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["2024年12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","待测物清洗液","国械备20240447号","Leica Biosystems Newcastle Ltd","Leica Biosystems Newcastle Ltd","2024-12-31 ","有效"]
["2","CMV探针试剂（原位杂交法）","国械备20240446号"," Leica Biosystems Newcastle Ltd","Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom","2024-12-31 ","有效"]
["3","骨刮匙","国械备20150444号","Boss Instruments, Ltd","104 Sommerfield Drive,Gordonsville, VA22942","2024-12-31 ","变更"]
["4","显微镊","国械备20150508号","Boss Instruments, Ltd","104 Sommerfield Drive Gordonsville,VA 22942","2024-12-31 ","变更"]
["5","骨科手术器械","国械备20240445号","Dentavex Corporation","Near John and Scot High School, Pir Hara Qabristan, Wazirabad Road Harar, Sialkot,Pakistan","2024-12-31 ","有效"]
["6","核酸提取或纯化试剂(Loopamp PURE DNA抽出キット)Loopamp PURE DNA Extraction Kit","国械备20140018号","栄研化学株式会社","日本国栃木県大田原市下石上1381-3 1381-3 Shimoishigami,Otawara-shi,Tochigi, 324-0036 JAPAN ","2024-12-31 ","变更"]
["7","超声探头穿刺架","国械备20200256号","BK Medical ApS","401 Science Park Road State College PA 16803 USA","2024-12-30 ","变更"]
["8","巴氏染色液 Pap staining solution","国械备20150386号","/","455-31，Noan-ro,Noan-myeon,Naju-si,Jeollanam-do.Korea","2024-12-26 ","变更"]
["9","抗酸染色液Acid fast staining solution(Fluorochrome)","国械备20150400号","/","455-31，Noan-ro,Noan-myeon,Naju-si,Jeollanam-do.Korea","2024-12-26 ","变更"]
["10","革兰染色液 Gram staining solution","国械备20150365号","/","455-31，Noan-ro,Noan-myeon,Naju-si,Jeollanam-do.Korea","2024-12-26 ","变更"]
["11","抗酸染色液 Acid fast staining solution(Ziehl-Neelsen)","国械备20150401号","/","455-31，Noan-ro,Noan-myeon,Naju-si,Jeollanam-do.Korea","2024-12-26 ","变更"]
["12","瑞氏-吉姆萨染色液 Wright-giemsa staining solution","国械备20150385号","/","455-31，Noan-ro,Noan-myeon,Naju-si,Jeollanam-do.Korea","2024-12-26 ","变更"]
["13","染色机 SMART AUTO  STAINER","国械备20150335号","Koreastandard Co.,Ltd.","455-31，Noan-ro,Noan-myeon,Naju-si,Jeollanam-do.Korea","2024-12-26 ","变更"]
["14","医用婴儿床","国械备20190888号","Hill-Rom, Inc.","County Road 300 East Batesville, Indiana 47006 UNITED STATES","2024-12-26 ","变更"]
["15","基底帽","国械备20240444号","General Implants GmbH Deutschland","Eisenbahnstrasse 100, DE-78573 Wurmlingen","2024-12-26 ","有效"]
["16","种植体扫描体","国械备20240443号","General Implants GmbH Deutschland","Eisenbahnstrasse 100, DE-78573 Wurmlingen","2024-12-26 ","有效"]
["17","转移体","国械备20240442号","General Implants GmbH Deutschland","Eisenbahnstrasse 100, DE-78573 Wurmlingen","2024-12-26 ","有效"]
["18","牙种植体手术器械包","国械备20240441号","General Implants GmbH Deutschland","Eisenbahnstrasse 100, DE-78573 Wurmlingen","2024-12-26 ","有效"]
