},"2020-11-17","2025-11-17","2025-11-16","2030-11-16",{"$nulls":12},"2"]
["鲁械注准20152400701",null,"脑脊液与尿蛋白（CSF）测定试剂盒（连苯三酚红钼法）",{"$nulls":9},"2020-11-16","2025-11-16","2025-11-15","2030-11-15",{"$nulls":12},"2"]
["鲁械注准20152400694",null,"触珠蛋白（HP）测定试剂盒（免疫比浊法）",{"$nulls":9},"2020-11-23","2025-11-23","2025-11-22","2030-11-22",{"$nulls":12},"2"]
["鲁械注准20152400698",null,"游离脂肪酸（NEFA）测定试剂盒（ACS-ACOD法）",{"$nulls":9},"2020-11-23","2025-11-23","2025-11-22","2030-11-22",{"$nulls":12},"2"]
["鲁械注准20152400697",null,"中性粒细胞明胶酶相关脂质运载蛋白（NGAL)测定试剂盒（胶乳免疫比浊法）",{"$nulls":9},"2020-11-28","2025-11-28","2025-11-27","2030-11-27",{"$nulls":12},"2"]
["鲁械注准20152400710",null,"降钙素原（PCT）测定试剂盒（胶乳免疫比浊法）",{"$nulls":9},"2020-11-23","2025-11-23","2025-11-22","2030-11-22",{"$nulls":12},"2"]
["鲁械注准20152400708",null,"胃蛋白酶原Ⅰ（PGⅠ）测定试剂盒（胶乳免疫比浊法）",{"$nulls":9},"2020-11-16","2025-11-16","2025-11-15","2030-11-15",{"$nulls":12},"2"]
["国械注进20162161587",null,"一次性使用眼科拉钩",{"$nulls":9},"2020-11-13","2025-11-13","2025-11-12","2030-11-12",{"$nulls":5},"美国爱尔康公司 Alcon Laboratories,Inc.",{"$nulls":6},"2"]
["粤械注准20162400489",null,"N-末端脑钠肽前体（NT-proBNP）测定试剂盒（免疫荧光层析法）",{"$nulls":9},"2020-09-29","2025-09-29","2025-09-28","2030-09-28",{"$nulls":12},"2"]
["粤械注准20162400490",null,"降钙素原（PCT）测定试剂盒（免疫荧光层析法）",{"$nulls":9},"2020-09-29","2025-09-29","2025-09-28","2030-09-28",{"$nulls":12},"2"]
["粤械注准20162400510",null,"超敏C反应蛋白（CRP）测定试剂盒（免疫荧光层析法）",{"$nulls":9},"2020-09-29","2025-09-29","2025-09-28","2030-09-28",{"$nulls":12},"2"]
["粤械注准20162400652",null,"胱抑素C（Cys-C）测定试剂盒（免疫荧光层析法）",{"$nulls":9},"2020-09-29","2025-09-29","2025-09-28","2030-09-28",{"$nulls":12},"2"]
["粤械注准20202402109",null,"血栓弹力图（普通杯）检测试剂盒（凝固法）",{"$nulls":9},"2020-12-17","2025-12-17","2025-12-16","2030-12-16",{"$nulls":12},"2"]
["国械注准20183141608",null,"一次性使用麻醉穿刺包",{"$nulls":5},"2023-04-17",{"$nulls":3},"2023-04-17",null,"2028-04-16",null,"国械注准20183141608",{"$nulls":8},"结构组成：一次性使用麻醉穿刺包由基本配置和选用配置组成，基本配置：一次性使用麻醉穿刺针、一次性使用硬膜外麻醉导管、一次性使用硬膜外麻醉导管加强型、一次性使用药液过滤器、导管接头；选用配置：全玻璃注射器、一次性使用无菌注射器、破皮针、一次性使用灭菌橡胶外科手套、一次性使用无菌注射针、无纺布复合洞巾、医用纱布块、消毒刷、负压管、一次性使用创可贴、胶条、托盘、无纺布复合方巾、无纺布复合包巾、自粘式伤口敷料、低阻力注射器、镊子、医用棉球。含润滑剂：二甲基硅氧烷、粘合剂：环氧树脂胶，不含药或涂层。一次性使用，环氧乙烷灭菌。",null,null,"3"]
