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| 2026年1月进口第一类医疗器械产品备案信息 | ||||||
| 序号 | 产品名称 | 备案号 | 备案人名称原文 | 生产地址原文 | 备案日期 | 状态 |
| 1 | 高速台式冷冻离心机 | 国械备20260022号 | Thermo Electron LED GmbH Zweigniederlassung Osterode | Am Kalkberg, 37520 Osterode am Harz, Germany | 2026-01-30 | 有效 |
| 2 | 高速台式离心机 | 国械备20260021号 | Thermo Electron LED GmbH Zweigniederlassung Osterode | Am Kalkberg, 37520 Osterode am Harz, Germany | 2026-01-30 | 有效 |
| 3 | 高速冷冻离心机 | 国械备20260020号 | Thermo Electron LED GmbH Zweigniederlassung Osterode | Am Kalkberg, 37520 Osterode am Harz, Germany | 2026-01-30 | 有效 |
| 4 | 口腔手术器械 | 国械备20260019号 | AEMCO Z.E (PVT) LTD | Arona Elahi Park, Elahiabad, Kashmir Road Sialkot, Pakistan | 2026-01-30 | 有效 |
| 5 | 医疗用黏性胶带 | 国械备20260018号 | BSN medical GmbH | 1 RUE DU MILLENAIRE, 72320 VIBRAYE, France | 2026-01-30 | 有效 |
| 6 | 橡皮障 | 国械备20151345号 | SANCTUARY HEALTH SDN BHD | No.16, Persiaran Perindustrian Kanthan 1, Kawasan Perindustrian Kanthan, 31200 Chemor, Perak, Malaysia | 2026-01-28 | 变更 |
| 7 | 牙科种植专用器械包 | 国械备20161332号 | DIO Corporation | 66, Centum seo-ro, Haeundae-gu, Busan, REPUBLIC OF KOREA | 2026-01-27 | 变更 |
| 8 | 手术放大镜 | 国械备20161081号 | General Scientific Corporation | 77 Enterprise Drive， Ann Arbor，Michigan 48103，United States | 2026-01-27 | 无效 |
| 9 | CD25抗体试剂（流式细胞仪法-SNv428） | 国械备20260017号 | Immunotech SAS A Beckman Coulter Company | 130 Avenue de Lattre de Tassigny BP 177 Marseille, Cedex 9 13276 France | 2026-01-27 | 有效 |
| 10 | 牙科骨磨 | 国械备20230091号 | A.Schweickhardt GmbH & Co.KG | Tuttlinger Straße 12 78606 Seitingen/ Tuttlingen Germany | 2026-01-26 | 变更 |
| 11 | 口腔科器械 | 国械备20240396号 | A.Schweickhardt GmbH＆Co.KG | Tuttlinger Straβe 12 78606 Seitingen-Oberflacht Germany | 2026-01-26 | 变更 |
| 12 | 口腔科器械 | 国械备20191336号 | A.Schweickhardt GmbH＆Co.KG | Tuttlinger Straße 12 78606 Seitingen / Tuttlingen Germany | 2026-01-26 | 变更 |
| 13 | 铸造蜡 | 国械备20191040号 | (주)일청덴탈약품 | 경기도 하남시 조정대로150, 941호(덕풍동，아이테코) | 2026-01-26 | 无效 |
| 14 | 间接嵌体蜡 | 国械备20191015号 | (주)일청덴탈약품 | 경기도 하남시 조정대로 150 , 941호 (덕풍동, 아이테코) | 2026-01-26 | 变更 |
| 15 | 医用检查手套 | 国械备20260016号 | Sri Trang Gloves (Thailand) Public Company Limited | 88/8, Moo 11, Khao Chai Rat, Pathio, Chumphon 86210, THAILAND | 2026-01-26 | 有效 |
| 16 | 血压袖带 | 国械备20210497号 | GE Medical Systems Information Technologies, Inc. | Calle Valle Del Cedro 1551, Juarez, Mexico 32575； 1F, 2F, 5F No.21 Jiankang Rd., Jhonghe Dist. New Taipei City 235, Taiwan | 2026-01-26 | 变更 |
| 17 | 医用透气胶布 | 国械备20240137号 | 仙峰科技實業有限公司 | 臺中市后里區義里里甲后路一段352巷65號 | 2026-01-26 | 变更 |
| 18 | 血液采集卡 | 国械备20260015号 | UAB RDA Spot | Dariaus ir Girèno g.32A-1, Vilnius | 2026-01-23 | 有效 |
| 19 | 手术放大镜 | 国械备20161081号 | General Scientific Corporation | 77 Enterprise Drive， Ann Arbor，Michigan 48103，United States | 2026-01-22 | 变更 |
