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["2024年6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","种植辅助工具","国械备20180425号","MIS Implants Technologies Ltd.","Bar Lev Industrial Park, 2015600, Israel","2024-06-28 ","变更"]
["2","种植安装辅助工具包","国械备20190883号","MIS Implants Technologies Ltd.","P.O. Box 7 Bar Lev Industrial Park, 2015600, Israel ","2024-06-28 ","变更"]
["3","弹力套","国械备20181380号","Sigvaris do Brasil Indústria e Comércio Ltda.","Av. José Benassi, 2323 Distrito Industrial Fazgran Jundiaí São Paulo 13213085 Brasil.","2024-06-28 ","变更"]
["4","牙科抛光碟","国械备20240222号","EVE Ernst Vetter GmbH","Neureutstr.6, 75210 Keltern, Germany","2024-06-27 ","有效"]
["5","腰椎固定器","国械备20151241号","Aspen Medical Products,Inc.","6481 Oak Canyon Irvine,CA 92618","2024-06-27 ","变更"]
["6","胸腰骶固定器","国械备20151193号","Aspen Medical Products,Inc.","6481 Oak Canyon Irvine,CA 92618","2024-06-27 ","变更"]
["7","颈椎固定器","国械备20151242号","Aspen Medical Products,Inc.","6481 Oak Canyon Irvine,CA 92618","2024-06-27 ","变更"]
["8","膝关节手术工具","国械备20190679号","Waldemar Link GmbH & Co. KG","Barkhausenweg 10 22339 Hamburg Germany","2024-06-27 ","变更"]
["9","骨凿"," 国械备20152050号 ","Waldemar Link GmbH & Co.KG","Barkhausenweg 10 22339 Hamburg\r\nGERMANY","2024-06-27 ","变更"]
["10","髋臼锉","国械备20152138号","Waldemar Link GmbH & Co.KG","Barkhausenweg 10 22339 Hamburg GERMANY","2024-06-26 ","变更"]
["11","髓腔铰刀","国械备20152135号","Waldemar Link GmbH & Co.KG","Barkhausenweg 10 22339 Hamburg GERMANY","2024-06-26 ","变更"]
["12","置骨器","国械备20161902号","A.B. Dental Devices Ltd","19 Hayahalomim Street Ashdod 7761117 Israel","2024-06-26 ","变更"]
["13","种植辅助器具","国械备20190085号","A.B. Dental Devices Ltd.","19 Hayahalomim Street Ashdod 7761117 Israel","2024-06-26 ","变更"]
["14","牙科种植定位器","国械备20161362号","A.B. Dental Devices Ltd.","19 Hayahalomim Street Ashdod 7761117 Israel","2024-06-26 ","变更"]
["15","扭力扳手","国械备20160798号","A.B. Dental Devices Ltd.","19 Hayahalomim Street Ashdod 77609 Israel","2024-06-26 ","变更"]
["16","种植辅助材料","国械备20230072号","A.B. Dental Devices Ltd.","19 Hayahalomim Street Ashdod 7761117 Israel","2024-06-26 ","变更"]
["17","牙科种植扫描体","国械备20200612号","A.B.Dental Devices Ltd.","19 Hayahalomim Street Ashdod 7761117 Israel","2024-06-26 ","变更"]
["18","螺丝起","国械备20160943号","A.B. Dental Devices Ltd.","19 Hayahalomim Street Ashdod 77611179 Israel","2024-06-26 ","变更"]
["19","塑料圆柱体","国械备20190084号","OSSTEM IMPLANT Co., Ltd. ","66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea","2024-06-26 ","变更"]
["20","口腔灯","国械备20150446号","G. COMM S.r. l.","VIA DONIZETTI 22 I-20872 CORNATE D’ADDA(MB)","2024-06-26 ","变更"]
["21","口腔灯","国械备20151258号","G. COMM S.r. l.","VIA DONIZETTI 22 I-20872 CORNATE D’ADDA(MB)","2024-06-26 ","变更"]
