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["附件："]
["2024年12月批准注册第二类医疗器械产品目录"]
["序号","注册证号","注册人名称","产品名称","备注栏内容","注册形式"]
[1,"粤械注准20242141656","广东瑞程医学科技有限公司","重组胶原蛋白液体敷料","受托生产企业名称：江苏创健健康科技有限公司；统一社会信用代码：91320412MA27FJAJXX。","首次注册"]
[2,"粤械注准20242141654","广东楠沃医疗科技有限公司","聚氨酯泡沫敷料",null,"首次注册"]
[3,"粤械注准20242061632","岱川医疗（深圳）有限责任公司","一次性使用电子上消化道成像导管",null,"首次注册"]
[4,"粤械注准20242401618","深圳市新产业生物医学工程股份有限公司","钙测定试剂盒（偶氮砷III法）",null,"首次注册"]
[5,"粤械注准20242401625","广州科方生物技术股份有限公司","Ⅳ型胶原测定试剂盒（化学发光法）",null,"首次注册"]
[6,"粤械注准20242141609","深圳库珀医疗股份有限公司","一次性使用胆管内引流管",null,"首次注册"]
[7,"粤械注准20242201610","广州泽润康医疗科技有限公司","艾灸治疗仪",null,"首次注册"]
[8,"粤械注准20242071611","深圳市从天科技有限公司","手臂式电子血压计",null,"首次注册"]
[9,"粤械注准20242081612","佛山市南海科日超声电子有限公司","网式雾化器",null,"首次注册"]
[10,"粤械注准20242401626","广州科方生物技术股份有限公司","层粘连蛋白（LN）测定试剂盒（化学发光法）",null,"首次注册"]
[11,"粤械注准20242401627","广州科方生物技术股份有限公司","抗环瓜氨酸肽（CCP）抗体测定试剂盒（化学发光法）",null,"首次注册"]
[12,"粤械注准20242061620","岱川医疗（深圳）有限责任公司","一次性使用电子下消化道成像导管",null,"首次注册"]
[13,"粤械注准20242061613","岱川医疗（深圳）有限责任公司","一次性使用电子下消化道成像导管",null,"首次注册"]
[14,"粤械注准20242161658","深圳市乾元医疗有限公司","一次性使用超声乳化冲洗吸引管路套件",null,"首次注册"]
[15,"粤械注准20242061633","岱川医疗（深圳）有限责任公司","一次性使用电子上消化道成像导管",null,"首次注册"]
[16,"粤械注准20242171648","梅州市金辉医疗器械有限公司","定制式矫治器",null,"首次注册"]
[17,"粤械注准20242171646","美尚（广州）医疗科技有限公司","定制式牙科种植用导板",null,"首次注册"]
[18,"粤械注准20242091635","东莞市译生医疗器械技术有限公司","中频治疗仪",null,"首次注册"]
[19,"粤械注准20242221629","深圳迎凯生物科技有限公司","全自动化学发光免疫分析仪",null,"首次注册"]
[20,"粤械注准20242061628","深圳市医思美科技有限公司","一体化肛门镜成像系统",null,"首次注册"]
[21,"粤械注准20242401608","深圳市朴瑞生物科技有限公司","心肌肌钙蛋白I/ 肌酸激酶同工酶/肌红蛋白联合测定试剂盒（荧光免疫层析法）",null,"首次注册"]
[22,"粤械注准20242221603","深圳迈瑞生物医疗电子股份有限公司","全自动微生物培养仪",null,"首次注册"]
[23,"粤械注准20242161634","东京光学（东莞）科技有限公司","手术显微镜",null,"首次注册"]
[24,"粤械注准20242401607","广州万孚生物技术股份有限公司","降钙素原（PCT）质控品",null,"首次注册"]
[25,"粤械注准20242401606","广州万孚生物技术股份有限公司","白介素-6（IL-6）质控品",null,"首次注册"]
[26,"粤械注准20242401605","广州万孚生物技术股份有限公司","D-二聚体（D-Dimer）质控品",null,"首次注册"]
[27,"粤械注准20242401663","深圳市新产业生物医学工程股份有限公司","腺苷脱氨酶测定试剂盒（过氧化物酶法）",null,"首次注册"]
[28,"粤械注准20242061621","广东实联医疗器械有限公司","电子内窥镜图像处理器",null,"首次注册"]
[29,"粤械注准20242401662","广州市康润生物科技有限公司","醛固酮（ALD）测定试剂盒(磁微粒化学发光法)",null,"首次注册"]
[30,"粤械注准20242401661","珠海丽珠试剂股份有限公司","抗β2糖蛋白1结构域1抗体IgG测定试剂盒（化学发光法）",null,"首次注册"]
