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["2024年11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","Lambda链探针试剂（原位杂交法）","国械备20180491号","Roche Diagnostics GmbH","1910 East Innovation Park Drive, Tucson, AZ, 85755, United States","2024-11-29 ","变更"]
["2","MSH6抗体试剂（免疫组织化学）","国械备20200236号","Roche Diagnostics GmbH","1910 East Innovation Park Drive, Tucson, AZ, 85755, United States","2024-11-29 ","变更"]
["3","Kappa链探针试剂（原位杂交法）","国械备20180492号","Roche Diagnostics GmbH","1910 East Innovation Park Drive, Tucson, AZ, 85755, United States","2024-11-29 ","变更"]
["4","眼球突出计","国械备20240399号","OCULUS Optikgeräte GmbH","Münchholzhäuser Str.29, 35582 Wetzlar, GERMANY","2024-11-28 ","有效"]
["5","成形片器械包","国械备20240398号","ÖNCÜ DENTAL TIBBİ MALZEME SANAYİ VE DIŞ TİCARET A.Ş.","Akçaburgaz Mah. 3028. Sk 1/33 Esenyurt/istanbul /TÜRKİYE","2024-11-28 ","有效"]
["6","骨科脊柱外科手术工具包","国械备20191169号","Mazor Robotics Ltd.","PO Box 3104, 5 Shacham St., North Industrial Park, Caesarea 3079567, Israel","2024-11-28 ","变更"]
["7","样本稀释液Diluent Universal","国械备20170606号","Scantibodies Laboratory, Inc.","Scantibodies Laboratory, Inc. 9336 Abraham Way, Santee, CA 92071, USA","2024-11-28 ","无效"]
["8","测深器","国械备20230416号","グンゼメディカル株式会社","東京都北区田端新町2-14-18","2024-11-27 ","变更"]
["9","埋头钻","国械备20230455号","グンゼメディカル株式会社","福島県石川郡石川町字大橋2-12、兵庫県多可郡多可町中区曽我井907番地90","2024-11-27 ","变更"]
["10","打入器","国械备20230456号","グンゼメディカル株式会社","京都府京都市南区久世殿城町126","2024-11-27 ","变更"]
["11","骨铰刀","国械备20230414号","グンゼメディカル株式会社","兵庫県多可郡多可町中区曽我井907番地90","2024-11-27 ","变更"]
["12","丝锥","国械备20230460号","グンゼメディカル株式会社","福島県石川郡石川町字大橋2-12，兵庫県多可郡多可町中区曽我井907番地90","2024-11-27 ","变更"]
["13","骨科用螺丝刀","国械备20230415号","グンゼメディカル株式会社","京都府京都市南区久世殿城町126","2024-11-27 ","变更"]
["14","夹持钳","国械备20230459号","グンゼメディカル株式会社","東京都北区田端新町2-14-18","2024-11-27 ","变更"]
["15","骨科钻孔调节定位器","国械备20230454号","グンゼメディカル株式会社","京都府京都市南区久世殿城町126","2024-11-27 ","变更"]
["16","夹持钳","国械备20230413号","グンゼメディカル株式会社","東京都北区田端新町2-14-18","2024-11-27 ","变更"]
["17","钻头","国械备20230461号","グンゼメディカル株式会社","福島県石川郡石川町字大橋2-12，兵庫県多可郡多可町中区曽我井907番地90","2024-11-27 ","变更"]
["18","测深器","国械备20230457号","グンゼメディカル株式会社","京都府京都市南区久世殿城町126","2024-11-27 ","变更"]
["19","医用放大镜","国械备20160791号","Volk Optical Inc.","7893 Enterprise Drive, Mentor, OH, 44060, USA","2024-11-26 ","无效"]
["20","定位膜","国械备20230556号","Qfix","440 Church Road Avondale Pennsylvania 19311 USA","2024-11-26 ","变更"]
["21","快装手柄","国械备20230458号","グンゼメディカル株式会社","神奈川県横浜市戸塚区上矢部町2265-3","2024-11-26 ","变更"]
["22","真空垫","国械备20230557号","Qfix ","440 Church Road Avondale Pennsylvania 19311 USA","2024-11-26 ","变更"]
["23","放射治疗患者用定位装置","国械备20240042号","Qfix","440 Church Road Avondale Pennsylvania 19311 USA","2024-11-26 ","变更"]
["24","Glypican 3抗体试剂（免疫组织化学）","国械备20180596号","Ventana Medical Systems, Inc.","1910 E. Innovation Park Drive, Tucson, AZ, 85755, USA","2024-11-26 ","变更"]
