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2021年12月進(jìn)口第一類(lèi)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):3863次
2022年1月11日,藥監(jiān)總局發(fā)布《2021年12月進(jìn)口第一類(lèi)醫(yī)療器械產(chǎn)品備案信息》公告,2021年最后一個(gè)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(gè)盡快醫(yī)療器械產(chǎn)品備案項(xiàng)目審批。

2022年1月11日,藥監(jiān)總局發(fā)布《2021年12月進(jìn)口第一類(lèi)醫(yī)療器械產(chǎn)品備案信息》公告,2021年最后一個(gè)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(gè)盡快醫(yī)療器械產(chǎn)品備案項(xiàng)目審批。

產(chǎn)品名稱(chēng)備案號(hào)備案人名稱(chēng)原文生產(chǎn)地址原文備案日期狀態(tài)
醫(yī)用絲綢膠帶國(guó)械備20210631號(hào)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(guó)械備20200356號(hào)//2021-12-31 變更
基臺(tái)就位器國(guó)械備20210042號(hào)//2021-12-31 變更
種植體系統(tǒng)工具國(guó)械備20140102號(hào)/959-21,Dae   Chon-dong,Buk-gu,Gwangju2021-12-31 變更
創(chuàng)口貼國(guó)械備20181401號(hào)東洋化學(xué)株式會(huì)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(guó)械備20200357號(hào)//2021-12-31 變更
創(chuàng)口貼國(guó)械備20181400號(hào)東洋化學(xué)株式會(huì)社滋賀県蒲生郡日野町寺尻1008番地2021-12-31 變更
動(dòng)力系統(tǒng)配套工具國(guó)械備20210630號(hào) Synthes GmbHEimattstrasse   3, 4436 Oberdorf, Switzerland2021-12-31 有效
動(dòng)脈瘤夾鉗國(guó)械備20210629號(hào)Aesculap   AGAm   Aesculap-Platz, 78532 Tuttlingen, Germany2021-12-31 有效
定位環(huán)國(guó)械備20200262號(hào)//2021-12-30 變更
醫(yī)用檢查手套國(guó)械備20210628號(hào)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(guó)械備20180880號(hào)Zimmer   Inc.1800W.   Center Street Warsaw Indiana 46580 USA2021-12-30 變更
耳鼻喉科用測(cè)量器國(guó)械備20210627號(hào)Grace   Medical, Inc.8500   Wolf Lake Drive, Suite 110 Memphis, Tennessee 38133, USA2021-12-30 有效
血細(xì)胞分析用染色液國(guó)械備20210626號(hào)Siemens   Healthcare Diagnostics Inc.Parc   Euromédecine, Rue du Caducée, BP 7290, Montpellier Cedex 4, 34184 France2021-12-30 有效
造口袋國(guó)械備20181323號(hào)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(guó)械備20190264號(hào)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(guó)械備20210625號(hào)Becker   Orthopedic Appliance Co.635   Executive Drive, Troy, Michigan, 48083, United States2021-12-30 有效
造口袋國(guó)械備20210169號(hào)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?cái)嗟?/td>國(guó)械備20210624號(hào)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(guó)械備20210623號(hào)AESCULAP   AGAm   Aesculap-Platz, 78532 Tuttlingen, GERMANY2021-12-29 有效
脊柱手術(shù)工具包國(guó)械備20210622號(hào)AESCULAP   AGAm   Aesculap-Platz, 78532 Tuttlingen, GERMANY2021-12-29 有效
醫(yī)用紙質(zhì)膠帶國(guó)械備20210621號(hào)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(dòng)血沉分析儀國(guó)械備20210620號(hào)Greiner   Bio-One GmbHVan   Rensselaerweg 4, 6956 AV Spankeren, The Netherlands2021-12-28 有效
牙科工具國(guó)械備20170151號(hào)MOZO-GRAU,   S.A.C/Santiago   López González, 7, 47197, Valladolid, Spain2021-12-28 變更
軟組織環(huán)切刀國(guó)械備20160054號(hào)MOZO   GRAU, S.A.C/Santiago   Lopez Gonzalez, 7, 47197, VALLADOLID, Spain2021-12-28 變更
牙科種植定位器國(guó)械備20160447號(hào)MOZO   GRAU,S.A.C/Santiago   Lopez Gonzalez, 7, 47197, VALLADOLID, Spain2021-12-28 變更
轉(zhuǎn)移帽國(guó)械備20160448號(hào)MOZO   GRAU,S.A.C/Santiago   Lopez Gonzalez, 7, 47197, VALLADOLID, Spain2021-12-28 變更
牙用尺國(guó)械備20160446號(hào)MOZO   GRAU,S.A.C/Santiago   Lopez Gonzalez, 7, 47197, VALLADOLID, Spain2021-12-28 變更
