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["常州市市场监督管理局第一类医疗器械备案目录（2025年四季度）"]
["序号","注册证编号/备案号","产品名称","注册人名称/备案人名称","办理事项"]
["1","苏常械备20250198","核酸提取或纯化试剂","崇柏特生物科技（常州）有限公司","首次备案"]
["2","苏常械备20250197","核酸提取或纯化试剂","崇柏特生物科技（常州）有限公司","首次备案"]
["3","苏常械备20250196","自粘性硅胶胶带","江苏卓见医疗用品有限公司","首次备案"]
["4","苏常械备20250195","医用离心机","基诺创仪（常州）科技有限公司","首次备案"]
["5","苏常械备20250194","医用诊疗床","常州创捷微创医疗器械有限公司","首次备案"]
["6","苏常械备20250193","可调式固定支具","常州普邦医疗设备有限公司","首次备案"]
["7","苏常械备20250192","前臂吊带","常州普邦医疗设备有限公司","首次备案"]
["8","苏常械备20250191","小儿漏斗胸专用器械专用器械包","常州集硕医疗器械有限公司","首次备案"]
["9","苏常械备20250190","脊柱通道专用器械包","常州集硕医疗器械有限公司","首次备案"]
["10","苏常械备20250189","椎体融合器专用器械包","常州集硕医疗器械有限公司","首次备案"]
["11","苏常械备20250188","跟骨锁定螺钉专用器械包","常州集硕医疗器械有限公司","首次备案"]
["12","苏常械备20250187","脊柱矫形系统专用器械包","常州集硕医疗器械有限公司","首次备案"]
["13","苏常械备20250186","骨科手术导航工具包","常州维卓致远医疗科技发展有限公司","首次备案"]
["14","苏常械备20250185","腰椎融合器器械包","常州华森医疗器械股份有限公司","首次备案"]
["15","苏常械备20250184","食道贲门狭窄扩张器套装","江苏格里特医疗科技有限公司","首次备案"]
["16","苏常械备20250183","全自动核酸提取仪","常州金麦格生物技术有限公司","首次备案"]
["17","苏常械备20250182","胸腰椎后路生长带系统专用器械包","常州集硕医疗器械有限公司","首次备案"]
["18","苏常械备20250181","核酸提取或纯化试剂","崇柏特生物科技（常州）有限公司","首次备案"]
["19","苏常械备20250180","施夹钳（不带夹）","镁格生物科技（江苏）有限公司","首次备案"]
["20","苏常械备20250179","X射线胶片观片灯","江苏智迪锐医用净化设备有限责任公司","首次备案"]
["21","苏常械备20250178","单髁膝关节置换工具","常州鼎健医疗器械有限公司","首次备案"]
["22","苏常械备20250177","刀头","常州市汇达医疗器械有限公司","首次备案"]
["23","苏常械备20250176","一次性使用牙探针","常州市泓帆自动化设备有限公司","首次备案"]
["24","苏常械备20250175","CD38抗体试剂","中汉（江苏）医学科技有限公司","首次备案"]
["25","苏常械备20250174","CDX-2抗体试剂","中汉（江苏）医学科技有限公司","首次备案"]
["26","苏常械备20250173","Ki-67抗体试剂","中汉（江苏）医学科技有限公司","首次备案"]
["27","苏常械备20250172","CD3抗体试剂","中汉（江苏）医学科技有限公司","首次备案"]
["28","苏常械备20250171","CD5抗体试剂","中汉（江苏）医学科技有限公司","首次备案"]
["29","苏常械备20250170","CD68抗体试剂","中汉（江苏）医学科技有限公司","首次备案"]
["30","苏常械备20250169","绒毛蛋白（Villin）抗体试剂","中汉（江苏）医学科技有限公司","首次备案"]
["31","苏常械备20250168","胎盘碱性磷酸酶（PLAP）抗体试剂","中汉（江苏）医学科技有限公司","首次备案"]
["32","苏常械备20250167","天冬氨酸蛋白酶（Napsin A）抗体试剂","中汉（江苏）医学科技有限公司","首次备案"]
["33","苏常械备20250166","细胞角蛋白7（CK7）抗体试剂","中汉（江苏）医学科技有限公司","首次备案"]
["34","苏常械备20250165","细胞角蛋白18（CK18）抗体试剂","中汉（江苏）医学科技有限公司","首次备案"]
["35","苏常械备20250164","胰岛素（Insulin）抗体试剂","中汉（江苏）医学科技有限公司","首次备案"]
["36","苏常械备20250163","细胞角蛋白20（CK20）抗体试剂","中汉（江苏）医学科技有限公司","首次备案"]
["37","苏常械备20250162","免疫显色试剂","中汉（江苏）医学科技有限公司","首次备案"]
["38","苏常械备20250161","磨钻手柄","常州市汇达医疗器械有限公司","首次备案"]
["39","苏常械备20250160","抓钳","常州市超然电力电子有限公司","首次备案"]
["40","苏常械备20250159","分离钳","常州市超然电力电子有限公司","首次备案"]
["41","苏常械备20250158","止血钳","常州市超然电力电子有限公司","首次备案"]
