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["附件："]
["2021年9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,"一次性使用输尿管导引鞘","深圳市益心达医学新技术有限公司","粤械注准20212021376","首次注册"]
[2,"一次性脑科手术用球囊导管套件","翌铭科技（广州）有限公司","粤械注准20212031326","首次注册"]
[3,"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20212061305","首次注册"]
[4,"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20212061306","首次注册"]
[5,"医用内窥镜冷光源","广东欧谱曼迪科技有限公司","粤械注准20212061310","首次注册"]
[6,"数字化X射线摄影系统","深圳柏斯生物科技有限公司","粤械注准20212061321","首次注册"]
[7,"数字化X射线摄影系统","深圳柏斯生物科技有限公司","粤械注准20212061328","首次注册"]
[8,"数字化X射线摄影系统","深圳柏斯生物科技有限公司","粤械注准20212061344","首次注册"]
[9,"超声引导系统","深圳市威尔德医疗电子有限公司","粤械注准20212061349","首次注册"]
[10,"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20212061358","首次注册"]
[11,"口腔内数字化X射线成像系统","深圳帧观德芯科技有限公司","粤械注准20212061373","首次注册"]
[12,"数字化X射线摄影系统","深圳市睿迪医疗器械有限公司","粤械注准20212061375","首次注册"]
[13,"车载X射线机","深圳市睿迪医疗器械有限公司","粤械注准20212061377","首次注册"]
[14,"手臂式电子血压计","深圳市攀高电子有限公司","粤械注准20212071289","首次注册"]
[15,"生命体征监测仪","深圳迈瑞生物医疗电子股份有限公司","粤械注准20212071291","首次注册"]
[16,"新生儿小儿生命体征监测仪","深圳迈瑞生物医疗电子股份有限公司","粤械注准20212071292","首次注册"]
[17,"血氧传感器","深圳源动创新科技有限公司","粤械注准20212071294","首次注册"]
[18,"红外线体温计","东莞市好康电子科技有限公司","粤械注准20212071295","首次注册"]
[19,"红外额温计","广东伟创医疗器械有限公司","粤械注准20212071296","首次注册"]
[20,"微型呼吸末二氧化碳监测仪","深圳市美的连医疗电子股份有限公司","粤械注准20212071314","首次注册"]
[21,"上臂式电子血压计","深圳市启蒙智慧医疗科技有限公司","粤械注准20212071315","首次注册"]
[22,"红外体温计","广东华睿远洋医疗科技有限公司","粤械注准20212071325","首次注册"]
[23,"无线电子体温计","深圳市奥化美宇健康医疗技术有限公司","粤械注准20212071329","首次注册"]
[24,"肺功能测试仪","广州市麦力声医疗器械有限公司","粤械注准20212071335","首次注册"]
[25,"一次性脉搏血氧饱和度传感器","深圳市科博瑞电子有限公司","粤械注准20212071348","首次注册"]
[26,"一次性使用阻抗传感器","深圳市美的连医疗电子股份有限公司","粤械注准20212071355","首次注册"]
[27,"医用红外体温计","深圳市巨燊宝实业有限公司","粤械注准20212071356","首次注册"]
[28,"上臂式电子血压计","深圳星脉医疗仪器有限公司","粤械注准20212071371","首次注册"]
[29,"一氧化氮检测仪","深圳市美好创亿医疗科技股份有限公司","粤械注准20212071382","首次注册"]
[30,"压电网式雾化器","深圳市麦瑞康科技有限公司","粤械注准20212081293","首次注册"]
[31,"医用分子筛制氧机","珠海凌特医学仪器有限公司","粤械注准20212081322","首次注册"]
[32,"呼吸湿化治疗仪管路套件","斯莱达医疗用品（惠州）有限公司","粤械注准20212081334","首次注册"]
[33,"一次性使用无菌气管插管","广东亿康医疗器械有限公司","粤械注准20212081380","首次注册"]