| 20 | 聚酯衬垫 | 国械备20171224号 | Mölnlycke Health Care AB | Ave. Mike Allen 1220, Edificio 5 Parque Industrial Reynosa Sección Norte Reynosa Tamaulipas C.P. 88788 Mexico | 2026-01-21 | 无效 |
| 21 | 排龈线填塞器 | 国械备20180025号 | 아트리아 | 서울특별시 성동구 성수일로8길 5 , 에이동7층 701-712호 (성수동2가, 서울숲에스케이브이1타워) | 2026-01-20 | 变更 |
| 22 | 口镜 | 国械备20162037号 | 아트리아 | 대한민국,서울특별시 성동구 성수일로8길 5, 에이동7층 701-712호 (성수동2가, 서울숲에스케이브이1타워) | 2026-01-20 | 变更 |
| 23 | 口腔麻醉注射架 | 国械备20162010号 | 아트리아 | 서울특별시 성동구 성수일로8길 5 , 에이동7층 701-712호 (성수동2가,서울숲에스케이브이1타워) | 2026-01-20 | 变更 |
| 24 | 耳钳 | 国械备20260014号 | NIBBLE SURGICAL | Abyala，P/O Box Dholo Bhelo，Sialkot-Pakistan | 2026-01-20 | 有效 |
| 25 | 视力表投影仪 | 国械备20191348号 | 株式会社トプコン | 山形県山形市大字漆山２７０番地の２ | 2026-01-19 | 变更 |
| 26 | 手术剪 | 国械备20230002号 | MICROMA Martin Alber GmbH & Co.KG | Hardtstraße 19 78597 lrndorf Germany | 2026-01-19 | 变更 |
| 27 | 螺丝起 | 国械备20260009号 | Medigma Biomedical GmbH | Siemensstraße 10 78564 Wehingen Germany | 2026-01-15 | 变更 |
| 28 | 口腔科器械 | 国械备20260013号 | AK GLOBAL MED | INFRONT OF RANI RANQUET,RORAS ROAD,MUZAFFARPURE,SIALKOT-51310,PAKISTAN. | 2026-01-15 | 有效 |
| 29 | 膝关节手术工具 | 国械备20181669号 | Meril Healthcare Pvt. Ltd. | First Floor, H1-H3, Meril Park, Survey No 135/2/B & 174/2, Muktanand Marg, Chala,Vapi, Gujarat, India - 396191 | 2026-01-14 | 变更 |
| 30 | 创口贴 | 国械备20181738号 | 3M Deutschland GmbH | Ul. Kwidzynska 6 51-416 Wroclaw, Poland | 2026-01-13 | 变更 |
| 31 | 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 | 桃園縣桃園市龍山里龍壽街81巷12弄2號 | 2026-01-13 | 变更 |
| 32 | 牙科种植材料取出器 | 国械备20260011号 | Anthogyr | 2237 avenue André Lasquin, 74700 SALLANCHES FRANCE | 2026-01-12 | 有效 |
| 33 | 种植辅助材料 | 国械备20181132号 | Anthogyr | 2237 avenue André Lasquin, 74700 SALLANCHES FRANCE | 2026-01-12 | 变更 |
| 34 | 流式细胞分析用溶血剂 IntraPrep Permeabilization Reagent | 国械备20180004号 | Immunotech S.A.S (a Beckman Coulter Company) | 130 Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France | 2026-01-12 | 变更 |
| 35 | 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 Company | 130 Avenue de Lattre de Tassigny BP 177 Marseille, Cedex 9 13276 France | 2026-01-12 | 有效 |
| 36 | 螺丝起 | 国械备20260009号 | Medigma Biomedical GmbH | Siemensstraße 10 78564 Wehingen Germany | 2026-01-12 | 有效 |
| 37 | 口腔科器械 | 国械备20260008号 | MUSFIRA SURGICAL | Street Chakki Wali, Near Imdad Karyana, Muhalla Rowail Pura, Fateh Garh Agency Stop, Sialkot-51310,Pakistan. | 2026-01-12 | 有效 |
| 38 | 膝部固定器 | 国械备20250159号 | SPORLASTIC GmbH & Co. KG | Weberstraße 1, 72622 Nürtingen, Germany | 2026-01-12 | 变更 |
| 39 | 转移帽 | 国械备20170348号 | MegaGen Implant Co., Ltd. | 472, Hanjanggun-ro, Jain-myeon, Gyeongsan-si, Gyeongsangbuk-do, Korea | 2026-01-09 | 变更 |