牙科種植工具國(guó)械備20160057號(hào)MOZO   GRAU, S.A.C/Santiago   Lopez Gonzalez, 7, 47197, VALLADOLID, Spain2021-12-28 變更
牙科工具國(guó)械備20190327號(hào)MOZO-GRAU,   S.A.C/Santiago   López González, 7, 47197 Valladolid. Spain2021-12-28 變更
牙科工具國(guó)械備20200153號(hào)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(guó)械備20170832號(hào)Bricon   GmbHVillingerstr.   33 78166 Donaueschingen Germany2021-12-28 變更
固定用彈力束帶國(guó)械備20181484號(hào)Bauerfeind   AGTriebeser   Straβe 16 07937 Zeulenroda- Triebes Germany2021-12-28 變更
緩沖液國(guó)械備20161681號(hào)Helena   Biosciences EuropeQueensway   South,Team Valley Trading Estate,Gateshead,Tyne and Wear,NE11 0SD,United   Kingdom2021-12-27 變更
緩沖液國(guó)械備20190186號(hào)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(guó)械備20210619號(hào)Berchtold   GmbH & Co. KGLudwigstaler   Stra?e 25, 78532 Tuttlingen, Germany2021-12-27 有效
全自動(dòng)樣本處理系統(tǒng)國(guó)械備20151954號(hào)Beckman   Coulter, Inc.Sauerbruchstr.   50, 81377, Muenchen, Germany2021-12-27 變更
染色機(jī) 國(guó)械備20151321號(hào)Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19 69226 Nussloch Germany2021-12-27 變更
一次性使用取樣器國(guó)械備20210196號(hào)Novosanis   NVBijkhoevelaan   32c, 2110 Wijnegem, Belgium2021-12-27 變更
瓣膜成形環(huán)測(cè)環(huán)器及組件國(guó)械備20160017號(hào)Corcym   S.r.l.Via   Crescentino sn 13040 SALUGGIA (VC) ITALY2021-12-24 變更
樣本稀釋液國(guó)械備20190227號(hào)Helena   Biosciences EuropeQueensway   South, Team Valley Trading Estate, Gateshead, Tyne and Wear, NE11 0SD, United   Kingdom2021-12-23 變更
清洗液國(guó)械備20161594號(hào)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(guó)械備20200250號(hào)Brainlab   AGOlof-Palme-Stra?e   9, 81829 München, Germany2021-12-23 變更
種植用手術(shù)導(dǎo)板國(guó)械備20170395號(hào)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(guó)械備20170494號(hào)FIMS   Co., Ltd.B1,   440 Changnyong-daero, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea Rep.2021-12-23 變更
電動(dòng)移位機(jī)國(guó)械備20200573號(hào)ArjoHuntleigh   ABul.ks.Wawrzyniaka   2, 62-052 Komorniki, Poland2021-12-23 變更
慢性淋巴細(xì)胞白血病染色體及基因異常檢測(cè)試劑盒(原位雜交法)國(guó)械備20181122號(hào)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(cè)試劑盒(原位雜交法)國(guó)械備20181112號(hào)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(cè)試劑盒(原位雜交法)國(guó)械備20181121號(hào)Abbott   Molecular Inc.1300   East Touhy Avenue, Des Plaines, IL 60018, USA2021-12-23 變更
CD56檢測(cè)試劑國(guó)械備20210618號(hào)BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-12-22 有效
CD56檢測(cè)試劑國(guó)械備20210617號(hào)BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-12-22 有效
CD56檢測(cè)試劑國(guó)械備20210616號(hào)BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-12-22 有效
CD45檢測(cè)試劑國(guó)械備20210615號(hào)BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-12-22 有效
CD45檢測(cè)試劑國(guó)械備20210614號(hào)BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-12-22 有效
CD56檢測(cè)試劑國(guó)械備20210613號(hào)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(guó)械備20210612號(hào)株式會(huì)社ニデック日本愛(ài)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(guó)械備20160424號(hào)Roche   Diabetes Care GmbHSandhofer   Strasse 116, 68305 Mannheim, Germany2021-12-22 變更
造口皮膚保護(hù)劑國(guó)械備20210611號(hào)康維德有限責(zé)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(guó)械備20210610號(hào)opcnM   inc.413,Exporo,Yusung-gu,Daejeon-si,Korea2021-12-22 有效
