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        當前位置:網站首頁>新聞動態 >2023年8月國家局累計批準進口第一類醫療器械產品備案112項
        2023年8月國家局累計批準進口第一類醫療器械產品備案112項
        發布日期:2023-09-07 19:37瀏覽次數:86次
        2023年9月6日,國家藥監局發布數據,2023年8月國家局累計批準進防漏膏、氣管插管固定器、造口護膚粉、口腔治療器具、鞘液 、眼用剪等進口第一類醫療器械產品備案112項,詳見正文,一起來看看還有哪些進口第一類醫療器械產品。

        2023年9月6日,國家藥監局發布數據,2023年8月國家局累計批準進防漏膏、氣管插管固定器、造口護膚粉、口腔治療器具、鞘液 、眼用剪等進口第一類醫療器械產品備案112項,詳見正文,一起來看看還有哪些進口第一類醫療器械產品。

        進口第一類醫療器械產品備案.jpg

        2023年8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防漏膏國械備20190580號Hollister   Incorporated 366 Draft Avenue Stuarts Draft, VA 24477 USA2023-08-31 變更
        2氣管插管固定器國械備20210478號 Hollister IncorporatedHollister   Incorporated  366 Draft Avenue Stuarts   Draft, VA USA 244772023-08-31 變更
        3造口護膚粉國械備20191349號Hollister   Incorporated 366 Draft Avenue Stuarts Draft, VA 24477 USA2023-08-31 變更
        4種植體安裝輔助器械包國械備20230390號Elos   Medtech Pinol A/SEngvej   33 G?rl?se 3330 Denmark2023-08-31 有效
        5口腔治療器具國械備20230389號EVERBEST   TRADING CO.S.I.E.,TIPU   ROAD,SIALKOT-PAKISTAN2023-08-31 有效
        6鞘液 國械備20160403號Luminex   Corporation12212   Technology Blvd, Austin, Texas 78727 USA2023-08-31 無效
        7鞘液國械備20160402號Luminex   Corporation12212 Technology Blvd, Austin, Texas 78727 USA2023-08-31 無效
        8眼用剪國械備20220538號KATENA   PRODUCTS, INC.6   CAMPUS DRIVE, SUITE 310, Parsippany, NJ 070542023-08-31 變更
        9眼用拉鉤國械備20220547號KATENA   PRODUCTS, INC.6   CAMPUS DRIVE, SUITE 310, Parsippany, NJ 070542023-08-31 變更
        10眼用鑷國械備20220536號KATENA   PRODUCTS, INC.6   CAMPUS DRIVE, SUITE 310, Parsippany, NJ 070542023-08-31 變更
        11眼用注吸沖洗器國械備20220537號KATENA   PRODUCTS, INC.6   CAMPUS DRIVE, SUITE 310, Parsippany, NJ 070542023-08-31 變更
        12眼用剪國械備20220546號KATENA   PRODUCTS, INC.6   CAMPUS DRIVE, SUITE 310, Parsippany, NJ 070542023-08-31 變更
        13眼用鑷國械備20220542號KATENA   PRODUCTS, INC.6   CAMPUS DRIVE, SUITE 310, Parsippany, NJ 070542023-08-31 變更
        14髖關節手術支撐牽引架國械備20230388號ConMed   Corporation452   Randolph Street, Abington, MA 02351 United States2023-08-31 有效
        15負氣壓式骨折固定保護氣墊國械備20170145號OPED   GmbHMedizinpark   1 83626 Valley/Oberlaindern GERMANY2023-08-31 變更
        16防水創口貼國械備20230387號Young   Chemical Co., Ltd.80-93,   Golden root-ro, Juchon-myeon, Gimhae-si, Gyeongsangnam-do, 50969, Korea2023-08-31 有效
        17CD28檢測試劑(流式細胞儀法)國械備20230386號BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-08-30 有效
        18耳鼻喉科手術器械國械備20181704號SURGICAL   SOURCES INDUSTRIESP.O.Box:1389,Small   Industrial Estate,Sialkot-Pakistan2023-08-29 變更
        19止血鉗國械備20181685號SURGICAL   SOURCES INDUSTRIESP.O.Box:1389,Small   Industrial Estate,Sialkot-Pakistan2023-08-29 變更
