| 序號(hào) | 產(chǎn)品名稱 | 備案號(hào) | 備案人名稱原文 | 生產(chǎn)地址原文 | 備案日期 | 狀態(tài) |
| 1 | 微孔板振蕩孵育器 | 國械備20200372號(hào) | Wallac Oy | Mustionkatu 6, FI-20750 Turku, Finland | 2024-02-29 | 變更 |
| 2 | 全自動(dòng)核酸提取儀 | 國械備20140357號(hào) | Wallac Oy | Mustionkatu 6, FI-20750 Turku, Finland | 2024-02-29 | 變更 |
| 3 | 造口皮膚保護(hù)劑 | 國械備20210611號(hào) | 康維德有限責(zé)任公司ConvaTec Limited | Unit 12A&12B Kings Court，Prince William Avenue，Sandycroft，Deeside，CH5 2FG, United Kingdom | 2024-02-29 | 變更 |
| 4 | 高分子固定繃帶 | 國械備20200440號(hào) | ConvaTec Limited | St Helens Road, Bolton, BL3 3PR, United Kingdom | 2024-02-29 | 變更 |
| 5 | 彈力繃帶 | 國械備20200388號(hào) | ConvaTec Limited | Lowmoor Business Park, Kirkby in Ashfield, Nottinghamshire, NG17 7JZ, UK. | 2024-02-29 | 變更 |
| 6 | 造口皮膚保護(hù)劑 | 國械備20210568號(hào) | 康維德有限責(zé)任公司ConvaTec Limited | Hickmans Road, Birkenhead, Wirral CH41 1JH United Kingdom | 2024-02-29 | 變更 |
| 7 | 醫(yī)用檢查手套 | 國械備20240056號(hào) | 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 | 牽開器 | 國械備20220171號(hào) | Rebstock Instruments GmbH | In Weiher?cker 7, 78589 Dürbheim Germany | 2024-02-29 | 變更 |
| 9 | 牙科成形片套裝 | 國械備20220355號(hào) | Bioclear Matrix Systems, LLC | 3802 S Warner Street Suite A Tacoma, WA US 98409 | 2024-02-29 | 變更 |
| 10 | 顯微剪 | 國械備20220161號(hào) | Rebstock Instruments GmbH | In Weiher?cker 7, 78589 Dürbheim Germany | 2024-02-28 | 變更 |
| 11 | 血管鉗 | 國械備20220170號(hào) | Rebstock Instruments GmbH | In Weiher?cker 7, 78589 Dürbheim Germany | 2024-02-28 | 變更 |
| 12 | 手術(shù)刀柄 | 國械備20150937號(hào) | Swann-Morton Limited | Owlerton Green Sheffield S6 2BJ United Kingdom | 2024-02-28 | 變更 |
| 13 | 手術(shù)刀片 | 國械備20150431號(hào) | Swann-Morton Limited | Owlerton Green Sheffield S6 2BJ United Kingdom | 2024-02-28 | 變更 |
| 14 | 手術(shù)刀 | 國械備20210404號(hào) | Swann-Morton Limited | Owlerton Green Sheffield S6 2BJ United Kingdom | 2024-02-28 | 變更 |
| 15 | 印模帽 | 國械備20240055號(hào) | BIOTEM CO., LTD. | 422, Sasang-ro, Sasang-gu, Busan-si, Republic of Korea | 2024-02-28 | 有效 |
| 16 | 種植輔助材料 | 國械備20190062號(hào) | (?)??? | ??? ??? ??? ???? 474 , 4? 411?, 4? 412? (????, ??????????) | 2024-02-27 | 變更 |
| 17 | 種植體安裝輔助工具 | 國械備20190673號(hào) | (?)??? | ??? ??? ??? ???? 474 , 4? 411?, 4? 412?(????, ??????????) | 2024-02-27 | 變更 |
| 18 | 種植體螺絲起 | 國械備20190674號(hào) | (?)??? | ??? ??? ??? ???? 474 , 4? 411?, 4? 412?(????, ??????????) | 2024-02-27 | 變更 |
| 19 | 壓力繃帶 | 國械備20150797號(hào) | 3M Deutschland GmbH |
| 2024-02-27 | 變更 |
