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["2024年8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","双目放大镜","国械备20240296号","HOYA TechnosurgicaI株式会社","栃木県芳賀郡益子町大字塙858； 栃木県芳賀郡茂木町增井140番地1","2024-08-30 ","有效"]
["2","骨科牵引架","国械备20240295号","Hill-Rom, Inc. ","1069 State Route 46 East Batesville, Indiana 47006 UNITED STATES; Avenida Del Telefono No. 200 Huinalá, Apodaca, Nuevo Leon C.P. 66640 MEXICO","2024-08-30 ","有效"]
["3","口腔科器械","国械备20240294号","Exlin(Pvt)Ltd  ","Nasir Road, Near Classico Chowk, Sialkot-51310 - Pakistan ","2024-08-30 ","有效"]
["4","硅橡胶复制材料","国械备20200514号","/","/","2024-08-29 ","变更"]
["5","干式激光成像仪","国械备20150254号","COLENTA Labortechnik GmbH & Co.KG","Neunkirchner Str.117 2700 Wiener Neustadt-Austria","2024-08-29 ","变更"]
["6","脊柱手术器械包","国械备20180523号","Synthes GmbH ","见附件","2024-08-28 ","变更"]
["7","器械钳","国械备20190573号","MED-EL Elektromedizinische Geräte GmbH","Fürstenweg 77A，6020 Innsbruck Austria","2024-08-28 ","变更"]
["8","牙科抛光磨头","国械备20240293号","Gebr. Brasseler GmbH & Co. KG","Trophagener Weg 25 32657 Lemgo Germany","2024-08-28 ","有效"]
["9","电动移位车","国械备20210509号","株式会社FUJI","74-1, AZA SHAGUCHI, NISHIHONGO-CHO, OKAZAKI-SHI, AICHI, 444-0947, JAPAN","2024-08-28 ","变更"]
["10","电动移位车","国械备20210491号","株式会社FUJI","74-1 Shaguchi,Nishihongo-cho,Okazaki,Aichi 444-0947 Japan","2024-08-28 ","变更"]
["11","牙科修整用金刚砂车针","国械备20240292号","Gebr. Brasseler GmbH & Co. KG","Trophagener Weg 25 32657 Lemgo Germany","2024-08-28 ","有效"]
["12","牙科修整用钨钢车针","国械备20240291号","Gebr. Brasseler GmbH & Co. KG","Trophagener Weg 25 32657 Lemgo Germany","2024-08-28 ","有效"]
["13","口腔科器械","国械备20240290号","Fima Instruments","H#8/121,Pura Haira,Rang Pura Road,Sialkot-Pakistan","2024-08-27 ","有效"]
["14","持针钳","国械备20151230号","Hu-Friedy Mfg. Co., LLC","美国伊利诺斯州芝加哥市北罗克韦尔大街3232号","2024-08-27 ","变更"]
["15","检查手套","国械备20170549号","Mexpo International Inc.","马来西亚，雪兰州，巴生，奥夫嘉兰马路，巴图5，嘉兰特拉泰，5091地段","2024-08-27 ","变更"]
["16","转移帽","国械备20160639号","Dentis Co., Ltd","#99, Seongseoseo-Ro, Dalseo-Gu, Daegu, Korea","2024-08-27 ","变更"]
["17","牙用尺","国械备20160637号","Dentis Co., Ltd","#99, Seongseoseo-Ro, Dalseo-Gu, Daegu, Korea","2024-08-27 ","变更"]
["18","转移帽","国械备20161044号","Dentis Co., Ltd","#99, Seongseoseo-Ro, Dalseo-Gu, Daegu, Korea","2024-08-27 ","变更"]
["19","牙科种植定位器","国械备20160653号","Dentis Co., Ltd","#99, Seongseoseo-Ro, Dalseo-Gu, Daegu, Korea","2024-08-27 ","变更"]
["20","螺丝起","国械备20160640号","Dentis Co., Ltd","#99, Seongseoseo-Ro, Dalseo-Gu, Daegu, Korea","2024-08-27 ","变更"]
["21","代型材料","国械备20170121号","Dentis Co., Ltd.","#99, Seongseoseo-Ro, Dalseo-Gu, Daegu, Korea","2024-08-27 ","变更"]
