| 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 | 微孔板振荡孵育器 | 国械备20200372号 | Wallac Oy | Mustionkatu 6, FI-20750 Turku, Finland | 2024-02-29 | 变更 |
| 2 | 全自动核酸提取仪 | 国械备20140357号 | Wallac Oy | Mustionkatu 6, FI-20750 Turku, Finland | 2024-02-29 | 变更 |
| 3 | 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 | 2024-02-29 | 变更 |
| 4 | 高分子固定绷带 | 国械备20200440号 | ConvaTec Limited | St Helens Road, Bolton, BL3 3PR, United Kingdom | 2024-02-29 | 变更 |
| 5 | 弹力绷带 | 国械备20200388号 | ConvaTec Limited | Lowmoor Business Park, Kirkby in Ashfield, Nottinghamshire, NG17 7JZ, UK. | 2024-02-29 | 变更 |
| 6 | 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 | 2024-02-29 | 变更 |
| 7 | 医用检查手套 | 国械备20240056号 | PT . HALONI JANE | Jl. Raya Serang Km. 13,8 Kawasan Industri Tristate, RT/RW 02/02, Desa Sukadamai, Kec. Cikupa | 2024-02-29 | 有效 |
| 8 | 牵开器 | 国械备20220171号 | Rebstock Instruments GmbH | In Weiher?cker 7, 78589 Dürbheim Germany | 2024-02-29 | 变更 |
| 9 | 牙科成形片套装 | 国械备20220355号 | Bioclear Matrix Systems, LLC | 3802 S Warner Street Suite A Tacoma, WA US 98409 | 2024-02-29 | 变更 |
| 10 | 显微剪 | 国械备20220161号 | Rebstock Instruments GmbH | In Weiher?cker 7, 78589 Dürbheim Germany | 2024-02-28 | 变更 |
| 11 | 血管钳 | 国械备20220170号 | Rebstock Instruments GmbH | In Weiher?cker 7, 78589 Dürbheim Germany | 2024-02-28 | 变更 |
| 12 | 手术刀柄 | 国械备20150937号 | Swann-Morton Limited | Owlerton Green Sheffield S6 2BJ United Kingdom | 2024-02-28 | 变更 |
| 13 | 手术刀片 | 国械备20150431号 | Swann-Morton Limited | Owlerton Green Sheffield S6 2BJ United Kingdom | 2024-02-28 | 变更 |
| 14 | 手术刀 | 国械备20210404号 | Swann-Morton Limited | Owlerton Green Sheffield S6 2BJ United Kingdom | 2024-02-28 | 变更 |
| 15 | 印模帽 | 国械备20240055号 | BIOTEM CO., LTD. | 422, Sasang-ro, Sasang-gu, Busan-si, Republic of Korea | 2024-02-28 | 有效 |
| 16 | 种植辅助材料 | 国械备20190062号 | (?)??? | ??? ??? ??? ???? 474 , 4? 411?, 4? 412? (????, ??????????) | 2024-02-27 | 变更 |
| 17 | 种植体安装辅助工具 | 国械备20190673号 | (?)??? | ??? ??? ??? ???? 474 , 4? 411?, 4? 412?(????, ??????????) | 2024-02-27 | 变更 |
| 18 | 种植体螺丝起 | 国械备20190674号 | (?)??? | ??? ??? ??? ???? 474 , 4? 411?, 4? 412?(????, ??????????) | 2024-02-27 | 变更 |
| 19 | 压力绷带 | 国械备20150797号 | 3M Deutschland GmbH |
| 2024-02-27 | 变更 |
| 20 | 样本萃取液 | 国械备20240054号 | Abbott Ireland Diagnostics Division | 940 Crossroads Blvd., Seguin, TX 78155 USA | 2024-02-27 | 有效 |
| 21 | 牙科模型材料 | 国械备20240053号 | delcone inc. | 428-8, Waryong-ro, Seo-gu, Daegu, Republic of Korea | 2024-02-26 | 有效 |
| 22 | 髋关节手术器械 | 国械备20151787号 | Smith & Nephew,Inc | 1450 Brooks Road, Memphis, Tennessee, 38116, USA；
Alemannenstraβe 14, D-78532, Tuttlingen, 78532, Germany;
2 lengkok Teluk Kumbar 1, Jalan Teluk Kumbar, 11920 Bayan Lepas, Penang, MALAYSIA;
Schachenallee 29, 5001 Aarau, SWITZERLAND;
Boulevard Héctor Terán #20120, Ciudad Industrial, Tijuana, B.C. 22444, Mexico.
