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    當前位置：網站首頁>新聞動態 >2024年2月國家局批準進口第一類醫療器械產品備案73項
    2024年2月國家局批準進口第一類醫療器械產品備案73項
    發布日期:2024-03-07 18:19瀏覽次數:143次
    來自國家藥監局數據，2024年2月，國家藥監局批準微孔板振蕩孵育器、全自動核酸提取儀、造口皮膚保護劑、高分子固定繃帶、彈力繃帶、醫用檢查手套、呼吸訓練器等，進口第一類醫療器械產品備案73項，詳見正文。

    來自國家藥監局數據，2024年2月，國家藥監局批準微孔板振蕩孵育器、全自動核酸提取儀、造口皮膚保護劑、高分子固定繃帶、彈力繃帶、醫用檢查手套、呼吸訓練器等，進口第一類醫療器械產品備案73項，詳見正文。

    進口第一類醫療器械產品備案.jpg

    2024年2月進口第一類醫療器械產品備案信息

    序號產品名稱備案號備案人名稱原文生產地址原文備案日期狀態
    1微孔板振蕩孵育器國械備20200372號Wallac   OyMustionkatu   6, FI-20750 Turku, Finland2024-02-29 變更
    2全自動核酸提取儀國械備20140357號Wallac   OyMustionkatu   6, FI-20750 Turku, Finland2024-02-29 變更
    3造口皮膚保護劑國械備20210611號康維德有限責任公司ConvaTec   LimitedUnit   12A&12B Kings Court，Prince William Avenue，Sandycroft，Deeside，CH5 2FG,   United Kingdom2024-02-29 變更
    4高分子固定繃帶國械備20200440號ConvaTec   LimitedSt   Helens Road, Bolton, BL3 3PR, United Kingdom2024-02-29 變更
    5彈力繃帶國械備20200388號ConvaTec   LimitedLowmoor   Business Park, Kirkby in Ashfield, Nottinghamshire, NG17 7JZ, UK.2024-02-29 變更
    6造口皮膚保護劑國械備20210568號康維德有限責任公司ConvaTec   LimitedHickmans   Road, Birkenhead, Wirral CH41 1JH United Kingdom2024-02-29 變更
    7醫用檢查手套國械備20240056號PT   . HALONI JANEJl.   Raya Serang Km. 13,8 Kawasan Industri Tristate, RT/RW 02/02, Desa Sukadamai,   Kec. Cikupa2024-02-29 有效
    8牽開器國械備20220171號Rebstock   Instruments GmbHIn   Weiher?cker 7, 78589 Dürbheim Germany2024-02-29 變更
    9牙科成形片套裝國械備20220355號Bioclear   Matrix Systems, LLC3802   S Warner Street Suite A Tacoma, WA US 984092024-02-29 變更
    10顯微剪國械備20220161號Rebstock   Instruments GmbHIn   Weiher?cker 7, 78589 Dürbheim Germany2024-02-28 變更
    11血管鉗國械備20220170號Rebstock   Instruments GmbHIn   Weiher?cker 7, 78589 Dürbheim Germany2024-02-28 變更
    12手術刀柄國械備20150937號Swann-Morton   LimitedOwlerton   Green Sheffield S6 2BJ United Kingdom2024-02-28 變更
    13手術刀片國械備20150431號Swann-Morton   LimitedOwlerton   Green Sheffield S6 2BJ United Kingdom2024-02-28 變更
    14手術刀國械備20210404號Swann-Morton   LimitedOwlerton   Green Sheffield S6 2BJ United Kingdom2024-02-28 變更
    15印模帽國械備20240055號BIOTEM   CO., LTD.422,   Sasang-ro, Sasang-gu, Busan-si, Republic of Korea2024-02-28 有效
    16種植輔助材料國械備20190062號(?)??????   ??? ??? ???? 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(?)??????   ??? ???  ???? 474  , 4? 411?, 4? 412?(????, ??????????)2024-02-27 變更
    18種植體螺絲起國械備20190674號(?)??????   ??? ???  ???? 474  , 4? 411?, 4? 412?(????, ??????????)2024-02-27 變更
    19壓力繃帶國械備20150797號3M   Deutschland GmbH
    		2024-02-27 變更
    20樣本萃取液國械備20240054號Abbott   Ireland Diagnostics Division940   Crossroads Blvd., Seguin, TX 78155 USA2024-02-27 有效
    21牙科模型材料國械備20240053號delcone   inc.428-8,   Waryong-ro, Seo-gu, Daegu, Republic of Korea2024-02-26 有效
    22髖關節手術器械國械備20151787號Smith   & Nephew,Inc1450   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膝關節手術器械國械備20160155號Smith   & Nephew, Inc./2024-02-26 變更
