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["附件："]
["2025年10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20252091318","广州湘医科技有限公司","激光治疗仪",null,"首次注册"]
[2,"粤械注准20252061319","珠海威瑞医疗科技有限公司","医用射线防护系统",null,"首次注册"]
[3,"粤械注准20252061320","深圳市宏济医疗技术开发有限公司","一次性使用电子膀胱肾盂内窥镜导管",null,"首次注册"]
[4,"粤械注准20252061321","深圳市宏济医疗技术开发有限公司","一次性电子膀胱肾盂镜",null,"首次注册"]
[5,"粤械注准20252221322","珠海美华医疗科技有限公司","微生物鉴定药敏分析系统",null,"首次注册"]
[6,"粤械注准20252221323","深圳市锦瑞生物科技股份有限公司","全自动血液分析仪",null,"首次注册"]
[7,"粤械注准20252191324","中山市钰民医疗科技有限公司","电动轮椅车",null,"首次注册"]
[8,"粤械注准20252171325","深圳市菲森影像科技有限公司","口腔数字印模仪",null,"首次注册"]
[9,"粤械注准20252191326","深圳市胜兴旺精密科技有限公司","盒式助听器",null,"首次注册"]
[10,"粤械注准20252091327","深圳前康医疗科技有限公司","空气波压力治疗系统",null,"首次注册"]
[11,"粤械注准20252091328","广州红象医疗科技有限公司","呼吸神经肌肉刺激仪",null,"首次注册"]
[12,"粤械注准20252211337","深圳市跃瑞医疗科技有限公司","心脏自主神经功能多参数处理软件","受托生产企业：浙江优诺艾医疗科技有限公司；统一社会信用代码：91331024MA2DUNCU0A。","首次注册"]
[13,"粤械注准20252081338","深圳市英美迪克医疗科技有限公司","压电网式雾化器",null,"首次注册"]
[14,"粤械注准20252191339","广东亨行健康科技有限公司","盒式数字助听器","受托生产企业：中山市小榄镇森蓝电子厂；统一社会信用代码：91442000L024028666。","首次注册"]
[15,"粤械注准20252081340","广东斐尔医疗科技有限公司","一次性使用可视气管插管",null,"首次注册"]
[16,"粤械注准20252091341","匡能科技（深圳）有限公司","脉冲磁治疗仪","受托生产企业：巨柯自动化设备（东莞）有限公司；统一社会信用代码：91441900MA4UMHBD41。","首次注册"]
[17,"粤械注准20252191342","广州华伟医疗设备有限公司","上肢康复训练与评估系统",null,"首次注册"]
[18,"粤械注准20252191343","深圳市兴汇科技有限公司","手功能康复训练与评估系统",null,"首次注册"]
[19,"粤械注准20252091344","广州人来康复设备制造有限公司","低中频电磁治疗仪",null,"首次注册"]
[20,"粤械注准20252161345","东京光学（东莞）科技有限公司","眼科光学相干断层扫描仪",null,"首次注册"]
[21,"粤械注准20252141346","深圳库珀医疗股份有限公司","经皮肾球囊扩张导管套件",null,"首次注册"]
[22,"粤械注准20252061347","奥立智内镜（广州）技术有限公司","医用内窥镜图像处理器","受托生产企业：广州奥立医疗设备有限公司；统一社会信用代码:91440101MA5ANT5R21。","首次注册"]
[23,"粤械注准20252221348","深圳市生强科技有限公司","玻片扫描影像系统",null,"首次注册"]
[24,"粤械注准20252221349","深圳市生强科技有限公司","玻片扫描影像系统",null,"首次注册"]
[25,"粤械注准20252081350","深圳微子医疗有限公司","一体化医用制氧机",null,"首次注册"]
[26,"粤械注准20252191351","深圳百聆鸟听力技术有限公司","耳背式助听器",null,"首次注册"]
[27,"粤械注准20252191352","广州一康医疗设备实业有限公司","手指关节康复评估系统",null,"首次注册"]
[28,"粤械注准20252061353","深圳市好克医疗仪器股份有限公司","磁共振高压造影注射系统",null,"首次注册"]
[29,"粤械注准20252091354","广州人来康复设备制造有限公司","叩击式排痰机",null,"首次注册"]
[30,"粤械注准20252081355","深圳市联安医疗科技有限公司","视频喉镜",null,"首次注册"]