["22","正畸钳","国械备20180071号","Ortho Organizers, Inc.","1.Ranger H.Q. Road Cantt, Sialkot – Pakistan；2.3232 N. Rockwell Street, Chicago, IL, 60618, United States；3.Nasir Road, Sialkot-Pakistan","2024-06-26 ","变更"]
["23","神经和心血管手术器械","国械备20240221号","WELDON INSTRUMENTS","Ganjay Wali street Rai Pur Stop, Wazirabad Road, Sialkot, 51310, Pakistan","2024-06-25 ","有效"]
["24","样本稀释液","国械备20240220号","Siemens Healthcare Diagnostics Products GmbH","Emil-von-Behring-Str. 76, 35041 Marburg, Germany","2024-06-25 ","有效"]
["25","眼科手术器械","国械备20240219号","WELDON INSTRUMENTS","Ganjay Wali street Rai Pur Stop, Wazirabad Road, Sialkot, 51310, Pakistan","2024-06-25 ","有效"]
["26","耳鼻喉科手术器械","国械备20240218号","WELDON INSTRUMENTS","Ganjay Wali street Rai Pur Stop, Wazirabad Road, Sialkot, 51310, Pakistan","2024-06-25 ","有效"]
["27","替代体","国械备20181194号","OSSTEM IMPLANT Co., Ltd. ","66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea","2024-06-25 ","变更"]
["28","牙科种植用深度测量尺","国械备20240217号","포인트임플란트(주)","부산광역시 북구 효열로 7 B1, 3F(금곡동)","2024-06-25 ","有效"]
["29","钻针深度停止器","国械备20240216号","포인트임플란트(주)","부산광역시 북구 효열로 7 B1, 3F(금곡동)","2024-06-25 ","有效"]
["30","转移体","国械备20240215号","포인트임플란트(주)","부산광역시 북구 효열로 7 B1, 3F(금곡동)","2024-06-25 ","有效"]
["31","种植体扫描体","国械备20240214号","포인트임플란트(주)","부산광역시 북구 효열로 7 B1, 3F(금곡동)","2024-06-25 ","有效"]
["32","牙科种植导板固定螺丝","国械备20240213号","포인트임플란트(주)","부산광역시 북구 효열로 7 B1, 3F(금곡동)","2024-06-25 ","有效"]
["33","种植体安装辅助器械","国械备20240212号","포인트임플란트(주)","부산광역시 북구 효열로 7 B1, 3F(금곡동)","2024-06-25 ","有效"]
["34","牙科用镊","国械备20240211号","포인트임플란트(주)","부산광역시 북구 효열로 7 B1, 3F(금곡동)","2024-06-25 ","有效"]
["35","吸引管","国械备20240210号","SONTEC INSTRUMENTS, INC.","7248 SOUTH TUCSON WAY CENTENNIAL, CO 80112","2024-06-25 ","有效"]
["36","牙科用刀","国械备20200063号","3R Industry and Commerce Eireli. ","290 Ptolomeu Street - Sao Paulo (SP)–Brazil–Zip Code: 04762-040","2024-06-25 ","变更"]
["37","牙科抛光条","国械备20200057号","3R Industry and Commerce Eireli.","290 Ptolomeu Street - Sao Paulo (SP)–Brazil–Zip Code: 04762-040","2024-06-24 ","变更"]
["38","牙科修整用钨钢车针","国械备20210044号","3R industry and commerce Eireli.","290 Ptolomeu Street - Sao Paulo (SP) – Brazil – Zip Code: 04762-040","2024-06-24 ","变更"]
["39","旋入扳手","国械备20181620号","澤方科技有限公司","臺中市大里區中興路一段2巷81弄17號1樓","2024-06-24 ","变更"]
["40","泌尿肛肠科手术器械","国械备20240209号","WELDON INSTRUMENTS","Ganjay Wali street Rai Pur Stop, Wazirabad Road, Sialkot, 51310, Pakistan","2024-06-24 ","有效"]
["41","妇产科手术器械","国械备20240208号","WELDON INSTRUMENTS","Ganjay Wali street Rai Pur Stop, Wazirabad Road, Sialkot, 51310, Pakistan","2024-06-24 ","有效"]
["42","骨科手术器械","国械备20240207号","WELDON INSTRUMENTS","Ganjay Wali street Rai Pur Stop, Wazirabad Road, Sialkot, 51310, Pakistan","2024-06-24 ","有效"]
