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["2024年9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","医用射线防护用具","国械备20240338号","SFXRAY LIMITED","Unit 12, Agnes Street Industrial Estate, Agnes Street,  Belfast, BT13 1GB","2024-09-30 ","有效"]
["2","冷冻包埋剂","国械备20240033号","SAKURA FINETEK U.S.A., INC.","1750 W 214th St TORRANCE, CA USA 90501","2024-09-30 ","变更"]
["3","耳鼻喉科用测量器","国械备20240337号","MED-EL Elektromedizinische Geräte GmbH","Fürstenweg 77A 6020 Innsbruck AUSTRIA","2024-09-30 ","有效"]
["4","隔离套","国械备20140134号","Kaz USA, Inc., A Helen of Troy Company","11287 Kiley Drive， Huntley， IL 60142 United States","2024-09-30 ","变更"]
["5","创口贴","国械备20190713号","LABORATOIRE HRA PHARMA","Coloplast utca2,4300 Nyírbátor, Hungary ","2024-09-30 ","无效"]
["6","创口贴","国械备20190697号","LABORATOIRE HRA PHARMA","Coloplast utca2,4300 Nyírbátor, Hungary ","2024-09-30 ","无效"]
["7","创口贴","国械备20190644号","LABORATOIRE HRA PHARMA","Coloplast utca2,4300 Nyírbátor, Hungary ","2024-09-30 ","无效"]
["8","创口贴","国械备20190699号","LABORATOIRE HRA PHARMA","Coloplast utca2,4300 Nyírbátor, Hungary ","2024-09-30 ","无效"]
["9","创口贴","国械备20190645号","LABORATOIRE HRA PHARMA","Coloplast utca2,4300 Nyírbátor, Hungary ","2024-09-30 ","无效"]
["10","创口贴","国械备20190701号","LABORATOIRE HRA PHARMA","Coloplast utca2,4300 Nyírbátor, Hungary ","2024-09-30 ","无效"]
["11","硅橡胶复制材料","国械备20230326号","プレミアムプラスジャパン株式会社","〒561-0805大阪府豐中市原田南一丁目13番5号","2024-09-30 ","变更"]
["12","牙探针","国械备20240336号","RISTEK INSTRUMENT","Street #7 Shahab Pura Road 51310 Sialkot,Pakistan","2024-09-30 ","有效"]
["13","水门汀充填器","国械备20240335号","RISTEK INSTRUMENT","Street #7 Shahab Pura Road 51310 Sialkot,Pakistan","2024-09-30 ","有效"]
["14","BCL-6 抗体试剂","国械备20240334号","Cell Marque Corporation","6600 Sierra College Blvd. Rocklin, CA 95677 USA ","2024-09-29 ","有效"]
["15","CD56 抗体试剂","国械备20240333号","Cell Marque Corporation","6600 Sierra College Blvd. Rocklin, CA 95677 USA ","2024-09-29 ","有效"]
["16","天冬氨酸蛋白酶（Napsin A）抗体试剂","国械备20240332号","Cell Marque Corporation","6600 Sierra College Blvd. Rocklin, CA 95677 USA ","2024-09-29 ","有效"]
["17","CD138 抗体试剂","国械备20240331号","Cell Marque Corporation","6600 Sierra College Blvd. Rocklin, CA 95677 USA ","2024-09-29 ","有效"]
["18","肾母细胞瘤基因（WT1）抗体试剂","国械备20240330号","Cell Marque Corporation","6600 Sierra College Blvd. Rocklin, CA 95677 USA ","2024-09-29 ","有效"]
["19","SOX-11 抗体试剂","国械备20240329号","Cell Marque Corporation","6600 Sierra College Blvd. Rocklin, CA 95677 USA ","2024-09-29 ","有效"]
["20","上皮细胞粘附分子（Ep-CAM）抗体试剂","国械备20240328号","Cell Marque Corporation","6600 Sierra College Blvd. Rocklin, CA 95677 USA ","2024-09-29 ","有效"]
["21","巨细胞病毒（CMV）抗体试剂","国械备20240327号","Cell Marque Corporation","6600 Sierra College Blvd. Rocklin, CA 95677 USA ","2024-09-29 ","有效"]
["22","幽门螺旋杆菌 （Helicobacter pylori）抗体试剂","国械备20240326号","Cell Marque Corporation","6600 Sierra College Blvd. Rocklin, CA 95677 USA ","2024-09-29 ","有效"]