["22","位置定位器","国械备20160638号","Dentis Co., Ltd","#99, Seongseoseo-Ro, Dalseo-Gu, Daegu, Korea","2024-08-27 ","变更"]
["23","模型树脂","国械备20190033号","DENTIS CO.,LTD.","99, Seongseoseo-ro, Dalseo-gu, Daegu, Republic of Korea","2024-08-27 ","变更"]
["24","种植体安装辅助器械","国械备20220552号","DENTIS. Co., LTD.","99, Seongseoseo-ro, Dalseo-gu, Daegu, Republic of Korea, 1F, B-dong, 6, Yulam-ro, Dong-gu, Daegu, Republic of Korea","2024-08-27 ","变更"]
["25","牙科种植导板","国械备20181249号","Dentis Co., Ltd.","99,Seongseoseo-ro,Dalseo-gu,Daegu,Republic of Korea","2024-08-27 ","变更"]
["26","代型材料","国械备20190060号","DENTIS CO.,LTD.","99, Seongseoseo-ro, Dalseo-gu, Daegu, Republic of Korea","2024-08-27 ","变更"]
["27","楔子","国械备20220354号","Bioclear Matrix Systems, LLC","3802 S Warner Street Suite A Tacoma, WA US 98409","2024-08-27 ","变更"]
["28","医用检查手套","国械备20240289号","Tan Sin Lian Industries Sdn. Bhd.","Lot 179-184, Jalan Industri 7, Alor Gajah Industrial Estate, Alor Gajah Phase III, Alor Gajah, 78000 Melaka, Malaysia","2024-08-26 ","有效"]
["29","种植体扫描体","国械备20180895号","Alpha-Bio Tec Ltd.","7 Hatnufa St., Kiryat Arye POB 3936, Petach Tikva 4951025 Israel","2024-08-26 ","变更"]
["30","替代体","国械备20210225号","/","/","2024-08-26 ","变更"]
["31","压力绷带","国械备20230080号","SIGVARIS Inc.","13055 Riley St., Suite 30 Holland, Michigan 49424 USA","2024-08-26 ","变更"]
["32","压力绷带","国械备20230079号","SIGVARIS Inc.","13055 Riley St., Suite 30 Holland, Michigan 49424 USA","2024-08-26 ","变更"]
["33","弹力套","国械备20210445号","SIGVARIS Inc. – Holland Facility","13055 Riley St Ste 30, Holland, MI USA 49424","2024-08-26 ","变更"]
["34","牙科塑料基底","国械备20190159号","Alpha-Bio Tec Ltd.","7 Hatnufa St., Kiryat Arye, POB 3936 Petach Tikva, 4951025 Israel","2024-08-26 ","变更"]
["35","替代体","国械备20181126号","Alpha-Bio Tec Ltd.","7 Hatnufa St., Kiryat Arye, POB 3936 Petach Tikva, 4951025 Israel","2024-08-26 ","变更"]
["36","螺丝起","国械备20170255号","Alpha-Bio Tec.LTD","7 Hatnufa St.,Kiryat Arye, POB 3936,Petach-TiKva,4951025,Israel","2024-08-26 ","变更"]
["37","螺丝起","国械备20190885号","Alpha-Bio Tec Ltd. ","7 Hatnufa St.,Kiryat Arye POB 3936， Petach Tikva 4951025 Israel","2024-08-26 ","变更"]
["38","口腔治疗器具","国械备20240288号","SEVEN EIGHT SIRGIKAL","Muslim Colony Christian Town PO Cantt, Sialkot 51310 Pakistan","2024-08-23 ","有效"]
["39","定位螺丝","国械备20240286号","Alpha Dent Implants GmbH","194, Jisan-ro 175beon-gil, Jinwi-myeon, Pyeongtaek-si, Gyeonggi-do, 17718 (Rep. of KOREA) ","2024-08-22 ","有效"]
["40","种植体安装辅助器械","国械备20240285号","Alpha Dent Implants GmbH","194, Jisan-ro 175beon-gil, Jinwi-myeon, Pyeongtaek-si, Gyeonggi-do, 17718 (Rep. of KOREA) ","2024-08-22 ","有效"]