[31,"粤械注准20242401616","广东阳光生物科技有限公司","N端中段骨钙素测定试剂盒（量子点荧光免疫层析法）",null,"首次注册"]
[32,"粤械注准20242401617","广东阳光生物科技有限公司","25-羟基维生素 D 测定试剂盒（量子点荧光免疫层析法）",null,"首次注册"]
[33,"粤械注准20242141653","经方精密医疗（深圳）有限公司","一次性一体式活检针",null,"首次注册"]
[34,"粤械注准20242171652","中山市卓瑞医疗科技有限公司","定制式固定义齿",null,"首次注册"]
[35,"粤械注准20242181649","广东善玺生物科技有限公司","卡波姆妇科凝胶",null,"首次注册"]
[36,"粤械注准20242021650","惠州华阳医疗器械有限公司","免缝胶带",null,"首次注册"]
[37,"粤械注准20242401693","瑞博奥（广州）生物科技股份有限公司","纤维蛋白（原）降解产物（FDP）测定试剂盒（化学发光法）",null,"首次注册"]
[38,"粤械注准20242401695","瑞博奥（广州）生物科技股份有限公司","胰岛素样生长因子结合蛋白3（IGFBP-3）测定试剂盒（化学发光法）",null,"首次注册"]
[39,"粤械注准20242401696","广州万孚生物技术股份有限公司","B型钠尿肽（BNP）质控品",null,"首次注册"]
[40,"粤械注准20242401739","广州市伊川生物科技有限公司","高敏肌钙蛋白T（hs-cTnT）测定试剂盒（化学发光免疫分析法）",null,"首次注册"]
[41,"粤械注准20242401740","中山生物工程有限公司","高敏C-反应蛋白（hsCRP）质控品",null,"首次注册"]
[42,"粤械注准20242401735","品峰（深圳）医疗器械有限公司","皮质醇（Cortisol）测定试剂盒（化学发光法）",null,"首次注册"]
[43,"粤械注准20242141676","深圳市慧极创新医疗科技有限公司","数显球囊扩充压力泵",null,"首次注册"]
[44,"粤械注准20242211675","深圳麦默康医疗科技有限公司","内窥镜图文工作站软件",null,"首次注册"]
[45,"粤械注准20242401724","广州达泰生物工程技术有限公司","维生素B12测定试剂盒（化学发光法）",null,"首次注册"]
[46,"粤械注准20242091673","广州红象医疗科技有限公司","呼吸分析与康复仪",null,"首次注册"]
[47,"粤械注准20242071672","深圳市迈德生物科技有限公司","一次性医用温度传感器探头",null,"首次注册"]
[48,"粤械注准20242181668","广东龙心医疗器械有限公司","体外受精显微操作管",null,"首次注册"]
[49,"粤械注准20242071767","深圳市憨憨智造科技有限公司","臂式电子血压计",null,"首次注册"]
[50,"粤械注准20242401758","深圳市新产业生物医学工程股份有限公司","补体C4测定试剂盒（免疫透射比浊法）",null,"首次注册"]
[51,"粤械注准20242401687","广州达泰生物工程技术有限公司","抗核小体抗体IgG测定试剂盒（化学发光法）",null,"首次注册"]
[52,"粤械注准20242061623","东莞安科医疗科技有限公司","数字化X射线摄影系统",null,"首次注册"]
[53,"粤械注准20242071624","广州析芒医疗科技有限公司","数字脑电图仪",null,"首次注册"]
[54,"粤械注准20242401665","广州市微米生物科技有限公司","CD62P/CD41/CD61检测试剂盒（流式细胞仪法）",null,"首次注册"]
[55,"粤械注准20242401641","瑞博奥（广州）生物科技股份有限公司","髓过氧化物酶（MPO）测定试剂盒（化学发光法）",null,"首次注册"]
[56,"粤械注准20242401640","瑞博奥（广州）生物科技股份有限公司","孕酮（Prog）测定试剂盒（化学发光法）",null,"首次注册"]
[57,"粤械注准20242401637","广州达泰生物工程技术有限公司","β2微球蛋白测定试剂盒（化学发光法）",null,"首次注册"]
[58,"粤械注准20242401741","中山生物工程有限公司","血清淀粉样蛋白A（SAA）质控品",null,"首次注册"]
[59,"粤械注准20242401744","品峰（深圳）医疗器械有限公司","非结合雌三醇（uE3）测定试剂盒（化学发光法）",null,"首次注册"]
[60,"粤械注准20242011785","珠海市司迈科技有限公司","刨削刀头",null,"首次注册"]
[61,"粤械注准20242141786","深圳市升昊科技有限公司","远端桡动脉压迫止血器",null,"首次注册"]
[62,"粤械注准20242021787","广东富江医学科技有限公司","一次性纤细通道用活检钳",null,"首次注册"]