["23","AE1/AE3混合分子量角蛋白抗体试剂","国械备20240325号","Cell Marque Corporation","6600 Sierra College Blvd. Rocklin, CA 95677 USA ","2024-09-29 ","有效"]
["24","乳牙成形冠套","国械备20240324号","frasaco GmbH ","Oberhofer Straße 18, 88069 Tettnang, Germany","2024-09-29 ","有效"]
["25","一次性使用丁腈橡胶检查手套","国械备20140135号","MULTISAFE SDN.BHD. MULTISAFE SDN.BHD.","Lot 764, Bidor Industrial Estate,35500 Bidor, Perak Darul Ridzuan, Malaysia","2024-09-26 ","变更"]
["26","骨锯保护套","国械备20240318号","Osstem Implant Co., Ltd.","66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea","2024-09-26 ","变更"]
["27","螺丝起","国械备20140285号","Nobel Biocare AB","Dimbovägen 2 SE-691 51 Karlskoga Sweden; 22715 Savi Ranch Parkway Yorba Linda California 92887 USA; Engvej 33, 3330 Gørløse, Denmark; Wilhelmstraβe 19 78600 Kolbingen Germany; Hanauer Straβe 5-7, 75181 Pforzheim.","2024-09-26 ","变更"]
["28","流式细胞分析用鞘液","国械备20170638号","Becton, Dickinson and Company, BD Biosciences","ul. Sowińskiego 11, 44-101 Gliwice, Poland","2024-09-26 ","变更"]
["29","造口底盘","国械备20200110号","ConvaTec Inc.","Carretera Sanchez, Km. 18.5, Parque Industrial Itabo S.A. Buildings 23, 29, 30 Haina, San Cristobal, 91000 Dominican Republic.","2024-09-25 ","变更"]
["30","造口袋","国械备20140062号","ConvaTec Inc.","Carretera Sanchez, Km. 18.5 Parque Industrial Itabo, S.A. Buidings 23, 29, 30 Haina, San Cristobal 91000 Dominican Republic.","2024-09-25 ","变更"]
["31","DOG1 抗体试剂","国械备20240323号","Cell Marque Corporation","6600 Sierra College Blvd. Rocklin, CA 95677 USA ","2024-09-24 ","有效"]
["32","巨细胞病毒（CMV）抗体试剂","国械备20240322号","Cell Marque Corporation","6600 Sierra College Blvd. Rocklin, CA 95677 USA ","2024-09-24 ","有效"]
["33","牙用充填器","国械备20161112号","Hu-Friedy Mfg. Co., LLC","3232 N. Rockwell Street, Chicago, IL 60618, United States","2024-09-24 ","变更"]
["34","牙骨凿","国械备20151353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","2024-09-24 ","变更"]
["35","牙用分离器","国械备20151443号","Hu-Friedy Mfg. Co., LLC","3232 N. Rockwell Street, Chicago, IL 60618, United States","2024-09-24 ","变更"]
["36","医用橡胶检查手套","国械备20240123号","PT. UNIVERSAL GLOVES","JI. Pertahanan No.17,Patumbak Deli Serdang-Sumatera Utara(20361 ) Indonesia","2024-09-24 ","变更"]
["37","医用橡胶检查手套","国械备20240122号","PT. UNIVERSAL GLOVES","JI. Pertahanan No.17,Patumbak Deli Serdang-Sumatera Utara(20361 ) Indonesia","2024-09-24 ","变更"]
["38","医用退热贴","国械备20200442号","新タツク化成株式会社","/","2024-09-24 ","无效"]
["39","牙科铸造蜡","国械备20240321号","엘에이치케이","경상북도 칠곡군 지천면 송정중리 3길, 9-20","2024-09-23 ","有效"]
["40","基础外科手术器械","国械备20240320号","S.R.R. Surgical Company","Kotli Behram, Airport Road, Sialkot, Pakistan","2024-09-19 ","有效"]
["41","显微外科手术器械包","国械备20170541号","Integra LifeSciences Production Corporation","/","2024-09-19 ","变更"]
["42","基础外科手术器械包","国械备20171214号","Integra LifeSciences Production Corporation","/","2024-09-19 ","变更"]
