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["2023年10月进口第一类医疗器械产品备案信息"]
["序号","产品名称","备案号","备案人名称原文","生产地址原文","备案日期","状态"]
["1","种植体安装辅助器械","国械备20230513号","Oneday Biotech Co., Ltd.","C-135, Seongseodong-ro, Dalseo-gu, Daegu, Republic of Korea","2023-10-31 ","有效"]
["2","种植辅助材料","国械备20230512号","Oneday Biotech Co., Ltd.","C-135, Seongseodong-ro, Dalseo-gu, Daegu, Republic of Korea","2023-10-31 ","有效"]
["3","牙科种植扫描体","国械备20230511号","Oneday Biotech Co., Ltd.","C-135, Seongseodong-ro, Dalseo-gu, Daegu, Republic of Korea","2023-10-31 ","有效"]
["4","清洗液","国械备20230510号","Siemens Healthcare Diagnostics Inc.","500 GBC Drive, P.O. Box 6101 Newark, DE, 19714, USA  ","2023-10-30 ","有效"]
["5","清洗液","国械备20230509号","Siemens Healthcare Diagnostics Inc. ","Northern Road, Chilton Industrial Estate, Sudbury, Suffolk CO10 2XQ, UK","2023-10-30 ","有效"]
["6","口腔科手术器械","国械备20230508号","IBBI DENTAL INSTRUMENTS","Haji Pura (Amba Wali Chapri) Near Dera Ch Ansar, Sialkot-Pakistan.","2023-10-27 ","有效"]
["7","口腔科手术器械","国械备20220065号","Vitra International","Marala Road 51360,Sialkot-Pakistan","2023-10-27 ","变更"]
["8","根管扩大器","国械备20220106号","株式会社背戸製作所","茨城県つくば市小田4596の1","2023-10-27 ","变更"]
["9","医用射线防护用品及装置","国械备20230507号","Barrier Technologies, LLC","7060 W. State Rd 84, Suite 8, Davie, Florida, 33317, United States","2023-10-25 ","有效"]
["10","自动加样系统","国械备20230506号","シスメックス株式会社","18735 Madrone Parkway Morgan Hill, CA 95037 United States of America","2023-10-25 ","有效"]
["11","髋关节手术工具","国械备20230505号","Zimmer Inc.","1800 W. Center Street Warsaw Indiana 46580 USA","2023-10-25 ","有效"]
["12","骨科牵引架","国械备20230259号","Allen Medical Systems, Inc.","100 Discovery Way Acton, MA 01720 USA","2023-10-24 ","变更"]
["13","口腔科手术器械","国械备20230504号","TITAN SURGICAL CO.","Adalat Ghara Nia,Sialkot-Pakistan","2023-10-24 ","有效"]
["14","手术肌腱整理平台","国械备20200045号","Arthrex,Inc.","6875 Arthrex Commerce Drive Ave Maria, FL USA 34142 ","2023-10-23 ","变更"]
["15","细胞角蛋白（广谱）抗体试剂（免疫组织化学）","国械备20190048号","Ventana Medical Systems, Inc.","1910E.Innovation Park Drive Tucson,Arizona 85755 USA","2023-10-23 ","变更"]
["16","清洗液","国械备20230503号","キヤノンメディカルシステムズ株式会社","1359-1 Kagamida, Kigoshi, Gosen-shi, Niigata,959-1695 Japan","2023-10-20 ","有效"]
["17","牙科种植工具包","国械备20230502号","Noris Medical Ltd.","8 Hataasia St., Nesher 3688808","2023-10-19 ","有效"]
["18","手术拉钩","国械备20150082号","FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH","Prager Ring 70, 52070 Aachen, Germany","2023-10-19 ","变更"]
["19","医用冰垫","国械备20150159号","彪仕醫技股份有限公司","台南市南區中華西路一段23號","2023-10-19 ","无效"]
["20","低速台式离心机","国械备20230501号","株式会社久保田製作所","群馬県藤岡市中大塚1065-3","2023-10-19 ","有效"]
["21","低速冷冻离心机","国械备20230500号","株式会社久保田製作所","群馬県藤岡市中大塚1065-3","2023-10-19 ","有效"]
["22","替代体","国械备20230499号","VIDA DENTAL SAN. VE TİC. A.Ş.","600 Evler Mah. Balıkesir Asf. Sol Taraf Cad. Ünallar Sitesi No: 10 Bandırma BALIKESİR / TURKEY","2023-10-19 ","有效"]
