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["附件："]
["2021年10月批准注册第二类医疗器械产品目录"]
["序号","产品名称","注册人名称","注册证号","注册形式","备注栏内容"]
[1,"一次性使用内窥镜取石篮","深圳市康医博科技发展有限公司","粤械注准20212021464","首次注册"]
[2,"掌式超声显像仪","广东启佑医疗有限公司","粤械注准20212061391","首次注册"]
[3,"一次性使用医用超声耦合剂","经方精密医疗（深圳）有限公司","粤械注准20212061401","首次注册"]
[4,"便携式彩色超声诊断仪","深圳市金慧医疗科技有限公司","粤械注准20212061402","首次注册"]
[5,"彩色多普勒超声系统","深圳迈瑞生物医疗电子股份有限公司","粤械注准20212061435","首次注册"]
[6,"便携式彩色多普勒超声系统","深圳迈瑞生物医疗电子股份有限公司","粤械注准20212061436","首次注册"]
[7,"便携式全数字彩色多普勒超声诊断系统","深圳市威尔德医疗电子有限公司","粤械注准20212061460","首次注册"]
[8,"便携式彩色多普勒超声系统","深圳迈瑞生物医疗电子股份有限公司","粤械注准20212061469","首次注册"]
[9,"彩色多普勒超声系统","深圳迈瑞生物医疗电子股份有限公司","粤械注准20212061474","首次注册"]
[10,"红外体温计","深圳市索达数码科技有限公司","粤械注准20212071388","首次注册"]
[11,"脉搏血氧仪","深圳源动创新科技有限公司","粤械注准20212071395","首次注册"]
[12,"心电血压计","深圳源动创新科技有限公司","粤械注准20212071403","首次注册"]
[13,"肺功能测试仪","深圳来福士雾化医学有限公司","粤械注准20212071406","首次注册"]
[14,"指夹式脉搏血氧仪","广东中科云瑞生物医疗科技有限公司","粤械注准20212071426","首次注册"]
[15,"腕部心电血压记录仪","华为终端有限公司","粤械注准20212071428","首次注册"]
[16,"中央监护系统","广东宝莱特医用科技股份有限公司","粤械注准20212071430","首次注册"]
[17,"电子听诊器","广州爱听贝科技有限公司","粤械注准20212071472","首次注册"]
[18,"一次性使用医用雾化器","广州天惜医疗科技有限公司","粤械注准20212081397","首次注册"]
[19,"一次性无菌气道接头","深圳因赛德思医疗科技有限公司","粤械注准20212081398","首次注册"]
[20,"一次性使用吸痰管","深圳市升昊科技有限公司","粤械注准20212081400","首次注册"]
[21,"压电网式雾化器","深圳市康时医疗器械有限公司","粤械注准20212081404","首次注册"]
[22,"医用呼吸湿化器","广州医软智能科技有限公司","粤械注准20212081416","首次注册"]
[23,"小型分子筛制氧机","深圳市海文生物科技有限公司","粤械注准20212081429","首次注册"]
[24,"一次性使用除颤电极片","深圳市美的连医疗电子股份有限公司","粤械注准20212081446","首次注册"]
[25,"一次性使用医用雾化器","东莞市健宝电子科技有限公司","粤械注准20212081451","首次注册"]
[26,"低频脉冲治疗仪","东莞市汇杰博瑞科技发展有限公司","粤械注准20212091389","首次注册"]
[27,"经颅电刺激仪","深圳市德匠科技有限公司","粤械注准20212091394","首次注册"]
[28,"冲击波治疗仪","深圳市百士康医疗设备有限公司","粤械注准20212091447","首次注册"]
[29,"生物反馈治疗仪","深圳市科瑞康实业有限公司","粤械注准20212091452","首次注册"]
[30,"空气波压力循环治疗系统","广州傅利叶智能科技有限公司","粤械注准20212091455","首次注册"]
[31,"电磁式冲击波治疗仪","深圳市新元素医疗技术开发有限公司","粤械注准20212091458","首次注册"]
