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["附件："]
["2025年11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20252221430","广州埃克森生物科技有限公司","电解质分析仪",null,"首次注册"]
[2,"粤械注准20252141431","广东先来医疗器械有限公司","一次性使用颅脑外引流导管套件",null,"首次注册"]
[3,"粤械注准20252221432","博奥泰生物科技（深圳）有限公司","电解质分析仪",null,"首次注册"]
[4,"粤械注准20252141433","深圳辰泰健康科技有限公司","无菌接管机",null,"首次注册"]
[5,"粤械注准20252011434","广州帕玛医疗科技有限公司","一次性射频等离子手术电极",null,"首次注册"]
[6,"粤械注准20252221435","珠海市丽拓生物科技股份有限公司","全自动微生物鉴定药敏分析仪",null,"首次注册"]
[7,"粤械注准20252061436","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"]
[8,"粤械注准20252061437","奥铂特医疗科技（深圳）有限公司","医用诊断X射线摄影系统",null,"首次注册"]
[9,"粤械注准20252061438","深圳市安健科技股份有限公司","医用诊断X射线透视摄影系统",null,"首次注册"]
[10,"粤械注准20252161439","深圳高视科技有限公司","眼电生理检查系统",null,"首次注册"]
[11,"粤械注准20252081440","斯莱达医疗用品（惠州）有限公司","网式雾化器",null,"首次注册"]
[12,"粤械注准20252221441","广州埃克森生物科技有限公司","全自动五分类血液分析仪",null,"首次注册"]
[13,"粤械注准20252401442","深圳唯公生物科技有限公司","十项细胞因子测定试剂盒（磁微粒发光法）",null,"首次注册"]
[14,"粤械注准20252081443","广州人峰医疗科技有限公司","一次性使用双腔支气管插管套件","受托生产企业：广州灵云医疗科技有限公司；统一社会信用代码：91440101MA5D64RR4M。","首次注册"]
[15,"粤械注准20252221444","佛山市德维医学诊断科技有限公司","一次性使用末梢血样采集容器",null,"首次注册"]
[16,"粤械注准20252181445","深圳长久康联生物科技有限公司","胚胎转移导管辅助器",null,"首次注册"]
[17,"粤械注准20252101446","广东唯正医疗器械有限公司","一次性使用腹膜透析机管路","受托生产企业：广东亿康医疗器械有限公司；统一社会信用代码：91440101MA59QMYTXC。","首次注册"]
[18,"粤械注准20252171447","汕头市康诺德医疗科技有限公司","定制式临时牙",null,"首次注册"]
[19,"粤械注准20252141448","珠海市尼诺生物科技有限公司","可调式鼻腔清洗器",null,"首次注册"]
[20,"粤械注准20252061449","珠海市迪谱医疗科技有限公司","内窥镜用冷光源","原注册证号：粤械注准20212060185","首次注册"]
[21,"粤械注准20252401450","尖果生物科技（深圳）有限公司","降钙素原（PCT）测定试剂盒（化学发光免疫分析法）",null,"首次注册"]
[22,"粤械注准20252401451","尖果生物科技（深圳）有限公司","白介素6（IL-6）测定试剂盒（化学发光免疫分析法）",null,"首次注册"]
[23,"粤械注准20252401453","广州朗坤生物科技有限公司","精子SP10蛋白检测试剂盒（胶体金法）",null,"首次注册"]
[24,"粤械注准20252401454","广东优尼德生物科技有限公司","锌转运蛋白8抗体（ZnT8A）测定试剂盒（化学发光法）",null,"首次注册"]
[25,"粤械注准20252401455","尖果生物科技（深圳）有限公司","促甲状腺素（TSH）测定试剂盒（化学发光免疫分析法）",null,"首次注册"]
[26,"粤械注准20252401456","深圳市国赛生物技术有限公司","同型半胱氨酸（HCY）测定试剂盒（免疫散射比浊法）",null,"首次注册"]
[27,"粤械注准20252081457","费雪派克医疗器械（广州）有限公司","医用呼吸湿化器",null,"首次注册"]
[28,"粤械注准20252221458","广东凯特生物医疗科技有限公司","全自动生化分析仪",null,"首次注册"]
[29,"粤械注准20252081459","深圳迈瑞生物医疗电子股份有限公司","心肺复苏机",null,"首次注册"]
[30,"粤械注准20252081460","深圳迈瑞生物医疗电子股份有限公司","心肺复苏机",null,"首次注册"]
[31,"粤械注准20252141461","广州驼人贝康医疗科技有限公司","输液泵",null,"首次注册"]
[32,"粤械注准20252211462","深圳华鹊景医疗科技有限公司","认知功能训练软件",null,"首次注册"]