["43","膝关节手术工具","国械备20210189号","DePuy Ireland UC","请见附件“生产地址”。","2024-09-19 ","变更"]
["44","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","2024-09-19 ","变更"]
["45","医用检查手套","国械备20240319号","A R MEDICOM (M) SDN. BHD.","No.110 Kanjanavanit Road, Pahtong Hat Yai, Songkhla 90230 Thailand","2024-09-19 ","有效"]
["46","骨锯保护套","国械备20240318号","Osstem Implant Co., Ltd.","66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea","2024-09-19 ","有效"]
["47","转移帽","国械备20160086号","Osstem Implant Co.,Ltd.","66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea","2024-09-19 ","变更"]
["48","口腔科阳性替换垫片","国械备20180209号","Osstem Implant Co., Ltd.","66-16，Bansong-ro 513beon-gil，Haeundae-gu，Busan，Korea","2024-09-19 ","变更"]
["49","骨劈开工具盒-直","国械备20161758号","Osstem Implant Co.,Ltd.","66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea","2024-09-19 ","变更"]
["50","种植体扫描体","国械备20170627号","Osstem Implant Co.,Ltd.","66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea","2024-09-19 ","变更"]
["51","外提升工具盒","国械备20161766号","Osstem Implant Co.,Ltd.","66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea","2024-09-19 ","变更"]
["52","骨劈开工具盒-弯","国械备20161765号","Osstem Implant Co.,Ltd.","66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea","2024-09-19 ","变更"]
["53","位置定位器","国械备20160011号","Osstem Implant Co.,Ltd.","66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea","2024-09-19 ","变更"]
["54","口腔科占位圈","国械备20180205号","Osstem Implant Co., Ltd. ","66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea","2024-09-19 ","变更"]
["55","口腔科技工室用抛光保护帽","国械备20190098号","OSSTEM IMPLANT Co., Ltd. ","66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea","2024-09-19 ","变更"]
["56","上颌窦提升器","国械备20151367号","Osstem Implant Co., Ltd.","66-16，Bansong-ro 513beon-gil，Haeundae-gu，Busan，Korea","2024-09-19 ","变更"]
["57","种植体内螺纹修复器","国械备20191424号","Osstem Implant Co.,Ltd.","66-16, Bansong-ro, 513beon-gil, Haeundae-gu, Busan, korea","2024-09-19 ","变更"]
["58","牙科种植定位器","国械备20150799号","Osstem Implant Co.,Ltd.","66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea","2024-09-19 ","变更"]
["59","牙科种植用延长器","国械备20191421号","Osstem Implant Co.,Ltd.","66-16, Bansong-ro, 513beon-gil, Haeundae-gu, Busan, korea","2024-09-19 ","变更"]
["60","牙科种植器械限深套","国械备20220137号","Osstem Implant Co., Ltd.","66-16，Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea","2024-09-19 ","变更"]
["61","γ-肌聚糖蛋白（Gamma Sarcoglycan）抗体试剂","国械备20240317号","Leica Biosystems Newcastle Ltd","Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom","2024-09-19 ","有效"]
["62","代型材料","国械备20160324号","Osstem Implant Co.,Ltd.","66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea","2024-09-19 ","变更"]
["63","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","2024-09-19 ","变更"]
["64","肌营养不良蛋白3（DYS3）抗体试剂","国械备20240316号","Leica Biosystems Newcastle Ltd","Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom","2024-09-19 ","有效"]