["19","种植体螺丝起","国械备20240440号","General Implants GmbH Deutschland","Eisenbahnstrasse 100, DE-78573 Wurmlingen","2024-12-26 ","有效"]
["20","牙科种植器械限深套","国械备20240439号","General Implants GmbH Deutschland","Eisenbahnstrasse 100, DE-78573 Wurmlingen","2024-12-25 ","有效"]
["21","牙科种植用测量器","国械备20240438号","General Implants GmbH Deutschland","Eisenbahnstrasse 100, DE-78573 Wurmlingen","2024-12-25 ","有效"]
["22","骨科电钻头","国械备20240437号","General Implants GmbH Deutschland","Eisenbahnstrasse 100, DE-78573 Wurmlingen","2024-12-25 ","有效"]
["23","牙科种植用延长器","国械备20240436号","General Implants GmbH Deutschland","Eisenbahnstrasse 100, DE-78573 Wurmlingen","2024-12-25 ","有效"]
["24","牙种植定位杆","国械备20240435号","General Implants GmbH Deutschland","Eisenbahnstrasse 100, DE-78573 Wurmlingen","2024-12-24 ","有效"]
["25","医用橡胶手套","国械备20171006号","HARPS INVESTMENT ASIA PTE.LTD","LOT 10558, JALAN PERUSAHAAN 3,KAMUNTING INDUSTRIAL ESTATE 34600 KAMUNTING, TAIPING, PERAK, MALAYSIA","2024-12-24 ","变更"]
["26","替代体","国械备20240434号","General Implants GmbH Deutschland","Eisenbahnstrasse 100, DE-78573 Wurmlingen","2024-12-24 ","有效"]
["27","牙科种植用连接件","国械备20240433号","General Implants GmbH Deutschland","Eisenbahnstrasse 100, DE-78573 Wurmlingen","2024-12-24 ","有效"]
["28","牙科种植用扳手","国械备20240432号","General Implants GmbH Deutschland","Eisenbahnstrasse 100, DE-78573 Wurmlingen","2024-12-24 ","有效"]
["29","手术辅助照明灯","国械备20240431号","DENTIS CO., LTD.","6, Yuram-ro, Dong-gu, Daegu, Korea ","2024-12-24 ","有效"]
["30","心电导联线","国械备20240430号","Philips Medizin Systeme Böblingen GmbH","Graf-Zeppelin-Straβe 21, 72202 Nagold, Germany","2024-12-24 ","有效"]
["31","钻针深度停止器","国械备20240429号","Ossvis Co., Ltd.","B1, 38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, Republic of Korea; 106, 107, 253-5, Wonsi-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Republic of Korea","2024-12-23 ","有效"]
["32","替代体","国械备20240428号","Ossvis Co., Ltd.","B1, 38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, Republic of Korea; 106, 107, 253-5, Wonsi-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Republic of Korea","2024-12-23 ","有效"]
["33","手动测量用器械","国械备20240427号","Ossvis Co., Ltd.","B1, 38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, Republic of Korea; 106, 107, 253-5, Wonsi-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Republic of Korea","2024-12-23 ","有效"]
["34","鞘液","国械备20200675号","Luminex Corporation ","12212 Technology Blvd. Austin TX 78727 USA","2024-12-23 ","变更"]
["35","鞘液","国械备20200650号","Luminex Corporation","12212 Technology Blvd. Austin TX 78727 USA","2024-12-23 ","变更"]