| 2024-02-26 | 变更 |
| 23 | 膝关节手术器械 | 国械备20160155号 | Smith & Nephew, Inc. | / | 2024-02-26 | 变更 |
| 24 | 轮转式切片机 | 国械备20160789号 | pfm medical gmbh | Wankelstraβe 60 50996 K?ln, Germany | 2024-02-26 | 变更 |
| 25 | 轮转式切片机 | 国械备20160787号 | pfm medical gmbh | Wankelstraβe 60 50996 K?ln, Germany | 2024-02-26 | 变更 |
| 26 | 轮转式切片机 | 国械备20160786号 | pfm medical gmbh | Wankelstraβe 60 50996 K?ln, Germany | 2024-02-26 | 变更 |
| 27 | 包埋机 | 国械备20190921号 | pfm medical gmbh | Wankelstra?e 60, 50996 K?ln, Germany | 2024-02-26 | 变更 |
| 28 | 手动推床 | 国械备20161591号 | Stryker Medical | 3800 E. Centre Avenue Portage Michigan 49002 USA | 2024-02-23 | 变更 |
| 29 | 妇产科诊疗床 | 国械备20240052号 | Stryker Medical | 3800 E. Centre Avenue Portage Michigan 49002 USA | 2024-02-23 | 有效 |
| 30 | 吸引管 | 国械备20240051号 | Surgivet Instruments Company | Wazirabad Road, Sialkot - Pakistan | 2024-02-22 | 有效 |
| 31 | 牙科刮治器 | 国械备20160969号 | PREMIER DENTAL PRODUCTS CO. | 1710 Romano Dr. Plymouth Meeting, PA 19462 | 2024-02-22 | 变更 |
| 32 | 牙探针 | 国械备20160838号 | PREMIER DENTAL PRODUCTS CO. | 1710 Romano Dr. Plymouth Meeting, PA 19462 | 2024-02-22 | 变更 |
| 33 | 腰部固定器 | 国械备20171027号 | Ottobock SE & Co. KGaA | Max N?derStra?e 15 37115 Duderstadt,Germany | 2024-02-22 | 变更 |
| 34 | 膝关节固定矫形器 | 国械备20150274号 | Ottobock SE & Co. KGaA | Max N?derStra?e 15 37115, Duderstadt,Germany | 2024-02-22 | 变更 |
| 35 | 牙科用分离器 | 国械备20240050号 | 株式会社デンテック | 東京都板橋区清水町５３－５ | 2024-02-22 | 有效 |
| 36 | 牙科修整用钨钢车针 | 国械备20200004号 | マニー株式会社 | 栃木県塩谷郡高根沢町中阿久津743； Tan Huong Commune, Pho Yen Town, Thai Nguyen Province, Vietnam | 2024-02-21 | 变更 |
| 37 | 牙科修整用金刚砂车针 | 国械备20240049号 | マニー株式会社 | ①栃木県塩谷郡高根沢町中阿久津743②Vang Residential Group, Tan Huong Ward, Pho Yen City, Thai Nguyen Province, Vietnam | 2024-02-21 | 有效 |
| 38 | 创口贴 | 国械备20210144号 | NICO MEDICAL CO., LTD. | 2579-2, Baegok-daero, Mohyeon-eup, Cheoin-gu, Yongin-si, Gyeonggi-do, Republic of Korea | 2024-02-21 | 无效 |
| 39 | 创口贴 | 国械备20210145号 | NICO MEDICAL CO., LTD. | 2579-2, Baegok-daero, Mohyeon-eup, Cheoin-gu, Yongin-si, Gyeonggi-do, Republic of Korea | 2024-02-21 | 无效 |
| 40 | X射线防护装置 | 国械备20240048号 | MAVIG GmbH | Stahlgruberring 5, 81829 Munich, Germany | 2024-02-20 | 有效 |
| 41 | 替代体 | 国械备20190919号 | Biodenta Swiss AG | Tramstr. 16 9442 Berneck Switzerland | 2024-02-20 | 变更 |
| 42 | 牙科种植体手术用工具 | 国械备20160835号 | Biodenta Swiss AG | Tramstr. 16 9442 Berneck Switzerland | 2024-02-20 | 变更 |
| 43 | 医用冰垫 | 国械备20151006号 | 璐瑪企業有限公司 | 桃园县新屋乡九斗村中山东路二段255号 | 2024-02-20 | 变更 |
| 44 | 导引针 | 国械备20200114号 | Search Medical Co., Ltd. | 16, Cheomdan venture so-ro 37 beon-gil, Buk-gu, Gwangju, Republic of Korea | 2024-02-20 | 变更 |
| 45 | 牙科刮治器 | 国械备20230040号 | PRODONT-HOLLIGER part of ACTEON group | 3 La Marnasse, 63880 OLLIERGUES, FRANCE | 2024-02-19 | 变更 |
| 46 | 电极导联线 | 国械备20220096号 | Natus Neurology Incorporated | 3150 Pleasant View Road Middleton Wisconsin 53562 USA； IDA Business Park Gort Co. Galway Ireland； 250 Okgucheondong-ro Siheung-si Gyeongi-do 15084 Republic of Korea | 2024-02-19 | 变更 |
| 47 | 缓冲液 | 国械备20151545号 | Leica Biosystems Newcastle Ltd | 3506 South Broadway Saint Louis MO 63118 | 2024-02-18 | 变更 |
| 48 | 免疫组化稀释液 | 国械备20151840号 | Leica Biosystems Newcastle Ltd | 3506 South Broadway, St Louis, MO 63118 | 2024-02-18 | 变更 |
| 49 | 水枪头 | 国械备20171171号 | PRODUITS DENTAIRES PIERRE ROLLAND SAS | 17 avenue Gustave Eiffel, Zone Industrielle du Phare, 33700 MERIGNAC FRANCE | 2024-02-08 | 变更 |