["65","肌营养不良蛋白2（DYS2）抗体试剂","国械备20240315号","Leica Biosystems Newcastle Ltd","Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom","2024-09-19 ","有效"]
["66","肌营养不良蛋白1（DYS1）抗体试剂","国械备20240314号","Leica Biosystems Newcastle Ltd","Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom","2024-09-19 ","有效"]
["67","口腔观察仪","国械备20171139号","Morpheus Co.,Ltd.","2F, 8, Daewangpangyo-ro395beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do","2024-09-19 ","变更"]
["68","牙科石膏","国械备20170140号","dentona AG","Otto-Hahn-Straβe 27. D-44227 Dortmund   with the branch  Am Kraftwerk Lippendorf. D-04575 Neukieritzsch","2024-09-19 ","变更"]
["69","丁腈检查手套","国械备20240313号","PT Universal Gloves","Jl. Pertahanan No. 17, Patumbak Deli Serdang – Sumatera Utara (20361) Indonesia","2024-09-18 ","有效"]
["70","口镜","国械备20200488号","詠豪科技股份有限公司","新竹縣竹北市新泰路31號8樓之1","2024-09-18 ","变更"]
["71","防雾口镜","国械备20200498号","詠豪科技股份有限公司","新竹縣竹北市新泰路31號8樓之1","2024-09-18 ","变更"]
["72","医用检查手套","国械备20210316号","PT. UNIVERSAL GLOVES","JI. Pertahanan No.17,Patumbak Deli Serdang-Sumatera Utara(20361 ) Indonesia","2024-09-14 ","变更"]
["73","耳镜","国械备20190170号","Welch Allyn, Inc.","4341 State Street Road, Skaneateles Falls, NY 13153, USA; Calle Emilio Flores 2471-A, Colonia Canon del Padre 22203 Tijuana, BC Mexico","2024-09-14 ","变更"]
["74","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","2024-09-13 ","变更"]
["75","弹性纤维染色液","国械备20220095号","Ventana Medical Systems, Inc.","1910 East Innovation Park Drive, Tucson,AZ, 85755, United States ","2024-09-12 ","变更"]
["76","弹性纤维染色液","国械备20220094号","Ventana Medical Systems, Inc. ","1910 East Innovation Park Drive, Tucson, AZ, 85755, United States","2024-09-12 ","变更"]
["77","种植辅助材料","国械备20170167号","Institut Straumann AG","Peter Merian-Weg 12，4002 Basel，Switzerland； Les Champs du Clos 2，2613 Villeret，Switzerland； 60 Minuteman Road，Andover，MA，01810，USA","2024-09-11 ","变更"]
["78","一次性使用口腔冲洗器","国械备20150611号","Intersurgical Ltd","Crane House, Molly Millars Lane, Wokingham, Berkshire, RG41 2RZ, UK","2024-09-11 ","变更"]
["79","牙用尺","国械备20171039号","Anthogyr SAS","2237 avenue André Lasquin, 74700 SALLANCHES FRANCE","2024-09-11 ","变更"]
["80","钻针深度停止器","国械备20240312号","Anthogyr SAS","2237 avenue André Lasquin, 74700 SALLANCHES FRANCE","2024-09-11 ","有效"]
["81","生物显微镜","国械备20220063号","株式会社二コン","244-8533　日本神奈川県横浜市栄区長尾台町471","2024-09-11 ","变更"]
["82","倒置生物显微镜","国械备20230515号","株式会社二コン","471, Nagaodai-Cho, Sakae-Ku, Yokohama, Kanagawa, 244-8533, Japan","2024-09-11 ","变更"]
["83","生物显微镜","国械备20240266号","NIKON CORPORATION","471, NAGAODAI-CHO, SAKAE-KU, YOKOHAMA, KANAGAWA, 244-8533, JAPAN","2024-09-11 ","变更"]
["84","螺丝起","国械备20171123号","HumanTech Dental GmbH","Gewerbestrasse 5, 71144 Steinenbronn, Germany","2024-09-11 ","变更"]
["85","置骨器","国械备20151366号","Osstem Implant Co.,Ltd.","66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea","2024-09-10 ","变更"]
