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2021年12月進口第一類醫(yī)療器械產(chǎn)品備案信息
發(fā)布日期:2022-01-13 00:00瀏覽次數(shù):3991次
2022年1月11日，藥監(jiān)總局發(fā)布《2021年12月進口第一類醫(yī)療器械產(chǎn)品備案信息》公告，2021年最后一個月藥監(jiān)總局完成醫(yī)用絲綢膠帶、醫(yī)用檢查手套等156個盡快醫(yī)療器械產(chǎn)品備案項目審批。

2022年1月11日，藥監(jiān)總局發(fā)布《2021年12月進口第一類醫(yī)療器械產(chǎn)品備案信息》公告，2021年最后一個月藥監(jiān)總局完成醫(yī)用絲綢膠帶、醫(yī)用檢查手套等156個盡快醫(yī)療器械產(chǎn)品備案項目審批。

產(chǎn)品名稱備案號備案人名稱原文生產(chǎn)地址原文備案日期狀態(tài)
醫(yī)用絲綢膠帶國械備20210631號Paul   Hartmann AGP.   I. Pla d'en Boet II, c/ Carrasco i Formiguera, 48, 08302 Mataró (Barcelona),   SPAIN2021-12-31 有效
牙骨錘國械備20200356號//2021-12-31 變更
基臺就位器國械備20210042號//2021-12-31 變更
種植體系統(tǒng)工具國械備20140102號/959-21,Dae   Chon-dong,Buk-gu,Gwangju2021-12-31 變更
創(chuàng)口貼國械備20181401號東洋化學株式會社滋賀県蒲生郡日野町寺尻1008番地2021-12-31 變更
牙科用剪國械備20200357號//2021-12-31 變更
創(chuàng)口貼國械備20181400號東洋化學株式會社滋賀県蒲生郡日野町寺尻1008番地2021-12-31 變更
動力系統(tǒng)配套工具國械備20210630號 Synthes GmbHEimattstrasse   3, 4436 Oberdorf, Switzerland2021-12-31 有效
動脈瘤夾鉗國械備20210629號Aesculap   AGAm   Aesculap-Platz, 78532 Tuttlingen, Germany2021-12-31 有效
定位環(huán)國械備20200262號//2021-12-30 變更
醫(yī)用檢查手套國械備20210628號Ara?onesa   de ExportaciónInternacional 24 S.L.AVDA.   DE LOS TRABAJADORES, 13, 03430 ONIL (ALICANTE)2021-12-30 有效
肩關(guān)節(jié)手術(shù)工具國械備20180880號Zimmer   Inc.1800W.   Center Street Warsaw Indiana 46580 USA2021-12-30 變更
耳鼻喉科用測量器國械備20210627號Grace   Medical, Inc.8500   Wolf Lake Drive, Suite 110 Memphis, Tennessee 38133, USA2021-12-30 有效
血細胞分析用染色液國械備20210626號Siemens   Healthcare Diagnostics Inc.Parc   Euromédecine, Rue du Caducée, BP 7290, Montpellier Cedex 4, 34184 France2021-12-30 有效
造口袋國械備20181323號ConvaTec   Inc.Carretera   Sanchez, Km. 18.5 qarque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina,   San Cristobal 91000 Dominican Republic2021-12-30 變更
防漏膏國械備20190264號ConvaTec   Inc.Carretera   Sanchez, Km. 18.5, Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina,   San Cristobal, 91000 Dominican Republic.2021-12-30 變更
固定器械包國械備20210625號Becker   Orthopedic Appliance Co.635   Executive Drive, Troy, Michigan, 48083, United States2021-12-30 有效
造口袋國械備20210169號ConvaTec   LimitedCarretera   Sanchez, Km. 18.5 Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina,   San Cristobal 91000 Dominican Republic2021-12-30 變更
截斷刀國械備20210624號Grace   Medical, Inc.8500   Wolf Lake Drive, Suite 110 Memphis, Tennessee 38133, USA2021-12-29 有效
脊柱手術(shù)工具包國械備20210623號AESCULAP   AGAm   Aesculap-Platz, 78532 Tuttlingen, GERMANY2021-12-29 有效
脊柱手術(shù)工具包國械備20210622號AESCULAP   AGAm   Aesculap-Platz, 78532 Tuttlingen, GERMANY2021-12-29 有效
醫(yī)用紙質(zhì)膠帶國械備20210621號Paul   Hartmann AGP.   I. Pla d'en Boet II, c/ Carrasco i Formiguera, 48, 08302 Mataró (Barcelona),   SPAIN2021-12-29 有效
全自動血沉分析儀國械備20210620號Greiner   Bio-One GmbHVan   Rensselaerweg 4, 6956 AV Spankeren, The Netherlands2021-12-28 有效
牙科工具國械備20170151號MOZO-GRAU,   S.A.C/Santiago   López González, 7, 47197, Valladolid, Spain2021-12-28 變更
軟組織環(huán)切刀國械備20160054號MOZO   GRAU, S.A.C/Santiago   Lopez Gonzalez, 7, 47197, VALLADOLID, Spain2021-12-28 變更
牙科種植定位器國械備20160447號MOZO   GRAU,S.A.C/Santiago   Lopez Gonzalez, 7, 47197, VALLADOLID, Spain2021-12-28 變更