[32,"医用一次性防护服","深圳市中明科技股份有限公司","粤械注准20212141393","首次注册"]
[33,"输液泵","深圳市科曼医疗设备有限公司","粤械注准20212141396","首次注册"]
[34,"一次性使用无菌导尿管","深圳市康医博科技发展有限公司","粤械注准20212141399","首次注册"]
[35,"定制式防鼾器","洋紫荆牙科器材（深圳）有限公司","粤械注准20212141405","首次注册"]
[36,"医用防护口罩","东莞市安保医用包装科技有限公司","粤械注准20212141417","首次注册"]
[37,"一次性使用无菌引流导管及附件","深圳市康医博科技发展有限公司","粤械注准20212141445","首次注册"]
[38,"一次性使用硅胶胃管","广东亿康医疗器械有限公司","粤械注准20212141448","首次注册"]
[39,"医用防护口罩","广州源临医疗器械有限公司","粤械注准20212141449","首次注册"]
[40,"医用外科口罩","广州源临医疗器械有限公司","粤械注准20212141450","首次注册"]
[41,"一次性使用无菌引流导管套装","深圳市惠心诺科技有限公司","粤械注准20212141459","首次注册"]
[42,"右股动脉电子压迫止血器","深圳市升昊科技有限公司","粤械注准20212141465","首次注册"]
[43,"医用一次性防护服","广州福泽龙卫生材料有限责任公司","粤械注准20212141470","首次注册"]
[44,"体腔器械导入润滑剂","深圳市先亚生物科技有限公司","粤械注准20212141475","首次注册"]
[45,"体腔器械导入润滑剂","深圳市先亚生物科技有限公司","粤械注准20212141476","首次注册"]
[46,"牙科气动马达手机","佛山市优爱医疗器械有限公司","粤械注准20212171418","首次注册"]
[47,"高速气涡轮手机","佛山市优爱医疗器械有限公司","粤械注准20212171431","首次注册"]
[48,"定制式固定义齿","深圳市威兰丹特牙科器械技术有限公司","粤械注准20212171453","首次注册"]
[49,"定制式活动义齿","深圳市威兰丹特牙科器械技术有限公司","粤械注准20212171454","首次注册"]
[50,"定制式固定义齿","珠海璞承医疗技术有限公司","粤械注准20212171456","首次注册"]
[51,"定制式活动义齿","珠海璞承医疗技术有限公司","粤械注准20212171457","首次注册"]
[52,"超声多普勒胎儿心率仪","广东中科云瑞生物医疗科技有限公司","粤械注准20212181427","首次注册"]
[53,"体外受精超净工作台","深圳致诚隆科技有限公司","粤械注准20212181468","首次注册"]
[54,"手动轮椅车","珠海市博森宇河医疗科技有限公司","粤械注准20212191434","首次注册"]
[55,"医学影像存储与传输系统软件","深圳坐标软件集团有限公司","粤械注准20212211419","首次注册"]
[56,"全自动血细胞分析仪","深圳市理邦精密仪器股份有限公司","粤械注准20212221387","首次注册"]
[57,"荧光免疫分析仪","广东唯实生物技术有限公司","粤械注准20212221390","首次注册"]
[58,"全自动化学发光免疫分析仪","广州天宝颂原生物科技开发有限公司","粤械注准20212221392","首次注册"]
[59,"粪便分析工作站","深圳市瑞图生物技术有限公司","粤械注准20212221466","首次注册"]
[60,"全自动化学发光免疫分析仪","深圳市巨东生物医学工程有限公司","粤械注准20212221467","首次注册"]
[61,"化学发光测定仪","深圳雷杜生命科学股份有限公司","粤械注准20212221471","首次注册"]
[62,"全自动生化分析仪","深圳市帝迈生物技术有限公司","粤械注准20212221473","首次注册"]
[63,"心肌肌钙蛋白I（cTnI）/ N末端脑利钠肽前体（NT—proBNP） /D—二聚体（D—Dimer）测定试剂盒（荧光免疫层析法）","广州市宝创生物技术有限公司","粤械注准20212401407","首次注册"]