| 20 | 樣本萃取液 | 國械備20240054號(hào) | Abbott Ireland Diagnostics Division | 940 Crossroads Blvd., Seguin, TX 78155 USA | 2024-02-27 | 有效 |
| 21 | 牙科模型材料 | 國械備20240053號(hào) | delcone inc. | 428-8, Waryong-ro, Seo-gu, Daegu, Republic of Korea | 2024-02-26 | 有效 |
| 22 | 髖關(guān)節(jié)手術(shù)器械 | 國械備20151787號(hào) | 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 | 變更 |
| 23 | 膝關(guān)節(jié)手術(shù)器械 | 國械備20160155號(hào) | Smith & Nephew, Inc. | / | 2024-02-26 | 變更 |
| 24 | 輪轉(zhuǎn)式切片機(jī) | 國械備20160789號(hào) | pfm medical gmbh | Wankelstraβe 60 50996 K?ln, Germany | 2024-02-26 | 變更 |
| 25 | 輪轉(zhuǎn)式切片機(jī) | 國械備20160787號(hào) | pfm medical gmbh | Wankelstraβe 60 50996 K?ln, Germany | 2024-02-26 | 變更 |
| 26 | 輪轉(zhuǎn)式切片機(jī) | 國械備20160786號(hào) | pfm medical gmbh | Wankelstraβe 60 50996 K?ln, Germany | 2024-02-26 | 變更 |
| 27 | 包埋機(jī) | 國械備20190921號(hào) | pfm medical gmbh | Wankelstra?e 60, 50996 K?ln, Germany | 2024-02-26 | 變更 |
| 28 | 手動(dòng)推床 | 國械備20161591號(hào) | Stryker Medical | 3800 E. Centre Avenue Portage Michigan 49002 USA | 2024-02-23 | 變更 |
| 29 | 婦產(chǎn)科診療床 | 國械備20240052號(hào) | Stryker Medical | 3800 E. Centre Avenue Portage Michigan 49002 USA | 2024-02-23 | 有效 |
| 30 | 吸引管 | 國械備20240051號(hào) | Surgivet Instruments Company | Wazirabad Road, Sialkot - Pakistan | 2024-02-22 | 有效 |
| 31 | 牙科刮治器 | 國械備20160969號(hào) | PREMIER DENTAL PRODUCTS CO. | 1710 Romano Dr. Plymouth Meeting, PA 19462 | 2024-02-22 | 變更 |
| 32 | 牙探針 | 國械備20160838號(hào) | PREMIER DENTAL PRODUCTS CO. | 1710 Romano Dr. Plymouth Meeting, PA 19462 | 2024-02-22 | 變更 |
| 33 | 腰部固定器 | 國械備20171027號(hào) | Ottobock SE & Co. KGaA | Max N?derStra?e 15 37115 Duderstadt,Germany | 2024-02-22 | 變更 |
| 34 | 膝關(guān)節(jié)固定矯形器 | 國械備20150274號(hào) | Ottobock SE & Co. KGaA | Max N?derStra?e 15 37115, Duderstadt,Germany | 2024-02-22 | 變更 |
| 35 | 牙科用分離器 | 國械備20240050號(hào) | 株式會(huì)社デンテック | 東京都板橋區(qū)清水町５３－５ | 2024-02-22 | 有效 |
| 36 | 牙科修整用鎢鋼車針 | 國械備20200004號(hào) | マニー株式會(huì)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 | 變更 |
| 37 | 牙科修整用金剛砂車針 | 國械備20240049號(hào) | マニー株式會(huì)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 | 創(chuàng)口貼 | 國械備20210144號(hào) | NICO MEDICAL CO., LTD. | 2579-2, Baegok-daero, Mohyeon-eup, Cheoin-gu, Yongin-si, Gyeonggi-do, Republic of Korea | 2024-02-21 | 無效 |
| 39 | 創(chuàng)口貼 | 國械備20210145號(hào) | NICO MEDICAL CO., LTD. | 2579-2, Baegok-daero, Mohyeon-eup, Cheoin-gu, Yongin-si, Gyeonggi-do, Republic of Korea | 2024-02-21 | 無效 |