[33,"粤械注准20252181463","广东毅达医疗科技股份有限公司","超声多普勒胎儿监护系统",null,"首次注册"]
[34,"粤械注准20252021464","深圳库珀医疗股份有限公司","一次性使用输尿管封堵导管",null,"首次注册"]
[35,"粤械注准20252211465","深圳元动科技有限公司","认知功能评估与训练软件",null,"首次注册"]
[36,"粤械注准20252161466","兆科（广州）眼科药物有限公司","热敷眼罩","受托生产企业：上海暖友实业有限公司；统一社会信用代码：91310120691551409A。","首次注册"]
[37,"粤械注准20252171467","东莞市跃莱美医疗器械有限公司","定制式固定义齿",null,"首次注册"]
[38,"粤械注准20252171468","东莞市跃莱美医疗器械有限公司","定制式活动义齿",null,"首次注册"]
[39,"粤械注准20252401469","深圳市迈科龙生物技术有限公司","睾酮测定试剂盒（免疫荧光层析法）",null,"首次注册"]
[40,"粤械注准20252401470","尖果生物科技（深圳）有限公司","甲功复合质控品",null,"首次注册"]
[41,"粤械注准20252221474","广州德成生物科技有限公司","荧光免疫层析分析仪",null,"首次注册"]
[42,"粤械注准20252081475","连科信医疗科技（深圳）有限公司","一次性使用除颤电极片",null,"首次注册"]
[43,"粤械注准20252081476","深圳海业医疗科技有限公司","可视喉镜",null,"首次注册"]
[44,"粤械注准20252071477","深圳麦科田生物医疗技术股份有限公司","病人监护仪",null,"首次注册"]
[45,"粤械注准20252071478","深圳京柏医疗科技股份有限公司","经皮黄疸检测仪",null,"首次注册"]
[46,"粤械注准20252071479","深圳市乐创享生物科技有限公司","母亲胎儿监护仪",null,"首次注册"]
[47,"粤械注准20252211480","赛维森（广州）医疗科技服务有限公司","数字病理图像远程存储传输软件",null,"首次注册"]
[48,"粤械注准20252071481","深圳市艾瑞康医疗设备有限公司","母亲胎儿监护仪",null,"首次注册"]
[49,"粤械注准20252081482","深圳市汉起科技有限公司","医用空气压缩机组",null,"首次注册"]
[50,"粤械注准20252071483","深圳子卿医疗器械有限公司","臂式电子血压计",null,"首次注册"]
[51,"粤械注准20252141484","美康迪医疗（深圳）有限公司","电动洗鼻器",null,"首次注册"]
[52,"粤械注准20252061485","珠海视新医用科技股份有限公司","电子鼻咽喉内窥镜",null,"首次注册"]
[53,"粤械注准20252071486","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"]
[54,"粤械注准20252221487","医华生物科技（深圳）有限公司","显微图像扫描仪","受托生产企业：宁波舜宇仪器有限公司；统一社会信用代码：91330281734247926M。","首次注册"]
[55,"粤械注准20252221488","广州万孚生物技术股份有限公司","全自动凝血分析仪",null,"首次注册"]
[56,"粤械注准20252221489","深圳市亿立方生物技术有限公司","自动核酸分子杂交仪",null,"首次注册"]
[57,"粤械注准20252141490","深圳市乐创享生物科技有限公司","输液泵",null,"首次注册"]
[58,"粤械注准20252401491","深圳市迈科龙生物技术有限公司","血清淀粉样蛋白A（SAA）测定试剂盒（免疫荧光层析法）",null,"首次注册"]
[59,"粤械注准20252401492","深圳天深医疗器械有限公司","抗甲状腺过氧化物酶抗体测定试剂盒（化学发光免疫分析法）","受托生产企业：广州万孚生物技术股份有限公司；统一社会信用代码：91440101618640472W。","首次注册"]
[60,"粤械注准20252021493","深圳市康医博科技发展有限公司","一次性使用输尿管测压导引鞘",null,"首次注册"]
[61,"粤械注准20252401494","深圳市亚辉龙生物科技股份有限公司","可溶性CD146检测试剂盒（化学发光法）",null,"首次注册"]
[62,"粤械注准20252091495","希迪克（深圳）康复科技有限公司","微电流刺激仪",null,"首次注册"]
[63,"粤械注准20252071496","广州和城医疗器械有限公司","指夹式脉搏血氧仪",null,"首次注册"]
[64,"粤械注准20252091497","华南脑控（广东）智能科技有限公司","脑电生物反馈治疗仪","受托生产企业：佛山凯洋医疗器械有限公司；统一社会信用代码：91440605MA57E2M39B。","首次注册"]
[65,"粤械注准20252081498","广东飞鱼医疗科技有限公司","医用压缩式雾化器",null,"首次注册"]
[66,"粤械注准20252141499","广州威科美容设备有限公司","电子辅助推进器",null,"首次注册"]