        20牙種植定位桿國械備20160177號Nobel   Biocare AB Dimbov?gen   2 SE-691 51 Karlskoga Sweden;22715 Savi Ranch Parkway Yorba Linda California   92887 USA;Engvej 33, 3330 G?rl?se, Denmark;74950 SCIONZIER France2023-08-29 變更
        21種植用手術導板國械備20160042號Nobel   Biocare ABDimbov?gen   2 SE-691 51 Karlskoga Sweden; 22715 Savi Ranch Parkway Yorba Linda California   92887 USA; 74950 SCIONZIER France2023-08-29 變更
        22螺絲起國械備20151914號Nobel   Biocare AB22715   Savi Ranch Parkway Yorba Linda California 92887 USA; Dimbov?gen 2 SE-691 51   Karlskoga Sweden; Engvej 33 3330 G?rl?se Denmark;74950 SCIONZIER France;Rue   de Boujean 122 CH-2501 Biel/Bienne2023-08-29 變更
        23種植用手術導板國械備20151418號Nobel   Biocare AB800   Corporate Drive Mahwah New Jersey 07430, USA 2023-08-29 變更
        24牙科輸送頭國械備20200327號Pulpdent   Corporation80   Oakland Street, Watertown, MA 02472 United States2023-08-29 變更
        25聚酯纖維繃帶國械備20181482號BL   TECH CO., LTD.韓國江原道春川市退溪農工路84號2023-08-29 變更
        26聚酯襯墊國械備20151171號BL   TECH CO.,LTD. 84,Toegyenonggong-ro, Chuncheon-si,   Gangwon-do, Korea2023-08-29 變更
        27醫用高分子夾板國械備20181486號BL   TECH CO., LTD84,   Toegyenonggong-ro, Chuncheon-si, Gangwon-do2023-08-29 變更
        28鞘液濃縮液國械備20160091號Luminex   Corporation12212   Technology Blvd, Austin, Texas 78727 USA2023-08-28 無效
        29根管銼國械備20160922號VDW   GmbHBayerwaldstraβe   15, 81737 München,Germany2023-08-28 變更
        30醫用退熱貼國械備20161526號香港思情用品有限公司香港葵涌健康街18號恒亞中心9樓10-12室2023-08-28 無效
        31DAB染色液國械備20150941號Richard-Allan   Scientific LLC46500   Kato Road, Fremont, CA, 94538, United States2023-08-25 變更
        32骨科用手術工具國械備20230384號Medtronic   Sofamor Danek USA, Inc.Werftstr.17,   94469 Deggendorf, GERMANY; 4340 Swinnea Road, Memphis TN 38118, USA;   Ulrichsberger Str.17, 94469 Deggendorf, GERMANY 2023-08-24 有效
        33創傷外科手術器械包國械備20180944號Synthes   GmbH見附件2023-08-24 變更
        34膝關節手術工具國械備20210189號DePuy   Ireland UC請見附件“生產地址”。2023-08-24 變更
        35扭力扳手國械備20230383號Elos   Medtech Pinol A/SEngvej   33, G?rl?se 3330, Denmark2023-08-24 有效
        36替代體國械備20190301號Zest   Anchors, LLC2875   Loker Avenue East Carlsbad California 92010 USA;2230 Enterprise Street   Escondido California 92029 USA2023-08-24 變更
        37止血鉗國械備20230382號MICROQORE   MEDICAL GmbHIm   Aachtal 1b D-78267 Aach2023-08-23 有效
        38器械鉗國械備20230381號MICROQORE   MEDICAL GmbHIm   Aachtal 1b D-78267 Aach2023-08-23 有效
        39組織鑷國械備20230380號MICROQORE   MEDICAL GmbHIm   Aachtal 1b D-78267 Aach2023-08-23 有效
        40手術剪國械備20230379號MICROQORE   MEDICAL GmbHIm   Aachtal 1b D-78267 Aach2023-08-23 有效
        41牙科手術器械包國械備20230378號Cowellmedi   Co., Ltd.48,   Hakgam-daero 221beon-gil, Sasang-gu, Busan, Republic of Korea2023-08-23 有效
