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["2023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","打拔器","国械备20181583号","MPS Micro Precision Systems AG","Chemin du Long-Champ 95, 2504 Biel-Bienne, Switzerland","2023-09-27 ","变更"]
["2","基础外科手术器械","国械备20230481号","RAIZ & SAJJAD SURGICAL (PVT) LTD.","Toor Abad Industrial Zone, Main Daska-Sialkot Road, P.O Box# 2947, Sialkot – Pakistan","2023-09-26 ","有效"]
["3","试模","国械备20230480号","Zimmer Trabecular Metal Technology, Inc.","10 Pomeroy Rd, Parsippany, NJ, 07054, USA","2023-09-26 ","有效"]
["4","耳鼻喉科手术器械","国械备20230479号","NJ Eeterprises","Block4,Rashid Minhas Road,Small Industrial Estate,Sialkot-Pakitan","2023-09-26 ","有效"]
["5","弹力绷带","国械备20200443号","THE MARENA GROUP, LLC","650 PROGRESS INDUSTRIAL BLVD. Lawrenceville, GA USA 30043","2023-09-26 ","变更"]
["6","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","2023-09-26 ","有效"]
["7","诊察辅助器械","国械备20230477号","NJ Eeterprises","Block4,Rashid Minhas Road,Small Industrial Estate,Sialkot-Pakitan","2023-09-26 ","有效"]
["8","全自动样品处理系统","国械备20180054号","Roche Diagnostics GmbH","Maybachstraβe 30 - 71332 Waiblingen, Germany; Bernhardslaicher Weg 10-71686 Remseck Germany","2023-09-26 ","变更"]
["9","医用离心机","国械备20160135号","Roche Diagnostics GmbH","Maybachstraβe 30 - 71332 Waiblingen, Germany; Bernhardslaicher Weg 10-71686 Remseck Germany","2023-09-26 ","变更"]
["10","分杯处理系统","国械备20160134号","Roche Diagnostics GmbH","Maybachstraβe 30 - 71332 Waiblingen, Germany; Bernhardslaicher Weg 10-71686 Remseck Germany","2023-09-26 ","变更"]
["11","分类处理系统","国械备20160289号","Roche Diagnostics GmbH","Maybachstraβe 30 - 71332 Waiblingen, Germany; Bernhardslaicher Weg 10-71686 Remseck, Germany","2023-09-26 ","变更"]
["12","移动式X射线检查支架","国械备20230476号","明基三豐醫療器材股份有限公司","桃園市龜山區山頂里山鶯路159號3樓","2023-09-26 ","有效"]
["13","牙科电动无油空压机","国械备20160794号","MGF Srl","Via Pascoli, 15-20081 Abbiategrasso-ITALY","2023-09-26 ","变更"]
["14","骨科手术器械","国械备20230475号","RAIZ & SAJJAD SURGICAL (PVT) LTD.","Toor Abad Industrial Zone, Main Daska-Sialkot Road, P.O Box# 2947, Sialkot – Pakistan","2023-09-25 ","有效"]
["15","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","2023-09-25 ","变更"]
["16","牙科输送头","国械备20181168号","Ultradent Products, Inc.","505 West Ultradent Drive (10200 South), South Jordan, Utah 84095, USA ","2023-09-25 ","变更"]
["17","牙科石膏","国械备20151606号"," Mungyo Gypsum & Engineering Co. ","1380-14，Gimhae-daero, Hallim-myeon, Gimhae-si, Gyeongsangnam-do ","2023-09-25 ","变更"]
["18","脑电(肌电)导联线","国械备20170600号","SPES MEDICA SPA","Via Europa Zona Industriale 84091 Battipaglia SA Italia","2023-09-21 ","变更"]
