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["常州市市场监管局第一类医疗器械备案目录（2025年一季度）"]
["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20250053","电动移位机","常州市友邦医疗康复器材有限公司","首次备案"]
["2","苏常械备20250052","牙科用软组织环切刀","常州瑞钛克医疗器械有限公司","首次备案"]
["3","苏常械备20250051","种植体内螺纹修复器","常州瑞钛克医疗器械有限公司","首次备案"]
["4","苏常械备20250050","牙科种植材料取出器","常州瑞钛克医疗器械有限公司","首次备案"]
["5","苏常械备20250049","断钉取出器械包","常州瑞钛克医疗器械有限公司","首次备案"]
["6","苏常械备20250048","乳牙成形冠套","奥派梅森（江苏）医疗科技有限公司","首次备案"]
["7","苏常械备20250047","一次性使用口腔器械盒","奥派梅森（江苏）医疗科技有限公司","首次备案"]
["8","苏常械备20250046","医用吸氧面罩","常州汉博生物科技有限公司","首次备案"]
["9","苏常械备20250045","骨科用锯片","圣塔菲医疗科技（常州）有限公司","首次备案"]
["10","苏常械备20250044","免疫显色试剂","江苏生源纳科新材料有限责任公司","首次备案"]
["11","苏常械备20250043","悬吊康复训练系统","常州迪普医疗器械科技有限公司","首次备案"]
["12","苏常械备20250042","股骨倒置髓内钉器械包","江苏创立康医疗器械有限公司","首次备案"]
["13","苏常械备20250041","胸腰椎矫形器械包","江苏创立康医疗器械有限公司","首次备案"]
["14","苏常械备20250040","脊柱内固定器械包","江苏创立康医疗器械有限公司","首次备案"]
["15","苏常械备20250039","重建骨盆接骨板手术器械包","江苏创立康医疗器械有限公司","首次备案"]
["16","苏常械备20250038","穴位压力刺激贴","常州心闺蜜生物科技有限公司","首次备案"]
["17","苏常械备20250037","弹性髓内钉器械包","常州永华医疗器械有限公司","首次备案"]
["18","苏常械备20250036","骨盆牵开器械包","常州康鼎医疗器械有限公司","首次备案"]
["19","苏常械备20250035","医用干式激光胶片","江苏泰威影像科技有限公司","首次备案"]
["20","苏常械备20250034","牙科开口器","常州益锐医疗器材有限公司","首次备案"]
["21","苏常械备20250033","肌腱钳","常州康鼎医疗器械有限公司","首次备案"]
["22","苏常械备20250032","自稳定型颈椎融合器专用器械包","朔崛（江苏）医疗科技有限公司","首次备案"]
["23","苏常械备20250031","医用离心机","朔崛（江苏）医疗科技有限公司","首次备案"]
["24","苏常械备20250030","钻针引导器","常州瑞钛克医疗器械有限公司","首次备案"]
["25","苏常械备20250029","颅颌面固定系统专用工具包","创辉医疗器械江苏有限公司","首次备案"]
["26","苏常械备20250028","棉球","常州市莱洁卫生材料有限公司","首次备案"]
["27","苏常械备20250027","护理垫单","常州市莱洁卫生材料有限公司","首次备案"]
["28","苏常械备20250026","牙科种植用扳手","常州华森医疗器械股份有限公司","首次备案"]
["29","苏常械备20250025","螺丝起","常州华森医疗器械股份有限公司","首次备案"]
["30","苏常械备20250024","皮肤组织穿孔器","常州海尔斯医疗器械科技有限公司","首次备案"]
["31","苏常械备20250023","骨科定位器","常州市康辉医疗器械有限公司","首次备案"]
["32","苏常械备20250022","CD42b抗体试剂","精匠诊断技术（江苏）有限公司","首次备案"]
["33","苏常械备20250021","CD41抗体试剂","精匠诊断技术（江苏）有限公司","首次备案"]
["34","苏常械备20250020","CD61抗体试剂","精匠诊断技术（江苏）有限公司","首次备案"]
["35","苏常械备20250019","CD42a抗体试剂","精匠诊断技术（江苏）有限公司","首次备案"]
["36","苏常械备20250018","CD62P抗体试剂","精匠诊断技术（江苏）有限公司","首次备案"]
["37","苏常械备20250017","同型对照抗体（IgG1）","精匠诊断技术（江苏）有限公司","首次备案"]
["38","苏常械备20250016","穴位压力刺激贴","常州明晨医疗科技有限公司","首次备案"]
["39","苏常械备20250015","穴位压力刺激贴","常州明晨医疗科技有限公司","首次备案"]
["40","苏常械备20250014","急救绷带","江苏卓见医疗用品有限公司","首次备案"]
["41","苏常械备20250013","医用体外引流器","常州市达华医疗器材有限公司","首次备案"]
["42","苏常械备20250012","CD127抗体试剂","常州麦德星生物技术有限公司","首次备案"]
["43","苏常械备20250011","CD25抗体试剂","常州麦德星生物技术有限公司","首次备案"]