["25","口腔科器械","国械备20240396号","A.Schweickhardt GmbH＆Co.KG","Tuttlinger Straβe 12 78606 Seitingen-Oberflacht Germany","2024-11-26 ","有效"]
["26","造口袋","国械备20190949号","Coloplast A/S","Kerék utca 4, 2800 Tatabánya, Hungary","2024-11-26 ","变更"]
["27","C-MET抗体试剂（免疫组织化学)","国械备20181055号","Ventana Medical Systems,Inc.","1910E.Innovation Park Drive Tucson, AZ 85755 USA","2024-11-26 ","变更"]
["28","Kappa链抗体试剂（免疫组织化学）","国械备20180643号","Ventana Medical Systems, Inc.","1910 E. Innovation Park Drive, Tucson, AZ, 85755, USA","2024-11-26 ","变更"]
["29","医用射线防护悬吊屏风","国械备20160828号","MAVIG GmbH","Stahlgruberring 5, 81829 Munchen, Germany","2024-11-25 ","变更"]
["30","吊架","国械备20180039号","MAVIG GmbH","Stahlgruberring 5, 81829 Munich, Germany","2024-11-25 ","变更"]
["31","防辐射帽","国械备20160985号","MAVIG GmbH","Stahlgruberring 5, 81829 Munchen, Germany","2024-11-25 ","变更"]
["32","医用射线防护面罩","国械备20160124号","MAVIG GmbH","Stahlgruberring 5, 81829, Muchen, Germany","2024-11-25 ","变更"]
["33","医用射线防护眼镜","国械备20151884号","MAVIG GmbH","Stahlgruberring 5，81829 München, GERMANY","2024-11-25 ","变更"]
["34","模板","国械备20230412号","グンゼメディカル株式会社","福島県石川郡石川町字大橋2-12","2024-11-25 ","变更"]
["35","防辐射围领","国械备20160561号","MAVIG GmbH","Stahlgruberring 5, 81829 Muchen, Germany","2024-11-25 ","变更"]
["36","医用射线防护帘","国械备20160562号","MAVIG GmbH","Stahlgruberring 5, 81829 Muchen, Germany","2024-11-25 ","变更"]
["37","手术辅助照明灯","国械备20191243号","MAVIG GmbH","Flossmannstr.28, 85560, Ebersberg, Germany","2024-11-25 ","变更"]
["38","医用射线防护屏","国械备20160987号","MAVIG GmbH","Stahlgruberring 5, 81829, Muchen, Germany","2024-11-25 ","变更"]
["39","医用射线防护帘","国械备20160831号","MAVIG GmbH","Stahlgruberring 5, 81829, Munchen, Germany","2024-11-25 ","变更"]
["40","体位外固定支撑器","国械备20220543号","Mölnlycke Health Care AB","11 Twin Rivers Drive Wiscasset Maine 04578 USA","2024-11-25 ","变更"]
["41","种植体扫描体","国械备20180660号","Elos Medtech Pinol A/S","Engvej 33, Gørløse 3330, Denmark","2024-11-25 ","变更"]
["42","样品前处理系统","国械备20240395号","GLOBAL BİYOMEDİKAL SAĞLIK HİZMETLERİ SANAYİ VE TİCARET LİMİTED ŞİRKETİ  ","YEŞİLKÖY MAH.ATATÜRK CAD.EGS BUSINESS PARK BLOK NO:12/368 BAKIRKÖY/ İSTANBUL / TÜRKİYE","2024-11-22 ","有效"]
["43","骨科手术器械包","国械备20171005号","SPINEWAY","7 Allee Moulin Berger,69130 ECULLY, France","2024-11-22 ","无效"]
["44","CD123抗体试剂","国械备20240394号","BioLegend,Inc.","8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121","2024-11-21 ","有效"]
["45","直径尺","国械备20151191号","Inion Oy","Lääkärinkatu 2 Tampere 33520 Finland","2024-11-21 ","变更"]
["46","快装手柄","国械备20151192 号","Inion Oy","Lääkärinkatu 2 Tampere 33520 Finland","2024-11-21 ","变更"]
["47","肩关节手术工具","国械备20160243号","Inion Oy","Lääkärinkatu 2 Tampere 33520 Finland","2024-11-21 ","变更"]
["48","骨科手术工具","国械备20140141号","Inion Oy","Lääkärinkatu 2 Tampere 33520 Finland","2024-11-21 ","变更"]