["浙械注准20162400755",null,"天门冬氨酸氨基转移酶线粒体同工酶测定试剂盒(免疫抑制法)",{"$nulls":9},"2016-09-26","2021-09-06","2021-09-25","2026-09-05",{"$nulls":12},"2"]
["浙械注准20162400834",null,"唾液酸测定试剂盒(连续监测法)",{"$nulls":9},"2016-10-25","2021-10-22","2021-10-24","2026-10-24",{"$nulls":12},"2"]
["国械注进20153171668",null,"光固化氢氧化钙间接盖髓剂",{"$nulls":9},"2020-04-28","2025-04-28","2025-04-27","2030-04-27",{"$nulls":12},"3"]
["粤械注准20232400244",null,"抗Sp100抗体测定试剂盒（化学发光免疫分析法）","抗Sp100抗体测定试剂盒（磁微粒化学发光法）",null,"国产",null,null,"2023-02-07",{"$nulls":3},"2023-02-07",null,"2028-02-06",{"$nulls":3},"广州市康润生物科技有限公司",{"$nulls":5},"试剂盒由R1、R2、校准品（如有）、复融液（如有）、试剂盒信息卡和校准品信息卡（如有）组成。其中,\nSp100磁珠包被物（R1）:含包被Sp100（重组抗原）的磁珠包被物的PBS缓冲液、表面活性剂、蛋白（牛白蛋白）、Proclin300。\n抗人IgG抗体吖啶酯标记物（R2）:含吖啶酯标记的抗人IgG抗体（羊多抗）结合物的PBS缓冲液、表面活性剂、蛋白（牛白蛋白）、Proclin300。\n复融液:含活性剂，Proclin300。\nSp100校准品C1-C2:含不同浓度Sp100抗体（人源）的冻干粉，牛血清白蛋白，Proclin300。\n试剂盒信息卡：含配套校准品信息，如校准品批号、有效期和校准品各浓度水平的信息。\n校准品信息卡：含校准品批号、有效期和校准品各浓度水平的信息。","试剂盒由试剂组分、对照组分和质控组分组成。其中试剂组分包括R1、R2和试剂盒信息卡；对照组分包括对照品、复溶液、对照品信息卡和对照品一维码；质控组分包括质控品、质控品信息卡和质控品一维码。试剂组分包括Sp100磁珠包被物（R1）：含包被Sp100（重组抗原）的磁珠包被物的PBS缓冲液、表面活性剂、蛋白（牛白蛋白）、Proclin300；Sp100吖啶酯标记物（R2）：含吖啶酯标记的抗人IgG抗体（羊多抗）结合物的PBS缓冲液、表面活性剂、蛋白（牛白蛋白）、Proclin300；试剂盒信息卡：含配套对照品信息，如对照品批号、有效期和对照品各浓度水平的信息。对照组分包括Sp100对照品C1-C2：含不同浓度Sp100抗体（人源）的冻干粉，牛血清白蛋白，Proclin300；复溶液：含活性剂，Proclin300；对照品信息卡：含对照品批号、有效期和对照品各浓度水平的信息；对照品一维码：含对照品批号、检测项目、水平相关信息。质控组分包括Sp100质控品QC1-QC2：含不同浓度Sp100抗体（人源）的冻干粉，牛血清白蛋白，Proclin300；质控品信息卡：含质控品批号、检测项目相关信息；质控品一维码：含质控品批号、检测项目、水平相关信息","用于体外定性检测人血清中抗Sp100 IgG抗体，临床上主要用于原发性胆汁性肝硬化（PBC）的辅助诊断。",null,"2"]
["国械注进20203180350",null,"胚胎移植液",{"$nulls":9},"2020-07-09","2025-07-09","2025-07-08","2030-07-08",{"$nulls":3},"瑞利芙（北京）医疗器械有限公司",null,"瑞利芙瑞典有限公司Vitrolife Sweden AB",{"$nulls":3},"产品组成成分包括：丙氨酸、丙氨酰谷 氨酰胺、精氨酸、天冬酰胺、天冬氨 酸、氯化钙、泛酸钙、胱氨酸、庆大霉 素、葡萄糖、谷氨酸、甘氨酸、组氨 酸、透明质酸、异亮氨酸、亮氨酸、赖 氨酸、硫酸镁、蛋氨酸、苯丙氨酸、氯 化钾、脯氨酸、盐酸吡哆醛、人重组白 蛋白、核黄素、丝氨酸、碳酸氢钠、氯 化钠、柠檬酸钠、磷酸二氢钠、乳酸 钠、丙酮酸钠、硫胺、苏氨酸、色氨 酸、酪氨酸、缬氨酸、注射用水。产品 经过滤除菌和无菌灌装工艺生产。货架 有效期24周。",null,"适用于体外生殖技术中胚胎的移植。","3"]