血細(xì)胞分析用染色液國(guó)械備20210609號(hào)SYSMEX   CORPORATION17   Takumidai,Ono,Hyogo 675-1322,Japan2021-12-21 有效
尿液分析用染色液國(guó)械備20210608號(hào)SYSMEX   CORPORATION17   Takumidai,Ono,Hyogo 675-1322,Japan2021-12-21 有效
醫(yī)用體位膠墊國(guó)械備20170691號(hào)M?lnlycke   Health Care AB3902   Hanna Cir Suites A, E & F Indianapolis,IN 462412021-12-21 變更
引流袋國(guó)械備20190792號(hào)Medela   AGL?ttichstrasse   4b 6341 Baar SWITZERLAND2021-12-20 變更
全自動(dòng)毛細(xì)管電泳儀國(guó)械備20160005號(hào)Helena   Biosciences EuropeSunderland   Enterprise Park Colima Avenue Sunderland SR5 3XB United Kingdom2021-12-20 變更
穴位壓力刺激貼國(guó)械備20210607號(hào)和光電研株式會(huì)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(guó)械備20180652號(hào)Polydentia   SAVia   Cantonale 47,CH-6805 Mezzovico2021-12-20 變更
牙科手術(shù)器械包國(guó)械備20181728號(hào)Polydentia   SAVia   Cantonale 47, CH-6805 Mezzovico2021-12-20 變更
口腔科手術(shù)器械國(guó)械備20210606號(hào)Asim   InstrumentsAir   Port Road Gohadpur Sialkot Pakistan2021-12-17 有效
創(chuàng)口貼國(guó)械備20190697號(hào)LABORATOIRE   HRA PHARMAColoplast   utca2,4300 Nyírbátor, Hungary 2021-12-16 變更
緩沖液國(guó)械備20190540號(hào)Helena   Biosciences EuropeQueensway   South Team Valley Trading Estate Gateshead Tyne and Wear NE11 0SD United   Kingdom2021-12-16 變更
緩沖液國(guó)械備20190136號(hào)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(guó)械備20210605號(hào)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(guó)械備20210604號(hào)INOVA   Diagnostics, Inc.VIA   FLAVIA 122 TRIESTE, Trieste ITALY 341472021-12-16 有效
蛋白提取試劑國(guó)械備20210603號(hào)INOVA   Diagnostics, Inc.9900   Old Grove Road San Diego California 92131 USA2021-12-16 有效
倒像鏡及裝置 國(guó)械備20180442號(hào)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(guó)械備20210045號(hào)SARSTEDT   AG & Co. KGWinterborner   Stra?e,D-51588 Nümbrecht-Winterborn2021-12-15 變更
膜提升水管國(guó)械備20210602號(hào)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(guó)械備20210601號(hào)Osstem   Implant Co., Ltd.66-16,   Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2021-12-15 有效
CD8檢測(cè)試劑國(guó)械備20180807號(hào)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(cè)試劑國(guó)械備20180800號(hào)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(xì)胞分析用溶血?jiǎng)?/td>國(guó)械備20140201號(hào)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(cè)試劑國(guó)械備20180791號(hào)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(cè)試劑國(guó)械備20180729號(hào)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(cè)試劑國(guó)械備20180789號(hào)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(cè)試劑國(guó)械備20180799號(hào)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(cè)試劑國(guó)械備20180795號(hào)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(cè)試劑國(guó)械備20180727號(hào)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(cè)試劑國(guó)械備20180787號(hào)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(cè)試劑國(guó)械備20180804號(hào)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(cè)試劑國(guó)械備20180786號(hào)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(cè)試劑國(guó)械備20180796號(hào)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(cè)試劑國(guó)械備20180793號(hào)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(cè)試劑國(guó)械備20180797號(hào)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
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