[63,"粤械注准20242401604","广州达泰生物工程技术有限公司","抗SS-A抗体测定试剂盒（化学发光法）",null,"首次注册"]
[64,"粤械注准20242401737","广州市伊川生物科技有限公司","糖类抗原242（CA242）测定试剂盒（化学发光免疫分析法）",null,"首次注册"]
[65,"粤械注准20242401747","深圳市晋百慧生物有限公司","胃蛋白酶原I/II (PGI/PGII)测定试剂盒（胶体金免疫层析法）",null,"首次注册"]
[66,"粤械注准20242401689","广州万孚生物技术股份有限公司","血清淀粉样蛋白A（SAA）/C反应蛋白（CRP）复合质控品",null,"首次注册"]
[67,"粤械注准20242401690","广州万孚生物技术股份有限公司","血清淀粉样蛋白A（SAA）质控品",null,"首次注册"]
[68,"粤械注准20242401691","广州万孚生物技术股份有限公司","C反应蛋白（CRP）质控品",null,"首次注册"]
[69,"粤械注准20242401743","中山生物工程有限公司","肌酸激酶同工酶（CK-MB）质控品",null,"首次注册"]
[70,"粤械注准20242071701","广州爱芯达电子有限公司","臂式电子血压计",null,"首次注册"]
[71,"粤械注准20242091702","深圳市开颜医疗器械有限公司","红外红光治疗仪",null,"首次注册"]
[72,"粤械注准20242161729","深圳市健希生物科技有限公司","液晶视力表","受托生产企业：深圳市通视达电子科技有限公司；统一社会信用代码：914403005956558731。","首次注册"]
[73,"粤械注准20242401736","广州市伊川生物科技有限公司","糖类抗原72-4（CA72-4）测定试剂盒（化学发光免疫分析法）",null,"首次注册"]
[74,"粤械注准20242401734","品峰（深圳）医疗器械有限公司","肾素（Renin）测定试剂盒（化学发光法）",null,"首次注册"]
[75,"粤械注准20242401738","广州市伊川生物科技有限公司","糖类抗原50（CA50）测定试剂盒（化学发光免疫分析法）",null,"首次注册"]
[76,"粤械注准20242061703","珠海市迪谱医疗科技有限公司","图像处理器",null,"首次注册"]
[77,"粤械注准20242011704","赛德欧科技（深圳）有限公司","磁性组织夹","受托生产企业：深圳市鑫华佳科技有限公司；统一社会信用代码:91440300565723388U。","首次注册"]
[78,"粤械注准20242091706","深圳影迈科技有限公司","强脉冲光治疗仪",null,"首次注册"]
[79,"粤械注准20242091707","深圳思莱德医疗科技有限公司","308nm紫外光治疗机",null,"首次注册"]
[80,"粤械注准20242181726","道简（深圳）医疗科技有限公司","全自动精液非连续密度梯度离心处理系统",null,"首次注册"]
[81,"粤械注准20242221727","深圳华康生物医学工程有限公司","全自动生化分析仪",null,"首次注册"]
[82,"粤械注准20242401614","珠海丽珠试剂股份有限公司","抗β2糖蛋白1结构域1抗体IgG质控品",null,"首次注册"]
[83,"粤械注准20242401615","广州达泰生物工程技术有限公司","癌胚抗原(CEA)/癌抗原15-3(CA15-3)测定试剂盒（流式荧光发光法）",null,"首次注册"]
[84,"粤械注准20242401664","广州达泰生物工程技术有限公司","免疫球蛋白G测定试剂盒（胶乳免疫比浊法）",null,"首次注册"]
[85,"粤械注准20242141728","珠海德瑞医疗器械有限公司","一次性使用亲水涂层硅胶测温导尿管",null,"首次注册"]
[86,"粤械注准20242221730","深圳拓诚检测设备研发有限公司","全自动化学发光免疫分析仪",null,"首次注册"]
[87,"粤械注准20242061731","深圳科光达医疗科技有限公司","电子支气管内窥镜","受托生产企业：河南驼人金泰克医疗器械有限责任公司；统一社会信用代码9141072807780543XF。","首次注册"]
[88,"粤械注准20242111732","深圳市美雅洁技术股份有限公司","全自动双舱内镜清洗消毒机",null,"首次注册"]
[89,"粤械注准20242221750","广州市宝创生物技术有限公司","干式荧光免疫分析仪","受托生产企业：宝创生物技术（珠海）有限公司；社会信用代码：91440400MA573KNU5G。","首次注册"]
[90,"粤械注准20242221745","深圳天辰医疗科技有限公司","全自动化学发光免疫分析仪",null,"首次注册"]
[91,"粤械注准20242071765","深圳新蕊科技有限公司","腕式电子血压计",null,"首次注册"]