[31,"粤械注准20252061356","深圳市科曼医疗设备有限公司","医用内窥镜图像处理器",null,"首次注册"]
[32,"粤械注准20252061357","珠海瑞明医疗设备有限公司","医用诊断X射线管组件",null,"首次注册"]
[33,"粤械注准20252141358","广州易介医疗科技有限公司","负压吸引泵",null,"首次注册"]
[34,"粤械注准20252171359","广州泛宇医疗科技有限公司","肌功能矫治器",null,"首次注册"]
[35,"粤械注准20252021360","广东微医光电科技有限公司","一次性使用无菌输尿管导引鞘",null,"首次注册"]
[36,"粤械注准20252141361","珠海德瑞医疗器械有限公司","负压引流器",null,"首次注册"]
[37,"粤械注准20252401362","深圳市辰纳生物科技有限公司","维生素B12（VB12）测定试剂盒（化学发光法）",null,"首次注册"]
[38,"粤械注准20252401363","广州市宝创生物技术有限公司","B型利钠肽（BNP）测定试剂盒（荧光免疫层析法）",null,"首次注册"]
[39,"粤械注准20252401364","深圳伯杰医疗科技有限公司","白介素12p70（IL-12p70）测定试剂盒（化学发光免疫分析法）",null,"首次注册"]
[40,"粤械注准20252401365","深圳伯杰医疗科技有限公司","白介素17A（IL-17A）测定试剂盒（化学发光免疫分析法）",null,"首次注册"]
[41,"粤械注准20252401366","深圳伯杰医疗科技有限公司","白介素2（IL-2）测定试剂盒（化学发光免疫分析法）",null,"首次注册"]
[42,"粤械注准20252401367","米度医疗科技（中山）有限公司","凝血多项复合质控品",null,"首次注册"]
[43,"粤械注准20252401368","珠海迪尔生物工程股份有限公司","厌氧菌鉴定药敏试剂盒（比色/比浊法）",null,"首次注册"]
[44,"粤械注准20252141369","穗海（广州）医疗科技有限公司","鼻腔喷雾器",null,"首次注册"]
[45,"粤械注准20252061370","深圳开立生物医疗科技股份有限公司","一次性使用内窥镜先端帽",null,"首次注册"]
[46,"粤械注准20252401371","广州市达瑞生物技术股份有限公司","人弹性蛋白酶抑制蛋白（Elafin）检测试剂盒（化学发光免疫分析法）",null,"首次注册"]
[47,"粤械注准20252401372","广州博粹医学检验科技有限公司","心肌标志物质控品",null,"首次注册"]
[48,"粤械注准20252401373","深圳伯杰医疗科技有限公司","白介素1β（IL-1β）测定试剂盒（化学发光免疫分析法）",null,"首次注册"]
[49,"粤械注准20252401374","深圳市迈科龙生物技术有限公司","游离三碘甲状腺原氨酸（FT3）测定试剂盒（免疫荧光层析法）",null,"首次注册"]
[50,"粤械注准20252401375","深圳伯杰医疗科技有限公司","白介素4（IL-4）测定试剂盒（化学发光免疫分析法）",null,"首次注册"]
[51,"粤械注准20252401376","广州博粹医学检验科技有限公司","血栓质控品",null,"首次注册"]
[52,"粤械注准20252401377","深圳伯杰医疗科技有限公司","白介素8（IL-8）测定试剂盒（化学发光免疫分析法）",null,"首次注册"]
[53,"粤械注准20252401378","深圳市帝迈生物技术有限公司","血细胞分析仪用质控物",null,"首次注册"]
[54,"粤械注准20252401379","深圳迈瑞生物医疗电子股份有限公司","骨钙素校准品",null,"首次注册"]
[55,"粤械注准20252401380","深圳迈瑞生物医疗电子股份有限公司","β-胶原特殊序列校准品",null,"首次注册"]
[56,"粤械注准20252401381","深圳迈瑞生物医疗电子股份有限公司","微量白蛋白质控品",null,"首次注册"]
[57,"粤械注准20252401382","深圳迈瑞生物医疗电子股份有限公司","骨钙素测定试剂盒（化学发光免疫分析法）",null,"首次注册"]
[58,"粤械注准20252401383","珠海北望生物科技有限公司","念珠菌显色琼脂培养基",null,"首次注册"]
[59,"粤械注准20252191384","广州华伟医疗设备有限公司","多关节等速训练与评估系统",null,"首次注册"]
[60,"粤械注准20252191385","河源市旋音科技有限公司","体佩式助听器",null,"首次注册"]
[61,"粤械注准20252061386","深圳市科曼医疗设备有限公司","医用内窥镜冷光源",null,"首次注册"]
[62,"粤械注准20252061387","深圳市科曼医疗设备有限公司","医用内窥镜冷光源",null,"首次注册"]