["36","鞘液浓缩液","国械备20200676号","Luminex Corporation","12212 Technology Blvd. Austin TX 78727 USA","2024-12-23 ","变更"]
["37","印模帽","国械备20240426号","Ossvis Co., Ltd.","B1, 38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, Republic of Korea; 106, 107, 253-5, Wonsi-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Republic of Korea","2024-12-23 ","有效"]
["38","种植体安装辅助器械","国械备20240425号","Ossvis Co., Ltd.","B1, 38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, Republic of Korea; 106, 107, 253-5, Wonsi-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Republic of Korea","2024-12-23 ","有效"]
["39","免疫显色试剂 ultraView SISH DNP Detection Kit","国械备20150436号","Roche Diagnostics GmbH","1910E.Innovation Park Drive Tucson, AZ 85755 USA","2024-12-20 ","变更"]
["40","自动加样系统","国械备20240424号","Hamilton Bonaduz AG","Via Crusch 8  7402 Bonaduz Switzerland","2024-12-20 ","有效"]
["41","放射治疗患者用定位装置","国械备20240042号","Qfix","440 Church Road Avondale Pennsylvania 19311 USA","2024-12-20 ","变更"]
["42","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","2024-12-19 ","变更"]
["43","引流管","国械备20200267号","Zimmer Surgical, Inc.","200 Nw Parkway Rd Riverside, Mo 64150 USA","2024-12-19 ","变更"]
["44","牙科用毛刷","国械备20240423号","3M ESPE Dental Products","2510 Conway Avenue, St. Paul MN 55144, USA","2024-12-19 ","有效"]
["45","尿沉渣计数板","国械备20240422号","77 Elektronika Müszeripari Kft.","Fehérvári út 98. 1116 Budapest Hungary","2024-12-18 ","有效"]
["46","医用干式胶片","国械备20170780号","富士フィルム株式会社","静岡県富士宮市大中里200番地","2024-12-18 ","变更"]
["47","上颌窦提升器","国械备20180609号","(주)오성엠앤디","경기도 김포시 양촌읍 황금로109번길 57","2024-12-18 ","变更"]
["48","牙科种植系统手术工具","国械备20181529号","(주)오성엠앤디","경기도 김포시 양촌읍 황금로109번길 57","2024-12-18 ","变更"]
["49","手术刀柄","国械备20180603号","(주)오성엠앤디","경기도 김포시 양촌읍 황금로109번길 57","2024-12-18 ","变更"]
["50","持针钳","国械备20170383号","(주)오성엠앤디","경기도 김포시 양촌읍 황금로109번길 57","2024-12-18 ","变更"]
["51","牙科用镊","国械备20170459号","(주)오성엠앤디","경기도 김포시 양촌읍 황금로109번길 57","2024-12-18 ","变更"]
["52","牙科用分离器","国械备20170834号","(주)오성엠앤디","경기도 김포시 양촌읍 황금로109번길 57","2024-12-18 ","变更"]
["53","帕巾钳","国械备20230288号","(주)오성엠앤디","경기도 김포시 양촌읍 황금로109번길 57","2024-12-18 ","变更"]
["54","牙科种植用扳手","国械备20230287号","(주)오성엠앤디","경기도 김포시 양촌읍 황금로109번길 57","2024-12-18 ","变更"]
["55","口腔正畸用反光镜","国械备20230286号","(주)오성엠앤디","경기도 김포시 양촌읍 황금로109번길 57","2024-12-18 ","变更"]
["56","牙科输送器","国械备20230284号","(주)오성엠앤디","경기도 김포시 양촌읍 황금로109번길 57","2024-12-18 ","变更"]
["57","牙科修整用金刚砂车针","国械备20200064号","(주)오성엠앤디","경기도 김포시 양촌읍 황금로109번길 57, 인천광역시 서구 가람로 14, 613호","2024-12-18 ","变更"]
["58","牙龈刀","国械备20180602号","(주)오성엠앤디","경기도 김포시 양촌읍 황금로109번길 57","2024-12-18 ","变更"]