["86","上颌窦提升器","国械备20160058号","Osstem Implant Co.,Ltd.","66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea","2024-09-10 ","变更"]
["87","橡皮障","国械备20210216号","Crosstex International Inc.","Sanctuary Health Sdn. Bhd. No. 16, Persiaran Perindustrian Kanthan 1, Kawasan Perindustrian Kanthan，31200 Chemor, Perak, Malaysia.","2024-09-10 ","变更"]
["88","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","2024-09-10 ","变更"]
["89","牵开器","国械备20190847号","Geister Medizintechnik GmbH","Föhrenstr. 2, 78532 Tuttlingen,  GERMANY","2024-09-10 ","变更"]
["90","口腔科用CT检查杆","国械备20210601号","Osstem Implant Co., Ltd.","66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea","2024-09-10 ","变更"]
["91","膜提升水管","国械备20210602号","Osstem Implant Co.,Ltd.","66-16, Bansong-ro 513beon-gil, Haeundae-gu,Busan,Korea","2024-09-10 ","变更"]
["92","口腔科用定位杆","国械备20210438号","Osstem Implant Co.,Ltd.","66-16, Bansong-ro, 513beon-gil, Haeundae-gu, Busan","2024-09-10 ","变更"]
["93","牙科种植导板固定螺丝","国械备20220035号","Osstem Implant Co., Ltd.","66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea","2024-09-10 ","变更"]
["94","牙科手术导板固定针 ","国械备20170786号","Osstem Implant Co.,Ltd.","66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea","2024-09-10 ","变更"]
["95","钻针深度停止器","国械备20160920号","Osstem Implant Co.,Ltd.","66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea","2024-09-10 ","变更"]
["96","牙用尺","国械备20150781号","Osstem Implant Co.,Ltd.","66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea","2024-09-10 ","变更"]
["97","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","2024-09-10 ","变更"]
["98","牙科输送器","国械备20160919号","Osstem Implant Co.,Ltd.","66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea","2024-09-10 ","变更"]
["99","扭力扳手","国械备20150782号","Osstem Implant Co.,Ltd.","66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea","2024-09-10 ","变更"]
["100","牙科种植手术工具","国械备20180134号","Institut Straumann AG","Peter Merian-Weg 12，4002 Basel，Switzerland； Les Champs du Clos 2，2613 Villeret，Switzerland； 60 Minuteman Road，Andover，MA，01810，USA","2024-09-09 ","变更"]
["101","种植辅助器械","国械备20170066号","Institut Straumann AG","Peter Merian-Weg 12，4002 Basel，Switzerland； Les Champs du Clos 2，2613 Villeret，Switzerland； 60 Minuteman Road，Andover，MA，01810，USA","2024-09-09 ","变更"]
["102","牙科种植体手术用工具","国械备20190920号","Institut Straumann AG","生产地址见申请表附件3","2024-09-09 ","变更"]
["103","牙科塑料基底","国械备20181407号","Institut Straumann AG","Peter Merian-Weg 12，4002 Basel，SWITZERLAND；Les Champs du Clos 2，2613 Villeret，SWITZERLAND；60 Minuteman Road，Andover，MA，01810，USA.","2024-09-09 ","变更"]
["104","牙用尺","国械备20170166号","Institut Straumann AG","Peter Merian-Weg 12，4002 Basel，Switzerland； Les Champs du Clos 2，2613 Villeret，Switzerland； 60 Minuteman Road，Andover，MA，01810，USA","2024-09-09 ","变更"]