[64,"抗缪勒氏管激素（AMH）测定试剂盒（荧光免疫层析法）","广州市宝创生物技术有限公司","粤械注准20212401408","首次注册"]
[65,"脂蛋白相关磷脂酶A2（Lp—PLA2）测定试剂盒（荧光免疫层析法）","广州市宝创生物技术有限公司","粤械注准20212401409","首次注册"]
[66,"D—二聚体（D—Dimer）测定试剂盒（荧光免疫层析法）","广州市宝创生物技术有限公司","粤械注准20212401410","首次注册"]
[67,"抗环瓜氨酸肽抗体测定试剂盒（胶乳免疫比浊法）","广东执诚生物科技有限公司","粤械注准20212401411","首次注册"]
[68,"血清淀粉样蛋白A测定试剂盒（胶乳免疫比浊法）","广东执诚生物科技有限公司","粤械注准20212401412","首次注册"]
[69,"肌酐测定试剂盒（氧化酶法）","广东执诚生物科技有限公司","粤械注准20212401413","首次注册"]
[70,"糖化白蛋白测定试剂盒（酶法）","广东执诚生物科技有限公司","粤械注准20212401414","首次注册"]
[71,"基质金属蛋白酶3（MMP—3）测定试剂盒（化学发光免疫分析法）","广州市康润生物科技有限公司","粤械注准20212401415","首次注册"]
[72,"促卵泡生成素（FSH）测定试剂盒（化学发光免疫分析法）","深圳市爱康试剂有限公司","粤械注准20212401420","首次注册"]
[73,"泌乳素（PRL）测定试剂盒（化学发光免疫分析法）","深圳市爱康试剂有限公司","粤械注准20212401421","首次注册"]
[74,"促黄体生成素（LH）测定试剂盒（化学发光免疫分析法）","深圳市爱康试剂有限公司","粤械注准20212401422","首次注册"]
[75,"睾酮（T）测定试剂盒（化学发光免疫分析法）","深圳市爱康试剂有限公司","粤械注准20212401423","首次注册"]
[76,"铁蛋白测定试剂盒（化学发光免疫分析法）","深圳市爱康试剂有限公司","粤械注准20212401424","首次注册"]
[77,"雌二醇（E2）测定试剂盒（化学发光免疫分析法）","深圳市爱康试剂有限公司","粤械注准20212401425","首次注册"]
[78,"抑制素B（INH—B）检测试剂盒（荧光免疫层析法）","广州市宝创生物技术有限公司","粤械注准20212401437","首次注册"]
[79,"β2—微球蛋白（β2—MG）检测试剂盒（荧光免疫层析法）","广州市宝创生物技术有限公司","粤械注准20212401438","首次注册"]
[80,"中性粒细胞明胶酶相关脂质运载蛋白（NGAL）检测试剂盒（荧光免疫层析法）","广州市宝创生物技术有限公司","粤械注准20212401439","首次注册"]
[81,"胱抑素C（CYS—C）检测试剂盒（荧光免疫层析法）","广州市宝创生物技术有限公司","粤械注准20212401440","首次注册"]
[82,"心肌肌钙蛋白I/心脏型脂肪酸结合蛋白（cTnI/H—FABP）检测试剂盒（荧光免疫层析法）","广州市宝创生物技术有限公司","粤械注准20212401441","首次注册"]
[83,"髓过氧化物酶（MPO）检测试剂盒（荧光免疫层析法）","广州市宝创生物技术有限公司","粤械注准20212401442","首次注册"]
[84,"胃蛋白酶原I/胃蛋白酶原II（PGⅠ/PGⅡ）检测试剂盒（荧光免疫层析法）","广州市宝创生物技术有限公司","粤械注准20212401443","首次注册"]
[85,"尿微量白蛋白（MAU）检测试剂盒（荧光免疫层析法）","广州市宝创生物技术有限公司","粤械注准20212401444","首次注册"]
[86,"铁蛋白测定试剂盒（化学发光免疫分析法）","深圳市新产业生物医学工程股份有限公司","粤械注准20212401461","首次注册"]
[87,"糖化血红蛋白（HbA1c）分析用洗脱液（高效液相色谱法）","深圳普门科技股份有限公司","粤械注准20212401462","首次注册"]
[88,"S100蛋白测定试剂盒（化学发光免疫分析法）","深圳市新产业生物医学工程股份有限公司","粤械注准20212401463","首次注册"]