["59","正畸钳","国械备20181528号","(주)오성엠앤디","경기도 김포시 양촌읍 황금로109번길 57","2024-12-18 ","变更"]
["60","橡皮障器械","国械备20170154号","(주)오성엠앤디","경기도 김포시 양촌읍 황금로109번길 57","2024-12-18 ","变更"]
["61","牙科用分离器","国械备20160967号","(주)오성엠앤디","57, Hwanggeum-ro 109 beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do, Korea","2024-12-18 ","变更"]
["62","牙科去冠器","国械备20230290号","(주)오성엠앤디","경기도 김포시 양촌읍 황금로109번길 57","2024-12-18 ","变更"]
["63","牙科骨粉调和用金属容器","国械备20230289号","(주)오성엠앤디","경기도 김포시 양촌읍 황금로109번길 57","2024-12-18 ","变更"]
["64","牙探针","国械备20170835号","(주)오성엠앤디","경기도 김포시 양촌읍 황금로109번길 57","2024-12-18 ","变更"]
["65","咬骨钳","国械备20170824号","(주)오성엠앤디","경기도 김포시 양촌읍 황금로109번길 57","2024-12-18 ","变更"]
["66","皮肤组织钻孔器","国械备20170854号","(주)오성엠앤디","경기도 김포시 양촌읍 황금로109번길 57","2024-12-18 ","变更"]
["67","止血钳","国械备20170370号","(주)오성엠앤디","경기도 김포시 양촌읍 황금로109번길 57","2024-12-18 ","变更"]
["68","牙骨锤","国械备20170844号","(주)오성엠앤디","경기도 김포시 양촌읍 황금로109번길 57","2024-12-18 ","变更"]
["69","牙科洁治器","国械备20170823号","(주)오성엠앤디","경기도 김포시 양촌읍 황금로109번길 57","2024-12-18 ","变更"]
["70","口腔麻醉注射架","国械备20170846号","(주)오성엠앤디","경기도 김포시 양촌읍 황금로109번길 57","2024-12-18 ","变更"]
["71","牙科用剪","国械备20160966号","(주)오성엠앤디","57, Hwanggeum-ro 109 beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do, Korea","2024-12-18 ","变更"]
["72","牙挺","国械备20180608号","(주)오성엠앤디","경기도 김포시 양촌읍 황금로109번길 57","2024-12-18 ","变更"]
["73","牙科开口器","国械备20170808号","(주)오성엠앤디","경기도 김포시 양촌읍 황금로109번길 57","2024-12-18 ","变更"]
["74","唇颊牵开器","国械备20170807号","(주)오성엠앤디","경기도 김포시 양촌읍 황금로109번길 57","2024-12-18 ","变更"]
["75","牙用尺","国械备20170845号","(주)오성엠앤디","경기도 김포시 양촌읍 황금로109번길 57","2024-12-18 ","变更"]
["76","持骨钳","国械备20170853号","(주)오성엠앤디","경기도 김포시 양촌읍 황금로109번길 57","2024-12-18 ","变更"]
["77","口镜","国械备20170391号","(주)오성엠앤디","경기도 김포시 양촌읍 황금로109번길 57","2024-12-18 ","变更"]
["78","牙骨凿","国械备20170382号","(주)오성엠앤디","경기도 김포시 양촌읍 황금로109번길 57","2024-12-18 ","变更"]
["79","骨锉","国械备20170847号","(주)오성엠앤디","경기도 김포시 양촌읍 황금로109번길 57","2024-12-18 ","变更"]
["80","牙科充填器","国械备20170371号","(주)오성엠앤디","경기도 김포시 양촌읍 황금로109번길 57","2024-12-18 ","变更"]
["81","拔牙钳","国械备20170840号","(주)오성엠앤디","경기도 김포시 양촌읍 황금로109번길 57","2024-12-18 ","变更"]
["82","组织拉钩","国械备20170839号","(주)오성엠앤디","경기도 김포시 양촌읍 황금로109번길 57","2024-12-18 ","变更"]
["83","吸唾管","国械备20170381号","(주)오성엠앤디","경기도 김포시 양촌읍 황금로109번길 57","2024-12-18 ","变更"]
["84","牙刮匙","国械备20170380号","(주)오성엠앤디","경기도 김포시 양촌읍 황금로109번길 57","2024-12-18 ","变更"]
["85","种植辅助器械","国械备20240421号","DENTSPLY Implants Manufacturing GmbH","见附页。","2024-12-17 ","有效"]
["86","种植体安装辅助器械","国械备20240420号","DENTSPLY Implants Manufacturing GmbH","见附页。","2024-12-17 ","有效"]