["43","医用放大镜","国械备20240206号","DermLite LLC","21 Argonaut Unit A Aliso Viejo, CA 92656 USA","2024-06-24 ","有效"]
["44","粉状型石膏绷带","国械备20240205号","Paul Hartmann AG","Mala Bukovina 50, 552 04 Chvalkovice, Czech Republic ","2024-06-24 ","有效"]
["45","医用放大镜","国械备20191216号","(주)크리스탈옵틱","인천광역시 미추홀구 석정로 148 (숭의동)","2024-06-24 ","变更"]
["46","刀柄","国械备20240204号","SONTEC INSTRUMENTS, INC.","7248 SOUTH TUCSON WAY CENTENNIAL, CO 80112","2024-06-24 ","有效"]
["47","探针","国械备20240203号","SONTEC INSTRUMENTS, INC.","7248 SOUTH TUCSON WAY CENTENNIAL, CO 80112","2024-06-24 ","有效"]
["48","样本处理系统","国械备20240202号","Roche Molecular Systems, Inc.","Neuwiesenstrasse 4, 8222 Beringen, Switzerland ","2024-06-21 ","有效"]
["49","医用高分子夹板","国械备20150965号","3M Deutschland GmbH","ul. Kwidzyska 6 51-416 Wroclaw, Poland","2024-06-21 ","无效"]
["50","造口护肤粉","国械备20191349号","Hollister Incorporated"," 366 Draft Avenue Stuarts Draft, VA 24477 USA","2024-06-21 ","变更"]
["51","造口袋","国械备20190233号","Hollister Incorporated"," 366 Draft Avenue Stuarts Draft, VA 24477 USA；Foxford Road Rehins, Ballina, Co. Mayo Ireland；1502 East LaHarpe Kirksville, MO 63501 USA","2024-06-21 ","变更"]
["52","造口底盘","国械备20181701号","Hollister Incorporated","366 Draft Avenue Stuarts Draft, VA 24477 USA","2024-06-21 ","变更"]
["53","造口袋","国械备20181702号","Hollister Incorporated"," 366 Draft Avenue Stuarts Draft, VA 24477 USA","2024-06-21 ","变更"]
["54","造口底盘","国械备20190311号","Hollister Incorporated","366 Draft Avenue Stuarts Draft, VA 24477 USA","2024-06-21 ","变更"]
["55","造口袋","国械备20181618号","Hollister Incorporated","366 Draft Ave STUARTS DRAFT,VA USA 24477","2024-06-21 ","变更"]
["56","造口底盘","国械备20200047号","Hollister Incorporated"," 366 Draft Avenue Stuarts Draft, VA 24477 USA","2024-06-21 ","变更"]
["57","造口袋","国械备20200048号","Hollister Incorporated"," 366 Draft Avenue Stuarts Draft, VA 24477 USA","2024-06-21 ","变更"]
["58","造口护理用品","国械备20200643号","Hollister Incorporated","/","2024-06-21 ","变更"]
["59","造口护理用品","国械备20210005号"," Hollister Incorporated","/","2024-06-21 ","变更"]
["60","造口护理用品","国械备20191352号","Hollister Incorporated","Fjarrviksvagen 22, SE-653 50 Karlstad, Sweden","2024-06-21 ","变更"]
["61","造口护理用品","国械备20191116号","Hollister Incorporated"," 366 Draft Avenue Stuarts Draft, VA 24477 USA","2024-06-21 ","变更"]
["62","造口袋","国械备20190980号","Hollister Incorporated"," 366 Draft Avenue Stuarts Draft, VA 24477 USA","2024-06-20 ","变更"]
["63","造口袋","国械备20190312号","Hollister Incorporated","366 Draft Avenue Stuarts Draft, VA 24477 USA","2024-06-20 ","变更"]
["64","造口袋","国械备20220506号","Hollister Incorporated","366 Draft Avenue Stuarts Draft, VA USA 24477 ","2024-06-20 ","变更"]