[89,"心梗三联（TNI—CKMB—MYO）测定试剂盒（微流控免疫荧光法）","深圳微点生物技术股份有限公司","粤械注准20142400124","延续","粤械注准20142400124"]
[90,"N端B型钠尿肽前体（NT—proBNP）测定试剂盒（微流控免疫荧光法）","深圳微点生物技术股份有限公司","粤械注准20142400125","延续","粤械注准20142400125"]
[91,"分枝杆菌快速变色液体培养基","深圳市怡百世生物技术有限公司","粤械注准20152400983","延续","粤械注准20152400983"]
[92,"结核分枝杆菌快速鉴定和药敏检测试剂盒（培养法）","深圳市怡百世生物技术有限公司","粤械注准20152400984","延续","粤械注准20152400984"]
[93,"高频手术电极","深圳华讯角度生物医疗电子科技有限公司","粤械注准20162011564","延续","粤械注准20162251564"]
[94,"一次性使用备皮包","广州中誉医疗器械有限公司","粤械注准20162020970","延续","粤械注准20162640970"]
[95,"腹腔镜手术器械","深圳市神州医疗设备有限公司","粤械注准20162021310","延续","粤械注准20162221310"]
[96,"椎间孔镜手术器械","深圳市神州医疗设备有限公司","粤械注准20162021494","延续","粤械注准20162221494"]
[97,"鼻窦镜手术器械","深圳市神州医疗设备有限公司","粤械注准20162021495","延续","粤械注准20162221495"]
[98,"关节镜手术器械","深圳市神州医疗设备有限公司","粤械注准20162021496","延续","粤械注准20162221496"]
[99,"微循环显微镜检查仪","深圳市道恩医疗科技发展有限公司","粤械注准20162060273","延续","粤械注准20162220273"]
[100,"医用诊断X射线摄影系统","深圳市贝斯达医疗股份有限公司","粤械注准20162061240","延续","粤械注准20162301240"]
[101,"便携式彩色多普勒超声诊断系统","深圳开立生物医疗科技股份有限公司","粤械注准20162061298","延续","粤械注准20162231298"]
[102,"支撑喉镜及手术器械","深圳市神州医疗设备有限公司","粤械注准20162061519","延续","粤械注准20162221519"]
[103,"中频电疗仪","广州一康医疗设备实业有限公司","粤械注准20162091306","延续","粤械注准20162261306"]
[104,"一次性使用无菌护脐包","广州中誉医疗器械有限公司","粤械注准20162140966","延续","粤械注准20162640966"]
[105,"一次性使用护理包","广州中誉医疗器械有限公司","粤械注准20162140968","延续","粤械注准20162640968"]
[106,"电动病床","中山荣南机械工业有限公司","粤械注准20162151082","延续","粤械注准20162561082"]
[107,"一次性使用口腔护理包","广州中誉医疗器械有限公司","粤械注准20162170969","延续","粤械注准20162640969"]
[108,"牙科综合治疗机","广东协禾医业有限公司","粤械注准20162171342","延续","粤械注准20162551342"]
[109,"乳酸脱氢酶测定试剂盒（IFCC推荐法）","深圳蓝韵生物技术有限公司","粤械注准20162401284","延续","粤械注准20162401284"]
[110,"镁测定试剂盒（二甲苯胺蓝法）","深圳蓝韵生物技术有限公司","粤械注准20162401361","延续","粤械注准20162401361"]
[111,"超敏C反应蛋白测定试剂盒（免疫透射比浊法）","深圳蓝韵生物技术有限公司","粤械注准20162401364","延续","粤械注准20162401364"]
[112,"C反应蛋白测定试剂盒（免疫透射比浊法）","深圳蓝韵生物技术有限公司","粤械注准20162401378","延续","粤械注准20162401378"]