["87","牙用尺","国械备20240419号","DENTSPLY Implants Manufacturing GmbH","见附页。","2024-12-17 ","有效"]
["88","拔牙钳","国械备20160018号","Hu-Friedy Mfg. Co., LLC","1666 E. Touhy Ave, Des Plaines, IL  60018-3607, United States","2024-12-17 ","变更"]
["89","骨水泥枪","国械备20210195号","Heraeus Medical GmbH","Fabrikstrasse 35, 3286 Muntelier, Switzerland","2024-12-17 ","变更"]
["90","PRAME抗体试剂（免疫组织化学法）","国械备20240418号","Cell Marque Corporation","6600 Sierra College Blvd. Rocklin, CA 95677 USA ","2024-12-17 ","有效"]
["91","五官科吸引管","国械备20240417号","FENTEXmedical GmbH","take-off Gewerbepark 2 78579 Neuhausen Ob Eck Germany","2024-12-16 ","有效"]
["92","骨盆固定器","国械备20240416号","Teleflex Medical","Buildings 3,6,8 and 9, Zona Franca de Nigua 11117 Nigua, San Cristobal Dominican Republic","2024-12-16 ","有效"]
["93","髋关节固定带","国械备20240415号","Bauerfeind AG","Triebeser Straße 16 07937 Zeulenroda-Triebes Germany","2024-12-16 ","有效"]
["94","骨科外固定夹板","国械备20181625号","Bauerfeind AG","Triebeser Straβe 16 07937 Zeulenroda- Triebes Germany","2024-12-16 ","变更"]
["95","膝关节固定器","国械备20230168号","Bauerfeind AG","Triebeser Straße 16 07937 Zeulenroda-Triebes Germany","2024-12-16 ","变更"]
["96","骨科保护支具","国械备20181589号","Bauerfeind AG","Triebeser Straβe 16 07937 Zeulenroda- Triebes Germany","2024-12-16 ","变更"]
["97","口腔科手术器械","国械备20240414号","SHENZHEN CHENLI MEDICAL INSTRUMENTS","Chohan Street, Mian Shakeel Road, Model Town,Sialkot-Pakistan","2024-12-16 ","有效"]
["98","踝部固定器","国械备20240413号","medi GmbH & Co. KG","č.p. 71, 67953 Benešov, Czech Republic","2024-12-13 ","有效"]
["99","上肢固定器","国械备20240412号","medi GmbH & Co. KG","č.p. 71, 67953 Benešov, Czech Republic","2024-12-13 ","有效"]
["100","腰部固定器","国械备20240411号","medi GmbH & Co. KG","Organize Sanayi Bölgesi No. 16, Salihli, Manisa, Turkey","2024-12-13 ","有效"]
["101","脊柱后路内固定系统手术工具","国械备20170833号","bricon GmbH","Villingerstr. 33 78166 Donaueschingen Germany","2024-12-12 ","变更"]
["102","脊柱后路内固定系统手术工具","国械备20190313号","Bricon GmbH","Villingerstr. 33 78166 Donaueschingen Germany","2024-12-12 ","变更"]
["103","带固定板的颈椎融合器手术工具","国械备20170867号","Bricon GmbH","Villingerstr. 33 78166 Donaueschingen Germany","2024-12-12 ","变更"]
["104","腰椎融合器手术工具","国械备20170101号","Bricon GmbH","Wasserkuppenstrasse 29-31 - 36043 Fulda Germany","2024-12-12 ","变更"]
["105","咬骨钳","国械备20171018号","bricon GmbH","Villingerstr. 33 78166 Donaueschingen Germany","2024-12-12 ","变更"]
["106","颈椎前路固定板系统手术工具","国械备20170832号","Bricon GmbH","Villingerstr. 33 78166 Donaueschingen Germany","2024-12-12 ","变更"]
["107","医用干式激光胶片","国械备20210522号","富士フイルム株式会社","静岡県富士宮市大中里200番地","2024-12-12 ","变更"]
["108","医用干式激光胶片","国械备20170694号","富士フィルム株式会社","静岡県富士宮市大中里200番地","2024-12-12 ","变更"]