["65","造口袋","国械备20190371号","Hollister Incorporated"," 366 Draft Avenue Stuarts Draft, VA 24477 USA","2024-06-20 ","变更"]
["66","气管插管固定器","国械备20210478号"," Hollister Incorporated","Hollister Incorporated  366 Draft Avenue Stuarts Draft, VA USA 24477","2024-06-20 ","变更"]
["67","造口腰带","国械备20230178号","Hollister Incorporated","SEI Medical S.A. de C.V Roberto Fierro #6420 & Francisco Sarabia Parque Industrial Aeropuerto Juarez, Chihuahua,  MEXICO 32685","2024-06-20 ","变更"]
["68","防漏膏","国械备20190580号","Hollister Incorporated"," 366 Draft Avenue Stuarts Draft, VA 24477 USA","2024-06-20 ","变更"]
["69","CD235a检测试剂（流式细胞仪法-FITC） ","国械备20240201号","Agilent Technologies Singapore (International) Pte. Ltd.","Produktionsvej 42 DK-2600 Glostrup DENMARK","2024-06-20 ","有效"]
["70","CD41抗体试剂(流式细胞仪法-FITC)","国械备20240200号","Agilent Technologies Singapore (International) Pte Ltd.","Produktionsvej 42 DK-2600 Glostrup DENMARK","2024-06-20 ","有效"]
["71","CD42b抗体试剂(流式细胞仪法-RPE)","国械备20240199号","Agilent Technologies Singapore (International) Pte Ltd.","Produktionsvej 42 DK-2600 Glostrup DENMARK","2024-06-20 ","有效"]
["72","CD235a检测试剂（流式细胞仪法-RPE）","国械备20240198号","Agilent Technologies Singapore (International) Pte. Ltd.","Produktionsvej 42 DK-2600 Glostrup DENMARK ","2024-06-20 ","有效"]
["73","血管钳","国械备20240197号","SONTEC INSTRUMENTS, INC.","7248 SOUTH TUCSON WAY CENTENNIAL, CO 80112","2024-06-20 ","有效"]
["74","牵开器","国械备20240196号","SONTEC INSTRUMENTS, INC.","7248 SOUTH TUCSON WAY CENTENNIAL, CO 80112","2024-06-20 ","有效"]
["75","可调式固定支具","国械备20240195号","豐利國際股份有限公司","南投縣南投市福興里永興路13號2、3樓","2024-06-20 ","有效"]
["76","肩关节手术工具  ","国械备20160569号","Biomet Orthopedics","56 East Bell Drive P.O. Box 587 Warsaw Indiana 46581 USA","2024-06-20 ","变更"]
["77","平足蛋白(Podoplanin)抗体试剂","国械备20240194号","Cell Marque Corporation","6600 Sierra College Blvd. Rocklin, CA 95677 USA ","2024-06-20 ","有效"]
["78","PAX-8 抗体试剂","国械备20240193号","Cell Marque Corporation","6600 Sierra College Blvd. Rocklin, CA 95677 USA ","2024-06-20 ","有效"]
["79","膝部固定器","国械备20220025号","豐利國際股份有限公司","南投縣南投市福興里永興路13號2、3樓","2024-06-20 ","变更"]
["80","膝关节固定器","国械备20240028号","豐利國際股份有限公司","南投縣南投市福興里永興路13號2、3樓","2024-06-20 ","变更"]
["81","组织剪","国械备20240192号","SONTEC INSTRUMENTS, INC.","7248 SOUTH TUCSON WAY CENTENNIAL, CO 80112","2024-06-19 ","有效"]
["82","组织镊","国械备20240191号","SONTEC INSTRUMENTS, INC.","7248 SOUTH TUCSON WAY CENTENNIAL, CO 80112","2024-06-19 ","有效"]
["83","冲洗器","国械备20240190号","SONTEC INSTRUMENTS, INC.","7248 SOUTH TUCSON WAY CENTENNIAL, CO 80112","2024-06-19 ","有效"]
["84","持针器","国械备20240189号","SONTEC INSTRUMENTS, INC.","7248 SOUTH TUCSON WAY CENTENNIAL, CO 80112","2024-06-19 ","有效"]