["41","牙科种植用测量器","国械备20240283号","Alpha Dent Implants GmbH","194, Jisan-ro 175beon-gil, Jinwi-myeon, Pyeongtaek-si, Gyeonggi-do, 17718 (Rep. of KOREA)","2024-08-22 ","有效"]
["42","牙科铸造蜡","国械备20151257号","BEGO Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG","Wilhelm-Herbst-Str. 1,28359 Bremen, Deutchland(Wilhelm-Herbst-Str. 1,28359 Bremen, Germany)","2024-08-22 ","变更"]
["43","牙科输送头","国械备20240282号","3M ESPE Dental Products","351, Asahi-machi Kasama-shi, Ibaraki-ken, 309-1717 Japan","2024-08-22 ","有效"]
["44","干式激光成像仪","国械备20150250号","COLENTA Labortechnik GmbH & Co.KG"," Neunkirchner Str.117 2700 Wiener Neustadt-Austria ","2024-08-22 ","变更"]
["45","牙科种植系统手术工具","国械备20161517号","SHINSAEGI MEDI-TECH Co., Ltd.","#501, Gimhae Biomedical Center, 80-59, Golden root-ro, Juchon-myeon, Gimhae-si, Gyeongsangnam-do, Korea","2024-08-22 ","变更"]
["46","医用外固定支具","国械备20181484号","Bauerfeind AG","Triebeser Straβe 16 07937 Zeulenroda- Triebes Germany","2024-08-22 ","变更"]
["47","固定用弹力束带","国械备20190925号","Bauerfeind AG","Triebeser Straße 16 07937 Zeulenroda-Triebes Germany","2024-08-22 ","变更"]
["48","超声耦合剂","国械备20240281号","(주)심플스틱 ","대구광역시 북구 중앙대로 612, 1층, 2층(침산동)","2024-08-20 ","有效"]
["49","口腔科手术器械","国械备20220065号","Vitra International","Marala Road 51360,Sialkot-Pakistan","2024-08-20 ","变更"]
["50","种植体扫描体","国械备20180613号","MegaGen Implant Co.,Ltd.","MegaGen Implant, 472, Hanjanggun-ro, Jain-myeon,Gyeongsan-si, Gyeongsangbuk-do","2024-08-19 ","变更"]
["51","牙科种植手术工具包","国械备20230478号","MegaGen Implant Co.,Ltd.","45, Secheon-ro 7-gil, Dasa-eup, Dalseong-gun, Daegu, Republic of Korea","2024-08-19 ","变更"]
["52","扭力扳手","国械备20170775号","MegaGen Implant Co.,Ltd.","MEGAGEN Implant, 472, Hanjanggun-ro, Jain-myeon, Gyeongsan-si, Gyeongsangbuk-do, Korea","2024-08-19 ","变更"]
["53","上颌窦提升器","国械备20170772号","MegaGen Implant Co.,Ltd.","472, Hanjanggun-ro, Jain-myeon, Gyeongsan-si, Gyeongsangbuk-do, Korea","2024-08-19 ","变更"]
["54","钻针深度停止器","国械备20170905号","MegaGen Implant Co.,Ltd.","MEGAGEN Implant, 472, Hanjanggun-ro, Jain-myeon, Gyeongsan-si, Gyeongsangbuk-do, Korea","2024-08-19 ","变更"]
["55","螺丝起","国械备20170384号","MegaGen Implant Co., Ltd.","472, Hanjanggun-ro, Jain-myeon, Gyeongsan-si, Gyeongsangbuk-do, Korea","2024-08-19 ","变更"]
["56","牙用尺","国械备20170776号","MegaGen Implant Co.,Ltd.","MEGAGEN Implant, 472, Hanjanggun-ro, Jain-myeon, Gyeongsan-si, Gyeongsangbuk-do, Korea","2024-08-19 ","变更"]
["57","口腔治疗器具","国械备20210541号","MegaGen Implant Co.,Ltd.","45, Secheon-ro 7-gil, Dasa-eup, Dalseong-gun, Daegu, Republic of Korea","2024-08-19 ","变更"]