[67,"粤械注准20252091500","广州析芒医疗科技有限公司","中频电疗仪",null,"首次注册"]
[68,"粤械注准20252031501","广东海思卡尔医疗科技有限公司","血管内介入微导丝",null,"首次注册"]
[69,"粤械注准20252071502","深圳市美连医疗电子股份有限公司","一次性无菌血压袖带","受托生产企业：始兴县美的连电子科技有限公司；统一社会信用代码：91440222675243940P。","首次注册"]
[70,"粤械注准20252141503","广东恒健制药有限公司","医用脱脂棉",null,"首次注册"]
[71,"粤械注准20252081504","深圳因赛德思医疗科技有限公司","一次性使用喉罩气道导管","受托生产企业：广东因赛德思医疗科技有限公司；统一社会信用代码：91441400MA55R5BP6D。","首次注册"]
[72,"粤械注准20252081505","深圳因赛德思医疗科技有限公司","一次性使用喉罩气道导管","受托生产企业：广东因赛德思医疗科技有限公司；统一社会信用代码：91441400MA55R5BP6D。","首次注册"]
[73,"粤械注准20252181506","深圳长久康联生物科技有限公司","人工授精导管",null,"首次注册"]
[74,"粤械注准20252181507","广东天康致远生物医疗科技有限公司","一次性使用子宫腔支架",null,"首次注册"]
[75,"粤械注准20252021508","珠海德瑞医疗器械有限公司","软组织松解手术器械",null,"首次注册"]
[76,"粤械注准20252191509","佛山市艺康医疗器械有限公司","手动轮椅车",null,"首次注册"]
[77,"粤械注准20252171510","广东盈立商贸有限公司","牙科综合治疗机",null,"首次注册"]
[78,"粤械注准20252401511","深圳市迈科龙生物技术有限公司","游离甲状腺素（FT4）测定试剂盒（免疫荧光层析法）",null,"首次注册"]
[79,"粤械注准20252401512","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）测定试剂盒 （化学发光免疫分析法）",null,"首次注册"]
[80,"粤械注准20252221513","深圳市亚辉龙生物科技股份有限公司","全自动荧光免疫分析仪",null,"首次注册"]
[81,"粤械注准20252141514","广州禾烽生物技术有限公司","输血输液加温仪",null,"首次注册"]
[82,"粤械注准20252061515","珠海视新医用科技股份有限公司","电子上消化道内窥镜",null,"首次注册"]
[83,"粤械注准20252171516","汕尾市葆丰医疗器械有限公司","根管预备机",null,"首次注册"]
[84,"粤械注准20252401517","深圳市迈科龙生物技术有限公司","白介素-6（IL-6）测定试剂盒（免疫荧光层析法）",null,"首次注册"]
[85,"粤械注准20252401518","尖果生物科技（深圳）有限公司","总三碘甲状腺原氨酸/总甲状腺素(TT3/TT4)二联测定试剂盒（化学发光免疫分析法）",null,"首次注册"]
[86,"粤械注准20252401519","广州市丰华生物股份有限公司","游离β-绒毛膜促性腺激素、妊娠相关血浆蛋白A复合质控品",null,"首次注册"]
[87,"粤械注准20252401520","广州市丰华生物股份有限公司","甲胎蛋白、游离β-绒毛膜促性腺激素、游离雌三醇复合质控品",null,"首次注册"]
[88,"粤械注准20252401521","深圳市科曼生物医疗有限公司","血细胞分析仪用校准物（光学法）",null,"首次注册"]
[89,"粤械注准20252401522","广州市丰华生物股份有限公司","抑制素A质控品",null,"首次注册"]
[90,"粤械注准20252401523","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20252031524","东莞市奥翔医疗科技有限公司","导丝",null,"首次注册"]
[92,"粤械注准20252221525","深圳市亚辉龙生物科技股份有限公司","化学发光免疫分析仪",null,"首次注册"]
[93,"粤械注准20252071526","东莞青雷医疗器材有限公司","医用电子体温计",null,"首次注册"]
[94,"粤械注准20252091527","深圳市慧康精密仪器有限公司","电磁式冲击波治疗仪",null,"首次注册"]
[95,"粤械注准20252071528","深圳市鲲维医疗电子有限公司","腕式电子血压计",null,"首次注册"]
[96,"粤械注准20252081529","深圳市安保医疗科技股份有限公司","麻醉视频喉镜",null,"首次注册"]
[97,"粤械注准20252191530","东声（惠州市）电子有限公司","耳内式助听器",null,"首次注册"]
[98,"粤械注准20252071531","深圳市博英医疗仪器科技有限公司","穿戴式动态心电记录仪",null,"首次注册"]
[99,"粤械注准20252181532","金宝医学科技（深圳）有限公司"," 胚胎移植导管",null,"首次注册"]