["42","苏常械备20250157","持针钳","常州市超然电力电子有限公司","首次备案"]
["43","苏常械备20250156","手术剪","常州市超然电力电子有限公司","首次备案"]
["44","苏常械备20250155","组织镊","常州市超然电力电子有限公司","首次备案"]
["45","苏常械备20250153","试模","常州市露通医疗器材有限公司","首次备案"]
["46","苏常械备20250152","样本释放剂/裂解液","常州华班亚生物科技有限公司","首次备案"]
["47","苏常械备20250151","根管锉","常州安趣医疗技术有限公司","首次备案"]
["48","苏常械备20250150","推注式给药器","江苏康进医疗器材有限公司","首次备案"]
["49","苏常械备20250149","根管器械取出套装","常州益锐医疗器材有限公司","首次备案"]
["50","苏常械备20250148","骨膜剥离器","江苏爱厚朴医疗器械有限公司","首次备案"]
["51","苏常械备20250147","手动推车","常州郎成智能科技有限公司","首次备案"]
["52","苏常械备20250146","橡皮障","常州至简医疗器械有限公司","首次备案"]
["53","苏常械备20250145","骨科牵引架","常州市博智创医疗科技有限公司","首次备案"]
["54","苏常械备20250144","肛门扩张固定器","江苏安诺锐科医疗器械有限公司","首次备案"]
["55","苏常械备20250143","截骨锁定板手术器械包","常州永华医疗器械有限公司","首次备案"]
["56","苏常械备20250142","脊柱内固定器械包","常州华森医疗器械股份有限公司","首次备案"]
["57","苏常械备20250141","缓冲液","中汉（江苏）医学科技有限公司","首次备案"]
["58","苏常械备20250140","免疫组化抗原修复缓冲液","中汉（江苏）医学科技有限公司","首次备案"]
["59","苏常械备20250139","免疫组化抗原修复缓冲液","中汉（江苏）医学科技有限公司","首次备案"]
["60","苏常械备20250138","免疫显色试剂","中汉（江苏）医学科技有限公司","首次备案"]
["61","苏常械备20250137","抗体稀释液","中汉（江苏）医学科技有限公司","首次备案"]
["62","苏常械备20250136","脱蜡液","中汉（江苏）医学科技有限公司","首次备案"]
["63","苏常械备20250135","缓冲液","中汉（江苏）医学科技有限公司","首次备案"]
["64","苏常械备20250134","膝关节手术器械包","常州康鼎医疗器械有限公司","首次备案"]
["65","苏常械备20250133","肩关节手术器械包","常州康鼎医疗器械有限公司","首次备案"]
["66","苏常械备20250132","医用干式激光胶片","江苏泰威影像科技有限公司","首次备案"]
["67","苏常械备20250131","转移帽","江苏领锋医疗器械有限公司","首次备案"]
["68","苏常械备20250194","医用诊疗床","常州创捷微创医疗器械有限公司","变更备案"]
["69","苏常械备20250175","CD38抗体试剂","中汉（江苏）医学科技有限公司","变更备案"]
["70","苏常械备20250174","CDX-2抗体试剂","中汉（江苏）医学科技有限公司","变更备案"]
["71","苏常械备20250173","Ki-67抗体试剂","中汉（江苏）医学科技有限公司","变更备案"]
["72","苏常械备20250172","CD3抗体试剂","中汉（江苏）医学科技有限公司","变更备案"]
["73","苏常械备20250171","CD5抗体试剂","中汉（江苏）医学科技有限公司","变更备案"]
["74","苏常械备20250170","CD68抗体试剂","中汉（江苏）医学科技有限公司","变更备案"]
["75","苏常械备20250169","绒毛蛋白（Villin）抗体试剂","中汉（江苏）医学科技有限公司","变更备案"]
["76","苏常械备20250168","胎盘碱性磷酸酶（PLAP）抗体试剂","中汉（江苏）医学科技有限公司","变更备案"]
["77","苏常械备20250167","天冬氨酸蛋白酶（Napsin A）抗体试剂","中汉（江苏）医学科技有限公司","变更备案"]
["78","苏常械备20250166","细胞角蛋白7（CK7）抗体试剂","中汉（江苏）医学科技有限公司","变更备案"]
["79","苏常械备20250165","细胞角蛋白18（CK18）抗体试剂","中汉（江苏）医学科技有限公司","变更备案"]
["80","苏常械备20250164","胰岛素（Insulin）抗体试剂","中汉（江苏）医学科技有限公司","变更备案"]
["81","苏常械备20250163","细胞角蛋白20（CK20）抗体试剂","中汉（江苏）医学科技有限公司","变更备案"]
["82","苏常械备20250138","免疫显色试剂","中汉（江苏）医学科技有限公司","变更备案"]
["83","苏常械备20250128","医用放大镜","赛乐（常州）医疗科技股份有限公司","变更备案"]
["84","苏常械备20250123","颈椎自稳型椎间融合器系统专用工具包","创辉医疗器械江苏有限公司","变更备案"]
["85","苏常械备20250123","颈椎自稳型椎间融合器系统专用工具包","创辉医疗器械江苏有限公司","变更备案"]
["86","苏常械备20250121","核酸提取试剂","星纯（常州）生物科技有限公司","变更备案"]