["58","种植体安装辅助器械包","国械备20190223号","MegaGen Implant Co.,Ltd.","45, Secheon-ro 7-gil, Dasa-eup, Dalseong-gun, Daegu, Republic of Korea","2024-08-19 ","变更"]
["59","软组织环切刀","国械备20170773号","MegaGen Implant Co.,Ltd.","472, Hanjanggun-ro, Jain-myeon, Gyeongsan-si, Gyeongsangbuk-do, Korea","2024-08-19 ","变更"]
["60","牙科种植体种植工具","国械备20170906号","MegaGen Implant Co.,Ltd.","MEGAGEN Implant, 472, Hanjanggun-ro, Jain-myeon, Gyeongsan-si, Gyeongsangbuk-do, Korea","2024-08-19 ","变更"]
["61","转移帽","国械备20170348号","MegaGen Implant Co., Ltd.","472, Hanjanggun-ro, Jain-myeon, Gyeongsan-si, Gyeongsangbuk-do, Korea","2024-08-19 ","变更"]
["62","替代体","国械备20181320号","MegaGen Implant Co.,Ltd.","45, Secheon-ro 7-gil, Dasa-eup, Dalseong-gun, Daegu","2024-08-19 ","变更"]
["63","苏木素染色液 Hematoxylin","国械备20150248号","Ventana Medical Systems, Inc.","1910E.Innovation Park Drive Tucson, AZ 85755 USA","2024-08-19 ","变更"]
["64","口腔科手术器械","国械备20240280号","Secure Dental Company","Near New Ghalla Mandi, Main Aiman Abad Road, Sialkot-51310-Pakistan","2024-08-16 ","有效"]
["65","种植体安装辅助器械","国械备20240279号","TERRATS MEDICAL, S.L.","C/Mogoda 75-99, 08210, Barberà del V. (BCN) Spain","2024-08-16 ","有效"]
["66","免疫显色试剂","国械备20240278号","Leica Biosystems Newcastle Ltd","Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom","2024-08-15 ","有效"]
["67","免疫显色试剂","国械备20240277号","Leica Biosystems Newcastle Ltd","Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom","2024-08-15 ","有效"]
["68","流式细胞分析用鞘液","国械备20180038号","Becton, Dickinson and Company, BD Biosciences","25242 County Road 95, Davis, CA 95616, USA","2024-08-15 ","变更"]
["69","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","2024-08-15 ","有效"]
["70","清洗液","国械备20160827号","Ventana Medical Systems, Inc.","1910E.Innovation Park Drive Tucson, AZ 85755 USA","2024-08-15 ","变更"]
["71","免疫组化抗原修复缓冲液","国械备20151564号","Ventana Medical Systems, Inc.","1910E.Innovation Park Drive Tucson, AZ 85755 USA;Sandhofer Strasse 116 68305 Mannheim, Germany","2024-08-15 ","变更"]
["72"," DAB染色液 OptiView DAB IHC Detection Kit ","国械备20151018号","Ventana Medical Systems, Inc.","1910E.Innovation Park Drive Tucson, AZ 85755 USA","2024-08-15 ","变更"]
["73","免疫组化抗原修复缓冲液 ULTRA Cell Conditioning Solution (ULTRA CC1)","国械备20151060号","Ventana Medical Systems, Inc.","1910E.Innovation Park Drive Tucson, AZ 85755 USA","2024-08-15 ","变更"]
["74","原位杂交蓝染染色液","国械备20160192号","Ventana Medical Systems, Inc.","1910E.Innovation Park Drive Tucson, AZ 85755 USA","2024-08-15 ","变更"]
["75","苏木素染色液","国械备20150245号","Ventana Medical Systems, Inc.","1910E.Innovation Park Drive Tucson, AZ 85755 USA","2024-08-15 ","变更"]