[100,"粤械注准20252171533","珠海市精齿口腔医疗科技有限公司","定制式活动义齿",null,"首次注册"]
[101,"粤械注准20252081534","广州迪克医疗器械有限公司","冲吸式口护吸痰管",null,"首次注册"]
[102,"粤械注准20252401535","珠海丽珠试剂股份有限公司","β淀粉样蛋白 1-42/β淀粉样蛋白 1-40 复合质控品",null,"首次注册"]
[103,"粤械注准20252401536","深圳市亚辉龙生物科技股份有限公司","可溶性生长刺激表达基因2蛋白测定试剂盒（化学发光法）",null,"首次注册"]
[104,"粤械注准20252401537","珠海丽珠试剂股份有限公司","β淀粉样蛋白1-42、β淀粉样蛋白1-40联合检测试剂盒（化学发光法）",null,"首次注册"]
[105,"粤械注准20252171538","深圳市云艺医疗科技有限公司","定制式矫治器",null,"首次注册"]
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[196,"粤械注准20212400613","深圳上泰生物工程有限公司","天门冬氨酸氨基转移酶测定试剂盒（天门冬氨酸底物法）",null,"延续注册"]
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[198,"粤械注准20202061966","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","原产品注册证号：粤械注准20202061966。","延续注册"]
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[200,"粤械注准20162170417","佛山市多易美医疗器材有限公司","高速涡轮手机","原产品注册证号：粤械注准20162170417。","延续注册"]
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[219,"粤械注准20222140347","京美德（深圳）医疗科技有限公司","颅脑外引流收集装置","原产品注册证号：粤械注准20222140347。","延续注册"]
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[222,"粤械注准20212021464","深圳市康医博科技发展有限公司","一次性使用内窥镜取石篮","原产品注册证号：粤械注准20212021464。","延续注册"]
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[225,"粤械注准20162090071","深圳市科瑞康实业有限公司","生物反馈神经功能重建治疗仪","原产品注册证号：粤械注准20162090071。","延续注册"]
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[227,"粤械注准20162060728","深圳市信冠机电有限公司","自动推注系统","原产品注册证号：粤械注准20162060728。","延续注册"]
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[230,"粤械注准20172030320","深圳市擎源医疗器械有限公司","一次性脑科手术用球囊导管套件","注册证有效期届满6个月前按明确后的管理类别向相应药品监督管理部门申请注册。","延续注册"]
[231,"粤械注准20152181224","深圳市金舜康医疗科技有限公司","电子阴道镜","原产品注册证号：粤械注准20152181224。","延续注册"]
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[235,"粤械注准20202061422","广州曼翔医药有限公司","便携式彩色超声诊断仪","原产品注册证号：粤械注准20202061422。","延续注册"]
[236,"粤械注准20212031861","深圳市擎源医疗器械有限公司","一次性使用组织扩张球囊导管套件","注册证有效期届满6个月前按明确后的管理类别向相应药品监督管理部门申请注册。","延续注册"]
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[248,"粤械注准20212400501","深圳上泰生物工程有限公司","小而密低密度脂蛋白胆固醇测定试剂盒（过氧化物酶法）",null,"延续注册"]
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[250,"粤械注准20162210224","深圳迈瑞生物医疗电子股份有限公司","中心监护系统","原产品注册证号：粤械注准20162070224。","延续注册"]
[251,"粤械注准20162071577","惠州科晖医用电子有限公司","心电电极","原产品注册证号：粤械注准20162071577。","延续注册"]
[252,"粤械注准20162400996","深圳市博卡生物技术有限公司","抗卵巢（O）抗体检测试剂盒（酶联免疫法）",null,"延续注册"]
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