["87","苏常械备20250120","探针","常州瑞神安医疗器械有限公司","变更备案"]
["88","苏常械备20250119","膝关节手术器械包","天衍医疗器材有限公司","变更备案"]
["89","苏常械备20250119","膝关节手术器械包","天衍医疗器材有限公司","变更备案"]
["90","苏常械备20250117","金属髓内针专用工具包","创辉医疗器械江苏有限公司","变更备案"]
["91","苏常械备20250117","金属髓内针专用工具包","创辉医疗器械江苏有限公司","变更备案"]
["92","苏常械备20250107","胫骨平台后外侧手术器械包","常州市康辉医疗器械有限公司","变更备案"]
["93","苏常械备20250105","牵开器","大瓷生物医疗科技（江苏）有限公司","变更备案"]
["94","苏常械备20250103","交叉韧带重建器械包","奥誉健医疗科技（常州）有限公司","变更备案"]
["95","苏常械备20250100","医用离心机","奥豪斯仪器（常州）有限公司","变更备案"]
["96","苏常械备20250097","位置定位器","江苏领锋医疗器械有限公司","变更备案"]
["97","苏常械备20250091","理疗电极","常州清治智能科技有限公司","变更备案"]
["98","苏常械备20250057","样本释放剂/裂解液","常州华班亚生物科技有限公司","变更备案"]
["99","苏常械备20250055","骨盆固定器","常州普邦医疗设备有限公司","变更备案"]
["100","苏常械备20250055","骨盆固定器","常州普邦医疗设备有限公司","变更备案"]
["101","苏常械备20250055","骨盆固定器","常州普邦医疗设备有限公司","变更备案"]
["102","苏常械备20250008","施夹钳（不带夹）","常州洛克曼医疗器械有限公司","变更备案"]
["103","苏常械备20250007","除夹钳","常州洛克曼医疗器械有限公司","变更备案"]
["104","苏常械备20240299","骨导引针","常州锦瑟医疗器械有限公司","变更备案"]
["105","苏常械备20240277","脂溶性维生素样本释放剂","常州华班亚生物科技有限公司","变更备案"]
["106","苏常械备20240276","水溶性维生素样本释放剂","常州华班亚生物科技有限公司","变更备案"]
["107","苏常械备20240271","牙科种植用测量器","博蔓医疗器械（常州）有限公司","变更备案"]
["108","苏常械备20240270","牙科种植用延长器","博蔓医疗器械（常州）有限公司","变更备案"]
["109","苏常械备20240253","康复训练器","江苏祝康康复医疗器材有限公司","变更备案"]
["110","苏常械备20240251","康复训练器","江苏祝康康复医疗器材有限公司","变更备案"]
["111","苏常械备20240243","助行架","江苏祝康康复医疗器材有限公司","变更备案"]
["112","苏常械备20240241","助行架","江苏祝康康复医疗器材有限公司","变更备案"]
["113","苏常械备20240227","全内交叉韧带重建器械包I型","常州市天晟医疗器械有限公司","变更备案"]
["114","苏常械备20240224","交叉韧带重建器械包","常州市天晟医疗器械有限公司","变更备案"]
["115","苏常械备20240213","上肢关节康复器","江苏祝康康复医疗器材有限公司","变更备案"]
["116","苏常械备20240208","人工椎体专用工具包","创辉医疗器械江苏有限公司","变更备案"]
["117","苏常械备20240193","牙科种植扫描定位件","常州华森医疗器械股份有限公司","变更备案"]
["118","苏常械备20240193","牙科种植扫描定位件","常州华森医疗器械股份有限公司","变更备案"]
["119","苏常械备20240187","牙科种植用连接件","博蔓医疗器械（常州）有限公司","变更备案"]
["120","苏常械备20240182","扭力扳手","博蔓医疗器械（常州）有限公司","变更备案"]
["121","苏常械备20240181","螺丝起","博蔓医疗器械（常州）有限公司","变更备案"]
["122","苏常械备20240113","刀头","博蔓医疗器械（常州）有限公司","变更备案"]
["123","苏常械备20240048","牙科种植扫描体","博蔓医疗器械（常州）有限公司","变更备案"]
["124","苏常械备20240046","牙龈分离器","博蔓医疗器械（常州）有限公司","变更备案"]
["125","苏常械备20240002","牙科种植用扩骨器","博蔓医疗器械（常州）有限公司","变更备案"]
["126","苏常械备20230324","免疫显色试剂","中汉（江苏）医学科技有限公司","变更备案"]
["127","苏常械备20230314","耳鼻喉科手术器械包","优尔爱（常州）医疗科技有限公司","变更备案"]
["128","苏常械备20230288","医用干式激光胶片","江苏泰威影像科技有限公司","变更备案"]
["129","苏常械备20230209","棉卷","健尔康医疗科技股份有限公司","变更备案"]
["130","苏常械备20230084","医用透气胶带","常州茂康医疗用品有限公司","变更备案"]
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