[113,"补体C4测定试剂盒（免疫透射比浊法）","深圳蓝韵生物技术有限公司","粤械注准20162401383","延续","粤械注准20162401383"]
[114,"细菌内毒素测定试剂盒（动态浊度法）","珠海迪尔生物工程有限公司","粤械注准20162401389","延续","粤械注准20162401389"]
[115,"总蛋白测定试剂盒（双缩脲法）","广州市伊川生物科技有限公司","粤械注准20162401430","延续","粤械注准20162401430"]
[116,"胱氨酸蛋白酶抑制剂C测定试剂盒（胶乳免疫透射比浊法）","广州市伊川生物科技有限公司","粤械注准20162401504","延续","粤械注准20162401504"]
[117,"尿酸测定试剂盒（尿酸酶法）","广州市伊川生物科技有限公司","粤械注准20162401527","延续","粤械注准20162401527"]
[118,"尿素测定试剂盒（脲酶—谷氨酸脱氢酶法）","广州市伊川生物科技有限公司","粤械注准20162401529","延续","粤械注准20162401529"]
[119,"同型半胱氨酸测定试剂盒（酶循环法）","广州市伊川生物科技有限公司","粤械注准20162401532","延续","粤械注准20162401532"]
[120,"微量白蛋白（mALB）测定试剂盒（胶乳增强免疫比浊法）","深圳市汇松科技发展有限公司","粤械注准20162401588","延续","粤械注准20162401588"]
[121,"总胆红素测定试剂盒（钒酸盐氧化法）","广州市伊川生物科技有限公司","粤械注准20162401615","延续","粤械注准20162401615"]
[122,"气腹针","广州迪克医疗器械有限公司","粤械注准20172020004","延续","粤械注准20172220004"]
[123,"手术中使用的切口保护器（套）","广州迪克医疗器械有限公司","粤械注准20172020028","延续","粤械注准20172660028"]
[124,"一次性使用套管穿刺器","广州迪克医疗器械有限公司","粤械注准20172020029","延续","粤械注准20172080029"]
[125,"超声探头导针架","昊朗科技（佛山）有限公司","粤械注准20172060166","延续","粤械注准20172230166"]
[126,"舌下微循环成像系统","广州医软智能科技有限公司","粤械注准20172060167","延续","粤械注准20172220167"]
[127,"医用胶片扫描仪","深圳市安健科技股份有限公司","粤械注准20172060348","延续","粤械注准20172310348"]
[128,"超声彩色多普勒诊断仪","深圳开立生物医疗科技股份有限公司","粤械注准20172060349","延续","粤械注准20172230349"]
[129,"电子体温计","广州爱芯达电子有限公司","粤械注准20172070435","延续","粤械注准20172200435"]
[130,"一次性心电电极","中山市西格勒医疗用品有限公司","粤械注准20172070485","延续","粤械注准20172210485"]
[131,"动态血压监测仪","深圳市博声医疗器械有限公司","粤械注准20172070555","延续","粤械注准20172210555"]
[132,"粘附性血氧探头","深圳市安普康科技有限公司","粤械注准20172071084","延续","粤械注准20172211084"]
[133,"重复性血氧探头","深圳市安普康科技有限公司","粤械注准20172071104","延续","粤械注准20172211104"]
[134,"人体成分分析仪","东莞市森普实业有限公司","粤械注准20172071119","延续","粤械注准20172211119"]
[135,"制氧机","广东欧格斯科技有限公司","粤械注准20172080401","延续","粤械注准20172540401"]
[136,"一次性使用气管插管","广东龙心医疗器械有限公司","粤械注准20172080425","延续","粤械注准20172660425"]
[137,"吞咽神经肌肉低频电刺激仪","广州龙之杰科技有限公司","粤械注准20172091226","延续","粤械注准20172261226"]