| 40 | X射線防護(hù)裝置 | 國械備20240048號(hào) | MAVIG GmbH | Stahlgruberring 5, 81829 Munich, Germany | 2024-02-20 | 有效 |
| 41 | 替代體 | 國械備20190919號(hào) | Biodenta Swiss AG | Tramstr. 16 9442 Berneck Switzerland | 2024-02-20 | 變更 |
| 42 | 牙科種植體手術(shù)用工具 | 國械備20160835號(hào) | Biodenta Swiss AG | Tramstr. 16 9442 Berneck Switzerland | 2024-02-20 | 變更 |
| 43 | 醫(yī)用冰墊 | 國械備20151006號(hào) | 璐瑪企業(yè)有限公司 | 桃園縣新屋鄉(xiāng)九斗村中山東路二段255號(hào) | 2024-02-20 | 變更 |
| 44 | 導(dǎo)引針 | 國械備20200114號(hào) | Search Medical Co., Ltd. | 16, Cheomdan venture so-ro 37 beon-gil, Buk-gu, Gwangju, Republic of Korea | 2024-02-20 | 變更 |
| 45 | 牙科刮治器 | 國械備20230040號(hào) | PRODONT-HOLLIGER part of ACTEON group | 3 La Marnasse, 63880 OLLIERGUES, FRANCE | 2024-02-19 | 變更 |
| 46 | 電極導(dǎo)聯(lián)線 | 國械備20220096號(hào) | 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 | 變更 |
| 47 | 緩沖液 | 國械備20151545號(hào) | Leica Biosystems Newcastle Ltd | 3506 South Broadway Saint Louis MO 63118 | 2024-02-18 | 變更 |
| 48 | 免疫組化稀釋液 | 國械備20151840號(hào) | Leica Biosystems Newcastle Ltd | 3506 South Broadway, St Louis, MO 63118 | 2024-02-18 | 變更 |
| 49 | 水槍頭 | 國械備20171171號(hào) | PRODUITS DENTAIRES PIERRE ROLLAND SAS | 17 avenue Gustave Eiffel, Zone Industrielle du Phare, 33700 MERIGNAC FRANCE | 2024-02-08 | 變更 |
| 50 | CD123檢測試劑（流式細(xì)胞儀法) | 國械備20240047號(hào) | BioLegend,Inc. | 8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121 | 2024-02-07 | 有效 |
| 51 | CD123檢測試劑（流式細(xì)胞儀法） | 國械備20240046號(hào) | BioLegend,Inc. | 8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121 | 2024-02-07 | 有效 |
| 52 | 快接頭 | 國械備20240045號(hào) | Synthes GmbH | Eimattstrasse 3,4436 Oberdorf, Switzerland | 2024-02-07 | 有效 |
| 53 | 醫(yī)用檢查手套 | 國械備20200070號(hào) | ?????? ???? ?? ??? ????????????????? ????? | 112 ??????????? ??? 45 ???????, ???????, ?????, 90110 | 2024-02-06 | 變更 |
| 54 | 全自動(dòng)微生物樣本處理系統(tǒng) | 國械備20210155號(hào) | BD Kiestra B.V. | 730 Fountain Street - Building 2, Cambridge, ON N3H 4R7, Canada | 2024-02-06 | 變更 |
| 55 | 牙科醫(yī)師椅 | 國械備20220259號(hào) | CEFLA S.C. | VIA BICOCCA 14/C-40026 IMOLA(BO)-ITALY | 2024-02-06 | 變更 |
| 56 | 抗原修復(fù)緩沖液 BOND Epitope Retrieval Solution 1 | 國械備20150328 號(hào) | Leica Biosystems Newcastle Ltd | Second Avenue, Heatherhouse Industrial Estate, Irvine, KA12 8NB, United Kingdom | 2024-02-05 | 變更 |