["105","种植体安装器械","国械备20162041号","Institut Straumann AG","Institut Straumann AG，Peter Merian-Weg 12，4002 Basel，Switzerland；Straumann Villeret SA，Les Champs du Clos 2，2613 Villeret，Switzerland；Straumann Manufacturing Inc，60 Minuteman Road，Andover，MA，01810，USA ","2024-09-09 ","变更"]
["106","牙钻延长器","国械备20200656号","Institut Straumann AG","Peter Merian-Weg 12, 4002 Basel, Switzerland；Les Champs du Clos 2, 2613 Villeret, Switzerland; Grand Rue 53 a, 2606 Corgémont,Switzerland; 60 Minuteman Road, Andover MA 01810, USA; Trophagener Weg 25, 32657 Lemgo, Germany","2024-09-09 ","变更"]
["107","牙科镊","国械备20170454号","Institut Straumann AG","Institut Straumann AG，Peter Merian-Weg 12，4002 Basel，Switzerland；Straumann Villeret SA，Les Champs du Clos 2，2613 Villeret，Switzerland；Straumann Manufacturing Inc，60 Minuteman Road，Andover，MA，01810，USA ","2024-09-09 ","变更"]
["108","牙科种植体丝攻","国械备20171227号","Institut Straumann AG","Peter Merian-Weg 12，4002 Basel，Switzerland； Les Champs du Clos 2，2613 Villeret，Switzerland； 60 Minuteman Road，Andover，MA，01810，USA","2024-09-09 ","变更"]
["109","牙科种植体手术用工具","国械备20170650号","Institut Straumann AG","Peter Merian-Weg 12，4002 Basel，Switzerland； Les Champs du Clos 2，2613 Villeret，Switzerland； 60 Minuteman Road，Andover，MA，01810，USA","2024-09-09 ","变更"]
["110","代型材料","国械备20170983号","MEGADENTA Dentalprodukte GmbH","Carl-Eschebach-Straβe 1 A, 01454 Radeberg, Germany","2024-09-09 ","变更"]
["111","测瓣器","国械备20240311号","サナメディ株式会社","福島県石川郡玉川村大字竜崎字原作田 27-1","2024-09-09 ","有效"]
["112","软轴牵开器","国械备20240310号","pro med instruments GmbH","Boetzinger Strasse 86 DE 79111 Freiburg","2024-09-09 ","有效"]
["113","刀片夹持器","国械备20160012号","Osstem Implant Co.,Ltd.","66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea","2024-09-09 ","变更"]
["114","牙骨锤","国械备20160009号","Osstem Implant Co.,Ltd.","66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea","2024-09-09 ","变更"]
["115","牙科用分离器","国械备20160958号","Osstem Implant Co.,Ltd.","66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea","2024-09-09 ","变更"]
["116","牙骨凿","国械备20160010号","Osstem Implant Co.,Ltd.","66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea","2024-09-09 ","变更"]
["117","根管中器械取出器","国械备20170067号","Osstem Implant Co.,Ltd.","66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea","2024-09-09 ","变更"]
["118","螺丝起","国械备20150871号","오스템임플란트(주)","66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea","2024-09-09 ","变更"]
["119","膝关节固定器","国械备20170278号","Össur hf.","Grjotháls 1-5 Reykjavik 110 Iceland","2024-09-09 ","变更"]
["120","细胞保存液","国械备20150806号","LGM INTERNATIONAL INC.","","2024-09-09 ","变更"]
["121","液基细胞处理试剂盒","国械备20160648号","LGM INTERNATIONAL INC.\t\t\t","3030 Venture Ln Ste 106 Melbourne.FL  USA\t\t\t\t\t \t\t\t\t\t","2024-09-09 ","变更"]
["122","骨刮匙","国械备20152020号","Waldemar Link GmbH & Co.KG","Barkhausenweg 10 22339 Hamburg GERMANY","2024-09-05 ","变更"]