轉(zhuǎn)移帽國械備20160448號MOZO   GRAU,S.A.C/Santiago   Lopez Gonzalez, 7, 47197, VALLADOLID, Spain2021-12-28 變更
牙用尺國械備20160446號MOZO   GRAU,S.A.C/Santiago   Lopez Gonzalez, 7, 47197, VALLADOLID, Spain2021-12-28 變更
牙科種植工具國械備20160057號MOZO   GRAU, S.A.C/Santiago   Lopez Gonzalez, 7, 47197, VALLADOLID, Spain2021-12-28 變更
牙科工具國械備20190327號MOZO-GRAU,   S.A.C/Santiago   López González, 7, 47197 Valladolid. Spain2021-12-28 變更
牙科工具國械備20200153號MOZO-GRAU,   S.A.C/   SANTIAGO LóPEZ GONZáLEZ 7 - 47197 VALLADOLID SPAIN2021-12-28 變更
頸椎前路固定板系統(tǒng)手術(shù)工具國械備20170832號Bricon   GmbHVillingerstr.   33 78166 Donaueschingen Germany2021-12-28 變更
固定用彈力束帶國械備20181484號Bauerfeind   AGTriebeser   Straβe 16 07937 Zeulenroda- Triebes Germany2021-12-28 變更
緩沖液國械備20161681號Helena   Biosciences EuropeQueensway   South，Team Valley Trading Estate，Gateshead，Tyne and Wear，NE11 0SD，United   Kingdom2021-12-27 變更
緩沖液國械備20190186號Helena   Biosciences EuropeQueensway   South, Team Valley Trading Estate, Gateshead, Tyne and Wear, NE11 0SD, United   Kingdom2021-12-27 變更
外科手術(shù)固定器械國械備20210619號Berchtold   GmbH & Co. KGLudwigstaler   Stra?e 25, 78532 Tuttlingen, Germany2021-12-27 有效
全自動樣本處理系統(tǒng)國械備20151954號Beckman   Coulter, Inc.Sauerbruchstr.   50, 81377, Muenchen, Germany2021-12-27 變更
染色機 國械備20151321號Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19 69226 Nussloch Germany2021-12-27 變更
一次性使用取樣器國械備20210196號Novosanis   NVBijkhoevelaan   32c, 2110 Wijnegem, Belgium2021-12-27 變更
瓣膜成形環(huán)測環(huán)器及組件國械備20160017號Corcym   S.r.l.Via   Crescentino sn 13040 SALUGGIA (VC) ITALY2021-12-24 變更
樣本稀釋液國械備20190227號Helena   Biosciences EuropeQueensway   South, Team Valley Trading Estate, Gateshead, Tyne and Wear, NE11 0SD, United   Kingdom2021-12-23 變更
清洗液國械備20161594號Helena   Biosciences EuropeQueensway   South, Team Valley Trading Estate, Gateshead, Tyne and Wear, NE11 0SD, United   Kingdom2021-12-23 變更
髖關(guān)節(jié)手術(shù)器械國械備20200250號Brainlab   AGOlof-Palme-Stra?e   9, 81829 München, Germany2021-12-23 變更
種植用手術(shù)導板國械備20170395號FIMS   Co., Ltd.B1,   440 Changnyong-daero, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea Rep.2021-12-23 變更
口腔科手術(shù)工具包國械備20170494號FIMS   Co., Ltd.B1,   440 Changnyong-daero, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea Rep.2021-12-23 變更
電動移位機國械備20200573號ArjoHuntleigh   ABul.ks.Wawrzyniaka   2, 62-052 Komorniki, Poland2021-12-23 變更
慢性淋巴細胞白血病染色體及基因異常檢測試劑盒（原位雜交法）國械備20181122號Abbott   Molecular Inc.1300   East Touhy Avenue, Des Plaines, IL 60018, USA2021-12-23 變更
骨髓增生異常綜合征染色體及基因異常檢測試劑盒（原位雜交法）國械備20181112號Abbott   Molecular Inc.1300   East Touhy Avenue, Des Plaines, IL 60018, USA2021-12-23 變更
骨髓增生異常綜合征染色體及基因異常檢測試劑盒（原位雜交法）國械備20181121號Abbott   Molecular Inc.1300   East Touhy Avenue, Des Plaines, IL 60018, USA2021-12-23 變更
CD56檢測試劑國械備20210618號BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-12-22 有效
CD56檢測試劑國械備20210617號BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-12-22 有效
CD56檢測試劑國械備20210616號BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-12-22 有效
CD45檢測試劑國械備20210615號BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-12-22 有效
CD45檢測試劑國械備20210614號BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-12-22 有效