["109","椎板固定板系统手术工具","国械备20220080号","Bricon GmbH","Eisenbahnstrasse 100 78573 Wurmlingen Germany","2024-12-12 ","变更"]
["110","膝部固定器","国械备20240410号","medi GmbH & Co. KG","Organize Sanayi Bölgesi No. 16, Salihli, Manisa, Turkey","2024-12-12 ","有效"]
["111","压力绷带","国械备20240409号","medi GmbH & Co. KG","Camino de Torrefarrera, Km 0,200, 25110, Alpicat, Lleida, Spain","2024-12-12 ","有效"]
["112","组织处理仪","国械备20240408号","DIAPATH S.p.A.","Via Savoldini, 71 - 24057 Martinengo (BG) - Italy","2024-12-12 ","有效"]
["113","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","2024-12-12 ","变更"]
["114","医用头灯","国械备20180679号","GENERAL SCIENTIFIC CORP.","77 Enterprise Dr., Ann Arbor, MI 48103","2024-12-12 ","变更"]
["115","手术放大镜","国械备20191191号","General Scientific Corporation","77 Enterprise Dr., Ann Arbor, MI 48103","2024-12-12 ","变更"]
["116","髋关节手术工具","国械备20161749号","Corentec Co.,Ltd.","12, Yeongsanhong 1-gil, Ipjang-myeon, Seobuk-gu, Cheonan-si, Chungcheongnam-do","2024-12-11 ","无效"]
["117","髋关节手术器械","国械备20161683号","Corentec Co.,Ltd.","12, Yeongsanhong 1-gil, Ipjang-myeon, Seobuk-gu, Cheonan-si, Chungcheongnam-do","2024-12-11 ","无效"]
["118","膝关节手术器械 ","国械备20161682号","Corentec Co.,Ltd.","12, Yeongsanhong 1-gil, Ipjang-myeon, Seobuk-gu, Cheonan-si, Chungcheongnam-do","2024-12-11 ","无效"]
["119","膝关节手术工具","国械备20161783号","Corentec Co.,Ltd.","12, Yeongsanhong 1-gil, Ipjang-myeon, Seobuk-gu, Cheonan-si, Chungcheongnam-do","2024-12-11 ","无效"]
["120","脊柱手术工具","国械备20180045号","Corentec Co.,Ltd.","12, Yeongsanhong 1-gil, Ipjang-myeon, Seobuk-gu, Cheonan-si, Chungcheongnam-do","2024-12-11 ","无效"]
["121","咬骨钳","国械备20160543号","Cardiomedical GmbH","Industriestraße 3A 30855 Langenhagen Germany","2024-12-10 ","变更"]
["122","医用镊","国械备20160122号","Cardiomedical GmbH","Industriestraβe 3A 30855 Langenhagen Germany","2024-12-10 ","变更"]
["123","医用剪","国械备20160118号","Cardiomedical GmbH","Industriestraße 3A 30855 Langenhagen Germany","2024-12-10 ","变更"]
["124","持针器","国械备20160119号","Cardiomedical GmbH","Industriestraβe 3A 30855 Langenhagen Germany","2024-12-10 ","变更"]
["125","手术刀","国械备20160123号","Cardiomedical GmbH","Industriestraße 3A 30855 Langenhagen Germany\t\t\t\t","2024-12-10 ","变更"]
["126","外科牵开器","国械备20160120号","Cardiomedical GmbH","Industriestraβe 3A 30855 Langenhagen Germany","2024-12-10 ","变更"]
["127","止血钳","国械备20160544号","Cardiomedical GmbH","Industriestraße 3A 30855 Langenhagen Germany","2024-12-10 ","变更"]
["128","外科牵开器","国械备20151189号","Medizintechnik Sattler GmbH","Werkstr. 9, 07426 Konigsee/Thuringen, Germany","2024-12-10 ","变更"]