["123","骨锥","国械备20152024号","Waldemar Link GmbH & Co.KG","Barkhausenweg 10 22339 Hamburg GERMANY","2024-09-05 ","变更"]
["124","钢丝穿引器","国械备20152023号","Waldemar Link GmbH & Co.KG","Barkhausenweg 10 22339 Hamburg GERMANY","2024-09-05 ","变更"]
["125","测深器","国械备20151879号","Waldemar Link GmbH & Co.KG","Barkhausenweg 10 22339 Hamburg GERMANY","2024-09-05 ","变更"]
["126","骨锉","国械备20152019号","Waldemar Link GmbH & Co.KG","Barkhausenweg 10 22339 Hamburg GERMANY","2024-09-05 ","变更"]
["127","骨拉钩","国械备20152012号","Waldemar Link GmbH & Co.KG","Barkhausenweg 10 22339 Hamburg GERMANY","2024-09-05 ","变更"]
["128","夹持器","国械备20152021号","Waldemar Link GmbH & Co.KG","Barkhausenweg 10 22339 Hamburg GERMANY","2024-09-05 ","变更"]
["129","骨撬","国械备20152018号","Waldemar Link GmbH & Co.KG","Barkhausenweg 10 22339 Hamburg GERMANY","2024-09-05 ","变更"]
["130","峨眉凿","国械备20151880号","Waldemar Link GmbH & Co.KG","Barkhausenweg 10 22339 Hamburg GERMANY","2024-09-05 ","变更"]
["131","股骨髓腔对线手柄套","国械备20152022号","Waldemar Link GmbH & Co.KG","Barkhausenweg 10 22339 Hamburg GERMANY","2024-09-05 ","变更"]
["132","耳鼻喉科手术器械","国械备20161455号","Spiggle & Theis Medizintechnik GmbH","Burghof 14 51491 Overath Germany","2024-09-05 ","变更"]
["133","显微外科手术器械","国械备20160602号","Spiggle & Theis Medizintechnik GmbH","Burghof 14 51491 Overath Germany","2024-09-05 ","变更"]
["134","耳鼻喉科手术器械","国械备20160604号","Spiggle & Theis Medizintechnik GmbH","Burghof 14 51491 Overath Germany","2024-09-05 ","变更"]
["135","夹头","国械备20240309号","ConMed Corporation","11311 Concept Boulevard LARGO, FL USA 33773","2024-09-05 ","有效"]
["136","口腔开口器","国械备20160763号","Spiggle & Theis Medizintechnik GmbH ","Burghof 14 51491 Overath Germany","2024-09-05 ","变更"]
["137","耳鼻喉科手术器械包","国械备20200361号","Spiggle & Theis Medizintechnik GmbH","Burghof 14 51491 Overath Germany","2024-09-05 ","变更"]
["138","医用离心机","国械备20171142号","Andreas Hettich GmbH & Co. KG","Fohrenstrasse 12,D-78532 Tuttlingen /Germany","2024-09-05 ","变更"]
["139","医用离心机","国械备20170929号","Andreas Hettich GmbH & Co. KG","Fohrenstrasse 12,D-78532 Tuttlingen /Germany","2024-09-05 ","变更"]
["140","医用离心机","国械备20171141号","Andreas Hettich GmbH & Co. KG","Fohrenstrasse 12,D-78532 Tuttlingen /Germany","2024-09-05 ","变更"]
["141","微量高速台式离心机","国械备20181514号","Andreas Hettich GmbH & Co. KG","Fohrenstrasse 12,D-78532 Tuttlingen /Germany","2024-09-05 ","变更"]
["142","医用离心机","国械备20171140号","Andreas Hettich GmbH & Co. KG","Fohrenstrasse 12,D-78532 Tuttlingen /Germany","2024-09-05 ","变更"]
["143","医用离心机","国械备20170993号","Andreas Hettich GmbH & Co. KG","Fohrenstrasse 12,D-78532 Tuttlingen /Germany","2024-09-05 ","变更"]
["144","耳鼻喉科手术器械","国械备20181443号","Spiggle & Theis Medizintechnik GmbH","Burghof 14 51491 Overath Germany","2024-09-05 ","变更"]
["145","髋关节手术工具","国械备20210138号","Symmetry Medical Manufacturing, Inc.","486 West 350 North, Warsaw, Indiana 46582 USA","2024-09-04 ","变更"]