[34,"空气波压力治疗仪","珠海康易鑫医疗设备有限公司","粤械注准20212091285","首次注册"]
[35,"便携式中频治疗仪","广州宝络康医疗科技有限公司","粤械注准20212091287","首次注册"]
[36,"痉挛肌低频治疗仪","东莞市汇杰博瑞科技发展有限公司","粤械注准20212091297","首次注册"]
[37,"经皮神经电刺激仪","东莞市汇杰博瑞科技发展有限公司","粤械注准20212091298","首次注册"]
[38,"盆底肌肉治疗头","广州辉博信息技术有限公司","粤械注准20212091299","首次注册"]
[39,"磁热综合治疗仪","广州宝络康医疗科技有限公司","粤械注准20212091309","首次注册"]
[40,"碳素光治疗仪","深圳市三恩诺中碳光灸医疗科技有限公司","粤械注准20212091312","首次注册"]
[41,"医用臭氧水治疗仪","深圳市橘井舒泉技术有限公司","粤械注准20212091354","首次注册"]
[42,"体外冲击波治疗仪","深圳普门科技股份有限公司","粤械注准20212091370","首次注册"]
[43,"脉冲磁治疗系统","柏斯速眠科技（深圳）有限公司","粤械注准20212091386","首次注册"]
[44,"内镜清洗工作站","广州市三妙医药科技有限公司","粤械注准20212111368","首次注册"]
[45,"医用外科口罩","珠海浩翰医疗器械有限公司","粤械注准20212141303","首次注册"]
[46,"一次性使用输尿管支架套件","深圳市益心达医学新技术有限公司","粤械注准20212141313","首次注册"]
[47,"一次性使用经鼻胃肠营养导管","深圳麦科田生命科学有限公司","粤械注准20212141317","首次注册"]
[48,"医用防护口罩","广东康居医药科技有限公司","粤械注准20212141336","首次注册"]
[49,"医用一次性防护服","广东凯迪服饰有限公司","粤械注准20212141337","首次注册"]
[50,"医用一次性防护服","广东金发科技有限公司","粤械注准20212141339","首次注册"]
[51,"肠内营养泵","佛山市汉康医疗设备有限公司","粤械注准20212141347","首次注册"]
[52,"注射泵","深圳市科曼医疗设备有限公司","粤械注准20212141350","首次注册"]
[53,"一次性使用无菌输尿管支架套件","深圳麦普奇医疗科技有限公司","粤械注准20212141369","首次注册"]
[54,"电动止血器","深圳市升昊科技有限公司","粤械注准20212141374","首次注册"]
[55,"一次性使用乳胶导尿管","广东亿康医疗器械有限公司","粤械注准20212141381","首次注册"]
[56,"一次性使用医用口罩","深圳市宏富盛科技有限公司","粤械注准20212141385","首次注册"]
[57,"免散瞳眼底照相机","东京光学（东莞）科技有限公司","粤械注准20212161316","首次注册"]
[58,"牙科低压电动马达","佛山市驰康医疗器材有限公司","粤械注准20212171300","首次注册"]
[59,"牙科综合治疗机","佛山市唯开医疗科技有限公司","粤械注准20212171302","首次注册"]
[60,"定制式附着义齿","深圳市康泰健牙科器材有限公司","粤械注准20212171304","首次注册"]
[61,"高速气涡轮手机","广东精美医疗科技有限公司","粤械注准20212171324","首次注册"]
[62,"定制式活动义齿","惠州市佳铭医疗器械有限公司","粤械注准20212171340","首次注册"]
[63,"定制式固定义齿","惠州市德高义齿有限公司","粤械注准20212171341","首次注册"]
[64,"定制式固定义齿","惠州市佳铭医疗器械有限公司","粤械注准20212171342","首次注册"]
[65,"定制式活动义齿","惠州市德高义齿有限公司","粤械注准20212171343","首次注册"]
[66,"定制式矫治器","深圳市国友义齿有限公司","粤械注准20212171345","首次注册"]
[67,"牙科低压电动马达","广东精美医疗科技有限公司","粤械注准20212171351","首次注册"]
[68,"踝关节智能康复装置","广东铭凯医疗机器人有限公司","粤械注准20212191352","首次注册"]
[69,"下肢振动训练系统","橙象医疗科技（广州）有限公司","粤械注准20212191353","首次注册"]
[70,"耳内式数字助听器","惠州市锦好医疗科技股份有限公司","粤械注准20212191357","首次注册"]
[71,"中央监护软件","深圳市柯林健康医疗有限公司","粤械注准20212211286","首次注册"]