| 40 | 凝血分析用稀释液 | 国械备20150089号 | DIAGNOSTICA STAGO | ZAC des Châtaigniers - 23/29 rue Constantin Pecqueur - 95150 Taverny - France | 2026-01-09 | 变更 |
| 41 | 桡骨小头系统手术工具 | 国械备20260007号 | Biomet Orthopedics | 56 East Bell Drive Po Box 587,Warsaw, Indiana Warsaw, IN USA 46581 | 2026-01-09 | 有效 |
| 42 | 造口袋 | 国械备20191032号 | ConvaTec Limited | Wendenschloßstraße 142,12557 Berlin Deutschland | 2026-01-08 | 变更 |
| 43 | 造口凸面嵌圈 | 国械备20150925号 | ConvaTec Limited | 211 American Avenue Greensboro North Carolina, 27409 USA | 2026-01-08 | 变更 |
| 44 | 高分子固定绷带 | 国械备20200440号 | ConvaTec Limited | St Helens Road, Bolton, BL3 3PR, United Kingdom | 2026-01-08 | 变更 |
| 45 | 弹力绷带 | 国械备20200388号 | ConvaTec Limited | Lowmoor Business Park, Kirkby in Ashfield, Nottinghamshire, NG17 7JZ, UK. | 2026-01-08 | 变更 |
| 46 | 造口袋 | 国械备20181323号 | ConvaTec Inc. | Carretera Sanchez, Km. 18.5 qarque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina, San Cristobal 91000 Dominican Republic | 2026-01-08 | 变更 |
| 47 | 造口底盘 | 国械备20181394号 | ConvaTec Inc. | Carretera Sanchez, Km. 18.5 Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina, San Cristobal 91000 Dominican Republic | 2026-01-08 | 变更 |
| 48 | 造口袋 | 国械备20190171号 | ConvaTec Inc. | Carretera Sanchez, Km. 18.5, Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina, San Cristobal, 91000 Dominican Republic. | 2026-01-08 | 变更 |
| 49 | 造口袋 | 国械备20190930号 | ConvaTec Inc. | Carretera Sanchez, Km. 18.5, Parque Industrial Itabo S.A. Buildings 23, 29, 30 Haina, San Cristobal, 91000 Dominican Republic; Priemyselny Park 3 07101 Michalovce Slovakia. | 2026-01-08 | 变更 |
| 50 | 造口袋 | 国械备20190626号 | ConvaTec Inc. | Carretera Sanchez, Km. 18.5, Parque Industrial Itabo S.A. Buildings 23, 29, 30 Haina, San Cristobal, 91000 Dominican Republic; Priemyselny Park 3 07101 Michalovce Slovakia. | 2026-01-08 | 变更 |
| 51 | 造口袋 | 国械备20240027号 | ConvaTec Inc. | Carretera Sanchez, Km. 18.5, Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina, San Cristobal, 91000 Dominican Republic. Priemyselny Park 3 07101 Michalovce Slovakia | 2026-01-08 | 变更 |
| 52 | 引流袋 | 国械备20210078号 | ConvaTec Limited | Carretera Sánchez, Km. 18.5 Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina, San Cristobal 91000 Dominican Republic. | 2026-01-08 | 变更 |
| 53 | 造口皮肤保护剂 | 国械备20210568号 | 康维德有限责任公司ConvaTec Limited | Hickmans Road, Birkenhead, Wirral CH41 1JH United Kingdom | 2026-01-08 | 变更 |
| 54 | 造口袋 | 国械备20140099号 | ConvaTec Limited | First Avenue, Deeside Industrial Park, Deeside, Flintshire, CH5 2NU, United Kingdom; Carretera Sanchez, Km. 18.5 Parque Industrial Itabo, S.A. Buidings 23, 29, 30 Haina, San Cristobal 91000 Dominican Republic. | 2026-01-08 | 变更 |
| 55 | 造口袋 | 国械备20210169号 | ConvaTec Limited | Carretera Sanchez, Km. 18.5 Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina, San Cristobal 91000 Dominican Republic | 2026-01-08 | 变更 |