    24輪轉式切片機國械備20160789號pfm   medical gmbhWankelstraβe   60  50996 K?ln, Germany2024-02-26 變更
    25輪轉式切片機國械備20160787號pfm   medical gmbhWankelstraβe   60  50996 K?ln, Germany2024-02-26 變更
    26輪轉式切片機國械備20160786號pfm   medical gmbhWankelstraβe   60  50996 K?ln, Germany2024-02-26 變更
    27包埋機國械備20190921號pfm   medical gmbhWankelstra?e   60, 50996 K?ln, Germany2024-02-26 變更
    28手動推床國械備20161591號Stryker   Medical 3800   E. Centre Avenue Portage Michigan 49002 USA2024-02-23 變更
    29婦產科診療床國械備20240052號Stryker   Medical3800   E. Centre Avenue Portage Michigan 49002 USA2024-02-23 有效
    30吸引管國械備20240051號Surgivet   Instruments CompanyWazirabad   Road, Sialkot - Pakistan2024-02-22 有效
    31牙科刮治器國械備20160969號PREMIER   DENTAL PRODUCTS CO.1710   Romano Dr. Plymouth Meeting, PA 194622024-02-22 變更
    32牙探針國械備20160838號PREMIER   DENTAL PRODUCTS CO.1710   Romano Dr. Plymouth Meeting, PA 194622024-02-22 變更
    33腰部固定器國械備20171027號Ottobock   SE & Co. KGaAMax   N?derStra?e 15 37115 Duderstadt,Germany2024-02-22 變更
    34膝關節固定矯形器國械備20150274號Ottobock   SE & Co. KGaAMax   N?derStra?e 15 37115, Duderstadt,Germany2024-02-22 變更
    35牙科用分離器國械備20240050號株式會社デンテック東京都板橋區清水町５３－５2024-02-22 有效
    36牙科修整用鎢鋼車針國械備20200004號マニー株式會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, Vietnam2024-02-21 變更
    37牙科修整用金剛砂車針國械備20240049號マニー株式會社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,   Vietnam2024-02-21 有效
    38創口貼國械備20210144號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創口貼國械備20210145號NICO   MEDICAL CO., LTD.2579-2,   Baegok-daero, Mohyeon-eup, Cheoin-gu, Yongin-si, Gyeonggi-do, Republic of   Korea 2024-02-21 無效
    40X射線防護裝置國械備20240048號MAVIG   GmbHStahlgruberring   5, 81829 Munich, Germany2024-02-20 有效
    41替代體國械備20190919號Biodenta   Swiss AGTramstr.   16 9442 Berneck Switzerland2024-02-20 變更
    42牙科種植體手術用工具國械備20160835號Biodenta   Swiss AGTramstr.   16 9442 Berneck Switzerland2024-02-20 變更
    43醫用冰墊國械備20151006號璐瑪企業有限公司桃園縣新屋鄉九斗村中山東路二段255號2024-02-20 變更
    44導引針國械備20200114號Search   Medical Co., Ltd.16,   Cheomdan venture so-ro 37 beon-gil, Buk-gu, Gwangju, Republic of Korea2024-02-20 變更
    45牙科刮治器國械備20230040號PRODONT-HOLLIGER   part of ACTEON group3   La Marnasse, 63880 OLLIERGUES, FRANCE2024-02-19 變更
    46電極導聯線國械備20220096號Natus   Neurology Incorporated3150   Pleasant View Road Middleton Wisconsin 53562 USA； IDA Business Park Gort Co.   Galway Ireland； 250 Okgucheondong-ro Siheung-si Gyeongi-do 15084 Republic of   Korea2024-02-19 變更
    47緩沖液國械備20151545號Leica   Biosystems Newcastle Ltd3506   South Broadway Saint Louis MO 631182024-02-18 變更
    48免疫組化稀釋液國械備20151840號Leica   Biosystems Newcastle Ltd3506   South Broadway, St Louis, MO 631182024-02-18 變更
    49水槍頭國械備20171171號PRODUITS   DENTAIRES PIERRE ROLLAND SAS17   avenue Gustave Eiffel, Zone Industrielle du Phare, 33700 MERIGNAC FRANCE2024-02-08 變更