[92,"粤械注准20242061766","汕头市昱维电子科技有限公司","医用内窥镜摄像系统",null,"首次注册"]
[93,"粤械注准20242401776","广州市伊川生物科技有限公司","醛固酮（ALD）测定试剂盒（化学发光免疫分析法）",null,"首次注册"]
[94,"粤械注准20242221751","呼研所生物安全科技（广州）股份有限公司","医用洁净工作台",null,"首次注册"]
[95,"粤械注准20242401754","中山生物工程有限公司","C反应蛋白（CRP）质控品",null,"首次注册"]
[96,"粤械注准20242401755","中山生物工程有限公司","心肌肌钙蛋白I（cTnI）质控品",null,"首次注册"]
[97,"粤械注准20242401761","中山生物工程有限公司","B型利钠肽（BNP）质控品",null,"首次注册"]
[98,"粤械注准20242401763","深圳迈瑞生物医疗电子股份有限公司","S100蛋白质控品",null,"首次注册"]
[99,"粤械注准20242021713","深圳市慧极创新医疗科技有限公司","一次性使用鼻腔切口保护套",null,"首次注册"]
[100,"粤械注准20242401700","广州市伊川生物科技有限公司","促肾上腺皮质激素(ACTH)测定试剂盒（化学发光免疫分析法）",null,"首次注册"]
[101,"粤械注准20242031784","深圳市金瑞凯利生物科技有限公司","血管鞘组","受托生产企业：威高奋威健康科技发展（上海）有限公司；统一社会信用代码：91310115MA1K4ED93K。","首次注册"]
[102,"粤械注准20242401788","广州达泰生物工程技术有限公司","妊娠相关血浆蛋白A测定试剂盒（化学发光法）",null,"首次注册"]
[103,"粤械注准20242401772","广州达泰生物工程技术有限公司","癌胚抗原（CEA）/细胞角蛋白19片段（CYFRA21-1）/神经元特异性烯醇化酶（NSE）测定试剂盒（流式荧光发光法）",null,"首次注册"]
[104,"粤械注准20242401774","中山生物工程有限公司","肌红蛋白（MYO）质控品",null,"首次注册"]
[105,"粤械注准20242221746","深圳市康立生物医疗有限公司","血气生化分析仪",null,"首次注册"]
[106,"粤械注准20242401721","广州达泰生物工程技术有限公司","抗Jo-1抗体测定试剂盒（化学发光法）",null,"首次注册"]
[107,"粤械注准20242401642","广州朗坤生物科技有限公司","抗缪勒管激素（AMH）测定试剂盒（化学发光免疫分析法）",null,"首次注册"]
[108,"粤械注准20242221769","深圳市康立生物医疗有限公司","荧光免疫血气分析仪",null,"首次注册"]
[109,"粤械注准20242061768","联合微创医疗器械（深圳）有限公司","一次性使用电子膀胱肾盂内窥镜导管",null,"首次注册"]
[110,"粤械注准20242171771","佛山市津上医疗科技有限公司","牙科低速手机",null,"首次注册"]
[111,"粤械注准20242401733","广州达泰生物工程技术有限公司","胃蛋白酶原I测定试剂盒（化学发光法）",null,"首次注册"]
[112,"粤械注准20242401688","广州达泰生物工程技术有限公司","癌胚抗原（CEA）/鳞状上皮细胞癌抗原（SCC）/细胞角蛋白19片段（CYFRA21-1）/胃泌素释放肽前体（proGRP）/神经元特异性烯醇化酶（NSE）测定试剂盒(流式荧光发光法)",null,"首次注册"]
[113,"粤械注准20242401692","瑞博奥（广州）生物科技股份有限公司","B型利钠肽（BNP）测定试剂盒(化学发光法)",null,"首次注册"]
[114,"粤械注准20242401694","瑞博奥（广州）生物科技股份有限公司","生长激素（GH）测定试剂盒(化学发光法)",null,"首次注册"]
[115,"粤械注准20242401757","中山生物工程有限公司","心肌肌钙蛋白T（cTnT）质控品",null,"首次注册"]
[116,"粤械注准20242401760","深圳迈瑞生物医疗电子股份有限公司","S100蛋白校准品",null,"首次注册"]
[117,"粤械注准20242401762","广州达泰生物工程技术有限公司","抗Sm/RNP抗体测定试剂盒（化学发光法）",null,"首次注册"]
[118,"粤械注准20242401775","中山生物工程有限公司","心脏型脂肪酸结合蛋白（H-FABP）质控品",null,"首次注册"]
[119,"粤械注准20242221777","中科伊和智能医疗科技（佛山）有限公司","染色体显微图像扫描系统",null,"首次注册"]
[120,"粤械注准20242401752","中山生物工程有限公司","D-二聚体（D-Dimer）质控品",null,"首次注册"]