["129","凝血分析用稀释液","国械备20240407号","DIAGNOSTICA STAGO","IDA Business Park - Bray, Co. Wicklow - Ireland","2024-12-10 ","有效"]
["130","测瓣器","国械备20170022号","Abbott Medical","177 County Road B E Saint Paul, MN USA 55117","2024-12-10 ","变更"]
["131","瓣成形环测环器及组件","国械备20150235号","Abbott Medical","177 County Road B East St. Paul Minnesota 55117 USA","2024-12-10 ","变更"]
["132","测瓣器","国械备20200680号","Abbott Medical","177 County Road B East St. Paul Minnesota 55117 USA","2024-12-10 ","变更"]
["133","心脏瓣膜成形环测环器套件","国械备20150289号","Abbott Medical","177 County Road B East St. Paul Minnesota 55117 USA","2024-12-10 ","变更"]
["134","人工机械心脏瓣膜测瓣器套件","国械备20150232号","Abbott Medical","177 County Road B East St. Paul Minnesota 55117 USA","2024-12-10 ","变更"]
["135","海绵防褥疮垫","国械备20210361号","LINET spol. s r.o.","Želevcice 5, 274 01 Slaný, CZECH REPUBLIC","2024-12-10 ","变更"]
["136","螺丝起","国械备20160842号","Zest Anchors, LLC","2875 Loker Avenue East Carlsbad California 92010 USA; 2230 Enterprise Street Escondido California 92029 USA","2024-12-09 ","变更"]
["137","机用螺丝刀","国械备20220305号","Gebr.Brasseler GmbH & Co.KG","Trophagener Weg 25 32657 Lemgo Germany","2024-12-09 ","变更"]
["138","医用干式激光胶片","国械备20240406号","Agfa NV"," Septestraat 27, 2640 Mortsel  Belgium ；1658 Bushy Park Road, Goose Creek,  South Carolina 29445, USA","2024-12-09 ","有效"]
["139","手术头架","国械备20181276号","MAQUET GmbH","Kehler Straße 31, 76437 Rastatt, Germany","2024-12-09 ","变更"]
["140","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","2024-12-09 ","变更"]
["141","牙科矫正器械包","国械备20180128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","2024-12-09 ","变更"]
["142","牙科骨内植入物附件包","国械备20190057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","2024-12-09 ","变更"]
["143","压力绷带","国械备20240405号","Knit-Rite LLC","167 Marks Creek Lane Hamlet North Carolina 28345 USA","2024-12-06 ","有效"]
["144","牙科种植工具","国械备20200456号","EASYFOR MEDICAL DEVICE SRL","VIA SAN FIRMINO 31 - 10070 BALANGERO (TO)","2024-12-06 ","变更"]
["145","口腔冲洗器","国械备20240404号","W&H Dentalwerk Bürmoos GmbH ","见附件","2024-12-05 ","有效"]
["146","牙科种植体手术用器械手柄","国械备20170358号","Osstem Implant Co.,Ltd.","66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea","2024-12-05 ","变更"]
["147","螺丝起","国械备20150871号","오스템임플란트(주)","66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea","2024-12-05 ","变更"]
["148","牙科种植材料取出器","国械备20191422号","Osstem Implant Co.,Ltd.","66-16, Bansong-ro, 513beon-gil, Haeundae-gu, Busan, korea","2024-12-05 ","变更"]
["149","牙用尺","国械备20170764号","(주)스누콘","대구광역시 달서구 성서로75길 5 1차단지 40B 4-10L","2024-12-04 ","变更"]