["85","CD123抗体试剂","国械备20240188号","BioLegend,Inc.","8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121","2024-06-18 ","有效"]
["86","CD9抗体试剂","国械备20240187号","BioLegend,Inc.","8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121","2024-06-18 ","有效"]
["87","义齿修复工具","国械备20161964号","Zest Anchors, LLC","2230 Enterprise Street, Escondido, California, 92029, USA","2024-06-18 ","变更"]
["88","扭力扳手","国械备20171138号","MIS Implants Technologies Ltd.","Bar Lev Industrial Park,2015600 Israel","2024-06-18 ","变更"]
["89","螺丝起 ","国械备20171261号","MIS Implants Technologies Ltd.","Bar Lev Industrial Park,2015600 Israel","2024-06-18 ","变更"]
["90","成形片","国械备20191356号","3R Industry and Commerce Eireli.","290 Ptolomeu Street - Sao Paulo (SP)–Brazil–Zip Code: 04762-040","2024-06-17 ","变更"]
["91","研磨工具包","国械备20161280号","3R Indstria e Comercio Ltda","RUA PTOLOMEU,N°290-VILA SOCORRO-SÃO PAULO-SP CEP:04762-040","2024-06-17 ","变更"]
["92","口外研磨材料","国械备20200046号","3R Industry and Commerce Eireli.","290 Ptolomeu Street - Sao Paulo (SP)–Brazil–Zip Code: 04762-040","2024-06-17 ","变更"]
["93","牙科测量尺","国械备20200056号","3R Industry and Commerce Eireli. ","290 Ptolomeu Street - Sao Paulo (SP)–Brazil–Zip Code: 04762-040","2024-06-17 ","变更"]
["94","冷冻包埋剂","国械备20240033号","SAKURA FINETEK U.S.A., INC.","1750 W 214th St TORRANCE, CA USA 90501","2024-06-14 ","变更"]
["95","膝关节手术器械","国械备20220235号","Blue Belt Technologies, Inc.","76 South Meridian Ave Oklahoma City Oklahoma 73107-6512 USA","2024-06-13 ","变更"]
["96","剥离器","国械备20240186号","SONTEC INSTRUMENTS, INC.","7248 SOUTH TUCSON WAY CENTENNIAL, CO 80112","2024-06-13 ","有效"]
["97","持瓣器","国械备20240185号","Edwards Lifesciences LLC","One Edwards Way Irvine, CA USA 92614","2024-06-13 ","有效"]
["98","手术头灯","国械备20240184号","I.C.LERCHER-Solutions GmbH","Im Sägenloh 8，78333 Stockach Germany","2024-06-12 ","有效"]
["99","牙科种植体手术工具包","国械备20230374号","Cowellmedi Co., Ltd.","48, Hakgam-daero 221beon-gil, Sasang-gu, Busan, Republic of Korea","2024-06-11 ","变更"]
["100","牙科修整用金刚砂车针","国械备20240183号","東權國際有限公司","新北市樹林區八德街3號6樓","2024-06-11 ","有效"]
["101","封片机","国械备20240182号","サクラ精機株式会社","長野県千曲市大字鋳物師屋75-5","2024-06-11 ","有效"]
["102","成形片夹放置钳","国械备20240181号","Sobytek Instruments Co.","Roras Road, Muzaffar Pur, Sialkot 51310- Pakistan","2024-06-11 ","有效"]
["103","头戴式检查灯","国械备20240180号","(주)크리스탈옵틱","인천광역시 중구 서해대로180번길 273층","2024-06-07 ","有效"]
["104","种植辅助材料","国械备20181132号","Anthogyr SAS","2237 avenue André Lasquin, 74700 SALLANCHES FRANCE","2024-06-06 ","变更"]
["105","牙科手术器械包","国械备20230378号","Cowellmedi Co., Ltd.","48, Hakgam-daero 221beon-gil, Sasang-gu, Busan, Republic of Korea","2024-06-06 ","变更"]
["106","种植辅助器械包","国械备20230375号","Cowellmedi Co., Ltd.","48, Hakgam-daero 221beon-gil, Sasang-gu, Busan, Republic of Korea","2024-06-06 ","变更"]