["44","苏常械备20250010","CD8抗体试剂","常州麦德星生物技术有限公司","首次备案"]
["45","苏常械备20250009","CD3抗体试剂","常州麦德星生物技术有限公司","首次备案"]
["46","苏常械备20250008","施夹钳（不带夹）","常州洛克曼医疗器械有限公司","首次备案"]
["47","苏常械备20250007","除夹钳","常州洛克曼医疗器械有限公司","首次备案"]
["48","苏常械备20250006","低速冷冻离心机","江苏道合瑞思生物科技有限公司","首次备案"]
["49","苏常械备20250005","棉片","常州茂康医疗用品有限公司","首次备案"]
["50","苏常械备20250004","一次性吸引管","健尔康医疗科技股份有限公司","首次备案"]
["51","苏常械备20250003","涂药棒","常州澄尔康医疗器械有限公司","首次备案"]
["52","苏常械备20250002","股骨髓内钉器械包","常州福美来医疗器械厂","首次备案"]
["53","苏常械备20250001","脊柱手术工具包","常州锦瑟医疗器械有限公司","首次备案"]
["54","苏常械备20250003","涂药棒","常州澄尔康医疗器械有限公司","变更备案"]
["55","苏常械备20240301","胫骨带锁髓内钉器械包","常州宏思博医疗器械有限公司","变更备案"]
["56","苏常械备20240301","胫骨带锁髓内钉器械包","常州宏思博医疗器械有限公司","变更备案"]
["57","苏常械备20240297","样本释放剂","常州玖明医疗科技有限公司","变更备案"]
["58","苏常械备20240294","医用体位垫","常州康有医疗科技有限公司","变更备案"]
["59","苏常械备20240293","样本稀释液","常州华班亚生物科技有限公司","变更备案"]
["60","苏常械备20240289","股骨带锁髓内钉器械包","常州宏思博医疗器械有限公司","变更备案"]
["61","苏常械备20240289","股骨带锁髓内钉器械包","常州宏思博医疗器械有限公司","变更备案"]
["62","苏常械备20240287","一次性使用牙科冲洗针","特超医疗器械（常州）有限公司","变更备案"]
["63","苏常械备20240286","皮肤滚针","常州市伊诺威医疗科技有限公司","变更备案"]
["64","苏常械备20240283","根管锉","赛乐（常州）医疗科技股份有限公司","变更备案"]
["65","苏常械备20240282","施夹钳（不带夹）","常州志卓精密机械制造有限公司","变更备案"]
["66","苏常械备20240281","待测物清洗液/洗脱液","启明基因科技（江苏）有限公司","变更备案"]
["67","苏常械备20240278","抗体稀释液","启明基因科技（江苏）有限公司","变更备案"]
["68","苏常械备20240266","消毒刷","江苏涵恒医疗科技有限公司","变更备案"]
["69","苏常械备20240265","样本释放剂/裂解液","常州佳净医疗科技有限公司","变更备案"]
["70","苏常械备20240263","细胞培养基","徕康细胞工程（常州）有限公司","变更备案"]
["71","苏常械备20240263","细胞培养基","徕康细胞工程（常州）有限公司","变更备案"]
["72","苏常械备20240262","细胞保存液","徕康细胞工程（常州）有限公司","变更备案"]
["73","苏常械备20240262","细胞保存液","徕康细胞工程（常州）有限公司","变更备案"]
["74","苏常械备20240261","睾丸核蛋白（NUT）抗体试剂","启明基因科技（江苏）有限公司","变更备案"]
["75","苏常械备20240258","液基细胞和微生物处理试剂","常州玖明医疗科技有限公司","变更备案"]
["76","苏常械备20240238","带剪持针钳","常州众一医疗器械有限公司","变更备案"]
["77","苏常械备20240234","待测物清洗液/洗脱液","常州昕美达微创医疗器械科技有限公司","变更备案"]
["78","苏常械备20240234","待测物清洗液/洗脱液","常州昕美达微创医疗器械科技有限公司","变更备案"]
["79","苏常械备20240233","待测物清洗液/洗脱液","常州茂康医疗用品有限公司","变更备案"]
["80","苏常械备20240232","免疫显色试剂","中汉（江苏）医学科技有限公司","变更备案"]
["81","苏常械备20240228","半月板修复器械包","常州市天晟医疗器械有限公司","变更备案"]
["82","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"]
["83","苏常械备20240226","全内交叉韧带重建器械包II型","常州市天晟医疗器械有限公司","变更备案"]
["84","苏常械备20240225","肩关节修复器械包","常州市天晟医疗器械有限公司","变更备案"]
["85","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"]
["86","苏常械备20240220","骨科用穿孔针","常州市天晟医疗器械有限公司","变更备案"]
["87","苏常械备20240207","自稳型颈椎前路椎间融合内固定系统专用器械包","常州集硕医疗器械有限公司","变更备案"]
["88","苏常械备20240206","肩锁关节脱位重建器械包","常州市天晟医疗器械有限公司","变更备案"]