["49","脊柱手术工具","国械备20161196号 ","Inion Oy","Lääkärinkatu 2 Tampere 33520 Finland","2024-11-21 ","变更"]
["50","骨固定手术工具","国械备20161195号 ","Inion Oy","Lääkärinkatu 2 Tampere 33520 Finland","2024-11-21 ","变更"]
["51","口腔科手术器械","国械备20240392号","AAYMED INSTRUMENTS","Kotli Behram 51310 Sialkot Pakistan","2024-11-21 ","有效"]
["52","CD41抗体试剂","国械备20240391号","BioLegend,Inc.","8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121","2024-11-21 ","有效"]
["53","CD200抗体试剂","国械备20240390号","BioLegend,Inc.","8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121","2024-11-21 ","有效"]
["54","CD42b抗体试剂","国械备20240389号","BioLegend,Inc.","8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121","2024-11-21 ","有效"]
["55","CD28抗体试剂","国械备20240388号","BioLegend,Inc.","8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121","2024-11-21 ","有效"]
["56","CD123抗体试剂","国械备20240387号","BioLegend,Inc.","8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121","2024-11-21 ","有效"]
["57","替代体","国械备20240273号","Terrats Medical S.L.","C/Mogoda 75-99, 08210, Barberà del V. (BCN) Spain","2024-11-21 ","变更"]
["58","种植体扫描体","国械备20240276号","Terrats Medical S.L.","C/Mogoda 75-99, 08210, Barberà del V. (BCN) Spain","2024-11-21 ","变更"]
["59","转移帽","国械备20240272号","TERRATS MEDICAL, S.L.","C/Mogoda 75-99, 08210, Barberà del V. (BCN) Spain","2024-11-21 ","变更"]
["60","骨科手术器械包","国械备20180241号","SPINEWAY","7 Allee Moulin Berger,69130 ECULLY, France","2024-11-21 ","无效"]
["61","扭力扳手","国械备20160751号","Zest Anchors, LLC","2061 Wineridge Place Escondido California 92029 USA","2024-11-19 ","变更"]
["62","牙科种植角度测量辅助件","国械备20160841号","Zest Anchors, LLC","2061 Wineridge Place Escondido California 92029 USA","2024-11-19 ","变更"]
["63","PTEN抗体试剂（免疫组织化学）","国械备20180434号","Ventana Medical Systems, Inc.","1910 East Innovation Park Drive, Tucson, AZ, 85755, United States","2024-11-19 ","变更"]
["64","PSA抗体试剂（免疫组织化学）","国械备20180622号","Ventana Medical Systems, Inc.","1910 E. Innovation Park Drive, Tucson, AZ, 85755, USA","2024-11-19 ","变更"]
["65","CD15抗体试剂（免疫组织化学）","国械备20181016号","Ventana Medical Systems,Inc.","1910E.Innovation Park Drive Tucson, AZ 85755 USA","2024-11-19 ","变更"]
["66","Chromogranin抗体试剂（免疫组织化学）","国械备20180250号","Ventana Medical Systems, Inc.","1910 East Innovation Park Drive, Tucson, AZ, 85755, United States","2024-11-19 ","变更"]
["67","S100抗体试剂（免疫组织化学）","国械备20180448号","Ventana Medical Systems, Inc.","1910 East Innovation Park Drive, Tucson, AZ, 85755, United States","2024-11-19 ","变更"]
["68","细胞周期蛋白D1抗体试剂（免疫组织化学）","国械备20190054号","Ventana Medical Systems, Inc.","1910E.Innovation Park Drive Tucson,Arizona 85755 USA","2024-11-19 ","变更"]
["69","CD3抗体试剂（免疫组织化学） ","国械备20190052号","Ventana Medical Systems, Inc.","1910E.Innovation Park Drive Tucson,Arizona 85755 USA","2024-11-19 ","变更"]
["70","抗广谱TRK  (EPR17341) 兔单克隆抗体试剂（免疫组织化学法）","国械备20190990号","Roche Diagnostics GmbH","1910 East Innovation Park Drive, Tucson, AZ 85755, United States","2024-11-19 ","变更"]