| 57 | 清洗液 BOND Wash Solution 10X Concentrate | 國械備20150492號(hào) | Leica Biosystems Newcastle Ltd | Second Avenue, Heather House Industrial Estate, Irvine, Ayrshire, Scotland, KA12 8NB, United Kingdom | 2024-02-05 | 變更 |
| 58 | 免疫顯色試劑 BOND Polymer Refine Detection | 國械備20150558號(hào) | Leica Biosystems Newcastle Ltd. | Balliol Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom | 2024-02-05 | 變更 |
| 59 | 脫蠟液 BOND Dewax Solution | 國械備20140293號(hào) | Leica Biosystems Newcastle Ltd | Balliol Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom | 2024-02-05 | 變更 |
| 60 | 抗原修復(fù)緩沖液 BOND Epitope Retrieval Solution 2 | 國械備20150327號(hào) | Leica Biosystems Newcastle Ltd | Second Avenue, Heather House Industrial Estate, Irvine, Ayrshire, Scotland, KA12 8NB, United Kingdom | 2024-02-05 | 變更 |
| 61 | 原位雜交用蛋白酶 BOND Enzyme Pretreatment Kit | 國械備20150495號(hào) | Leica Biosystems Newcastle Ltd | Balliol Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom | 2024-02-05 | 變更 |
| 62 | 集尿袋 | 國械備20150559號(hào) | ConvaTec Limited | Priemyselny Park 3, 07101 Michalovce, Slovakia | 2024-02-04 | 無效 |
| 63 | 造口袋 | 國械備20140099號(hào) | 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 | 變更 |
| 64 | 輪轉(zhuǎn)式切片機(jī) | 國械備20200279號(hào) | pfm medical gmbh | Wankelstr. 60, 50996 K?ln, Germany | 2024-02-04 | 變更 |
| 65 | 牙墊 | 國械備20210540號(hào) | SigmaStim Domestic LLC | 19799 S.W.95th Avenue Tualatin OR 97062 USA | 2024-02-04 | 變更 |
| 66 | 髓過氧化物酶（MPO）檢測試劑 Anti-Myeloperoxydase-FITC | 國械備20180342號(hào) | Immunotech S.A.S (a Beckman Coulter Company) | 130 Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France | 2024-02-04 | 變更 |
| 67 | 髓過氧化物酶（MPO）檢測試劑 Anti-Myeloperoxydase-PE | 國械備20181294號(hào) | Immunotech S.A.S (a Beckman Coulter Company) | 130 Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France | 2024-02-04 | 變更 |
| 68 | 創(chuàng)口貼 | 國械備20200661號(hào) | curea medical GmbH | Münsterstra?e 61-65 48565 Steinfurt Deutschland | 2024-02-04 | 變更 |
| 69 | 創(chuàng)口貼 | 國械備20210097號(hào) | (?)?????? | ??? ??? ???? ??? 142，3? 301?(???, ?????) | 2024-02-04 | 變更 |
| 70 | 義眼片 | 國械備20240044號(hào) | Kunstaugeninstitut Pro-Ocular Roland Lautne | Bahnhofstra?e 2,90518 Altdorf,Deutschland | 2024-02-04 | 有效 |
| 71 | 造口底盤 | 國械備20200110號(hào) | 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 | 變更 |
| 72 | 呼吸訓(xùn)練器 | 國械備20240043號(hào) | 貝斯美德股份有限公司 | 新北市五股區(qū)五工二路116巷5號(hào) | 2024-02-02 | 有效 |
| 73 | 樣品后處理系統(tǒng) | 國械備20220396號(hào) | 醫(yī)全實(shí)業(yè)股份有限公司 | 新北市五股區(qū)五權(quán)路 34 號(hào) 1 樓 | 2024-02-01 | 變更 |