["107","牙科工具包","国械备20230376号","Cowellmedi Co., Ltd.","48, Hakgam-daero 221beon-gil, Sasang-gu, Busan, Republic of Korea","2024-06-06 ","变更"]
["108","X射线防护装置","国械备20181414号","Kenex (Electro-Medical) Ltd","Unit 17, RO24 Greenway, Harlow Business Park, Harlow, Essex, CM19 5QB,UK","2024-06-06 ","变更"]
["109","种植体安装辅助器械","国械备20240109号","Izenimplant Co., Ltd.","1, 2Dong, 26-32, Suworam 4-gil, Seotan-myeon, Pyeongtaek-si, Gyeonggi-do","2024-06-05 ","变更"]
["110","样本萃取液","国械备20240179号","Abbott Ireland Diagnostics Division","940 Crossroads Blvd., Seguin, TX 78155 USA","2024-06-05 ","有效"]
["111","样本萃取液","国械备20240178号","Abbott Ireland Diagnostics Division","940 Crossroads Blvd., Seguin, TX 78155 USA","2024-06-05 ","有效"]
["112","荧光生物显微镜","国械备20240177号","EUROIMMUN Medizinische Labordiagnostika AG","An der Trave 1, 23923 Selmsdorf, Germany","2024-06-05 ","有效"]
["113","缓冲液","国械备20240176号","Roche Diagnostics GmbH","Sandhofer Strasse 116,68305 Mannheim,Germany","2024-06-05 ","有效"]
["114","手术辅助照明灯","国械备20151610号","MAQUET SAS","Parc de Limere-Avenue de la Pomme de Pin, CS 10008 Ardon 45074 ORLEANS CEDEX 2 FRANCE","2024-06-05 ","变更"]
["115","手动测量用器械","国械备20240091号","Izenimplant Co., Ltd. ","1, 2Dong, 26-32, Suworam 4-gil, Seotan-myeon, Pyeongtaek-si, Gyeonggi-do","2024-06-05 ","变更"]
["116","种植用牙钻限深导向器","国械备20240093号","Izenimplant Co., Ltd.","1, 2Dong, 26-32, Suworam 4-gil, Seotan-myeon, Pyeongtaek-si, Gyeonggi-do","2024-06-04 ","变更"]
["117","种植辅助材料","国械备20240092号","Izenimplant Co., Ltd.","1, 2Dong, 26-32, Suworam 4-gil, Seotan-myeon, Pyeongtaek-si, Gyeonggi-do","2024-06-04 ","变更"]
["118","聚氨酯衬垫绷带","国械备20170523号","Lohmann & Rauscher International GmbH & Co. KG","Irlicher Strasse 55, 56567 Neuwied, GERMANY","2024-06-04 ","变更"]
["119","全自动电泳仪","国械备20171158号","SEBIA","Parc Technologique Léonard de Vinci, CP 8010 – Lisses 91008 EVRY CEDEX FRANCE","2024-06-04 ","变更"]
["120","足部固定器","国械备20191292号","Össur hf","Grjotháls 1-5 Reykjavik 110 Iceland","2024-06-04 ","变更"]
["121","骨科电钻头","国械备20240175号","株式会社デンテック","東京都板橋区清水町５３－５","2024-06-04 ","有效"]
["122","医用退热贴","国械备20240174号","東和製薬株式会社","和歌山県紀の川市貴志川町丸栖1229","2024-06-03 ","有效"]
["123","眼底广角观察镜","国械备20210581号","OCULUS Optikgeräte GmbH","Münchholzhäuser Str.29, 35582 Wetzlar, Germany","2024-06-03 ","变更"]
["124","细胞处理试剂盒","国械备20181662号","Oxford Immunotec Ltd.","94C Innovation Drive Milton Park,Abingdon Oxfordshire,OX14 4RZ,UK","2024-06-03 ","变更"]
["125","口腔治疗器具","国械备20240173号","Next Instruments","410/E, Khadim Ali Road, Sialkot-51310-Pakistan","2024-06-03 ","有效"]
["126","颜面系列手术器械（包）","国械备20180582号","亞太醫療器材科技股份有限公司","彰化縣伸港鄉溪底村工三路二號","2024-06-03 ","变更"]