["19","超声洁牙机工作尖","国械备20230474号"," B&L Biotech, Inc.","502, 95, Gwangdeokdong-ro, Danwon-gu, Ansan-si, Gyeonggi-do, 15462, Republic of Korea","2023-09-21 ","有效"]
["20","医用拉钩","国械备20190737号","安井株式会社","宮崎県東臼杵郡門川町大字加草2725番地","2023-09-21 ","变更"]
["21","核酸提取仪","国械备20230473号","MP Biomedicals Asia Pacific Pte Ltd","4F., No. 188, Wenhe Rd, Guishan Dist., Taoyuan City 333, Taiwan","2023-09-21 ","有效"]
["22","钻孔器","国械备20230469号","Howmedica Osteonics Corp.","325 Corporate Drive, Mahwah, New Jersey, 07430, USA","2023-09-21 ","有效"]
["23","妇产科器械","国械备20230468号","NJ Eeterprises","Block4,Rashid Minhas Road,Small Industrial Estate,Sialkot-Pakitan","2023-09-20 ","有效"]
["24","硅橡胶复制材料","国械备20161887号","Müller–Omicron GmbH & Co. KG","Schlosserstraße 1,51789 Lindlar, Germany","2023-09-19 ","变更"]
["25","基础外科手术器械","国械备20230467号","Khanna Industries","New Abadi West, Muradpur, Sialkot -Pakistan.","2023-09-19 ","有效"]
["26","DAB染色增强液","国械备20230466号","Ventana Medical Systems, Inc. ","1910 East Innovation Park Drive, Tucson AZ 85755, USA","2023-09-19 ","有效"]
["27","口外研磨材料","国械备20230465号","Ultradent Products, Inc.","505 West Ultradent Drive (10200 South), South Jordan, Utah 84095, USA","2023-09-19 ","有效"]
["28","核酸提取或纯化试剂","国械备20230464号","Promega Corporation","2800 Woods Hollow Road Madison Wisconsin 53711-5399 USA","2023-09-19 ","有效"]
["29","核酸提取或纯化试剂","国械备20230463号","Promega Corporation","2800 Woods Hollow Road Madison Wisconsin 53711-5399 USA","2023-09-19 ","有效"]
["30","烧结膏","国械备20230462号","DENTACO GmbH ＆ Co.KG","Max-Keith-Straβe 46 45136 Essen Germany","2023-09-19 ","有效"]
["31","造口袋","国械备20190312号","Hollister Incorporated","366 Draft Avenue Stuarts Draft, VA 24477 USA","2023-09-18 ","变更"]
["32","踝关节固定器","国械备20170234号","Össur hf.","Grjotháls 1-5 Reykjavik 110 Iceland","2023-09-18 ","变更"]
["33","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","2023-09-18 ","变更"]
["34","造口袋","国械备20181618号","Hollister Incorporated","366 Draft Ave STUARTS DRAFT,VA USA 24477","2023-09-18 ","变更"]
["35","造口护理用品","国械备20191116号","Hollister Incorporated"," 366 Draft Avenue Stuarts Draft, VA 24477 USA","2023-09-18 ","变更"]
["36","造口护理用品","国械备20191352号","Hollister Incorporated","Fjarrviksvagen 22, SE-653 50 Karlstad, Sweden","2023-09-18 ","变更"]
["37","造口袋","国械备20200048号","Hollister Incorporated"," 366 Draft Avenue Stuarts Draft, VA 24477 USA","2023-09-18 ","变更"]
["38","造口袋","国械备20190980号","Hollister Incorporated"," 366 Draft Avenue Stuarts Draft, VA 24477 USA","2023-09-18 ","变更"]
["39","造口袋","国械备20181702号","Hollister Incorporated"," 366 Draft Avenue Stuarts Draft, VA 24477 USA","2023-09-18 ","变更"]
["40","造口底盘","国械备20200047号","Hollister Incorporated"," 366 Draft Avenue Stuarts Draft, VA 24477 USA","2023-09-18 ","变更"]