        42牙科種植用測量器國械備20230377號Cowellmedi   Co., Ltd.48,   Hakgam-daero 221beon-gil, Sasang-gu, Busan, Republic of Korea2023-08-23 有效
        43牙科工具包國械備20230376號Cowellmedi   Co., Ltd.48,   Hakgam-daero 221beon-gil, Sasang-gu, Busan, Republic of Korea2023-08-23 有效
        44種植輔助器械包國械備20230375號Cowellmedi   Co., Ltd.48,   Hakgam-daero 221beon-gil, Sasang-gu, Busan, Republic of Korea2023-08-23 有效
        45牙科種植體手術工具包國械備20230374號Cowellmedi   Co., Ltd.48,   Hakgam-daero 221beon-gil, Sasang-gu, Busan, Republic of Korea2023-08-23 有效
        46生物顯微鏡國械備20210399號株式會社エビデント長野県上伊那郡辰野町大字伊那富6666番地2023-08-22 變更
        47組織鉗國械備20210381號Deusch   Medizintechnik GmbHEsslinger   StraBe 13,78532 Tuttlingen2023-08-22 變更
        48牽開器國械備20210383號Deusch   Medizintechnik GmbHEsslinger   StraBe 13,78532 Tuttlingen2023-08-22 變更
        49鉤針國械備20210444號Deusch   Medizintechnik GmbHEsslinger   StraBe 13,78532 Tuttlingen2023-08-22 變更
        50鼻窺器國械備20210384號Deusch   Medizintechnik GmbHEsslinger   StraBe 13,78532 Tuttlingen2023-08-22 變更
        51吸引管國械備20210349號Deusch   Medizintechnik GmbHEsslinger   StraBe 13,78532 Tuttlingen2023-08-22 變更
        52綁扎膠布國械備20150828號彪仕醫技股份有限公司臺南市南區中華西路一段23號2023-08-22 無效
        53醫用冰墊國械備20150827號彪仕醫技股份有限公司臺南市南區中華西路一段23號2023-08-22 無效
        54頸椎固定帶國械備20151041號彪仕醫技股份有限公司臺南市南區中華西路一段23號2023-08-22 無效
        55上/下肢醫用外固定支具國械備20151045號彪仕醫技股份有限公司臺南市南區中華西路一段23號2023-08-22 無效
        56腰椎固定帶國械備20151036號彪仕醫技股份有限公司臺南市南區中華西路一段23號2023-08-22 無效
        57牙科種植輔助器械包國械備20180988號ALTATEC   GmbHMaybachstr.   5, 71299 Wimsheim, Germany2023-08-21 變更
        58口腔燈國械備20170125號?   ????(Baekseok-dong,   Ilsan technotown),1003-1, 1003, 138, Ilsan-ro, Ilsandong-gu, Goyang-si,   Gyeonggi-do, Korea2023-08-21 變更
        59鼻部沖洗器國械備20230373號FLAEM   NUOVA SPAVIA   COLLI STORICI 221/223/225 25015 SAN MARTINO DELLA BATTAGLIA (BS) ITALY2023-08-21 有效
        60鞘液濃縮液國械備20200676號Luminex   Corporation12212   Technology Blvd. Austin TX 78727 USA2023-08-18 變更
        61鞘液國械備20200675號Luminex   Corporation 12212   Technology Blvd. Austin TX 78727 USA2023-08-18 變更
        62鞘液國械備20200650號Luminex   Corporation12212   Technology Blvd. Austin TX 78727 USA2023-08-18 變更
        63給藥指套國械備20220363號H.Dam   K?rgaard A/SBorupvang   9,2750 Ballerup,Denmark2023-08-18 變更
        64固定用彈力束帶國械備20190925號Bauerfeind   AGTriebeser   Stra?e 16 07937 Zeulenroda-Triebes Germany2023-08-18 變更
        65種植體安裝輔助工具國械備20190673號(?)??????   ??? ???  ???? 474  , 4? 411?, 4? 412?(????, ??????????)2023-08-17 變更
        66種植輔助材料國械備20190062號(?)??????   ??? ??? ???? 474 , 4? 411?, 4? 412? (????, ??????????)2023-08-17 變更
        67種植體螺絲起國械備20190674號(?)??????   ??? ???  ???? 474  , 4? 411?, 4? 412?(????, ??????????)2023-08-17 變更