    50CD123檢測試劑（流式細胞儀法)國械備20240047號BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212024-02-07 有效
    51CD123檢測試劑（流式細胞儀法）國械備20240046號BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212024-02-07 有效
    52快接頭國械備20240045號Synthes   GmbHEimattstrasse   3,4436 Oberdorf, Switzerland2024-02-07 有效
    53醫用檢查手套國械備20200070號??????   ???? ?? ??? ????????????????? ?????112   ??????????? ??? 45 ???????, ???????, ?????, 901102024-02-06 變更
    54全自動微生物樣本處理系統國械備20210155號BD   Kiestra B.V.730   Fountain Street - Building 2, Cambridge, ON N3H 4R7, Canada2024-02-06 變更
    55牙科醫師椅國械備20220259號CEFLA   S.C.VIA   BICOCCA 14/C-40026 IMOLA(BO)-ITALY2024-02-06 變更
    56抗原修復緩沖液   BOND Epitope Retrieval Solution 1國械備20150328   號Leica   Biosystems Newcastle LtdSecond   Avenue, Heatherhouse Industrial Estate, Irvine, KA12 8NB, United Kingdom2024-02-05 變更
    57清洗液   BOND Wash Solution 10X Concentrate國械備20150492號Leica   Biosystems Newcastle Ltd Second   Avenue, Heather House Industrial Estate, Irvine, Ayrshire, Scotland, KA12   8NB, United Kingdom2024-02-05 變更
    58免疫顯色試劑   BOND Polymer Refine Detection國械備20150558號Leica   Biosystems Newcastle Ltd.Balliol   Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom2024-02-05 變更
    59脫蠟液   BOND Dewax Solution國械備20140293號Leica   Biosystems Newcastle LtdBalliol   Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom2024-02-05 變更
    60抗原修復緩沖液   BOND Epitope Retrieval Solution 2國械備20150327號Leica   Biosystems Newcastle LtdSecond   Avenue, Heather House Industrial Estate, Irvine, Ayrshire, Scotland, KA12   8NB, United Kingdom2024-02-05 變更
    61原位雜交用蛋白酶   BOND Enzyme Pretreatment Kit國械備20150495號Leica   Biosystems Newcastle LtdBalliol   Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom2024-02-05 變更
    62集尿袋 國械備20150559號ConvaTec   LimitedPriemyselny   Park 3, 07101 Michalovce, Slovakia2024-02-04 無效
    63造口袋國械備20140099號ConvaTec   LimitedFirst   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輪轉式切片機國械備20200279號pfm   medical gmbhWankelstr.   60, 50996 K?ln, Germany2024-02-04 變更
    65牙墊國械備20210540號SigmaStim   Domestic LLC19799   S.W.95th Avenue Tualatin OR 97062 USA2024-02-04 變更
    66髓過氧化物酶（MPO）檢測試劑   Anti-Myeloperoxydase-FITC國械備20180342號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創口貼國械備20200661號curea   medical GmbHMünsterstra?e   61-65 48565 Steinfurt Deutschland2024-02-04 變更
    69創口貼國械備20210097號(?)?????????   ??? ???? ??? 142，3? 301?(???, ?????)2024-02-04 變更
    70義眼片國械備20240044號Kunstaugeninstitut   Pro-Ocular Roland LautneBahnhofstra?e   2,90518 Altdorf,Deutschland2024-02-04 有效
    71造口底盤國械備20200110號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呼吸訓練器國械備20240043號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樣品后處理系統國械備20220396號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 變更

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