[63,"粤械注准20252401388","深圳伯杰医疗科技有限公司","白介素5（IL-5）测定试剂盒（化学发光免疫分析法）",null,"首次注册"]
[64,"粤械注准20252401389","深圳迈瑞生物医疗电子股份有限公司","癌抗原CA72-4测定试剂盒 （化学发光免疫分析法）",null,"首次注册"]
[65,"粤械注准20252091390","东莞追行来医疗器械有限公司","中频综合治疗仪 ",null,"首次注册"]
[66,"粤械注准20252201391","中晟生物科技（广东）有限公司","艾灸仪",null,"首次注册"]
[67,"粤械注准20252061392","汕头市超声仪器研究所股份有限公司","全数字彩色多普勒超声诊断系统",null,"首次注册"]
[68,"粤械注准20252221393","深圳市帝迈生物技术有限公司","全自动血液细胞分析仪",null,"首次注册"]
[69,"粤械注准20252181394","深圳亿杉医疗科技有限公司","胎儿心率记录仪",null,"首次注册"]
[70,"粤械注准20252181395","深圳市莱康宁医用科技股份有限公司","多参数胎儿心率仪",null,"首次注册"]
[71,"粤械注准20252211396","国药通用（深圳）医疗影像有限公司","超声影像处理软件",null,"首次注册"]
[72,"粤械注准20252171397","中山锦冠桥义齿有限公司","定制式正畸矫治器",null,"首次注册"]
[73,"粤械注准20252061398","深圳市科曼医疗设备有限公司","医用内窥镜图像处理器",null,"首次注册"]
[74,"粤械注准20252401399","深圳市帝迈生物技术有限公司","血液分析仪用校准物",null,"首次注册"]
[75,"粤械注准20252401400","深圳市帝迈生物技术有限公司","血细胞分析仪用质控物",null,"首次注册"]
[76,"粤械注准20252071401","深圳市奥生科技有限公司","一次性无创脑电传感器",null,"首次注册"]
[77,"粤械注准20252081402","广东朝野医疗器械有限公司","医用分子筛制氧机",null,"首次注册"]
[78,"粤械注准20252181403","广州科松医疗智能科技有限公司","胎心宫缩检测仪",null,"首次注册"]
[79,"粤械注准20252011404","密尔医疗科技（深圳）有限公司","一次性使用激光光纤",null,"首次注册"]
[80,"粤械注准20252061405","岱川医疗（深圳）有限责任公司","一次性使用电子支气管内窥镜导管",null,"首次注册"]
[81,"粤械注准20252061406","汕头市超声仪器研究所股份有限公司","便携式X射线及超声成像系统",null,"首次注册"]
[82,"粤械注准20252221407","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"]
[83,"粤械注准20252221408","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"]
[84,"粤械注准20252181409","深圳市莱康宁医用科技股份有限公司","多参数胎儿心率仪",null,"首次注册"]
[85,"粤械注准20252021410","广东索维特医用新材料有限公司","非吸收性外科缝线",null,"首次注册"]
[86,"粤械注准20252181411","深圳长久康联生物科技有限公司","胚胎移植导管",null,"首次注册"]
[87,"粤械注准20252061412","深圳开立生物医疗科技股份有限公司","一次性使用内窥镜先端帽",null,"首次注册"]
[88,"粤械注准20252401413","深圳普迪特生命科技有限公司","抗缪勒氏管激素（AMH）检测试剂盒（胶体金法）","受托生产企业：深圳赛柏生物有限公司；统一社会信用代码：91440300MA5G3ETD6R。","首次注册"]
[89,"粤械注准20252401414","深圳迈瑞生物医疗电子股份有限公司","总Ⅰ型胶原氨基端延长肽（Total-P1NP）校准品",null,"首次注册"]
[90,"粤械注准20252401415","深圳市科曼生物医疗有限公司","血细胞分析仪用质控物（光学法）",null,"首次注册"]
[91,"粤械注准20252071416","广州优听电子科技有限公司","诱发电位检测系统",null,"首次注册"]
[92,"粤械注准20252401417","深圳市迈科龙生物技术有限公司","心肌肌钙蛋白T（cTnT）测定试剂盒（免疫荧光层析法）",null,"首次注册"]
[93,"粤械注准20252141418","广州暨创医疗生物科技有限公司","重组胶原蛋白凝胶敷料",null,"首次注册"]