[72,"病理影像传输与通讯软件","广州秉理科技有限公司","粤械注准20212211301","首次注册"]
[73,"医学图像处理软件","深圳市一图智能科技有限公司","粤械注准20212211346","首次注册"]
[74,"超声影像管理软件","广州爱孕记信息科技有限公司","粤械注准20212211372","首次注册"]
[75,"冠状动脉CT影像处理软件","深圳睿心智能医疗科技有限公司","粤械注准20212211378","首次注册"]
[76,"微量元素分析仪","广州齐力生物技术有限公司","粤械注准20212221290","首次注册"]
[77,"全自动凝血分析仪","深圳优迪生物技术有限公司","粤械注准20212221311","首次注册"]
[78,"细胞医学图像分析仪","深圳深析智能有限公司","粤械注准20212221320","首次注册"]
[79,"糖化血红蛋白分析仪","深圳市国赛生物技术有限公司","粤械注准20212221323","首次注册"]
[80,"一次性使用无菌采样拭子","广州云睿医疗科技有限公司","粤械注准20212221338","首次注册"]
[81,"全自动化学发光测定仪","深圳市爱康生物科技有限公司","粤械注准20212221367","首次注册"]
[82,"促卵泡生成素测定试剂盒（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20212401288","首次注册"]
[83,"B型钠尿肽（BNP）质控品","广州万孚生物技术股份有限公司","粤械注准20212401307","首次注册"]
[84,"肌钙蛋白T（TnT）质控品","广州万孚生物技术股份有限公司","粤械注准20212401308","首次注册"]
[85,"肌钙蛋白I（TnI）质控液","深圳微点生物技术股份有限公司","粤械注准20212401318","首次注册"]
[86,"D—二聚体（D—Dimer）测定试剂盒（化学发光免疫分析法）","深圳沃德生命科技有限公司","粤械注准20212401319","首次注册"]
[87,"肌酐（Cr）质控品","深圳市国赛生物技术有限公司","粤械注准20212401330","首次注册"]
[88,"凝血综合质控品","深圳市国赛生物技术有限公司","粤械注准20212401331","首次注册"]
[89,"总β—人绒毛膜促性腺激素（Tβ—HCG）质控品","深圳市国赛生物技术有限公司","粤械注准20212401332","首次注册"]
[90,"孕酮（PROG）质控品","深圳市国赛生物技术有限公司","粤械注准20212401333","首次注册"]
[91,"总三碘甲状腺原氨酸测定试剂盒（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20212401359","首次注册"]
[92,"C肽测定试剂盒（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20212401360","首次注册"]
[93,"游离三碘甲状腺原氨酸测定试剂盒（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20212401361","首次注册"]
[94,"抗甲状腺微粒体抗体测定试剂盒（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20212401362","首次注册"]
[95,"总甲状腺素测定试剂盒（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20212401363","首次注册"]
[96,"促甲状腺素测定试剂盒（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20212401364","首次注册"]
[97,"睾酮测定试剂盒（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20212401365","首次注册"]
[98,"胰岛素测定试剂盒（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20212401366","首次注册"]
[99,"D—二聚体（D—dimer）测定试剂盒（荧光免疫层析法）","中山市创艺生化工程有限公司","粤械注准20212401379","首次注册"]
[100,"电针治疗仪","深圳市东迪欣科技有限公司","粤械注准20152201184","延续注册","粤械注准20152261184"]