        68膝關節固定器國械備20170278號?ssur   hf.Grjotháls   1-5 Reykjavik 110 Iceland2023-08-17 變更
        69熱塑膜國械備20230372號MACROMEDICS   BVOostbaan   670, 2841ML Moordrecht, The Netherlands2023-08-16 有效
        70顯微外科手術器械國械備20170838號Synovis   Micro Companies Alliance,Inc439   Industrial Lane, Birmingham, Alabama 35211 USA2023-08-16 變更
        71牙科輸送器國械備20181637號DMG   Chemisch-Pharmazeutische Fabrik GmbHElbgaustraβe   248 22547 Hamburg Germany2023-08-15 變更
        72造口底盤國械備20200155號Welland   Medical LimitedHydehurst   Lane, Crawley, West Sussex, RH10 9AS, United Kingdom2023-08-15 變更
        73造口護理用品國械備20200116號Welland   Medical LimitedHydehurst   Lane, Crawley, West Sussex, RH10 9AS, United Kingdom2023-08-15 變更
        74造口袋國械備20200157號Welland   Medical LimitedHydehurst   Lane, Crawley, West Sussex, RH10 9AS, United Kingdom2023-08-15 變更
        75造口袋國械備20190372號Welland   Medical LimitedHydehurst   Lane, Crawley, West Sussex, RH10 9AS, United Kingdom2023-08-14 變更
        76造口底盤國械備20190401號Welland   Medical LimitedHydehurst   Lane, Crawley, West Sussex, RH10 9AS, United Kingdom2023-08-14 變更
        77造口袋國械備20190402號Welland   Medical LimitedHydehurst   Lane, Crawley, West Sussex, RH10 9AS, United Kingdom2023-08-14 變更
        78病人推床國械備20161127號Hill-Rom,   Inc.Avenida   Del Telefono No.200 Huinala, Apodaca Nuevo Leon C.P. 66640 Mexico2023-08-14 變更
        79醫用放大鏡國械備20181539號(?)?????????,???   ?? ???? 592023-08-14 變更
        80集尿袋國械備20170831號//2023-08-14 變更
        81洗板機國械備20181472號Agilent   Technologies, Inc.100   Tigan Street Highland Park Winooski, VT 05404-0998 USA2023-08-14 無效
        82洗板機國械備20190496號Agilent   Technologies, Inc.100   Tigan Street Highland Park Winooski, VT 05404-0998 USA2023-08-14 無效
        83洗板機國械備20190874號Agilent   Technologies, Inc.100   Tigan Street Highland Park Winooski, VT 05404-0998 USA2023-08-14 無效
        84凝血分析用稀釋液國械備20150936號DIAGNOSTICA   STAGOIDA   Business Park, Bary CO. WICKLOW IRELAND2023-08-14 變更
        85代型材料國械備20170964號Ivoclar   Vivadent AG Bendererstrasse   2, 9494 Schaan, Liechtenstein 2023-08-11 變更
        86子彈型光固化樹脂輸送器國械備20230371號Ivoclar   Vivadent AGBendererstrasse   2, 9494 Schaan, LIECHTENSTEIN;Schweizersbildstrasse 57, 8200 Schaffhausen,   Switzerland2023-08-11 有效
        87CD27檢測試劑(流式細胞儀法)國械備20230370號BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-08-10 有效
        88CD27檢測試劑(流式細胞儀法)國械備20230369號BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-08-10 有效
        89CD41檢測試劑(流式細胞儀法)國械備20230368號BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-08-10 有效
        90CD9抗體試劑(流式細胞儀法)國械備20230367號BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-08-10 有效