| 50 | CD123检测试剂（流式细胞仪法) | 国械备20240047号 | BioLegend,Inc. | 8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121 | 2024-02-07 | 有效 |
| 51 | CD123检测试剂（流式细胞仪法） | 国械备20240046号 | BioLegend,Inc. | 8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121 | 2024-02-07 | 有效 |
| 52 | 快接头 | 国械备20240045号 | Synthes GmbH | Eimattstrasse 3,4436 Oberdorf, Switzerland | 2024-02-07 | 有效 |
| 53 | 医用检查手套 | 国械备20200070号 | ?????? ???? ?? ??? ????????????????? ????? | 112 ??????????? ??? 45 ???????, ???????, ?????, 90110 | 2024-02-06 | 变更 |
| 54 | 全自动微生物样本处理系统 | 国械备20210155号 | BD Kiestra B.V. | 730 Fountain Street - Building 2, Cambridge, ON N3H 4R7, Canada | 2024-02-06 | 变更 |
| 55 | 牙科医师椅 | 国械备20220259号 | CEFLA S.C. | VIA BICOCCA 14/C-40026 IMOLA(BO)-ITALY | 2024-02-06 | 变更 |
| 56 | 抗原修复缓冲液 BOND Epitope Retrieval Solution 1 | 国械备20150328 号 | Leica Biosystems Newcastle Ltd | Second Avenue, Heatherhouse Industrial Estate, Irvine, KA12 8NB, United Kingdom | 2024-02-05 | 变更 |
| 57 | 清洗液 BOND Wash Solution 10X Concentrate | 国械备20150492号 | Leica Biosystems Newcastle Ltd | Second Avenue, Heather House Industrial Estate, Irvine, Ayrshire, Scotland, KA12 8NB, United Kingdom | 2024-02-05 | 变更 |
| 58 | 免疫显色试剂 BOND Polymer Refine Detection | 国械备20150558号 | Leica Biosystems Newcastle Ltd. | Balliol Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom | 2024-02-05 | 变更 |
| 59 | 脱蜡液 BOND Dewax Solution | 国械备20140293号 | Leica Biosystems Newcastle Ltd | Balliol Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom | 2024-02-05 | 变更 |
| 60 | 抗原修复缓冲液 BOND Epitope Retrieval Solution 2 | 国械备20150327号 | Leica Biosystems Newcastle Ltd | Second Avenue, Heather House Industrial Estate, Irvine, Ayrshire, Scotland, KA12 8NB, United Kingdom | 2024-02-05 | 变更 |
| 61 | 原位杂交用蛋白酶 BOND Enzyme Pretreatment Kit | 国械备20150495号 | Leica Biosystems Newcastle Ltd | Balliol Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom | 2024-02-05 | 变更 |
| 62 | 集尿袋 | 国械备20150559号 | ConvaTec Limited | Priemyselny Park 3, 07101 Michalovce, Slovakia | 2024-02-04 | 无效 |
| 63 | 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. | 2024-02-04 | 变更 |
| 64 | 轮转式切片机 | 国械备20200279号 | pfm medical gmbh | Wankelstr. 60, 50996 K?ln, Germany | 2024-02-04 | 变更 |
| 65 | 牙垫 | 国械备20210540号 | SigmaStim Domestic LLC | 19799 S.W.95th Avenue Tualatin OR 97062 USA | 2024-02-04 | 变更 |
| 66 | 髓过氧化物酶（MPO）检测试剂 Anti-Myeloperoxydase-FITC | 国械备20180342号 | Immunotech S.A.S (a Beckman Coulter Company) | 130 Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France | 2024-02-04 | 变更 |
| 67 | 髓过氧化物酶（MPO）检测试剂 Anti-Myeloperoxydase-PE | 国械备20181294号 | Immunotech S.A.S (a Beckman Coulter Company) | 130 Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France | 2024-02-04 | 变更 |
| 68 | 创口贴 | 国械备20200661号 | curea medical GmbH | Münsterstra?e 61-65 48565 Steinfurt Deutschland | 2024-02-04 | 变更 |
| 69 | 创口贴 | 国械备20210097号 | (?)?????? | ??? ??? ???? ??? 142，3? 301?(???, ?????) | 2024-02-04 | 变更 |
| 70 | 义眼片 | 国械备20240044号 | Kunstaugeninstitut Pro-Ocular Roland Lautne | Bahnhofstra?e 2,90518 Altdorf,Deutschland | 2024-02-04 | 有效 |
| 71 | 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. | 2024-02-02 | 变更 |
| 72 | 呼吸训练器 | 国械备20240043号 | 貝斯美德股份有限公司 | 新北市五股區五工二路116巷5號 | 2024-02-02 | 有效 |
| 73 | 样品后处理系统 | 国械备20220396号 | 醫全實業股份有限公司 | 新北市五股區五權路 34 號 1 樓 | 2024-02-01 | 变更 |