[121,"粤械注准20242401753","中山生物工程有限公司","N末端B型利钠肽前体（NT-proBNP）质控品",null,"首次注册"]
[122,"粤械注准20242401756","中山生物工程有限公司","白介素-6（IL-6）质控品",null,"首次注册"]
[123,"粤械注准20242401759","深圳迈瑞生物医疗电子股份有限公司","S100蛋白测定试剂盒（化学发光免疫分析法）",null,"首次注册"]
[124,"粤械注准20242401773","广州市康润生物科技有限公司","自身抗体谱IgG检测试剂盒(间接免疫荧光法)",null,"首次注册"]
[125,"粤械注准20242061680","深圳市艾克瑞电气有限公司","双能X射线骨密度仪",null,"首次注册"]
[126,"粤械注准20242401678","广州市康润生物科技有限公司","髓过氧化物酶（MPO）测定试剂盒(磁微粒化学发光法)",null,"首次注册"]
[127,"粤械注准20242061622","深圳英美达医疗技术有限公司","电子下消化道内窥镜",null,"首次注册"]
[128,"粤械注准20242071681","深圳市丰盛生物科技有限公司","多参数脑电监测系统",null,"首次注册"]
[129,"粤械注准20242081682","深圳市安普康科技有限公司","一次性使用除颤电极",null,"首次注册"]
[130,"粤械注准20242071683","深圳阿斯克医疗有限公司","尿流量检测仪",null,"首次注册"]
[131,"粤械注准20242081684","深圳智信生物医疗科技有限公司","气管插管用喉镜",null,"首次注册"]
[132,"粤械注准20242221685","深圳雷杜生命科学股份有限公司","全自动生化分析仪",null,"首次注册"]
[133,"粤械注准20242141708","广东瀚润生物科技有限公司","医用疤痕凝胶",null,"首次注册"]
[134,"粤械注准20242181711","广州和弘生物科技有限责任公司","胚胎转移导管辅助器",null,"首次注册"]
[135,"粤械注准20242171712","深圳壹美齿研数字科技有限公司","定制式活动义齿",null,"首次注册"]
[136,"粤械注准20242191716","中山市康政医疗器材有限公司","手动轮椅车",null,"首次注册"]
[137,"粤械注准20242011674","佛山市宇森医疗器械有限公司","手术动力系统",null,"首次注册"]
[138,"粤械注准20242161671","东京光学（东莞）科技有限公司","手术显微镜",null,"首次注册"]
[139,"粤械注准20242091670","深圳市宗匠科技有限公司","光子治疗仪","受托生产企业：深圳市景欣泰家居用品有限公司，统一社会信用代码：914403005627611275。","首次注册"]
[140,"粤械注准20242091669","深圳市东迪欣科技有限公司","冲击波治疗仪",null,"首次注册"]
[141,"粤械注准20242191667","河源市旋音科技有限公司","耳内式助听器",null,"首次注册"]
[142,"粤械注准20242031677","深圳大凡制造有限公司","经皮肾扩张套件",null,"首次注册"]
[143,"粤械注准20242221686","深圳迎凯生物科技有限公司","全自动化学发光免疫分析仪",null,"首次注册"]
[144,"粤械注准20242401697","广州科方生物技术股份有限公司","胰岛素样生长因子结合蛋白-3（IGFBP-3）测定试剂盒（化学发光法）",null,"首次注册"]
[145,"粤械注准20242401619","广州万孚生物技术股份有限公司","睾酮测定试剂盒（化学发光免疫分析法）",null,"首次注册"]
[146,"粤械注准20242091659","广州市鸿年科技有限公司","医用弹力袜",null,"首次注册"]
[147,"粤械注准20242031657","深圳復瑞德医疗科技有限公司","一次性使用导管鞘套装",null,"首次注册"]
[148,"粤械注准20242171651","中山市卓瑞医疗科技有限公司","定制式活动义齿",null,"首次注册"]
[149,"粤械注准20242141710","广州保瑞医疗技术有限公司","一次性使用无菌润滑导尿包",null,"首次注册"]
[150,"粤械注准20242171709","广州睿格正畸医疗器械研究有限公司","定制式正畸矫治器",null,"首次注册"]
[151,"粤械注准20242171714","深圳市健美义齿技术有限公司","定制式活动义齿",null,"首次注册"]
[152,"粤械注准20242171715","深圳市健美义齿技术有限公司","定制式固定义齿",null,"首次注册"]
[153,"粤械注准20242201719","广州博联思医疗技术有限公司","一次性使用无菌皮肤滚针",null,"首次注册"]