[101,"乳腺触诊诊断仪","深圳世强生物医疗电子有限公司","粤械注准20162061244","延续注册","粤械注准20162211244"]
[102,"医用内窥镜冷光源","深圳开立生物医疗科技股份有限公司","粤械注准20162061252","延续注册","粤械注准20162221252"]
[103,"多参数监护仪","深圳市威浩康医疗器械有限公司","粤械注准20162070760","延续注册","粤械注准20162210760"]
[104,"医用红外体温计","深圳市家康科技有限公司","粤械注准20162071185","延续注册","粤械注准20162201185"]
[105,"脉搏血氧仪","广东宝莱特医用科技股份有限公司","粤械注准20162071260","延续注册","粤械注准20162211260"]
[106,"呼气氢测试仪","深圳市中核海得威生物科技有限公司","粤械注准20162071453","延续注册","粤械注准20162401453"]
[107,"医用中心供氧系统","深圳市尚荣医疗股份有限公司","粤械注准20162080363","延续注册","粤械注准20162560363"]
[108,"体外红光照射治疗仪","国医华科（深圳）医疗科技发展有限公司","粤械注准20162091547","延续注册","粤械注准20162261547"]
[109,"鼻腔喷雾器","珠海市尼诺生物科技有限公司","粤械注准20162141271","延续注册","粤械注准20162641271"]
[110,"桡动脉压迫止血带","深圳市升昊科技有限公司","粤械注准20162141312","延续注册","粤械注准20162541312"]
[111,"桡动脉压迫止血带","深圳市升昊科技有限公司","粤械注准20162141321","延续注册","粤械注准20162541321"]
[112,"一次性使用治疗巾","稳健医疗用品股份有限公司","粤械注准20162141488","延续注册","粤械注准20162641488"]
[113,"定制式固定义齿","普宁市威兰德义齿有限公司","粤械注准20162170891","延续注册","粤械注准20162630891"]
[114,"定制式固定义齿","普宁市威兰德义齿有限公司","粤械注准20162170892","延续注册","粤械注准20162630892"]
[115,"定制式活动义齿","普宁市威兰德义齿有限公司","粤械注准20162170893","延续注册","粤械注准20162630893"]
[116,"定制式活动义齿","深圳市普罗丹特牙科技术有限公司","粤械注准20162171106","延续注册","粤械注准20162631106"]
[117,"光固化机","佛山市南海区靓雅齿科器材有限公司","粤械注准20162171393","延续注册","粤械注准20162551393"]
[118,"远程会诊系统","深圳绰曦互动科技有限公司","粤械注准20162211251","延续注册","粤械注准20162701251"]
[119,"一次性使用真空采血管","深圳市柏明胜医疗器械有限公司","粤械注准20162221391","延续注册","粤械注准20162411391"]
[120,"全自动血培养仪","珠海美华医疗科技有限公司","粤械注准20162221455","延续注册","粤械注准20162401455"]
[121,"呼气试验测试仪","深圳市中核海得威生物科技有限公司","粤械注准20162221557","延续注册","粤械注准20162401557"]
[122,"碱性磷酸酶测定试剂盒（IFCC推荐法）","深圳蓝韵生物技术有限公司","粤械注准20162401281","延续注册","粤械注准20162401281"]
[123,"葡萄糖测定试剂盒（葡萄糖氧化酶法）","深圳蓝韵生物技术有限公司","粤械注准20162401282","延续注册","粤械注准20162401282"]
[124,"肌酸激酶MB型同工酶测定试剂盒（连续监测法）","深圳蓝韵生物技术有限公司","粤械注准20162401285","延续注册","粤械注准20162401285"]
[125,"糖化血红蛋白测定试剂盒（免疫透射比浊法）","深圳蓝韵生物技术有限公司","粤械注准20162401286","延续注册","粤械注准20162401286"]
[126,"γ—谷氨酰转移酶测定试剂盒（连续监测法）","深圳蓝韵生物技术有限公司","粤械注准20162401287","延续注册","粤械注准20162401287"]
[127,"天门冬氨酸氨基转移酶测定试剂盒（IFCC推荐法）","深圳蓝韵生物技术有限公司","粤械注准20162401288","延续注册","粤械注准20162401288"]
