来自国家药监局2026年2月9日公开披露的数据，国家药监局2026年1月批准73个进口第一类医疗器械产品备案事项，具体产品包括高速台式冷冻离心机、高速台式离心机、口腔手术器械、医疗用黏性胶带、橡皮障、牙科种植专用器械包、手术放大镜、牙科骨磨、造口袋、造口皮肤保护剂等，一起来看具体内容。
2026年1月进口第一类医疗器械产品备案信息
产品名称备案号备案人名称原文备案日期高速台式冷冻离心机国械备20260022号Thermo Electron LED GmbH Zweigniederlassung Osterode2026-01-30高速台式离心机国械备20260021号Thermo Electron LED GmbH Zweigniederlassung Osterode2026-01-30高速冷冻离心机国械备20260020号Thermo Electron LED GmbH Zweigniederlassung Osterode2026-01-30口腔手术器械国械备20260019号AEMCO Z.E (PVT) LTD2026-01-30医疗用黏性胶带国械备20260018号BSN medical GmbH2026-01-30橡皮障国械备20151345号SANCTUARY HEALTH SDN BHD2026-01-28牙科种植专用器械包国械备20161332号DIO Corporation2026-01-27手术放大镜国械备20161081号General Scientific Corporation2026-01-27CD25抗体试剂（流式细胞仪法-SNv428）国械备20260017号Immunotech SAS A Beckman Coulter Company2026-01-27牙科骨磨国械备20230091号A.Schweickhardt GmbH & Co.KG2026-01-26口腔科器械国械备20240396号A.Schweickhardt GmbH＆Co.KG2026-01-26口腔科器械国械备20191336号A.Schweickhardt GmbH＆Co.KG2026-01-26铸造蜡国械备20191040号(?)??????2026-01-26间接嵌体蜡国械备20191015号(?)??????2026-01-26医用检查手套国械备20260016号Sri Trang Gloves (Thailand) Public Company Limited2026-01-26血压袖带国械备20210497号GE Medical Systems Information Technologies, Inc.2026-01-26医用透气胶布国械备20240137号仙峰科技實業有限公司2026-01-26血液采集卡国械备20260015号UAB RDA Spot2026-01-23手术放大镜国械备20161081号General Scientific Corporation2026-01-22聚酯衬垫国械备20171224号M?lnlycke Health Care AB2026-01-21排龈线填塞器国械备20180025号????2026-01-20口镜国械备20162037号????2026-01-20口腔麻醉注射架国械备20162010号????2026-01-20耳钳国械备20260014号NIBBLE SURGICAL2026-01-20视力表投影仪国械备20191348号株式会社トプコン2026-01-19手术剪国械备20230002号MICROMA Martin Alber GmbH & Co.KG2026-01-19螺丝起国械备20260009号Medigma Biomedical GmbH2026-01-15口腔科器械国械备20260013号AK GLOBAL MED2026-01-15膝关节手术工具国械备20181669号Meril Healthcare Pvt. Ltd.2026-01-14创口贴国械备20181738号3M Deutschland GmbH2026-01-13核酸提取或纯化试剂国械备20170757号台灣圓點奈米技術股份有限公司2026-01-13牙科种植材料取出器国械备20260011号Anthogyr2026-01-12种植辅助材料国械备20181132号Anthogyr2026-01-12流式细胞研究用溶血剂 IntraPrep Permeabilization Reagent国械备20180004号Immunotech S.A.S (a Beckman Coulter Company)2026-01-12人类白细胞抗原DR抗体试剂（流式细胞仪法-SNv428）国械备20260010号Immunotech SAS A Beckman Coulter Company2026-01-12螺丝起国械备20260009号Medigma Biomedical GmbH2026-01-12口腔科器械国械备20260008号MUSFIRA SURGICAL2026-01-12膝部固定器国械备20250159号SPORLASTIC GmbH & Co. KG2026-01-12转移帽国械备20170348号MegaGen Implant Co., Ltd.2026-01-09凝血研究用稀释液国械备20150089号DIAGNOSTICA STAGO2026-01-09桡骨小头系统手术工具国械备20260007号Biomet Orthopedics2026-01-09造口袋国械备20191032号ConvaTec Limited2026-01-08造口凸面嵌圈国械备20150925号ConvaTec Limited2026-01-08高分子固定绷带国械备20200440号ConvaTec Limited2026-01-08弹力绷带国械备20200388号ConvaTec Limited2026-01-08造口袋国械备20181323号ConvaTec Inc.2026-01-08造口底盘国械备20181394号ConvaTec Inc.2026-01-08造口袋国械备20190171号ConvaTec Inc.2026-01-08造口袋国械备20190930号ConvaTec Inc.2026-01-08造口袋国械备20190626号ConvaTec Inc.2026-01-08造口袋国械备20240027号ConvaTec Inc.2026-01-08引流袋国械备20210078号ConvaTec Limited2026-01-08造口皮肤保护剂国械备20210568号康维德有限责任公司ConvaTec Limited2026-01-08造口袋国械备20140099号ConvaTec Limited2026-01-08造口袋国械备20210169号ConvaTec Limited2026-01-08造口皮肤保护剂国械备20191366号ConvaTec Limited2026-01-07一件式造口袋国械备20200123号ConvaTec Limited2026-01-07造口皮肤保护剂国械备20210611号康维德有限责任公司ConvaTec Limited2026-01-07造口袋国械备20240105号ConvaTec Limited2026-01-07造口底盘国械备20200110号ConvaTec Inc.2026-01-07防漏膏国械备20190264号ConvaTec Inc.2026-01-07造口袋国械备20140062号ConvaTec Inc.2026-01-07造口袋国械备20210159号ConvaTec Inc.2026-01-07牙科种植手术工具包国械备20230478号MegaGen Implant Co.,Ltd.2026-01-07组织钳国械备20260006号BMC-PRIMA GmbH2026-01-05人工肩关节系统手术器械包国械备20260005号TORNIER, INC.2026-01-05踝关节系统手术器械包国械备20260004号WRIGHT MEDICAL TECHNOLOGY, INC.2026-01-05牵开器国械备20260003号BMC-PRIMA GmbH2026-01-05骨凿国械备20260002号BMC-PRIMA GmbH2026-01-05可挤压式四肢压力带国械备20260001号BSN medical Inc.2026-01-05医用外固定支具国械备20181484号Bauerfeind AG2026-01-05医用体位胶垫国械备20170691号SUNDANCE ENTERPRISES, INC.2026-01-21弹性绷带国械备20180690号M?lnlycke Health Care AB2026-01-21如有进口第一类医疗器械产品备案、进口医疗器械注册代理服务需求，欢迎您随时方便与北京飞速度医疗科技有限公司联络，联系人：施经理，电话：19103801095，微信同。
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