CD56檢測試劑國械備20210613號BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-12-22 有效
視力表投影儀國械備20210612號株式會社ニデック日本愛知県額田郡幸田町大字久保田字社口7番地2021-12-22 有效
采血筆國械備20160424號Roche   Diabetes Care GmbHSandhofer   Strasse 116, 68305 Mannheim, Germany2021-12-22 變更
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 Kingdom2021-12-22 有效
醫(yī)用外固定支具國械備20210610號opcnM   inc.413,Exporo,Yusung-gu,Daejeon-si,Korea2021-12-22 有效
血細胞分析用染色液國械備20210609號SYSMEX   CORPORATION17   Takumidai,Ono,Hyogo 675-1322,Japan2021-12-21 有效
尿液分析用染色液國械備20210608號SYSMEX   CORPORATION17   Takumidai,Ono,Hyogo 675-1322,Japan2021-12-21 有效
醫(yī)用體位膠墊國械備20170691號M?lnlycke   Health Care AB3902   Hanna Cir Suites A, E & F Indianapolis，IN 462412021-12-21 變更
引流袋國械備20190792號Medela   AGL?ttichstrasse   4b 6341 Baar SWITZERLAND2021-12-20 變更
全自動毛細管電泳儀國械備20160005號Helena   Biosciences EuropeSunderland   Enterprise Park Colima Avenue Sunderland SR5 3XB United Kingdom2021-12-20 變更
穴位壓力刺激貼國械備20210607號和光電研株式會社大阪府八尾市太田新町1丁目33番地2021-12-20 有效
成形片國械備20180652號Polydentia   SAVia   Cantonale 47,CH-6805 Mezzovico2021-12-20 變更
牙科手術(shù)器械包國械備20181728號Polydentia   SAVia   Cantonale 47, CH-6805 Mezzovico2021-12-20 變更
口腔科手術(shù)器械國械備20210606號Asim   InstrumentsAir   Port Road Gohadpur Sialkot Pakistan2021-12-17 有效
創(chuàng)口貼國械備20190697號LABORATOIRE   HRA PHARMAColoplast   utca2,4300 Nyírbátor, Hungary 2021-12-16 變更
緩沖液國械備20190540號Helena   Biosciences EuropeQueensway   South Team Valley Trading Estate Gateshead Tyne and Wear NE11 0SD United   Kingdom2021-12-16 變更
緩沖液國械備20190136號Helena   Biosciences EuropeQueensway   South, Team Valley Trading Estate, Gateshead, Tyne and Wear, NE11 0SD, United   Kingdom2021-12-16 變更
醫(yī)用脫敏膠布帶國械備20210605號Paul   Hartmann AGP.   I. Pla d'en Boet II, c/ Carrasco i Formiguera, 48, 08302 Mataró (Barcelona),   SPAIN2021-12-16 有效
一次性糞便蛋白提取裝置國械備20210604號INOVA   Diagnostics, Inc.VIA   FLAVIA 122 TRIESTE, Trieste ITALY 341472021-12-16 有效
蛋白提取試劑國械備20210603號INOVA   Diagnostics, Inc.9900   Old Grove Road San Diego California 92131 USA2021-12-16 有效
倒像鏡及裝置 國械備20180442號OCULUS   Optikger?te GmbHMünchholzh?user   Str.29, 35582 Wetzlar，Germany2021-12-16 變更
一次性使用末梢采血管國械備20210045號SARSTEDT   AG & Co. KGWinterborner   Stra?e，D-51588 Nümbrecht-Winterborn2021-12-15 變更
膜提升水管國械備20210602號Osstem   Implant Co.,Ltd.66-16,   Bansong-ro 513beon-gil, Haeundae-gu,Busan,Korea2021-12-15 有效
口腔科用CT檢查桿國械備20210601號Osstem   Implant Co., Ltd.66-16,   Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2021-12-15 有效
CD8檢測試劑國械備20180807號Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2021-12-15 變更
CD3檢測試劑國械備20180800號Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2021-12-15 變更
血細胞分析用溶血劑國械備20140201號Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2021-12-15 變更
HLA-DR檢測試劑國械備20180791號Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2021-12-15 變更
CD8檢測試劑國械備20180729號Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2021-12-15 變更
CD7檢測試劑國械備20180789號Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2021-12-15 變更
CD5檢測試劑國械備20180799號Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2021-12-15 變更
CD4檢測試劑國械備20180795號Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2021-12-15 變更