[138,"一次性使用灭菌橡胶外科手套","广东汇通乳胶制品集团有限公司","粤械注准20172140158","延续","粤械注准20172660158"]
[139,"防水透气护创敷料","怡越医疗（广东）有限公司","粤械注准20172140458","延续","粤械注准20172640458"]
[140,"体腔器械导入润滑液","怡越医疗（广东）有限公司","粤械注准20172140461","延续","粤械注准20172660461"]
[141,"电动洗鼻器","怡越医疗（广东）有限公司","粤械注准20172140796","延续","粤械注准20172540796"]
[142,"定制式活动义齿","广州市鸿柏基医疗器械有限公司","粤械注准20172170161","延续","粤械注准20172630161"]
[143,"定制式固定义齿","广州市鸿柏基医疗器械有限公司","粤械注准20172170162","延续","粤械注准20172630162"]
[144,"高速牙科手机","佛山市稳健医疗器械有限公司","粤械注准20172170229","延续","粤械注准20172550229"]
[145,"低速牙钻手机","佛山市稳健医疗器械有限公司","粤械注准20172170230","延续","粤械注准20172550230"]
[146,"高速涡轮牙科手机","广东协禾医业有限公司","粤械注准20172170354","延续","粤械注准20172550354"]
[147,"口腔溃疡含漱液","怡越医疗（广东）有限公司","粤械注准20172170459","延续","粤械注准20172630459"]
[148,"定制式活动义齿","广州如齿美医疗器械有限公司","粤械注准20172170645","延续","粤械注准20172630645"]
[149,"定制式固定义齿","广州如齿美医疗器械有限公司","粤械注准20172170646","延续","粤械注准20172630646"]
[150,"低速牙科手机","东莞市迅捷精密医疗器械有限公司","粤械注准20172170683","延续","粤械注准20172550683"]
[151,"超声多普勒胎儿心率仪","深圳邦健生物医疗设备股份有限公司","粤械注准20172180278","延续","粤械注准20172230278"]
[152,"活性炭阴道填塞","怡越医疗（广东）有限公司","粤械注准20172180460","延续","粤械注准20172640460"]
[153,"耳鸣声治疗器","佛山博智医疗科技有限公司","粤械注准20172190353","延续","粤械注准20172460353"]
[154,"D—二聚体（D—Dimer）测定试剂盒（胶乳增强免疫比浊法）","深圳市汇松科技发展有限公司","粤械注准20172400010","延续","粤械注准20172400010"]
[155,"肌钙蛋白I（TnI）测定试剂盒（微流控免疫荧光法）","深圳微点生物技术股份有限公司","粤械注准20172400044","延续","粤械注准20172400044"]
[156,"凝血酶原时间/活化部分凝血活酶时间二联检测卡（动态电流法）","深圳微点生物技术股份有限公司","粤械注准20172400045","延续","粤械注准20172400045"]
[157,"降钙素原（PCT）测定试剂盒（微流控免疫荧光法）","深圳微点生物技术股份有限公司","粤械注准20172400046","延续","粤械注准20172400046"]
[158,"腺苷脱氨酶（ADA）测定试剂盒（速率法）","广州科方生物技术股份有限公司","粤械注准20172400243","延续","粤械注准20172400243"]
[159,"载脂蛋白A1（ApoA1） 测定试剂盒（免疫透射比浊法）","广州科方生物技术股份有限公司","粤械注准20172400244","延续","粤械注准20172400244"]
[160,"载脂蛋白B（ApoB）测定试剂盒（免疫比浊法）","广州科方生物技术股份有限公司","粤械注准20172400245","延续","粤械注准20172400245"]