[94,"粤械注准20252171419","东莞市熠耀科技发展有限公司","肌功能矫治器",null,"首次注册"]
[95,"粤械注准20252181420","穗海（广州）医疗科技有限公司","卡波姆妇科凝胶",null,"首次注册"]
[96,"粤械注准20252141421","广州曼翔医药有限公司","钛质中耳通气管",null,"首次注册"]
[97,"粤械注准20252021422","联合微创医疗器械（深圳）有限公司","一次性套管穿刺器套装",null,"首次注册"]
[98,"粤械注准20252021423","联合微创医疗器械（深圳）有限公司","一次性套管穿刺器套装",null,"首次注册"]
[99,"粤械注准20252061424","广东欧谱曼迪科技股份有限公司","胸腹腔内窥镜",null,"首次注册"]
[100,"粤械注准20252071425","深圳市博英医疗仪器科技有限公司","穿戴式心电传感器",null,"首次注册"]
[101,"粤械注准20252401426","深圳市帝迈生物技术有限公司","C-反应蛋白（CRP）测定试剂盒（胶乳增强免疫散射比浊法）",null,"首次注册"]
[102,"粤械注准20252401427","广州瑞辉生物科技股份有限公司","白介素-6（IL-6）测定试剂盒（磁微粒化学发光法）",null,"首次注册"]
[103,"粤械注准20252401428","珠海科域生物工程股份有限公司","便隐血测定试剂盒（荧光层析法）",null,"首次注册"]
[104,"粤械注准20202140992","湛江市通灵医学生物工程有限公司","一次性使用医用口罩","原产品注册证号：粤械注准20202140992。","延续注册"]
[105,"粤械注准20162141271","珠海市尼诺生物科技有限公司","鼻腔喷雾器","原产品注册证号：粤械注准20162141271。","延续注册"]
[106,"粤械注准20212400608","深圳市卓润生物科技有限公司","孕酮测定试剂盒（化学发光法）","受托生产企业：湖南卓润生物科技有限公司；统一社会信用代码：91430300MA4RTJCD1N。 ","延续注册"]
[107,"粤械注准20212400569","深圳市卓润生物科技有限公司","总甲状腺素测定试剂盒（化学发光法）","受托生产企业：湖南卓润生物科技有限公司；统一社会信用代码：91430300MA4RTJCD1N。 ","延续注册"]
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[185,"粤械注准20212071089","深圳市同源生物医疗科技有限公司","一次性无创脑电传感器","原产品注册证号：粤械注准20212071089。","延续注册"]
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[232,"粤械注准20162400842","珠海森龙生物科技有限公司","乳酸脱氢酶测定试剂盒（乳酸底物法）",null,"延续注册"]
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[235,"粤械注准20172221103","深圳微点生物技术股份有限公司","电化学检测仪","原产品注册证号：粤械注准20172221103。","延续注册"]
[236,"粤械注准20212400609","深圳市卓润生物科技有限公司","25—羟基维生素D测定试剂盒（化学发光法）","受托生产企业：湖南卓润生物科技有限公司；统一社会信用代码：91430300MA4RTJCD1N。","延续注册"]
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[241,"粤械注准20172080482","广东海鸥医疗器械股份有限公司","一次性使用无菌吸痰管","原产品注册证号：粤械注准20172080482。","延续注册"]
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[245,"粤械注准20162220292","深圳市先亚生物科技有限公司","红细胞寿命测定呼气试验仪","原产品注册证号：粤械注准20162220292。","延续注册"]
[246,"粤械注准20172400511","广州天宝颂原生物科技开发有限公司","心肌肌钙蛋白I/肌红蛋白/肌酸激酶同工酶联合检测试剂盒（荧光免疫层析法）",null,"延续注册"]
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[258,"粤械注准20212400607","深圳市卓润生物科技有限公司","降钙素原测定试剂盒（化学发光法）","受托生产企业：湖南卓润生物科技有限公司；统一社会信用代码：91430300MA4RTJCD1N。","延续注册"]
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