["76","免疫显色试剂","国械备20161582号","Ventana Medical Systems, Inc.","1910E.Innovation Park Drive Tucson, AZ 85755 USA","2024-08-15 ","变更"]
["77","地高辛染色液","国械备20200241号","Ventana Medical Systems, Inc.","1910 East Innovation Park Drive, Tucson, AZ, 85755, United States","2024-08-15 ","变更"]
["78","DAB染色液","国械备20180400号","Ventana Medical Systems, Inc.","1910E.Innovation Park Drive Tucson, AZ 85755 USA","2024-08-15 ","变更"]
["79","口腔科手术器械","国械备20240275号","Don Dental Supply","B-Block，402，City Housing, Sialkot Sialkot","2024-08-14 ","有效"]
["80","牙科塑料基底","国械备20240274号","Terrats Medical S.L.","C/Mogoda 75-99, 08210, Barberà del V. (BCN) Spain","2024-08-14 ","有效"]
["81","替代体","国械备20240273号","Terrats Medical S.L.","C/Mogoda 75-99, 08210, Barberà del V. (BCN) Spain","2024-08-14 ","有效"]
["82","转移帽","国械备20240272号","TERRATS MEDICAL, S.L.","C/Mogoda 75-99, 08210, Barberà del V. (BCN) Spain","2024-08-14 ","有效"]
["83","膝关节手术工具","国械备20162002号","Symmetry Medical Manufacturing, Inc.","486 West 350 North, Warsaw, IN  46582 USA","2024-08-14 ","变更"]
["84","牙科手术器械包","国械备20240271号","TOP BM","7a, bld. 2, apt. 44b, Novatorov str., Moscow, 119421, Russia","2024-08-14 ","有效"]
["85","成形片夹放置钳","国械备20240270号","Zaryab Instruments","Mohallah Pir Sabz Harar,Wazirabad Road,Sialkot-51310-Pakistan","2024-08-13 ","有效"]
["86","牙科输送头","国械备20200072号","(주)세일글로발","부산광역시 금정구 개좌로 191 ,1층, 4층","2024-08-13 ","变更"]
["87","菌斑指示剂","国械备20240269号","Dr Wyman Chan International Limited","1st Floor, 29 Frith Street, London, W1D 5LG","2024-08-13 ","有效"]
["88","CD38抗体试剂（流式细胞仪法-FITC）","国械备20240268号","CYTOGNOS, S.L.","PolÍgono. La Serna, Nave 9, 37900 - Santa Marta de Tormes (SALAMANCA), SPAIN","2024-08-13 ","有效"]
["89","菌斑指示剂","国械备20240267号","Produits Dentaires SA","18 Rue des Bosquets, 1800 Vevey. Switzerland","2024-08-13 ","有效"]
["90","生物显微镜","国械备20240266号","NIKON CORPORATION","471, NAGAODAI-CHO, SAKAE-KU, YOKOHAMA, KANAGAWA, 244-8533, JAPAN","2024-08-13 ","有效"]
["91","种植体扫描体","国械备20240265号","Hiossen, Inc.","85 Ben Fairless Drive, Fairless Hills, PA, 19030, USA","2024-08-12 ","有效"]
["92","骨锉","国械备20152019号","Waldemar Link GmbH & Co.KG","Barkhausenweg 10 22339 Hamburg GERMANY\r\n","2024-08-12 ","变更"]
["93","牙科种植器械工具","国械备20240264号","HOOWON EDI Co., Ltd.","20-13, Seogimhaesandan-ro, Gimhae-si, Gyeongsangnam-do, Republic of Korea","2024-08-12 ","有效"]
["94","高速台式离心机","国械备20190719号","Andreas Hettich GmnH & Co. KG","Föhrenstraße 12,D-78532 Tuttlingen Germany","2024-08-12 ","变更"]