["豫械注准20202081304",null,"一次性使用吸痰包",{"$nulls":9},"2020-10-16","2025-10-16","2025-10-15","2030-10-15",{"$nulls":12},"2"]
["豫械注准20202140630",null,"医用手术薄膜",{"$nulls":9},"2020-10-30","2025-10-30","2025-10-29","2030-10-29",{"$nulls":12},"2"]
["豫械注准20202141254",null,"一次性使用鼻胃肠管",{"$nulls":9},"2020-09-28","2025-09-28","2025-09-27","2030-09-27",{"$nulls":12},"2"]
["苏械注准20232061773",null,"一次性使用电子关节内窥镜","一次性使用关节穿刺成像导管","中国",{"$nulls":3},"2023-12-12",null,"2024-03-19",null,"2023-12-12",null,"2028-12-11",{"$nulls":3},"新光维医疗科技（苏州）股份有限公司",{"$nulls":5},"产品由头端部、插入部、操作部、插头部及附件组成。附件包括：一次性镜鞘、一次性穿刺针、一次性闭孔器。产品以无菌状态提供，经环氧乙烷灭菌，一次性使用。",null,"本产品与本公司生产的内窥镜图像处理装置（HDVS-S100A、HDVS-S100B、HDVS-S100C、HDVS-S100D、HDVS-S200A、HDVS-S200B、HDVS-S200C、HDVS-S200D、HDVS-S300A、HDVS-S300B、HDVS-S300C、HDVS-S300D）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。",null,"2"]
["苏械注准20232061800",null,"一次性使用电子脊柱内窥镜","一次性使用脊柱成像导管",{"$nulls":4},"2023-12-22",null,"2024-03-19",null,"2023-12-22",null,"2028-12-21",{"$nulls":3},"新光维医疗科技（苏州）股份有限公司",{"$nulls":5},"由头端部、插入部、操作部、插头部及工作套管组成。产品以无菌状态提供，经环氧乙烷灭菌，一次性使用。",null,"本产品与本公司生产的内窥镜图像处理装置（HDVS-S100A、HDVS-S100B、HDVS-S100C、HDVS-S100D、HDVS-S200A、HDVS-S200B、HDVS-S200C、HDVS-S200D、HDVS-S300A、HDVS-S300B、HDVS-S300C、HDVS-S300D）配合使用，通过视频监视器提供影像，用于脊柱区域的观察、诊断、摄影和治疗用。",null,"2"]
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["湘械注准20162400057",null,"同型半胱氨酸测定试剂盒（循环酶法）",{"$nulls":9},"2021-02-02","2026-02-02","2026-02-01","2031-02-01",{"$nulls":12},"2"]
["湘械注准20162400110",null,"高密度脂蛋白胆固醇测定试剂盒（直接测定法）",{"$nulls":9},"2021-02-05","2026-02-05","2026-02-04","2031-02-04",{"$nulls":12},"2"]
["湘械注准20162400111",null,"低密度脂蛋白胆固醇测定试剂盒（直接测定法）",{"$nulls":9},"2021-02-05","2026-02-05","2026-02-04","2031-02-04",{"$nulls":12},"2"]
["国械注准20163130348",null,"脊柱前路板钉系统",{"$nulls":7},"2023-04-20","2025-05-21","2020-10-26","2025-10-26","2025-10-25","2030-10-25",{"$nulls":8},"脊柱前路板钉系统由脊柱前路板、脊柱螺钉和铆钉组成。其中脊柱前路板由符合GB/T13810-2017标准规定的TA3G纯钛材料制成；铆钉及脊柱螺钉由符合GB/T13810-2017标准规定的TC4钛合金材料制成。产品表面分非阳极氧化和微弧阳极氧化两种处理方式。产品分非灭菌和灭菌两种交付状态，非灭菌状态交付的产品货架有效期为五年，灭菌状态交付的产品经辐照灭菌，灭菌有效期为五年。","脊柱前路板钉系统由脊柱前路板、脊柱螺钉和铆钉组成。其中脊柱前路板由符合 GB/T 13810-2017 标准规定的 TA3G 纯钛材料制成；铆钉及脊柱螺钉由符合GB/T 13810-2017 标准规定的 TC4 钛合金材料制成。产品表面分非阳极氧化和微弧阳极氧化两种处理方式。产品为非灭菌交付状态，非灭菌状态交付的产品货架有效期为五年。",null,null,"3"]