["71","MLH1抗体试剂（免疫组织化学）","国械备20200337号","Roche Diagnostics GmbH","1910 East Innovation Park Drive, Tucson, AZ, 85755, United States","2024-11-19 ","变更"]
["72","BRAF抗体试剂（免疫组织化学）","国械备20200234号","Roche Diagnostics GmbH","1910 East Innovation Park Drive, Tucson, AZ, 85755, United States","2024-11-19 ","变更"]
["73","PMS2 抗体试剂（免疫组织化学）","国械备20200235号","Roche Diagnostics GmbH","1910 East Innovation Park Drive, Tucson, AZ, 85755, United States","2024-11-19 ","变更"]
["74","CLDN18抗体检测试剂（免疫组织化学法）","国械备20200586号","Roche Diagnostics GmbH","1910 East Innovation Park Drive, Tucson, AZ, 85755, United States","2024-11-19 ","变更"]
["75","清洗液","国械备20160944号","Ventana Medical Systems, Inc.","1.1910E.Innovation Park Drive Tucson, AZ 85755 USA; 2.Sandhofer Strasse 116, 68305 Mannheim,Germany","2024-11-19 ","变更"]
["76","吉姆萨染色液","国械备20161978号","Ventana Medical Systems, Inc.","1910E.Innovation Park Drive Tucson, AZ 85755 USA","2024-11-19 ","变更"]
["77","刚果红染色液 Congo Red Staining Kit","国械备20140017号","Ventana Medical Systems, Inc.","1910E.Innovation Park Drive Tucson,Arizona 85755 USA","2024-11-19 ","变更"]
["78","过碘酸雪夫染色液","国械备20160195号","Ventana Medical Systems, Inc.","1910E.Innovation Park Drive Tucson,AZ 85755 USA ","2024-11-19 ","变更"]
["79","基础外科手术器械","国械备20240386号","HICO SURGICAL (PVT.) LTD","Noul Mor, Wazirabad Road, Sialkot, Pakistan","2024-11-19 ","有效"]
["80","口腔治疗器具","国械备20240385号","SURGIALL INTERNATIONAL","Roras Road, Near Khilji Sports, Street Rabia Masjid, Sialkot-51310, Pakistan","2024-11-19 ","有效"]
["81","苏木素染色液 Hematoxylin","国械备20150248号","Ventana Medical Systems, Inc.","1910E.Innovation Park Drive Tucson, AZ 85755 USA","2024-11-19 ","变更"]
["82","MSH2抗体试剂（免疫组织化学）","国械备20200237号","Roche Diagnostics GmbH","1910 East Innovation Park Drive, Tucson, AZ, 85755, United States","2024-11-19 ","变更"]
["83","转移帽","国械备20160820号","Zest Anchors, LLC","2061 Wineridge Place Escondido California 92029 USA","2024-11-19 ","变更"]
["84","口腔科器械","国械备20240384号","HATIM AMEEN CORPORATION","P.O.BOX 850,DEFENCE ROAD SUBLIME CHOWK SIALKOT PAKISTAN","2024-11-19 ","有效"]
["85","螺丝起","国械备20190300号","Zest Anchors, LLC ","2875 Loker Avenue East Carlsbad California 92010 USA;2230 Enterprise Street Escondido California 92029 USA","2024-11-19 ","变更"]
["86","种植用手术导板","国械备20151335号","Osstem Implant Co.,Ltd.","66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea","2024-11-19 ","变更"]
["87","血型分析用稀释液","国械备20240383号","Ortho-Clinical Diagnostics","1001 U.S. Highway 202, Raritan NJ 08869, USA","2024-11-19 ","有效"]
["88","耳镜","国械备20210152号","Welch Allyn, Inc.","4341 State Street Road, Skaneateles Falls, NY, 13153, United States of America","2024-11-18 ","变更"]
["89","医用检查灯","国械备20160927号","WELCH ALLYN, INC","CALLE EMILIO FLORES 2471-A, COL.CANON DEL PADRE, TIJUANA, Baja California MEXICO CO 22203","2024-11-18 ","变更"]