[154,"粤械注准20242401660","广州博粹医学检验科技有限公司","自身免疫性肌炎9项质控品",null,"首次注册"]
[155,"粤械注准20242401655","瑞博奥（广州）生物科技股份有限公司","高敏肌钙蛋白I（hs-cTnI）测定试剂盒(化学发光法)",null,"首次注册"]
[156,"粤械注准20242401644","深圳市昭蓝生物科技有限公司","多项免疫复合质控品","受托生产企业：深圳市亚辉龙生物科技股份有限公司；统一社会信用代码：91440300680376756U。","首次注册"]
[157,"粤械注准20242171647","东莞市凌天医疗器械科技有限公司","机用根管锉",null,"首次注册"]
[158,"粤械注准20242221636","广州达安基因股份有限公司","全自动化学发光免疫分析仪","受托生产企业名称：广州市达安医疗器械有限公司；统一社会信用代码：91440116MA59ANKD5Q。","首次注册"]
[159,"粤械注准20242141645","广州暨创医疗生物科技有限公司","重组胶原蛋白液体敷料",null,"首次注册"]
[160,"粤械注准20242081631","深圳市科曼医疗设备有限公司","心肺复苏机",null,"首次注册"]
[161,"粤械注准20242071630","深圳泰和智能医疗科技有限公司","生命体征监测仪",null,"首次注册"]
[162,"粤械注准20242401643","深圳市昭蓝生物科技有限公司","可溶性CD146质控品","受托生产企业：深圳市亚辉龙生物科技股份有限公司；统一社会信用代码：91440300680376756U。","首次注册"]
[163,"粤械注准20242401698","广州市康润生物科技有限公司","肾素（Renin）测定试剂盒(磁微粒化学发光法)",null,"首次注册"]
[164,"粤械注准20242401699","广州市伊川生物科技有限公司","神经元特异性烯醇化酶（NSE）测定试剂盒（化学发光免疫分析法）",null,"首次注册"]
[165,"粤械注准20242401722","广州达泰生物工程技术有限公司","铁蛋白测定试剂盒（化学发光免疫分析法）",null,"首次注册"]
[166,"粤械注准20242401639","广州达泰生物工程技术有限公司","前列腺酸性磷酸酶测定试剂盒（化学发光法）",null,"首次注册"]
[167,"粤械注准20242401638","广州达泰生物工程技术有限公司","转铁蛋白测定试剂盒（胶乳免疫比浊法）",null,"首次注册"]
[168,"粤械注准20242181717","慈达（广州）生物技术有限公司","一次性使用子宫颈样本采集器",null,"首次注册"]
[169,"粤械注准20242401723","广州达泰生物工程技术有限公司","组织多肽特异性抗原测定试剂盒（化学发光法）",null,"首次注册"]
[170,"粤械注准20242401679","瑞博奥（广州）生物科技股份有限公司","性激素结合球蛋白（SHBG）测定试剂盒（化学发光法）",null,"首次注册"]
[171,"粤械注准20242071718","深圳市康坪科技医疗有限公司","心电电极",null,"首次注册"]
[172,"粤械注准20242401720","广州达泰生物工程技术有限公司","肾素测定试剂盒（化学发光法）",null,"首次注册"]
[173,"粤械注准20242401725","广州市伊川生物科技有限公司","全段甲状旁腺激素（PTH）测定试剂盒（化学发光免疫分析法）",null,"首次注册"]
[174,"粤械注准20242401742","中山生物工程有限公司","降钙素原（PCT）质控品",null,"首次注册"]
[175,"粤械注准20242091705","深圳影迈科技有限公司","强脉冲光治疗仪",null,"首次注册"]
[176,"粤械注准20242221770","深圳市康立生物医疗有限公司","荧光免疫血气分析仪",null,"首次注册"]
[177,"粤械注准20242091778","普威医疗科技（广州）有限公司","神经肌肉刺激仪",null,"首次注册"]
[1,"粤械注准20152171071","深圳市贝特义齿技术有限公司","定制式固定义齿","原产品注册证号：粤械注准20152171071。","延续注册"]
[2,"粤械注准20152090478","广东祺达医疗器械有限公司","远红外伤痛贴","原产品注册证号：粤械注准20152090478。","延续注册"]
[3,"粤械注准20142090338","广州国灸医疗科技有限公司","灸疗贴","原产品注册证号：粤械注准20142090338。","延续注册"]
[4,"粤械注准20192061271","广州友沃医疗设备有限公司","CT造影注射装置","原产品注册证号：粤械注准20192061271。","延续注册"]
[5,"粤械注准20152170434","佛山市新格医疗器材有限公司","牙科综合治疗机","原产品注册证号：粤械注准20152170434。","延续注册"]