[161,"总胆固醇（TCHO）测定试剂盒（酶法）","广州科方生物技术股份有限公司","粤械注准20172400246","延续","粤械注准20172400246"]
[162,"总胆汁酸（TBA）测定试剂盒（循环酶法）","广州科方生物技术股份有限公司","粤械注准20172400247","延续","粤械注准20172400247"]
[163,"肌酐（Cr）测定试剂盒（肌氨酸氧化酶法）","广州科方生物技术股份有限公司","粤械注准20172400248","延续","粤械注准20172400248"]
[164,"高密度脂蛋白胆固醇（HDL—C）测定试剂盒（直接法）","广州科方生物技术股份有限公司","粤械注准20172400249","延续","粤械注准20172400249"]
[165,"甘油三酯（TG）测定试剂盒（酶法）","广州科方生物技术股份有限公司","粤械注准20172400250","延续","粤械注准20172400250"]
[166,"二氧化碳（CO2）测定试剂盒（PEPC酶法）","广州科方生物技术股份有限公司","粤械注准20172400251","延续","粤械注准20172400251"]
[167,"低密度脂蛋白胆固醇（LDL—C）测定试剂盒（直接法）","广州科方生物技术股份有限公司","粤械注准20172400252","延续","粤械注准20172400252"]
[168,"肌酸激酶测定试剂盒（磷酸肌酸底物法）","深圳市凯特生物医疗电子科技有限公司","粤械注准20172400362","延续","粤械注准20172400362"]
[169,"腺苷脱氨酶测定试剂盒（过氧化物酶法）","深圳市凯特生物医疗电子科技有限公司","粤械注准20172400363","延续","粤械注准20172400363"]
[170,"直接胆红素测定试剂盒（钒酸盐氧化法）","深圳市凯特生物医疗电子科技有限公司","粤械注准20172400370","延续","粤械注准20172400370"]
[171,"总胆汁酸测定试剂盒（酶循环法）","深圳市凯特生物医疗电子科技有限公司","粤械注准20172400371","延续","粤械注准20172400371"]
[172,"铁测定试剂盒（亚铁嗪法）","深圳市凯特生物医疗电子科技有限公司","粤械注准20172400372","延续","粤械注准20172400372"]
[173,"载脂蛋白A1测定试剂盒（免疫比浊法）","深圳市凯特生物医疗电子科技有限公司","粤械注准20172400376","延续","粤械注准20172400376"]
[174,"载脂蛋白B测定试剂盒（免疫比浊法）","深圳市凯特生物医疗电子科技有限公司","粤械注准20172400377","延续","粤械注准20172400377"]
[175,"磷测定试剂盒（磷钼酸盐法）","深圳市凯特生物医疗电子科技有限公司","粤械注准20172400382","延续","粤械注准20172400382"]
[176,"乳酸脱氢酶测定试剂盒（乳酸底物法）","深圳市凯特生物医疗电子科技有限公司","粤械注准20172400389","延续","粤械注准20172400389"]
[177,"免疫球蛋白M测定试剂盒（免疫比浊法）","深圳市凯特生物医疗电子科技有限公司","粤械注准20172400390","延续","粤械注准20172400390"]
[178,"胆碱酯酶测定试剂盒（丁酰硫代胆碱底物法）","深圳市凯特生物医疗电子科技有限公司","粤械注准20172400392","延续","粤械注准20172400392"]
[179,"肌酸激酶同工酶测定试剂盒（免疫抑制法）","深圳市凯特生物医疗电子科技有限公司","粤械注准20172400394","延续","粤械注准20172400394"]
[180,"心血管病测定特定蛋白比浊试剂盒","深圳市国赛生物技术有限公司","粤械注准20172400419","延续","粤械注准20172400419"]
[181,"肌酐（CREA）测定试剂盒（肌氨酸氧化酶法）","深圳迈瑞生物医疗电子股份有限公司","粤械注准20172400960","延续","粤械注准20172400960"]
[182,"免疫球蛋白A（IgA）测定试剂盒（免疫透射比浊法）","深圳迈瑞生物医疗电子股份有限公司","粤械注准20172400962","延续","粤械注准20172400962"]