["89","苏常械备20240206","肩锁关节脱位重建器械包","常州市天晟医疗器械有限公司","变更备案"]
["90","苏常械备20240202","股骨颈固定系统专用工具包","创辉医疗器械江苏有限公司","变更备案"]
["91","苏常械备20240199","皮肤滚针","常州泰美瑞生物科技有限公司","变更备案"]
["92","苏常械备20240199","皮肤滚针","常州泰美瑞生物科技有限公司","变更备案"]
["93","苏常械备20240190","免疫组化抗原修复缓冲液","启明基因科技（江苏）有限公司","变更备案"]
["94","苏常械备20240188","骨科牵引架","三丰东星医疗器材（江苏）有限公司","变更备案"]
["95","苏常械备20240184","生长抑素受体2（SSTR 2）抗体试剂","启明基因科技（江苏）有限公司","变更备案"]
["96","苏常械备20240159","断钉取出手术器械包","常州华诺医疗科技有限公司","变更备案"]
["97","苏常械备20240115","医用吸氧面罩","常州汉博生物科技有限公司","变更备案"]
["98","苏常械备20240077","一次性口腔器械盒","常州美康源医疗用品集团有限公司","变更备案"]
["99","苏常械备20240060","牙科用镊","常州美康源医疗用品集团有限公司","变更备案"]
["100","苏常械备20240050","消毒刷","常州澄尔康医疗器械有限公司","变更备案"]
["101","苏常械备20240044","悬吊康复训练系统","常州市金誉医用器材有限公司","变更备案"]
["102","苏常械备20240043","手功能综合训练桌","常州市金誉医用器材有限公司","变更备案"]
["103","苏常械备20240042","钻头","常州瑞钛克医疗器械有限公司","变更备案"]
["104","苏常械备20240041","牙科种植用连接件","常州瑞钛克医疗器械有限公司","变更备案"]
["105","苏常械备20240034","医用超声耦合剂","常州美康源医疗用品集团有限公司","变更备案"]
["106","苏常械备20240028","聚醚醚酮钉鞘系统工具包","常州市天晟医疗器械有限公司","变更备案"]
["107","苏常械备20240021","骨定位针","常州市天晟医疗器械有限公司","变更备案"]
["108","苏常械备20240020","组织钳","常州市天晟医疗器械有限公司","变更备案"]
["109","苏常械备20240019","钻头","常州市天晟医疗器械有限公司","变更备案"]
["110","苏常械备20240005","医用胶布","江苏卓见医疗用品有限公司","变更备案"]
["111","苏常械备20240004","医用隔离垫","常州美康源医疗用品集团有限公司","变更备案"]
["112","苏常械备20230301","骨科用保护器","常州市天晟医疗器械有限公司","变更备案"]
["113","苏常械备20230300","医用吸氧面罩","常州汉博生物科技有限公司","变更备案"]
["114","苏常械备20230289","膝关节韧带手术剪","常州市天晟医疗器械有限公司","变更备案"]
["115","苏常械备20230266","肋骨接骨板手术器械包","江苏冠创医疗科技有限公司","变更备案"]
["116","苏常械备20230265","胸骨接骨板手术器械包","江苏冠创医疗科技有限公司","变更备案"]
["117","苏常械备20230236","口垫","江苏常美医疗器械有限公司","变更备案"]
["118","苏常械备20230192","医用钙石灰","安普诺医疗科技（常州）有限公司","变更备案"]
["119","苏常械备20230192","医用钙石灰","安普诺医疗科技（常州）有限公司","变更备案"]
["120","苏常械备20230042","医用透气胶带","健尔康医疗科技股份有限公司","变更备案"]
["121","苏常械备20220514","弹力绷带","江苏安诺锐科医疗器械有限公司","变更备案"]
["122","苏常械备20220512","口腔科用隔离面罩","常州美康源医疗用品集团有限公司","变更备案"]
["123","苏常械备20220507","踝关节固定带","常州普邦医疗设备有限公司","变更备案"]
["124","苏常械备20220475","肋骨固定带","常州普邦医疗设备有限公司","变更备案"]
["125","苏常械备20220472","膝关节固定器","常州普邦医疗设备有限公司","变更备案"]
["126","苏常械备20220465","骨科手术手部固定板","常州普邦医疗设备有限公司","变更备案"]
["127","苏常械备20220454","引流袋","常州美康源医疗用品集团有限公司","变更备案"]
["128","苏常械备20220453","楔子","常州美康源医疗用品集团有限公司","变更备案"]
["129","苏常械备20220452","一次性使用手术废物收集袋","常州美康源医疗用品集团有限公司","变更备案"]
["130","苏常械备20220318","洗手衣","常州美康源医疗用品集团有限公司","变更备案"]
["131","苏常械备20220317","牙科修复体粘接棒","常州美康源医疗用品集团有限公司","变更备案"]
["132","苏常械备20220316","牙科测量尺","常州美康源医疗用品集团有限公司","变更备案"]
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