["95","CD61抗体试剂","国械备20240263号","BioLegend,Inc.","8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121","2024-08-12 ","有效"]
["96","打磨抛光组件","国械备20210570号","TOP BM","7a, bld. 2, apt. 44b, Novatorov str., Moscow, 119421, Russia","2024-08-08 ","变更"]
["97","楔子","国械备20181357号","TOP BM","119421, Россия, r. Москва,  ул. Новаторов, д.7А, корп.2","2024-08-08 ","变更"]
["98","牙科橡皮障套装","国械备20240262号","Dent4You AG","235 Ascot Parkway Cuyahoga Falls, OH 44223 United States of America","2024-08-08 ","有效"]
["99","基础外科手术器械","国械备20240261号","DURABLE HOSPITAL SUPPLIES ","Noal More Roras Road Sialkot Pakistan 51310 Sialkot Pakistan","2024-08-08 ","有效"]
["100","种植体清洁刷","国械备20240260号","(주)한스코리아","경기도 파주시 가람로116번길 107 314호 (와동동, 운정한강듀클래스)","2024-08-08 ","有效"]
["101","显微持针钳","国械备20240259号","SCANLAN INTERNATIONAL, INC","ONE SCANLAN PLAZA Saint Paul, MN USA 55107","2024-08-06 ","有效"]
["102","手术床","国械备20160430号","漢記儀器有限公司","高雄市大寮區民貴街35號","2024-08-06 ","变更"]
["103","热塑膜","国械备20240258号","Orfit Industries","Vosveld 9a 2110 Wijnegem Belgium","2024-08-06 ","有效"]
["104","耳用钻孔定位工具包","国械备20240257号","MED-EL Elektromedizinische Geräte GmbH","Fürstenweg 77A 6020 Innsbruck AUSTRIA","2024-08-05 ","有效"]
["105","牙科橡胶抛光头","国械备20240256号","ダイワラビン株式会社","埼玉県草加市稲荷 2-1-8","2024-08-02 ","有效"]
["106","射频治疗仪用凝胶","国械备20240255号","(주)클래시스"," 대한민국,충청북도 청주시 흥덕구 오송읍 오송생명6로 22 ","2024-08-02 ","有效"]
["107","医用放大镜","国械备20150130号","XENOSYS CO., LTD.","2F, 2, Venture-ro 100beon-gil, Yeonsu-gu, Incheon","2024-08-01 ","变更"]
["108","牙科种植专用器械包","国械备20170105号","Neobiotech Co., Ltd.","104, 24/102, 103, 104-1, 104-2, 105, 106, 205, 212, 312, 509, 510, 511, 10F, 36, Digital-ro 27-gil, Guro-gu, Seoul, KOREA","2024-08-01 ","变更"]
["109","牙科种植体取出工具包","国械备20170096号","Neobiotech Co., Ltd.","104, 24/102, 103, 104-1, 104-2, 105, 106, 205, 212, 312, 509, 510, 511, 10F, 36, Digital-ro 27-gil, Guro-gu, Seoul, KOREA","2024-08-01 ","变更"]
["110","转移帽","国械备20170082号","Neobiotech Co., Ltd.","104, 24/102, 103, 104-1, 104-2, 105, 106, 205, 212, 312, 509, 510, 511, 10F, 36, Digital-ro 27-gil, Guro-gu, Seoul, KOREA","2024-08-01 ","变更"]
["111","牙科种植用延长器","国械备20190865号","Neobiotech Co., Ltd.","102, 103, 104-1, 104-2, 105, 106, 205, 212, 312, 509, 510, 511, 608, 10F, 36, Digital-ro 27-gil, Guro-gu, Seoul / 104, 24, Digital-ro 27-gil, Guro-gu, Seoul / 1F, 60 Gasan digital 2-ro, Geumcheon-gu Seoul, Korea Rep.","2024-08-01 ","变更"]
["112","骨科手术器械","国械备20240254号","CarboFix Orthopedics Ltd.","11 Ha'hoshlim St., Herzeliya 4672411, Israel","2024-08-01 ","有效"]
["113","DAB染色液","国械备20161300号","Life Technologies Corporation","7335 Executive Way Frederick, MD 21704 USA","2024-08-21 ","无效"]