[183,"免疫球蛋白M（IgM）测定试剂盒（免疫透射比浊法）","深圳迈瑞生物医疗电子股份有限公司","粤械注准20172400963","延续","粤械注准20172400963"]
[184,"碱性磷酸酶（ALP）测定试剂盒（AMP缓冲液法）","深圳迈瑞生物医疗电子股份有限公司","粤械注准20172400965","延续","粤械注准20172400965"]
[185,"免疫球蛋白G（IgG）测定试剂盒（免疫透射比浊法）","深圳迈瑞生物医疗电子股份有限公司","粤械注准20172400966","延续","粤械注准20172400966"]
[186,"尿素（UREA）测定试剂盒（紫外—谷氨酸脱氢酶法）","深圳迈瑞生物医疗电子股份有限公司","粤械注准20172400967","延续","粤械注准20172400967"]
[187,"葡萄糖（Glu）测定试剂盒（己糖激酶法）","深圳迈瑞生物医疗电子股份有限公司","粤械注准20172400968","延续","粤械注准20172400968"]
[188,"天门冬氨酸氨基转移酶（AST）测定试剂盒（IFCC法）","深圳迈瑞生物医疗电子股份有限公司","粤械注准20172400971","延续","粤械注准20172400971"]
[189,"总胆固醇（TC）测定试剂盒（氧化酶法）","深圳迈瑞生物医疗电子股份有限公司","粤械注准20172400972","延续","粤械注准20172400972"]
[190,"总胆红素（T—Bil）测定试剂盒（钒酸盐氧化法）","深圳迈瑞生物医疗电子股份有限公司","粤械注准20172400973","延续","粤械注准20172400973"]
[191,"直接胆红素（D—Bil）测定试剂盒（钒酸盐氧化法）","深圳迈瑞生物医疗电子股份有限公司","粤械注准20172400974","延续","粤械注准20172400974"]
[192,"脂蛋白（a）[Lp（a）]测定试剂盒（免疫透射比浊法）","深圳迈瑞生物医疗电子股份有限公司","粤械注准20172400978","延续","粤械注准20172400978"]
[193,"总胆汁酸（TBA）测定试剂盒（循环酶法）","深圳迈瑞生物医疗电子股份有限公司","粤械注准20172400979","延续","粤械注准20172400979"]
[194,"总蛋白（TP）测定试剂盒（双缩脲法）","深圳迈瑞生物医疗电子股份有限公司","粤械注准20172400980","延续","粤械注准20172400980"]
[195,"肌酸激酶（CK）测定试剂盒（IFCC法）","深圳迈瑞生物医疗电子股份有限公司","粤械注准20172400981","延续","粤械注准20172400981"]
[196,"补体因子C4（C4）测定试剂盒（免疫透射比浊法）","深圳迈瑞生物医疗电子股份有限公司","粤械注准20172400982","延续","粤械注准20172400982"]
[197,"丙氨酸氨基转移酶（ALT）测定试剂盒（IFCC法）","深圳迈瑞生物医疗电子股份有限公司","粤械注准20172400983","延续","粤械注准20172400983"]
[198,"补体因子C3（C3）测定试剂盒（免疫透射比浊法）","深圳迈瑞生物医疗电子股份有限公司","粤械注准20172400984","延续","粤械注准20172400984"]
[199,"甘油三酯（TG）测定试剂盒（氧化酶法）","深圳迈瑞生物医疗电子股份有限公司","粤械注准20172400985","延续","粤械注准20172400985"]
[200,"γ—谷氨酰转移酶（γ—GT）测定试剂盒（IFCC法）","深圳迈瑞生物医疗电子股份有限公司","粤械注准20172400988","延续","粤械注准20172400988"]
[201,"白蛋白（ALB）测定试剂盒（溴甲酚绿法）","深圳迈瑞生物医疗电子股份有限公司","粤械注准20172400989","延续","粤械注准20172400989"]
[202,"心肌肌钙蛋白I/N末端B型钠尿肽原联检试剂（荧光免疫层析法）","广州万孚生物技术股份有限公司","粤械注准20172401237","延续","粤械注准20172401237"]
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