[128,"丙氨酸氨基转移酶测定试剂盒（IFCC推荐法）","深圳蓝韵生物技术有限公司","粤械注准20162401290","延续注册","粤械注准20162401290"]
[129,"α—淀粉酶测定试剂盒（EPS—G7法）","深圳蓝韵生物技术有限公司","粤械注准20162401291","延续注册","粤械注准20162401291"]
[130,"肌酸激酶测定试剂盒（连续监测法）","深圳蓝韵生物技术有限公司","粤械注准20162401292","延续注册","粤械注准20162401292"]
[131,"尿酸测定试剂盒（尿酸酶—过氧化物酶法）","深圳蓝韵生物技术有限公司","粤械注准20162401351","延续注册","粤械注准20162401351"]
[132,"甘油三酯测定试剂盒（氧化酶法）","深圳蓝韵生物技术有限公司","粤械注准20162401355","延续注册","粤械注准20162401355"]
[133,"白蛋白测定试剂盒（溴甲酚绿法）","深圳蓝韵生物技术有限公司","粤械注准20162401357","延续注册","粤械注准20162401357"]
[134,"总蛋白测定试剂盒（双缩脲法）","深圳蓝韵生物技术有限公司","粤械注准20162401359","延续注册","粤械注准20162401359"]
[135,"尿素测定试剂盒（脲酶—谷氨酸脱氢酶法）","深圳蓝韵生物技术有限公司","粤械注准20162401360","延续注册","粤械注准20162401360"]
[136,"总胆红素测定试剂盒（钒酸盐氧化法）","深圳蓝韵生物技术有限公司","粤械注准20162401363","延续注册","粤械注准20162401363"]
[137,"无机磷测定试剂盒（磷钼酸法）","深圳蓝韵生物技术有限公司","粤械注准20162401366","延续注册","粤械注准20162401366"]
[138,"低密度脂蛋白胆固醇测定试剂盒（直接法）","深圳蓝韵生物技术有限公司","粤械注准20162401373","延续注册","粤械注准20162401373"]
[139,"高密度脂蛋白胆固醇测定试剂盒（直接法）","深圳蓝韵生物技术有限公司","粤械注准20162401375","延续注册","粤械注准20162401375"]
[140,"二氧化碳测定试剂盒（酶法）","深圳蓝韵生物技术有限公司","粤械注准20162401377","延续注册","粤械注准20162401377"]
[141,"血清铁测定试剂盒（比色法）","深圳蓝韵生物技术有限公司","粤械注准20162401382","延续注册","粤械注准20162401382"]
[142,"肌酐测定试剂盒（酶法）","深圳蓝韵生物技术有限公司","粤械注准20162401385","延续注册","粤械注准20162401385"]
[143,"移动式数字X射线摄影系统","深圳市宝润科技有限公司","粤械注准20172060065","延续注册","粤械注准20172300065"]
[144,"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20172060237","延续注册","粤械注准20172230237"]
[145,"全数字彩色多普勒超声诊断系统","广州索诺星信息科技有限公司","粤械注准20172060326","延续注册","粤械注准20172230326"]
[146,"全数字超声诊断系统","深圳市威尔德医疗电子有限公司","粤械注准20172060426","延续注册","粤械注准20172230426"]
[147,"自动动态血压监测仪","鸿邦电子（深圳）有限公司","粤械注准20172070153","延续注册","粤械注准20172200153"]
[148,"多参数监测仪","深圳市保身欣科技电子有限公司","粤械注准20172070218","延续注册","粤械注准20172210218"]
[149,"红外线体温计","深圳市康贝科技有限公司","粤械注准20172070546","延续注册","粤械注准20172200546"]
[150,"人体脂肪测量仪","东莞市森普实业有限公司","粤械注准20172071120","延续注册","粤械注准20172211120"]
[151,"便携式超声雾化器","深圳来福士雾化医学有限公司","粤械注准20172080713","延续注册","粤械注准20172230713"]
[152,"便携式超声雾化器","深圳来福士雾化医学有限公司","粤械注准20172080714","延续注册","粤械注准20172230714"]
[153,"便携式超声雾化器","深圳来福士雾化医学有限公司","粤械注准20172080854","延续注册","粤械注准20172230854"]