["146","CD200抗体试剂","国械备20240308号","BioLegend,Inc.","8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121","2024-09-04 ","有效"]
["147","CD15抗体试剂","国械备20240307号","BioLegend,Inc.","8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121","2024-09-04 ","有效"]
["148","全自动红细胞沉降率测定仪","国械备20220076号","DIESSE Diagnostica Senese S.p.A.","Strada dei Laghi 39, 53035 Monteriggioni (SI) Italy","2024-09-04 ","变更"]
["149","全自动红细胞沉降率测定仪","国械备20220074号","DIESSE Diagnostica Senese S.p.A.","Strada dei Laghi 39, 53035 Monteriggioni (SI) Italy","2024-09-04 ","变更"]
["150","人类白细胞抗原DR抗体试剂","国械备20240306号","BioLegend,Inc.","8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 92121","2024-09-04 ","有效"]
["151","根管充填器","国械备20151026号","マニー株式会社","栃木県塩谷郡高根沢町中阿久津743(743 NaKaakutsu, Takanezawa,Tochigi, 329-1234,Japan)；Tan Huong Commune,Pho Yen District, Thai Nguyen Province,Vietnam","2024-09-03 ","变更"]
["152","平滑肌肌球蛋白（Smooth Muscle Myosin）抗体试剂","国械备20240305号","Cell Marque Corporation","6600 Sierra College Blvd. Rocklin, CA 95677 USA ","2024-09-03 ","有效"]
["153","精氨酸酶-1（Arginase-1）抗体试剂","国械备20240304号","Cell Marque Corporation","6600 Sierra College Blvd. Rocklin, CA 95677 USA ","2024-09-03 ","有效"]
["154","磷脂酰肌醇蛋白聚糖3（Glypican-3）蛋白抗体试剂","国械备20240303号","Cell Marque Corporation","6600 Sierra College Blvd. Rocklin, CA 95677 USA ","2024-09-03 ","有效"]
["155","AMACR/p504s抗体试剂","国械备20240302号","Cell Marque Corporation","6600 Sierra College Blvd. Rocklin, CA 95677 USA ","2024-09-03 ","有效"]
["156","干式激光成像仪","国械备20150250号","COLENTA Labortechnik GmbH & Co.KG"," Neunkirchner Str.117 2700 Wiener Neustadt-Austria ","2024-09-03 ","变更"]
["157","Pax-8抗体试剂","国械备20240301号","Cell Marque Corporation","6600 Sierra College Blvd. Rocklin, CA 95677 USA ","2024-09-03 ","有效"]
["158","SOX-10抗体试剂","国械备20240300号","Cell Marque Corporation","6600 Sierra College Blvd. Rocklin, CA 95677 USA ","2024-09-03 ","有效"]
["159","特异AT序列结合蛋白2（SATB2）抗体试剂","国械备20240299号","Cell Marque Corporation","6600 Sierra College Blvd. Rocklin, CA 95677 USA ","2024-09-03 ","有效"]
["160","腹部造口弹性绷带","国械备20200551号","Tytex A/S","Chemlonská 1,06601 Humenné,Slovakia","2024-09-03 ","变更"]
["161","防辐射衣","国械备20160729号","MAVIG GmbH","Stahlgruberring 5, 81829, Munchen, Germany","2024-09-03 ","变更"]
["162","干式成像仪","国械备20200497号","COLENTA Labortechnik GmbH & Co.KG","Neunkirchner Straβe 117 2700 Wiener Neustadt Austria","2024-09-02 ","变更"]
["163","干式成像仪","国械备20200499号","COLENTA Labortechnik GmbH & Co.KG","Neunkirchner Straβe 117 2700 Wiener Neustadt Austria ","2024-09-02 ","变更"]
["164","口腔科手术器械","国械备20210606号","Asim Instruments","Air Port Road Gohadpur Sialkot Pakistan","2024-09-02 ","变更"]
["165","CD117抗体试剂（免疫组织化学法）","国械备20240298号","Cell Marque Corporation","6600 Sierra College Blvd. Rocklin, CA 95677 USA ","2024-09-02 ","有效"]
["166","CD10抗体试剂","国械备20240297号","Cell Marque Corporation","6600 Sierra College Blvd. Rocklin, CA 95677 USA ","2024-09-02 ","有效"]