["90","棘轮手柄","国械备20240382号","Gauthier Biomedical, Inc.","2221 Washington Street, Grafton, Wisconsin 53024 USA","2024-11-18 ","有效"]
["91","手术头架","国械备20240381号","NORAS MRI products GmbH","Leibnizstrasse 4, 97204 Höchberg, Germany","2024-11-18 ","有效"]
["92","医用放大镜","国械备20240380号","Bryant Medical Ltd t/a Bryant Dental","The Barns, Hilltop Farm, Lyne Lane, Chertsey, KT16 0AW, Surrey, United Kingdom","2024-11-18 ","有效"]
["93","模型树脂","国械备20180695号","VERICOM CO., LTD","48，Toegyegongdan 1-gil，Chuncheon-si, Gangwon-do, 200-944,Republic of KOREA","2024-11-18 ","变更"]
["94","牙科修整用金刚砂车针","国械备20240378号","VERDENT Sp. z o.o.","ul. Lodowa 138, 93-232 Łódź, Poland","2024-11-15 ","有效"]
["95","导航手术工具","国械备20200654号","Brainlab AG","Olof-Palme-Straße 9, 81829 München,Germany","2024-11-15 ","变更"]
["96","自动加样系统","国械备20240377号","QIAGEN GmbH","Via Crusch 8 7402 Bonaduz Switzerland","2024-11-14 ","有效"]
["97","耳用钻孔定位工具包","国械备20240257号","MED-EL Elektromedizinische Geräte GmbH","Fürstenweg 77A 6020 Innsbruck AUSTRIA","2024-11-13 ","变更"]
["98","耳鼻喉科用测量器","国械备20240337号","MED-EL Elektromedizinische Geräte GmbH","Fürstenweg 77A 6020 Innsbruck AUSTRIA","2024-11-13 ","变更"]
["99","耳用钻孔定位工具包","国械备20240247号","MED-EL Elektromedizinische Geräte GmbH","Fürstenweg 77A 6020 Innsbruck AUSTRIA","2024-11-13 ","变更"]
["100","定位膜","国械备20240376号","Anatomical Geometry, S.L.","C/ FORMACIÓN, Nº 6 (NAVE), PARQUE INDUSTRIAL Y DE SERVICIOS ALJARAFE, 41927 MAIRENA DEL ALJARAFE - SEVILLA (ESPAÑA)","2024-11-13 ","有效"]
["101","人工肩关节系统手术器械包","国械备20240375号","Tornier, Inc","10801 Nesbitt Avenue South Bloomington Minnesota 55437 USA","2024-11-12 ","有效"]
["102","干式激光成像仪","国械备20150250号","COLENTA Labortechnik GmbH & Co.KG"," Neunkirchner Str.117 2700 Wiener Neustadt-Austria ","2024-11-08 ","变更"]
["103","基础外科手术器械","国械备20240374号","RedMed Industries","New Muslim Town, Airport Road, Kotli Behram, Silakot-51310-Pakistan.","2024-11-08 ","有效"]
["104","钳式牵开器","国械备20150686号","OpInstruments GmbH","Friedrich-Ebert-Anlage 36, Frankfurt am Main, Germany","2024-11-08 ","变更"]
["105","脊柱手术器械（包）","国械备20190615号","台湾微创医疗器材股份有限公司","新竹科學工業園區新竹縣竹北市生醫路二段26號1樓","2024-11-08 ","变更"]
["106","脊柱手术器械（包）","国械备20170942号","台湾微创医疗器材股份有限公司","新竹縣竹東鎮三重里中興路1段221號","2024-11-08 ","变更"]
["107","脊柱手术器械（包）","国械备20151858号","台湾微创医疗器材股份有限公司","新竹縣竹東鎮三重里中興路1段221號","2024-11-08 ","变更"]
["108","尿液分析用鞘液 iQ® LaminaTM","国械备20150059号","Beckman Coulter Ireland Inc.","7381 Empire Drive, Florence, Kentucky 41042, USA","2024-11-08 ","变更"]
["109","牙科工具","国械备20190327号","MOZO-GRAU, S.A.","C/Santiago López González, 7, 47197 Valladolid. Spain","2024-11-08 ","变更"]
["110","髋关节手术器械","国械备20240373号","Tecomet Inc.","5307 95th Avenue Kenosha Wisconsin 53144 USA","2024-11-07 ","有效"]
["111","血细胞分析用稀释液","国械备20140159号","Beckman coulter, Inc.","7381 Empire Drive, Florence, Kentucky 41042, USA","2024-11-07 ","变更"]