["湘械注准20162400113",null,"乳酸脱氢酶测定试剂盒（乳酸底物法）",{"$nulls":9},"2021-02-07","2026-02-07","2026-02-06","2031-02-06",{"$nulls":12},"2"]
["湘械注准20162400112",null,"γ-谷氨酰氨基转移酶测定试剂盒（速率法）",{"$nulls":9},"2021-02-08","2026-02-08","2026-02-07","2031-02-07",{"$nulls":12},"2"]
["国械注准20153141369",null,"一次性使用吊瓶式输液器 带针",{"$nulls":9},"2020-06-09","2025-06-24","2025-06-08","2030-06-23",{"$nulls":9},"一次性使用吊瓶式输液器带针产品由：瓶塞穿刺器保护套、瓶塞穿刺器、空气过滤器、开/关夹子、悬挂装置、加药口、注射件、吊瓶、乳胶管、滴管、滴斗、管路、流量调节器、药液过滤器、外圆锥接头、外圆锥接头保护套和一次性使用静脉输液针组成。其中开/关夹子、乳胶管、外圆锥接头保护套、注射件和一次性使用静脉输液针为可选配件。产品经环氧乙烷灭菌，无菌，无热源。一次性使用。",null,"本产品适用于某些大容量药液进行分装输液且对输液剂量精度要求不高的场合。","3"]
["湘械注准20162400068",null,"尿素测定试剂盒（脲酶UV法）",{"$nulls":9},"2021-02-08","2026-02-08","2026-02-07","2031-02-07",{"$nulls":12},"2"]
["湘械注准20162400071",null,"铁蛋白测定试剂盒（胶乳增强免疫比浊法）",{"$nulls":9},"2021-02-08","2026-02-08","2026-02-07","2031-02-07",{"$nulls":12},"2"]
["浙械注准20162400842",null,"1,5-脱水葡糖醇测定试剂盒(酶偶联-两点法)",{"$nulls":9},"2016-10-25","2021-10-22","2021-10-24","2026-10-24",{"$nulls":12},"2"]
["浙械注准20162400843",null,"肌红蛋白测定试剂盒(免疫比浊法)",{"$nulls":9},"2016-10-25","2021-10-22","2021-10-24","2026-10-24",{"$nulls":12},"2"]
["国械注进20153183137",null,"洗精受精液",{"$nulls":9},"2020-07-30","2025-07-30","2025-07-29","2030-07-29",{"$nulls":3},"瑞利芙（北京）医疗器械有限公司",null,"瑞利芙瑞典有限公司Vitrolife Sweden AB",{"$nulls":3},"该产品组成成分包括：氯化钠、氯化钾、磷酸二氢钠、硫酸镁、葡萄糖、果糖、乳酸钠、丙酮酸钠、丙氨酰谷氨酰胺、丙氨酸、天门冬氨酸、天冬酰胺、谷氨酸、脯氨酸、甘氨酸、丝氨酸、牛磺酸、乙二胺四乙酸、庆大霉素、碳酸氢钠、氯化钙、人血清白蛋白、注射用水。产品经膜过滤法除菌。",null,"该产品适用于配子准备和处理以及体外受精培养。","3"]
["国械注进20203180311",null,"胚胎培养液",{"$nulls":9},"2020-06-09","2025-06-09","2025-06-08","2030-06-08",{"$nulls":3},"瑞利芙（北京）医疗器械有限公司",null,"瑞利芙瑞典有限公司Vitrolife Sweden AB",{"$nulls":3},"产品组成成分包括：L-丙氨酸、丙氨酰谷氨酰胺、天冬酰胺、天冬氨酸、氯化钙、泛酸钙、乙二胺四乙酸、庆大霉素、葡萄糖、谷氨酸、甘氨酸、人血清白蛋白、透明质酸、硫酸镁、氯化钾、脯氨酸、盐酸吡哆醛、核黄素、丝氨酸、碳酸氢钠、氯化钠、柠檬酸钠、磷酸二氢钠、氢氧化钠、乳酸钠、丙酮酸钠、牛磺酸、盐酸硫胺素、精氨酸、胱氨酸、组氨酸、异亮氨酸、亮氨酸、赖氨酸、蛋氨酸、苯丙氨酸、苏氨酸、色氨酸、酪氨酸、缬氨酸、注射用水。产品经过滤除菌和无菌灌装工艺生产。货架有效期25周。",null,"适用于辅助生殖技术中胚胎在时差培养系统中从受精卵至囊胚期的培养。","3"]