[154,"网式雾化器","深圳来福士雾化医学有限公司","粤械注准20172080855","延续注册","粤械注准20172230855"]
[155,"低频电子脉冲治疗仪","深圳德佳智联科技有限公司","粤械注准20172090530","延续注册","粤械注准20172260530"]
[156,"一次性使用防逆流负压引流瓶","广东先来医疗器械有限公司","粤械注准20172140075","延续注册","粤械注准20172660075"]
[157,"一次性使用无菌敷贴","佛山市平创医疗科技有限公司","粤械注准20172140131","延续注册","粤械注准20172640131"]
[158,"电脑验光仪","东京光学（东莞）科技有限公司","粤械注准20172161245","延续注册","粤械注准20172221245"]
[159,"定制式活动义齿","深圳市仿生美学科技有限公司","粤械注准20172170092","延续注册","粤械注准20172630092"]
[160,"定制式固定义齿","深圳市仿生美学科技有限公司","粤械注准20172170093","延续注册","粤械注准20172630093"]
[161,"定制式附着义齿","深圳市仿生美学科技有限公司","粤械注准20172170146","延续注册","粤械注准20172630146"]
[162,"定制式正畸矫治器","广州市普泰德医疗器械有限公司","粤械注准20172170171","延续注册","粤械注准20172630171"]
[163,"定制式附着义齿","广州市普泰德医疗器械有限公司","粤械注准20172170172","延续注册","粤械注准20172630172"]
[164,"定制式矫治器","深圳市仿生美学科技有限公司","粤械注准20172170219","延续注册","粤械注准20172630219"]
[165,"定制式固定义齿","东莞市新诺达义齿制作有限公司","粤械注准20172170256","延续注册","粤械注准20172630256"]
[166,"定制式活动义齿","东莞市新诺达义齿制作有限公司","粤械注准20172170259","延续注册","粤械注准20172630259"]
[167,"喷沙洁牙机","佛山市山月医疗器械有限公司","粤械注准20172170437","延续注册","粤械注准20172550437"]
[168,"定制式活动义齿","东莞市华跃义齿科技有限公司","粤械注准20172170477","延续注册","粤械注准20172630477"]
[169,"定制式固定义齿","东莞市华跃义齿科技有限公司","粤械注准20172170478","延续注册","粤械注准20172630478"]
[170,"活性炭阴道填塞","佛山市平创医疗科技有限公司","粤械注准20172180177","延续注册","粤械注准20172640177"]
[171,"手动轮椅车","佛山市锐世迈医疗科技有限公司","粤械注准20172190345","延续注册","粤械注准20172560345"]
[172,"上肢智能反馈训练系统","广州一康医疗设备实业有限公司","粤械注准20172191092","延续注册","粤械注准20172261092"]
[173,"全自动生化分析仪","深圳迈瑞生物医疗电子股份有限公司","粤械注准20172220081","延续注册","粤械注准20172400081"]
[174,"全自动冷沉淀制备仪","佛山沃塘医疗科技有限公司","粤械注准20172220178","延续注册","粤械注准20172400178"]
[175,"幽门螺杆菌检测卡（脲酶法）","珠海市丽拓生物科技有限公司","粤械注准20172400117","延续注册","粤械注准20172400117"]
[176,"视黄醇结合蛋白测定试剂盒（免疫透射比浊法）","广州市伊川生物科技有限公司","粤械注准20172400201","延续注册","粤械注准20172400201"]
[177,"丙氨酸氨基转移酶测定试剂盒（丙氨酸底物法）","深圳市凯特生物医疗电子科技有限公司","粤械注准20172400202","延续注册","粤械注准20172400202"]
[178,"葡萄糖测定试剂盒（葡萄糖氧化酶法）","广州市伊川生物科技有限公司","粤械注准20172400203","延续注册","粤械注准20172400203"]
[179,"天门冬氨酸氨基转移酶测定试剂盒（天门冬氨酸底物法）","深圳市凯特生物医疗电子科技有限公司","粤械注准20172400224","延续注册","粤械注准20172400224"]
[180,"肌酐测定试剂盒（肌氨酸氧化酶法）","深圳市凯特生物医疗电子科技有限公司","粤械注准20172400387","延续注册","粤械注准20172400387"]