["112","样本稀释液","国械备20151243号","日本電子株式会社","2023-1, Endo, Fujisawa-shi，Kanagawa, 252-0816, Japan","2024-11-06 ","变更"]
["113","胸腰骶固定器","国械备20170217号","Össur hf.","Grjóthálsi 1 - 5, IS-110 Reykjavik, Iceland","2024-11-06 ","变更"]
["114","髋关节手术工具","国械备20240372号","Howmedica Osteonics Corp","325 Corporate Drive, Mahwah, New Jersey, 07430, USA","2024-11-06 ","有效"]
["115","干式成像仪","国械备20200499号","COLENTA Labortechnik GmbH & Co.KG","Neunkirchner Straβe 117 2700 Wiener Neustadt Austria ","2024-11-06 ","变更"]
["116","干式成像仪","国械备20200497号","COLENTA Labortechnik GmbH & Co.KG","Neunkirchner Straβe 117 2700 Wiener Neustadt Austria","2024-11-06 ","变更"]
["117","干式激光成像仪","国械备20150254号","COLENTA Labortechnik GmbH & Co.KG","Neunkirchner Str.117 2700 Wiener Neustadt-Austria","2024-11-06 ","变更"]
["118","医用剪","国械备20150704号","/","Friedrich-Ebert-Anlage 36, Frankfurt am Main, Germany","2024-11-05 ","变更"]
["119","显微组织镊","国械备20150705号","OpInstruments GmbH","Friedrich-Ebert-Anlage 36, Frankfurt am Main，Germany","2024-11-05 ","变更"]
["120","显微止血夹","国械备20150716号","OPInstruments GmbH","Friedrich-Ebert-Anlage 36,Frankfurt am Main，Germany","2024-11-05 ","变更"]
["121","胆道探条","国械备20190926号","OpInstruments GmbH","Bessemerstrasse 7 Frankfurt am Main 60388 Germany","2024-11-05 ","变更"]
["122","咬骨钳","国械备20150717号","/","Friedrich-Ebert-Anlage 36, Frankfurt am Main, Germany","2024-11-05 ","变更"]
["123","打孔器","国械备20190992号","OpInstruments GmbH","Bessemerstrasse 7 Frankfurt am Main 60388 Germany","2024-11-05 ","变更"]
["124","医用头灯","国械备20190889号","OpInstruments GmbH","Bessemerstrasse 7 Frankfurt am Main 60388 Germany","2024-11-05 ","变更"]
["125","医用头灯","国械备20210495号","OpInstruments GmbH","Bessemerstrasse 7, 60388 Frankfurt am Main, Germany","2024-11-05 ","变更"]
["126","双目手术放大镜","国械备20150719号","/","Friedrich-Ebert-Anlage 36, Frankfurt am Main, Germany","2024-11-05 ","变更"]
["127","双目手术放大镜","国械备20210493号","/","/","2024-11-05 ","变更"]
["128","显微剪","国械备20150703号","OPInstruments GmbH","Friedrich-Ebert-Anlage 36, Frankfurt am Main，Germany","2024-11-05 ","变更"]
["129","显微持针钳","国械备20150702号","OpInstruments GmbH","Friedrich-Ebert-Anlage 36, Frankfurt am Main, Germany","2024-11-05 ","变更"]
["130","持针钳","国械备20150701号","OPInstruments GmbH","弗里德里希-艾伯特园区 36号，60325美茵河畔法兰克福，德国","2024-11-05 ","变更"]
["131","外科牵开器","国械备20150688号","OPInstruments GmbH","Friedrich-Ebert-Anlage 36,Frankfurt am Main，Germany","2024-11-05 ","变更"]
["132","CD62L检测试剂(流式细胞仪法)","国械备20240371号","BioLegend,Inc.","8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121","2024-11-01 ","有效"]
["133","CD62L检测试剂(流式细胞仪法)","国械备20240370号","BioLegend,Inc.","8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121","2024-11-01 ","有效"]
["134","CD99检测试剂（流式细胞仪法）","国械备20240369号","BioLegend,Inc.","8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121","2024-11-01 ","有效"]