["150","转移帽","国械备20170360号","(주)스누콘","대구광역시 달서구 성서로 75길 5 1차단지 40B 4-10L","2024-12-04 ","变更"]
["151","机用螺丝刀","国械备20170762号","(주)스누콘","대구광역시 달서구 성서로75길 5 1차단지 40B 4-10L","2024-12-04 ","变更"]
["152","口腔科抛光保护帽","国械备20230269号","(주)스누콘","대구광역시 달서구 성서로75길 5 대구광역시 달서구 성서로75길 9","2024-12-04 ","变更"]
["153","牙科种植扫描体","国械备20230267号","(주)스누콘","대구광역시 달서구 성서로75길 5 대구광역시 달서구 성서로75길 9","2024-12-04 ","变更"]
["154","种植辅助器械包","国械备20200058号","(주)스누콘","대구광역시 달서구 성서로75길 5, 대구광역시 달서구 달서대로64길 54","2024-12-04 ","变更"]
["155","定位螺丝","国械备20230266号","(주)스누콘","대구광역시 달서구 성서로75길 5 대구광역시 달서구 성서로75길 9","2024-12-04 ","变更"]
["156","种植体安装器械","国械备20170766号","(주)스누콘","대구광역시 달서구 성서로 75길 5 1차단지 40B 4-10L","2024-12-04 ","变更"]
["157","牙科种植手术工具","国械备20230268号","(주)스누콘","대구광역시 달서구 성서로75길 5 대구광역시 달서구 성서로75길 9","2024-12-04 ","变更"]
["158","低速离心机","国械备20180863号","Eppendorf SE","Portitzer Allee 15, 04329 Leipzig, Germany","2024-12-03 ","变更"]
["159","高速冷冻离心机","国械备20170331号","Eppendorf SE","Barkhausenweg 1, 22339 Hamburg, Germany","2024-12-03 ","变更"]
["160","高速离心机","国械备20171120号","Eppendorf SE","Barkhausenweg 1, 22339 Hamburg, Germany","2024-12-03 ","变更"]
["161","低速离心机","国械备20171118号","Eppendorf SE","Barkhausenweg 1, 22339 Hamburg, Germany","2024-12-03 ","变更"]
["162","牙科手术器械","国械备20200721号","Bernhard Forster GmbH","Westliche Karl-Friedrich-Straße 15175172 Pforzheim","2024-12-02 ","变更"]
["163","咬合纸","国械备20190624号","Parkell  Inc.","300 Executive Drive, Edgewood, NY, 11717, United States","2024-12-02 ","变更"]
["164","一次性使用吹嘴","国械备20240403号","QuinTron Instrument Company, Inc.","2855 South James Drive, New Berlin, WI USA 53151","2024-12-02 ","有效"]
["165","一次性使用吹嘴","国械备20240402号","QuinTron Instrument Company, Inc.","2855 South James Drive, New Berlin, WI USA 53151","2024-12-02 ","有效"]
["166","口外研磨材料","国械备20240401号","VITA Zahnfabrik H. Rauter Gmbh & Co.KG","Spitalgasse 3, 79713 Bad Säckingen, Germany","2024-12-02 ","有效"]
["167","助行器","国械备20240400号","Rollz International B.V.","臺南市安南區政安路149巷20號1楼","2024-12-02 ","有效"]

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["2024年12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","待测物清洗液","国械备20240447号","Leica Biosystems Newcastle Ltd","Leica Biosystems Newcastle Ltd","2024-12-31","有效"]
["2","CMV探针试剂（原位杂交法）","国械备20240446号","Leica Biosystems Newcastle Ltd","Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom","2024-12-31","有效"]
["3","PRAME抗体试剂（免疫组织化学法）","国械备20240418号","Cell Marque Corporation","6600 Sierra College Blvd. Rocklin, CA 95677 USA","2024-12-17","有效"]
["4","凝血分析用稀释液","国械备20240407号","DIAGNOSTICA STAGO","IDA Business Park - Bray, Co. Wicklow - Ireland","2024-12-10","有效"]