["41","造口护理用品","国械备20200643号","Hollister Incorporated","型号78500生产地址：\nHOLLISTER INCORPORATED \n366 Draft Ave STUARTS DRAFT, VA USA 24477\n型号78501生产地址：\nANDERSONBRECON INC. \n1129 18th Ave ROCKFORD, IL, USA 61104","2023-09-18 ","变更"]
["42","造口护理用品","国械备20210005号"," Hollister Incorporated","Hollister Incorporated 1502 East LaHarpe Kirksville, MO USA 63501 ","2023-09-18 ","变更"]
["43","造口底盘","国械备20190311号","Hollister Incorporated","366 Draft Avenue Stuarts Draft, VA 24477 USA","2023-09-18 ","变更"]
["44","造口底盘","国械备20181701号","Hollister Incorporated","366 Draft Avenue Stuarts Draft, VA 24477 USA","2023-09-18 ","变更"]
["45","造口袋","国械备20190371号","Hollister Incorporated"," 366 Draft Avenue Stuarts Draft, VA 24477 USA","2023-09-18 ","变更"]
["46","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","2023-09-18 ","有效"]
["47","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","2023-09-18 ","有效"]
["48","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","2023-09-18 ","有效"]
["49","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","2023-09-18 ","有效"]
["50","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","2023-09-15 ","有效"]
["51","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","2023-09-15 ","有效"]
["52","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","2023-09-15 ","有效"]
["53","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","2023-09-15 ","有效"]
["54","骨科手术器械","国械备20230134号","Ulrich AG ","Mövenstraße 12, 9015 St. Gallen, SCHWEIZ","2023-09-15 ","变更"]
["55","种植体辅助安装器械","国械备20230453号","(주)써지덴트","대구광역시 동구 혁신대로 423-7 1층,2층,3층","2023-09-15 ","有效"]
["56","口腔科器械","国械备20230452号","NJ Eeterprises","Block4,Rashid Minhas Road,Small Industrial Estate,Sialkot-Pakitan","2023-09-15 ","有效"]
["57","橡皮障器械包","国械备20180036号","SANCTUARY HEALTH SDN BHD","57, Hwanggeum-ro, 109beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do, Korea","2023-09-15 ","变更"]
["58","螺丝起","国械备20230451号","(주)써지덴트","대구광역시 동구 혁신대로 423-7 1층,2층,3층","2023-09-15 ","有效"]
["59","种植体安装辅助器械","国械备20230450号","(주)써지덴트","대구광역시 동구 혁신대로 423-7 1층,2층,3층","2023-09-15 ","有效"]
["60","牙科种植器械限深套","国械备20230449号","(주)써지덴트","대구광역시 동구 혁신대로 423-7 1층,2층,3층","2023-09-15 ","有效"]
["61","牙科种植体手术用工具","国械备20230448号","(주)써지덴트","대구광역시 동구 혁신대로 423-7 1층,2층,3층","2023-09-15 ","有效"]
["62","种植体安装辅助器械","国械备20230447号","(주)써지덴트","대구광역시 동구 혁신대로 423-7 1층,2층,3층","2023-09-15 ","有效"]
["63","种植体安装辅助器械","国械备20230446号","(주)써지덴트","대구광역시 동구 혁신대로 423-7 1층,2층,3층","2023-09-15 ","有效"]
["64","上颌窦提升手术器械","国械备20230445号","(주)써지덴트","대구광역시 동구 혁신대로 423-7 1층,2층,3층","2023-09-15 ","有效"]
["65","颈部固定器","国械备20230444号","PAVIS S.P.A.","Via G.Rossini,11/B-21020 BUGUGGIATE (VA), Italy","2023-09-14 ","有效"]