["135","CD200抗体试剂","国械备20240367号","BioLegend,Inc.","8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121","2024-11-01 ","有效"]
["136","CD79b抗体试剂","国械备20240366号","BioLegend,Inc.","8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121","2024-11-01 ","有效"]
["137","CD27抗体试剂","国械备20240365号","BioLegend,Inc.","8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121","2024-11-01 ","有效"]
["138","CD95检测试剂（流式细胞仪法-PE）","国械备20240364号","BioLegend,Inc.","8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121","2024-11-01 ","有效"]
["139","种植用手术导板","国械备20171066号","RAY Co., Ltd","3F, 4F, 332-7, Samsung 1-ro, Hwaseong-si, Gyeonggi-do","2024-11-01 ","无效"]

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["2024年11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,"样品前处理系统","国械备20240395号","GLOBAL BİYOMEDİKAL SAĞLIK HİZMETLERİ SANAYİ VE TİCARET LİMİTED ŞİRKETİ","YEŞİLKÖY MAH.ATATÜRK CAD.EGS BUSINESS PARK BLOK NO:12/368 BAKIRKÖY/ İSTANBUL / TÜRKİYE","2024-11-22","有效"]
[2,"CD123抗体试剂","国械备20240394号","BioLegend,Inc.","8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121","2024-11-21","有效"]
[3,"CD41抗体试剂","国械备20240391号","BioLegend,Inc.","8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121","2024-11-21","有效"]
[4,"CD200抗体试剂","国械备20240390号","BioLegend,Inc.","8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121","2024-11-21","有效"]
[5,"CD42b抗体试剂","国械备20240389号","BioLegend,Inc.","8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121","2024-11-21","有效"]
[6,"CD28抗体试剂","国械备20240388号","BioLegend,Inc.","8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121","2024-11-21","有效"]
[7,"CD123抗体试剂","国械备20240387号","BioLegend,Inc.","8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121","2024-11-21","有效"]
[8,"血型分析用稀释液","国械备20240383号","Ortho-Clinical Diagnostics","1001 U.S. Highway 202, Raritan NJ 08869, USA","2024-11-19","有效"]
[9,"CD62L检测试剂(流式细胞仪法)","国械备20240371号","BioLegend,Inc.","8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121","2024-11-01","有效"]
[10,"CD62L检测试剂(流式细胞仪法)","国械备20240370号","BioLegend,Inc.","8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121","2024-11-01","有效"]
[11,"CD99检测试剂（流式细胞仪法）","国械备20240369号","BioLegend,Inc.","8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121","2024-11-01","有效"]
[12,"CD200抗体试剂","国械备20240367号","BioLegend,Inc.","8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121","2024-11-01","有效"]
[13,"CD79b抗体试剂","国械备20240366号","BioLegend,Inc.","8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121","2024-11-01","有效"]
[14,"CD27抗体试剂","国械备20240365号","BioLegend,Inc.","8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121","2024-11-01","有效"]
[15,"CD95检测试剂（流式细胞仪法-PE）","国械备20240364号","BioLegend,Inc.","8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121","2024-11-01","有效"]