["苏械注准20202021135",null,"一次性快速交换取石球囊",{"$nulls":9},"2020-10-23","2025-10-23","2025-10-22","2030-10-22",{"$nulls":12},"2"]
["国械注准20163130595",null,"冠状动脉钴铬合金可降解涂层雷帕霉素药物洗脱支架系统",null,null,"中国/北京",null,"万瑞飞鸿（北京）医疗器材有限公司",null,"2024-12-13",null,null,"2020-10-09","2025-10-09","2025-10-08","2030-10-08",null,"国械注准20163130595",null,"万瑞飞鸿（北京）医疗器材有限公司",{"$nulls":5},"该产品为预装在快速交换输送系统上的药物洗脱支架系统。支架系统由支架、球囊导管、可降解高分子聚合物、雷帕霉素组成。其中支架采用L-605钴铬(CoCr)合金制造，包被由免疫抑制剂药物西罗莫司和医用聚乳酸(P-D,L-LA)组成的混合物。载药密度为140μg/cm^2，载药剂量范围为88μg～580μg。球囊导管的结构为导丝快速交换型，有效工作长度为142cm，主要组成材料为Pebax、铂铱合金、尼龙、高密度聚乙烯、聚碳酸酯、不锈钢等，球囊材料为Pebax7233。环氧乙烷灭菌,产品一次性使用，产品货架有效期两年。",null,"适用于由于个别新生的天然冠脉病灶而引发症状性和无症状性的缺血性心脏病的患者，可以用于改善冠脉腔内直径，参照血管直径为2.5-4.0mm，单个病变长度不大于33mm。","3","3"]
["鲁械注准20152400707",null,"血管紧张素转化酶（ACE）测定试剂盒（FAPGG底物法）",{"$nulls":9},"2020-11-16","2025-11-16","2025-11-15","2030-11-15",{"$nulls":12},"2"]
["鲁械注准20152400712",null,"载脂蛋白E（ApoE）测定试剂盒（免疫比浊法）",{"$nulls":9},"2020-11-16","2025-11-16","2025-11-15","2030-11-15",{"$nulls":12},"2"]
["鲁械注准20152400717",null,"铁（Fe）测定试剂盒（亚铁嗪法）",{"$nulls":9},"2020-11-16","2025-11-16","2025-11-15","2030-11-15",{"$nulls":12},"2"]
["湘械注准20162400056",null,"尿微量白蛋白测定试剂盒（免疫比浊法）",{"$nulls":9},"2021-02-02","2026-02-02","2026-02-01","2031-02-01",{"$nulls":12},"2"]
["国械注进20153171366",null,"双凝基牙修复树脂",{"$nulls":9},"2020-04-28","2025-04-28","2025-04-27","2030-04-27",{"$nulls":12},"3"]
["浙甬械备20210290号",null,"HLA-DR检测试剂","人类白细胞抗原DR抗体试剂",{"$nulls":4},"2023-09-28",null,null,"2025-09-05","2023-09-28",null,"2099-12-31",{"$nulls":3},"泛肽生物科技（浙江）有限公司",{"$nulls":5},"主要成分包括磷酸盐缓冲液、蛋白质稳定剂、防腐剂、荧光标记鼠抗人HLA-DR单克隆抗体","由磷酸盐缓冲液、蛋白稳定剂、防腐剂、荧光标记的鼠抗人HLA-DR单克隆抗体组成。","检测人体生物标本中HLA-DR的表达，为医师提供诊断的辅助信息","用于辅助人体样本中人类白细胞抗原DR(HLA-DR)的检测，临床上用于为医师提供诊断的辅助信息，不得用于指导临床用药或伴随诊断。","1"]
["国械注准20153141942",null,"一次性无菌旋塞",{"$nulls":9},"2020-07-31","2025-07-31","2025-07-31","2030-07-30",{"$nulls":12},"3"]