[6,"粤械注准20152141512","广州维力医疗器械股份有限公司","输尿管扩张器套件","原产品注册证号：粤械注准20152141512。","延续注册"]
[7,"粤械注准20172400101","梅州康立高科技有限公司","总二氧化碳（TCO2）测定试剂（量压法）",null,"延续注册"]
[8,"粤械注准20192090256","深圳市睿迪医疗器械有限公司","冲击波治疗仪","原产品注册证号：粤械注准20192090256。","延续注册"]
[9,"粤械注准20192061272","广州友沃医疗设备有限公司","血管造影高压注射装置","原产品注册证号：粤械注准20192061272。","延续注册"]
[10,"粤械注准20152170303","中山市科艺义齿加工厂","定制式固定义齿","原产品注册证号：粤械注准20152170303。","延续注册"]
[11,"粤械注准20192141042","广东益邦生物医疗有限公司","输液泵","原产品注册证号：粤械注准20192141042。","延续注册"]
[12,"粤械注准20152401362","深圳市亚辉龙生物科技股份有限公司","25—羟基维生素D测定试剂盒（化学发光法）",null,"延续注册"]
[13,"粤械注准20152171070","深圳市贝特义齿技术有限公司","定制式活动义齿","原产品注册证号：粤械注准20152171070。","延续注册"]
[14,"粤械注准20152220605","深圳市希莱恒医用电子有限公司","半自动生化分析仪","原产品注册证号：粤械注准20152220605。","延续注册"]
[15,"粤械注准20162140265","深圳市盛康泰医疗器械有限公司","体腔器械导入润滑剂","原产品注册证号：粤械注准20162140265。","延续注册"]
[16,"粤械注准20202402058","深圳市国赛生物技术有限公司","D—二聚体（D—Dimer）质控品",null,"延续注册"]
[17,"粤械注准20152170302","中山市科艺义齿加工厂","定制式活动义齿","原产品注册证号：粤械注准20152170302。","延续注册"]
[18,"粤械注准20152170997","东莞市富诚医疗用品有限公司","定制式正畸矫治器","原产品注册证号：粤械注准20152170997。","延续注册"]
[19,"粤械注准20152221143","深圳迈瑞生物医疗电子股份有限公司","全自动生化分析仪","原产品注册证号：粤械注准20152221143。","延续注册"]
[20,"粤械注准20202401082","深圳市瑞图生物技术有限公司","阴道炎联合检测试剂盒（酶化学反应法）",null,"延续注册"]
[21,"粤械注准20162400488","深圳普门科技股份有限公司","糖化血红蛋白（HbA1c）质控品","受托生产企业名称：广东普门生物医疗科技有限公司，统一社会信用代码：91441900MA4UHLWH4C。","延续注册"]
[22,"粤械注准20152401360","深圳市亚辉龙生物科技股份有限公司","妊娠相关蛋白A测定试剂盒（化学发光法）",null,"延续注册"]
[23,"粤械注准20162401007","深圳迈瑞生物医疗电子股份有限公司","同型半胱氨酸（HCY）质控品",null,"延续注册"]
[24,"粤械注准20152140596","佛山市康复医疗设备厂","外科纱布敷料","原产品注册证号：粤械注准20152140596。","延续注册"]
[25,"粤械注准20152140699","广州润虹医药科技股份有限公司","自粘性无菌敷料","原产品注册证号：粤械注准20152140699。","延续注册"]
[26,"粤械注准20142080090","广州耀远实业有限公司","一次性使用无菌喉罩气道导管","原产品注册证号：粤械注准20142080090。","延续注册"]
[27,"粤械注准20202400985","深圳华迈兴微医疗科技有限公司","抗缪勒管激素（AMH）测定试剂盒（微流控磁微粒化学发光法）",null,"延续注册"]
[28,"粤械注准20202400986","深圳华迈兴微医疗科技有限公司","抗缪勒管激素（AMH）质控品",null,"延续注册"]
[29,"粤械注准20192401325","广东执诚生物科技有限公司","全程C反应蛋白（hsCRP+常规CRP）测定试剂盒 （荧光免疫层析法）",null,"延续注册"]
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[58,"粤械注准20152140375","江门市舒而美医疗用品有限公司","一次性使用医用口罩","原产品注册证号：粤械注准20152140375。","延续注册"]
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[79,"粤械注准20162140004","深圳市兴业卓辉实业有限公司","一次性使用手术衣","原产品注册证号：粤械注准20162140004。","延续注册"]