["23","免疫组化抗原修复缓冲液Novocastra Epitope Retrieval Solution pH9","国械备20160676号","Leica Biosystems Newcastle Ltd","Second Avenue, Heather House Industrial Estate, Irvine, Ayrshire, Scotland, KA12 8NB, United Kingdom","2023-10-18 ","变更"]
["24","脱蜡液 BOND Dewax Solution","国械备20140293号","Leica Biosystems Newcastle Ltd","Balliol Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom","2023-10-18 ","变更"]
["25","免疫组化抗原修复缓冲液Novocastra Epitope Retrieval Solution pH6","国械备20160677号","Leica Biosystems Newcastle Ltd","Second Avenue, Heather House Industrial Estate, Irvine, Ayrshire, Scotland, KA12 8NB, United Kingdom","2023-10-18 ","变更"]
["26","样本稀释液","国械备20210596号","富士レビオ株式会社","日本国東京都八王子市小宮町51番地","2023-10-18 ","变更"]
["27","样本稀释液","国械备20160414号","富士レビオ株式会社","東京都八王子市小宮町51番地","2023-10-18 ","变更"]
["28","全自动免疫检验系统用底物液","国械备20160413号","富士レビオ株式会社","東京都八王子市小宮町５１番地","2023-10-18 ","变更"]
["29","手术用动力手柄连接套管（带参考架）","国械备20230498号","Medtronic Powered Surgical Solutions","4620 North Beach Street Fort Worth Texas 76137 USA","2023-10-17 ","有效"]
["30","Gomori 三色染色液（绿）","国械备20230497号","Leica Biosystems Richmond, Inc.","5205 Route 12, P.O.Box 528, Richmond, Illinois 60071, USA","2023-10-17 ","有效"]
["31","夹持钳","国械备20230496号","FENTEXmedical GmbH","take-off Gewerbepark 2 78579 Neuhausen Ob Eck Germany","2023-10-17 ","有效"]
["32","骨用牵开器","国械备20230495号","Thompson Surgical Instruments, Inc.","10341 E. Cherry Bend Road, Traverse City, MI, 49684 United States of America","2023-10-17 ","有效"]
["33","Gomori 三色染色液（蓝）","国械备20230494号","Leica Biosystems Richmond, Inc.","5205 Route 12, P.O.Box 528, Richmond, Illinois 60071, USA","2023-10-17 ","有效"]
["34","组织固定液 O-FIX","国械备20160444号","Leica Biosystems Richmond,Inc.","5205 Route 12 P.O.Box 528 Richmond Illinois 60071 USA","2023-10-17 ","变更"]
["35","染色机","国械备20140016号","Leica Biosystems Melbourne Pty Ltd","495 Blackburn Road Mt Waverley Victoria 3149 Australia","2023-10-16 ","变更"]
["36","自动组织脱水机","国械备20180309号","Leica Biosystems Melbourne Pty Ltd","495 Blackburn Road, Mount Waverley, VIC3149, Australia","2023-10-16 ","变更"]
["37","染色机","国械备20140277号","Leica Biosystems Melbourne Pty Ltd","495 Blackburn Road Mt Waverley Victoria 3149 Australia","2023-10-16 ","变更"]
["38","过碘酸雪夫染色液","国械备201619640号","Leica Biosystems Richmond, Inc.","5205 Route 12 P.O. Box 528 Richmond Illinois 60071 USA","2023-10-16 ","无效"]
["39","阿利辛蓝－过碘酸雪夫氏染色液","国械备20161937号","Leica Biosystems Richmond, Inc.","5205 Route 12 P.O. Box 528 Richmond Illinois 60071 USA","2023-10-16 ","无效"]
["40","医用图像打印机","国械备20140244号","/","Max-Planck-Strasse 1, 82380 Peiβenberg, Germany","2023-10-16 ","变更"]
["41","CD123检测试剂（流式细胞仪法）","国械备20230493号","BioLegend,Inc.","8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121","2023-10-16 ","有效"]