["国械注准20203010861",null,"电切镜手术电极","一次性使用电切镜手术电极",{"$nulls":4},"2020-11-03","2025-06-20",null,null,"2020-11-03","2025-11-03","2025-11-02","2030-11-02",{"$nulls":8},"DS-I型产品由贵金属环、陶瓷管、不锈钢支架、高温导线、定位片、热缩绝缘管、防水塞、固定座、电缆线（含插头）组成。\nDS-II型产品由贵金属环、陶瓷管、不锈钢支架、高温导线、定位片、热缩绝缘管、防水塞、固定座、电缆线（含插头带控制芯片）组成。\nDS-III型、DD-III型产品由贵金属环、绝缘管、加粗绝缘管、不锈钢支架、定位片、尾梢组成。","DS-I型产品由贵金属环、陶瓷管、不锈钢管支架、高温导线、定位片、热缩绝缘管、防水塞、固定座、电缆线组成。DS-Ⅱ型产品由贵金属环、陶瓷管、不锈钢管支架、高温导线、定位片、热缩绝缘管、防水塞、固定座、电缆线组成。DS-Ⅲ型、DD-Ⅲ型产品由贵金属环、陶瓷管(粗环状不适用)、绝缘管、加粗绝缘管、不锈钢管支架、定位片、金属固定座组成。DS-Ⅳ型产品由贵金属环、陶瓷管、不锈钢管支架、热缩管、手柄、电缆线组成。","在医疗机构中与电切镜及相关的高频设备配套使用，用于泌尿外科和妇科手术中对人体组织进行切割、凝血。",null,"3"]
["川械注准20222020023",null,"一次性使用泌尿道导丝",{"$nulls":5},"2022-01-27",{"$nulls":3},"2022-01-27",null,"2027-01-26",{"$nulls":3},"成都维信电子科大新技术有限公司","成都维信电子科技有限公司",{"$nulls":4},"一次性使用泌尿道导丝由导丝、推管和导丝保护组件组成，其中导丝由芯丝、弹簧软头和热缩管组成。芯丝由镍钛合金制成，弹簧软头由304不锈钢制成，热缩管由聚四氟乙烯（PTFE）制成，推管由聚丙烯（PP）制成，导丝保护组件主要由聚乙烯（PE）制成。产品出厂前经环氧乙烷灭菌，无菌。",null,"内窥镜下与J型导管和微创扩张引流套装配套使用，起支撑、引导作用。",null,"2"]
["川械注准20222030170",null,"经皮肾扩张器",{"$nulls":5},"2022-09-20",{"$nulls":3},"2022-09-20",null,"2027-09-19",{"$nulls":3},"成都维信电子科大新技术有限公司","成都维信电子科技有限公司",{"$nulls":4},"经皮肾扩张器由扩张管及扩张鞘组成，其中扩张管由扩张管及扩张管接头组成，扩张鞘由扩张鞘体及扩张鞘接头组成。扩张管体采用聚丙烯（含硫酸钡）材料制成，扩张管接头采用聚丙烯材料制成，扩张鞘体采用聚四氟乙烯（喊氧化铋）材料组成，扩张鞘接头采用ABS材料制成。产品经环氧乙烷灭菌，应无菌。",null,"用于经皮肾盂穿刺时，扩张皮下组织、肌肉、肾实质组织，以建立和保持经皮通路。",null,"2"]
["国械注准20203140909",null,"电动注药泵",{"$nulls":5},"2020-11-25","2025-02-28",null,null,"2020-11-25","2025-11-25","2025-11-24","2030-11-24",null,null,"爱普科学仪器（江苏）有限公司",{"$nulls":5},"本产品由电动注药泵和配用液袋组成，其中注药泵型号、规格：DDB-I-A1、DDB-I-B1；配用液袋型号、规格：DDB-50、DDB-100、DDB-120、DDB-150、DDB-200、DDB-250、DDB-300、DDB-350、DDB-400。电动注药泵由主机组成；配用液袋由药囊、外壳、管夹、输液导管、液袋袋体、圆锥接头、延长管、过滤器组成，其中与药液直接接触的有胶囊、输液导管、液袋袋体、圆锥接头、延长管和过滤器，药囊采用硅橡胶制造，输液导管、液袋袋体、圆锥接头、延长管和过滤器采用软聚氯乙烯塑料（增塑剂为DEHP）制造。","本产品由电动注药泵与配用液袋组成，其中配用液袋由贮液装置和延长管组成。贮液装置由液袋袋体、药囊、内外导管、内圆锥接头、外壳、止流夹、护冒组成；延长管由导管、外圆锥接头、过滤器、正压单向阀（选配）、护冒组成。","该产品用于持续或间断输注镇痛、化疗药物，在医疗机构中由产品培训合格的医护人员使用。",null,"3"]
["粤械注准20152401259",null,"精子核DNA完整性检测试剂盒（精子染色质扩散法）","精子DNA碎片检测试剂盒（精子染色质扩散法）",{"$nulls":8},"2020-06-19","2025-06-19","2025-06-18","2030-06-18",{"$nulls":12},"2"]

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