CD4檢測試劑國械備20180727號Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2021-12-15 變更
CD8檢測試劑國械備20180787號Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2021-12-15 變更
CD13檢測試劑國械備20180804號Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2021-12-15 變更
CD45RA檢測試劑國械備20180786號Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2021-12-15 變更
CD8檢測試劑國械備20180796號Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2021-12-15 變更
CD45RO檢測試劑國械備20180793號Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2021-12-15 變更
CD45檢測試劑國械備20180797號Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2021-12-15 變更
CD45檢測試劑國械備20180794號Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2021-12-15 變更
CD45檢測試劑國械備20180788號Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2021-12-15 變更
CD25檢測試劑國械備20180805號Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2021-12-15 變更
牙科成形片及配套工具國械備20152003號DENTSPLY   Caulk38   West Clarke Avenue Milford, DE 19963 USA2021-12-15 變更
透析用廢液袋國械備20210600號Gambro   Dasco S.p.A Medolla Facility Stegne   11 Ljubljana 1000 Slovenia2021-12-14 有效
牙科種植工具國械備20191423號Cybermed,Inc.6-26,   Yuseong-daero 1205beon-gil, Yuseong-gu, Daejeon 34104 Republic of Korea2021-12-14 變更
MSH6抗體試劑（免疫組織化學）國械備20210599號Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom 2021-12-14 有效
動力系統(tǒng)配套工具國械備20210407號The   Anspach Effort, Inc4500   Riverside Drive,Palm Beach Gardens,FL 334102021-12-14 變更
醫(yī)用退熱貼 國械備20190981號東和製藥株式會社和歌山県紀の川市貴志川町丸棲１２２９番地2021-12-13 變更
牙科種植工具包國械備20210598號Nanoden204,   88, Somang-gil, Juchon-myeon, Gimhae-si, Gyeongsangnam-do, Republic of Korea   ; 1-101, 32, Gongam-gil, Sangbuk-myeon, Yangsan-si, Gyeongsangnam-do,   Republic of Korea2021-12-10 有效
牙科刮治器國械備20210597號PRODONT-HOLLIGER   SOCIETE PAR ACTIONSLieu-dit   La Marnasse,63880 OLLIERGUES,France2021-12-10 有效
樣本稀釋液國械備20210596號富士レビオ株式會社日本國東京都八王子市小宮町51番地2021-12-10 有效
CDX-2抗體試劑（免疫組織化學）國械備20210595號Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA2021-12-09 有效
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造口袋國械備20181323號ConvaTec   Inc.Carretera   Sanchez, Km. 18.5 qarque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina,   San Cristobal 91000 Dominican Republic2021-12-03 變更
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MSH2抗體試劑（免疫組織化學）國械備20190562號BOND   Ready-to-Use Primary Antibody MSH2 (Mismatch Repair Protein) (25D12)Balliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom.2021-12-03 無效
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骨科手術(shù)器械包國械備20171005號SPINEWAY7   Allee Moulin Berger,69130 ECULLY, France2021-12-02 變更
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CD34抗體試劑（免疫組織化學）國械備20210573號Biocare   Medical,LLC60   Berry Drive Pacheco,CA 94553 2021-12-02 有效
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打磨拋光組件國械備20210570號TOP   BM7a,   bld. 2, apt. 44b, Novatorov str., Moscow, 119421, Russia2021-12-01 有效
成形片國械備20210569號TOP   BM7a,bld.2,apt.44b,Novatorov   str.,Moscow,119421,Russia2021-12-01 有效
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造口袋國械備20210567號 B. Braun Medical SAS Z.l.de   Layats, 64500 Saint-Jean-de-Luz, FRANCE; 13 rue Croix la Comtesse, 28400   Nogent-le-Rotrou, FRANCE 2021-12-01 有效

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