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[81,"粤械注准20152171498","广州悦君义齿研制有限公司","定制式固定义齿","原产品注册证号：粤械注准20152171498。","延续注册"]
[82,"粤械注准20152081411","斯莱达医疗用品（惠州）有限公司","医用呼吸道湿化器","原产品注册证号：粤械注准20152081411。","延续注册"]
[83,"粤械注准20202400559","深圳市活水床旁诊断仪器有限公司","葡萄糖/糖化白蛋白测定试剂盒（酶法）","受托生产企业：江苏达伯药业有限公司","延续注册"]
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[85,"粤械注准20202021308","广州保瑞医疗技术有限公司","微创筋膜闭合器","原产品注册证号：粤械注准20202021308。","延续注册"]
[86,"粤械注准20152400941","广州东林生物科技有限公司","直接胆红素（DBIL）测定试剂盒（钒酸盐氧化法）",null,"延续注册"]
[87,"粤械注准20152400930","广州东林生物科技有限公司","葡萄糖（GLU）测定试剂盒（葡萄糖氧化酶法）",null,"延续注册"]
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[89,"粤械注准20152020576","佛山特种医用导管有限责任公司","一次性使用套管穿刺针","原产品注册证号：粤械注准20152020576。","延续注册"]
[90,"粤械注准20202400465","广州市康润生物科技有限公司","抗环瓜氨酸肽(CCP)抗体测定试剂盒（磁微粒化学发光法）",null,"延续注册"]
[91,"粤械注准20152170244","深圳市技艺齿科技术有限公司","定制式固定义齿","原产品注册证号：粤械注准20152170244。","延续注册"]
[92,"粤械注准20202400592","广州市康润生物科技有限公司","抗心磷脂IgA抗体(aCL IgA)测定试剂盒（磁微粒化学发光法）",null,"延续注册"]
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[96,"粤械注准20202170292","深圳市福恬沃医疗器械有限公司","定制式活动义齿","原产品注册证号：粤械注准20202170292。","延续注册"]
[97,"粤械注准20202191970","广州穗海新峰医疗设备制造股份有限公司","上下肢主被动训练器","原产品注册证号：粤械注准20202191970。","延续注册"]
[98,"粤械注准20202170001","韶关市德维雅义齿技术开发有限公司","定制式活动义齿","原产品注册证号：粤械注准20202170001。","延续注册"]
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[100,"粤械注准20152171388","广州熙福医疗器材有限公司","金刚砂车针","原产品注册证号：粤械注准20152171388。","延续注册"]
[101,"粤械注准20202400463","广州市康润生物科技有限公司","抗髓过氧化物酶(MPO)抗体测定试剂盒（磁微粒化学发光法）",null,"延续注册"]
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[108,"粤械注准20202400809","深圳麦科田生物医疗技术股份有限公司","氨基末端脑利钠肽前体（NT—proBNP）测定试剂盒（化学发光免疫分析法）",null,"延续注册"]
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[110,"粤械注准20152400848","深圳迈瑞生物医疗电子股份有限公司","肌酸激酶同工酶MB（CK—MB）测定试剂盒（化学发光免疫分析法）",null,"延续注册"]
[111,"粤械注准20152140728","台山市弘毅医疗用品有限公司","导管固定装置","原产品注册证号：粤械注准20152140728。","延续注册"]
[112,"粤械注准20192070896","东莞百绿电子科技有限公司","红外线体温计","原产品注册证号：粤械注准20192070896。","延续注册"]
[113,"粤械注准20202080242","斯莱达医疗用品（惠州）有限公司","婴儿呼吸管路套件","原产品注册证号：粤械注准20202080242。","延续注册"]
[114,"粤械注准20202210957","东莞市高济智慧医疗科技有限公司","医学影像存储与传输系统软件","原产品注册证号：粤械注准20202210957。","延续注册"]
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