[181,"γ—谷氨酰基转移酶测定试剂盒（GCANA底物法）","深圳市凯特生物医疗电子科技有限公司","粤械注准20172400393","延续注册","粤械注准20172400393"]
[182,"甘油三酯测定试剂盒（GPO—PAP法）","深圳市凯特生物医疗电子科技有限公司","粤械注准20172400396","延续注册","粤械注准20172400396"]
[183,"总胆固醇测定试剂盒（CHOD—PAP法）","深圳市凯特生物医疗电子科技有限公司","粤械注准20172400397","延续注册","粤械注准20172400397"]
[184,"血细胞分析仪用质控物（光学法）","深圳雷杜生命科学股份有限公司","粤械注准20172400492","延续注册","粤械注准20172400492"]
[185,"血细胞分析仪用校准物（阻抗法）","深圳雷杜生命科学股份有限公司","粤械注准20172400493","延续注册","粤械注准20172400493"]
[186,"血细胞分析仪用质控物（阻抗法）","深圳雷杜生命科学股份有限公司","粤械注准20172400494","延续注册","粤械注准20172400494"]
[187,"血细胞分析仪用校准物（光学法）","深圳雷杜生命科学股份有限公司","粤械注准20172400495","延续注册","粤械注准20172400495"]
[188,"微量白蛋白测定试剂盒（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20172400520","延续注册","粤械注准20172400520"]
[189,"真菌分离培养基（培养法）","珠海市银科医学工程股份有限公司","粤械注准20172400582","延续注册","粤械注准20172400582"]
[190,"支原体检测琼脂培养基（培养法）","珠海市银科医学工程股份有限公司","粤械注准20172400583","延续注册","粤械注准20172400583"]
[191,"肌红蛋白（Myo）测定试剂（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20172401011","延续注册","粤械注准20172401011"]
[192,"肌酸激酶同工酶（CK—MB）测定试剂（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20172401012","延续注册","粤械注准20172401012"]
[193,"N末端B型钠尿肽原（NT—proBNP）测定试剂（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20172401013","延续注册","粤械注准20172401013"]
[194,"心肌肌钙蛋白I（cTnI）测定试剂（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20172401014","延续注册","粤械注准20172401014"]
[195,"妊娠相关血浆蛋白A测定试剂盒（化学发光免疫分析法）","广州市达瑞生物技术股份有限公司","粤械注准20172401058","延续注册","粤械注准20172401058"]
[196,"游离β人绒毛膜促性腺激素测定试剂盒（化学发光免疫分析法）","广州市达瑞生物技术股份有限公司","粤械注准20172401059","延续注册","粤械注准20172401059"]
[197,"C肽测定试剂盒（化学发光免疫分析法）","广州市达瑞生物技术股份有限公司","粤械注准20172401061","延续注册","粤械注准20172401061"]
[198,"甲胎蛋白/人绒毛膜促性腺激素游离β亚基定量测定试剂盒（时间分辨免疫荧光法）","广州市达瑞生物技术股份有限公司","粤械注准20172401123","延续注册","粤械注准20172401123"]
[199,"红细胞渗透脆性检测试剂盒（一管法）","广州市米基医疗器械有限公司","粤械注准20172401158","延续注册","粤械注准20172401158"]
[200,"糖类抗原50（CA50）测定试剂盒（时间分辨免疫荧光法）","广州市达瑞生物技术股份有限公司","粤械注准20212401327","延续注册","国械注准20173401248"]
[201,"过敏原特异性IgE抗体检测试剂盒（酶联免疫法）","深圳市博卡生物技术有限公司","粤械注准20212401383","延续注册","国械注准20173400648"]
[202,"过敏原特异性IgE抗体检测试剂盒（酶联免疫法）","深圳市博卡生物技术有限公司","粤械注准20212401384","延续注册","国械注准20173400645"]