| 56 | 造口皮肤保护剂 | 国械备20191366号 | ConvaTec Limited | UNIT 22, VALLEY ROAD BUSINESS PARK, BIDSTON, WIRRAL, MERSEYSIDE. CH41 7EL, UNITED KINGDOM | 2026-01-07 | 变更 |
| 57 | 一件式造口袋 | 国械备20200123号 | ConvaTec Limited | Carretera Sanchez, Km. 18.5, Parque Industrial Itabo S.A. Buildings 23, 29, 30 Haina, San Cristobal, 91000 Dominican Republic. | 2026-01-07 | 变更 |
| 58 | 造口皮肤保护剂 | 国械备20210611号 | 康维德有限责任公司ConvaTec Limited | Unit 12A&12B Kings Court，Prince William Avenue，Sandycroft，Deeside，CH5 2FG, United Kingdom | 2026-01-07 | 变更 |
| 59 | 造口袋 | 国械备20240105号 | ConvaTec Limited | Priemyselny Park 3 07101 Michalovce Slovakia | 2026-01-07 | 变更 |
| 60 | 造口底盘 | 国械备20200110号 | ConvaTec Inc. | Carretera Sanchez, Km. 18.5, Parque Industrial Itabo S.A. Buildings 23, 29, 30 Haina, San Cristobal, 91000 Dominican Republic. | 2026-01-07 | 变更 |
| 61 | 防漏膏 | 国械备20190264号 | ConvaTec Inc. | Carretera Sanchez, Km. 18.5, Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina, San Cristobal, 91000 Dominican Republic. | 2026-01-07 | 变更 |
| 62 | 造口袋 | 国械备20140062号 | ConvaTec Inc. | Carretera Sanchez, Km. 18.5 Parque Industrial Itabo, S.A. Buidings 23, 29, 30 Haina, San Cristobal 91000 Dominican Republic. | 2026-01-07 | 变更 |
| 63 | 造口袋 | 国械备20210159号 | ConvaTec Inc. | Carretera Sanchez, Km. 18.5 Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina, San Cristobal 91000 Dominican Republic | 2026-01-07 | 变更 |
| 64 | 牙科种植手术工具包 | 国械备20230478号 | MegaGen Implant Co.,Ltd. | 45, Secheon-ro 7-gil, Dasa-eup, Dalseong-gun, Daegu, Republic of Korea | 2026-01-07 | 变更 |
| 65 | 组织钳 | 国械备20260006号 | BMC-PRIMA GmbH | Herrenbachstraße 17, 73066 Uhingen Germany | 2026-01-05 | 有效 |
| 66 | 人工肩关节系统手术器械包 | 国械备20260005号 | TORNIER, INC. | 161 rue Lavoisier Montbonnot Saint-Martin, Isere FRANCE 38330 | 2026-01-05 | 有效 |
| 67 | 踝关节系统手术器械包 | 国械备20260004号 | WRIGHT MEDICAL TECHNOLOGY, INC. | 11576 Memphis-Arlington Rd Arlington, TN USA 38002 | 2026-01-05 | 有效 |
| 68 | 牵开器 | 国械备20260003号 | BMC-PRIMA GmbH | Herrenbachstraße 17, 73066 Uhingen Germany | 2026-01-05 | 有效 |
| 69 | 骨凿 | 国械备20260002号 | BMC-PRIMA GmbH | Herrenbachstraße 17, 73066 Uhingen Germany | 2026-01-05 | 有效 |
| 70 | 可挤压式四肢压力带 | 国械备20260001号 | BSN medical Inc. | 见附件 | 2026-01-05 | 有效 |
| 71 | 医用外固定支具 | 国械备20181484号 | Bauerfeind AG | Triebeser Straβe 16 07937 Zeulenroda- Triebes Germany | 2026-01-05 | 变更 |
| 72 | 医用体位胶垫 | 国械备20170691号 | SUNDANCE ENTERPRISES, INC. | 3902 Hanna Cir Suites A, E & F Indianapolis，IN 46241 | 2026-01-21 | 无效 |
| 73 | 弹性绷带 | 国械备20180690号 | Mölnlycke Health Care AB | Tubiton House Medlock Street Oldham OL1 3HS United Kingdom | 2026-01-21 | 无效 |
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