["42","CD4检测试剂","国械备20230492号","BioLegend,Inc.","8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121","2023-10-16 ","有效"]
["43","CD117检测试剂","国械备20210480号","BioLegend, Inc.","8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121","2023-10-16 ","变更"]
["44","CD14检测试剂","国械备20230491号","BioLegend,Inc.","8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121","2023-10-16 ","有效"]
["45","造口袋","国械备20200543号","Coloplast A/S","Búzavirág út 15, 2800 Tatabánya, Hungary /Calle 58, Zona Franca La Lima, La Lima, Guadalupe, 30106 Cartago, Costa Rica","2023-10-13 ","变更"]
["46","二件式造口袋","国械备20190784号","Coloplast A/S","Coloplast Hungary KFT, Búzavirág út 15, 2800 Tatabánya, Hungary","2023-10-13 ","变更"]
["47","橡皮障夹钳","国械备20230490号","Secure Dental Company","Near New Ghalla Mandi, Main Aiman Abad Road, Sialkot - 51310 – Pakistan","2023-10-13 ","有效"]
["48","橡皮障支架","国械备20230489号","Secure Dental Company","Near New Ghalla Mandi, Main Aiman Abad Road, Sialkot - 51310 - Pakistan","2023-10-13 ","有效"]
["49","压力绷带","国械备20171055号","MAXIS a.s.","Francouzska 171/28, 12000 Praha 2 – Vinohrady, Czech Republic","2023-10-13 ","变更"]
["50","FOXO1（13q14）基因断裂探针试剂（荧光原位杂交法）","国械备20230488号","Kreatech Biotechnology B.V."," Vlierweg 20, 1032 LG Amsterdam, The Netherlands","2023-10-12 ","有效"]
["51","液体敷料","国械备20190860号","ConvaTec Limited","Units 12A & 12B kings Court, Prince William Avenue, Sandycroft, Deeside CH5 2FG, United Kingdom","2023-10-12 ","无效"]
["52","脊柱手术器械","国械备20210228号","Synthes GmbH","Industriestrasse 28, 2545 Selzach, Switzerland","2023-10-12 ","变更"]
["53","脊柱微创手术工具包","国械备20190164号","Medos International SARL","50 Scotland Blvd, Bridgewater Massachusetts, 02324 USA","2023-10-12 ","变更"]
["54","固定用弹力束带","国械备20181484号","Bauerfeind AG","Triebeser Straβe 16 07937 Zeulenroda- Triebes Germany","2023-10-12 ","变更"]
["55","牙科手术器械包","国械备20230487号","AMMAR INDUSTRIES","Near Ballanwala Post Office, Infront of Jamia Masjid Muhammadi Ahlayhadees, Sialkot - Pakistan","2023-10-12 ","有效"]
["56","缓冲液","国械备20200682号","RAL DIAGNOSTICS","Site Montesquieu 33650 MARTILLAC FRANCE","2023-10-12 ","变更"]
["57","橡皮障打孔器","国械备20230486号","Secure Dental Company","Near New Ghalla Mandi, Main Aiman Abad Road, Sialkot - 51310 - Pakistan","2023-10-12 ","有效"]
["58","橡皮障夹","国械备20230485号","Secure Dental Company","Near New Ghalla Mandi, Main Aiman Abad Road, Sialkot - 51310 - Pakistan","2023-10-12 ","有效"]
["59","自动加样系统","国械备20230484号","Beckman Coulter, Inc.","11800 SW 147TH AVE Miami, FL USA 33196","2023-10-12 ","有效"]
["60","全自动免疫检验系统用底物液","国械备20230483号","Beckman Coulter, Inc.","1000 Lake Hazeltine Drive, Chaska, MN 55318-1084","2023-10-12 ","有效"]
["61","创口贴","国械备20200613号","/","/","2023-10-12 ","变更"]
["62","牙科抛光磨头","国械备20230482号","EVE Ernst Vetter GmbH","Neureutstr.6, 75210 Keltern, Germany","2023-10-10 ","有效"]