        91CD81檢測試劑(流式細胞儀法)國械備20230366號BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-08-10 有效
        92髖關節手術工具國械備20230365號SERF85   Avenue des Bruyères,69150 DECINES-CHARPIEU,FRANCE2023-08-10 有效
        93吸潮紙尖國械備20140199號META   BIOMED CO., LTD.136,   Mochung-ro, Heungdeok-gu Cheongju -si, Chungcheongbuk-do2023-08-10 變更
        94注射器輔助推進槍國械備20230090號Owen   Mumford LimitedPrimsdown   Industrial Estate, Worcester Road, Chipping Norton, Oxfordshire,OX7 5XP,   United Kingdom2023-08-10 變更
        95液體敷料國械備20181717號LABORATOIRES   URGO   Parc   Excellence 2000-2 avenue de Strasbourg-21800 CHEVIGNY SAINT SAUVEUR-FRANCE2023-08-10 無效
        96髖關節手術工具國械備20210150號DePuy   Ireland UC請見附件“生產地址”。2023-08-08 變更
        97唾液樣本采集管(DNA自采集工作包,ORAcollect)國械備20170939號DNA   Genotek Inc.3000-500   Palladium Drive Ottawa Ontario K2V 1C2 Canada2023-08-08 變更
        98一次性使用唾液采集器國械備20230045號DNA   Genotek Inc.3000   - 500 Palladium Drive; Ottawa, ON; K2V1C2 CANADA2023-08-08 變更
        99唾液樣本采集管(DNA自采集工作包,Oragene)國械備20170946號DNA   Genotek Inc.3000-500   Palladium Drive Ottawa Ontario K2V 1C2 Canada2023-08-08 變更
        100糞便DNA采樣包國械備20171075號DNA   Genotek Inc.3000-500   Palladium Drive, Ottawa, Ontario, Canada K2V 1C22023-08-08 變更
        101放射治療患者用固定裝置國械備20230364號Medtec,   LLC dba CIVCO Radiotherapy1401   8th St.SE,Orange City,IA,51041,United States2023-08-04 有效
        102牙科刮治器國械備20230363號株式會社YDM埼玉県東松山市今泉28番地2023-08-03 有效
        103動力系統配套工具國械備20210407號The   Anspach Effort, Inc4500   Riverside Drive,Palm Beach Gardens,FL 334102023-08-03 變更
        104骨科手術器械國械備20180814號Synthes   GmbH見附件。2023-08-03 變更
        105夾頭國械備20230362號Stryker   Instruments250W   KENSINGER DR STE 400 Cranberry Township,PA USA 160662023-08-03 有效
        106牙科種植材料取出器國械備20191422號Osstem   Implant Co.,Ltd.66-16,   Bansong-ro, 513beon-gil, Haeundae-gu, Busan, korea2023-08-03 變更
        107顯微眼用鑷國械備20151247號D.O.R.C.   Dutch Ophthalmic Research Center (International) B.V.Scheijdelveweg   2 3214 VN Zuidland The Netherlands2023-08-01 變更
        108干式激光成像儀國械備20200021號Bermedi   Medical Solutions GmbHB?lschestra?e   27, 12587 Berlin, Germany2023-08-01 變更
        109牙科輸送器國械備20160919號Osstem   Implant Co.,Ltd.66-16,   Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2023-08-01 變更
        110顯微眼用剪國械備20151163號D.O.R.C.   Dutch Ophthalmic Research Center (International) B.V.Scheijdelveweg   2 3214 VN Zuidland The Netherlands2023-08-01 變更
        111骨科手術器械國械備20170643號ulrich   GmbH & Co. KGBuchbrunnenweg   12, 89081 Ulm, GERMANY2023-08-31 無效
        112咬骨鉗國械備20170804號ulrich   GmbH & Co. KGBuchbrunnenweg   12, 89081 Ulm, GERMANY2023-08-31 無效

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