["66","肘部固定器","国械备20230443号","PAVIS S.P.A.","Via G.Rossini,11/B-21020 BUGUGGIATE (VA), Italy","2023-09-14 ","有效"]
["67","脊柱内固定手术器械（包）","国械备20190807号","Medos International SARL ","50 Scotland Blvd, Bridgewater Massachusetts, 02324 USA","2023-09-14 ","变更"]
["68","上肢固定器","国械备20230442号","PAVIS S.P.A.","Via G.Rossini,11/B-21020 BUGUGGIATE (VA), Italy","2023-09-14 ","有效"]
["69","髋关节手术工具","国械备20210150号","DePuy Ireland UC","请见附件“生产地址”。","2023-09-14 ","变更"]
["70","EGFR（7p11）/ SE7（D7Z1）基因扩增探针试剂（荧光原位杂交法）","国械备20230441号","Kreatech Biotechnology B.V."," Vlierweg 20, 1032 LG Amsterdam, The Netherlands","2023-09-14 ","有效"]
["71","下肢固定器","国械备20230440号","PAVIS S.P.A.","Via G.Rossini,11/B-21020 BUGUGGIATE (VA), Italy","2023-09-14 ","有效"]
["72","肩部固定器","国械备20230439号","PAVIS S.P.A.","Via G.Rossini,11/B-21020 BUGUGGIATE (VA), Italy","2023-09-14 ","有效"]
["73","膝部固定器","国械备20230438号","PAVIS S.P.A.","Via G.Rossini,11/B-21020 BUGUGGIATE (VA), Italy","2023-09-14 ","有效"]
["74","腹部固定器","国械备20230437号","PAVIS S.P.A.","Via G.Rossini,11/B-21020 BUGUGGIATE (VA), Italy","2023-09-14 ","有效"]
["75","躯干固定器","国械备20230436号","PAVIS S.P.A.","Via G.Rossini,11/B-21020 BUGUGGIATE (VA), Italy","2023-09-14 ","有效"]
["76","腰部固定器","国械备20230435号","PAVIS S.P.A.","Via G.Rossini,11/B-21020 BUGUGGIATE (VA), Italy","2023-09-14 ","有效"]
["77","腕关节固定器","国械备20230434号","PAVIS S.P.A.","Via G.Rossini,11/B-21020 BUGUGGIATE (VA), Italy","2023-09-14 ","有效"]
["78","牙科种植体手术用工具","国械备20230433号","(주)써지덴트","대구광역시 동구 혁신대로 423-7 1층,2층,3층","2023-09-14 ","有效"]
["79","手指固定器","国械备20230432号","PAVIS S.P.A.","Via G.Rossini,11/B-21020 BUGUGGIATE (VA), Italy","2023-09-14 ","有效"]
["80","牙科种植体手术用工具","国械备20230431号","(주)써지덴트","대구광역시 동구 혁신대로 423-7 1층,2층,3층","2023-09-14 ","有效"]
["81","牙科种植体手术用工具","国械备20230430号","(주)써지덴트","대구광역시 동구 혁신대로 423-7 1층,2층,3층","2023-09-14 ","有效"]
["82","牙科种植体手术用工具","国械备20230429号","(주)써지덴트","대구광역시 동구 혁신대로 423-7 1층,2층,3층","2023-09-14 ","有效"]
["83","牙科种植体手术用工具","国械备20230428号","(주)써지덴트","대구광역시 동구 혁신대로 423-7 1층,2층,3층","2023-09-14 ","有效"]
["84","牙科种植定位器","国械备20230427号","X-Nav Technologies, LLC","1555 Bustard Road, Suite 75&110 Lansdale, Pennsylvania 19446 United States","2023-09-13 ","有效"]
["85","牙科种植体手术用工具","国械备20230426号","(주)써지덴트","대구광역시 동구 혁신대로 423-7 1층,2층,3층","2023-09-13 ","有效"]
["86","上颌窦提升手术器械","国械备20230425号","(주)써지덴트","대구광역시 동구 혁신대로 423-7 1층,2층,3층","2023-09-13 ","有效"]
["87","种植体辅助安装器械","国械备20230424号","(주)써지덴트","대구광역시 동구 혁신대로 423-7 1층,2층,3층","2023-09-13 ","有效"]
["88","牙科种植体手术用工具","国械备20230423号","(주)써지덴트","대구광역시 동구 혁신대로 423-7 1층,2층,3층","2023-09-13 ","有效"]
["89","眼科手术工具包","国械备20220555号","KATENA PRODUCTS, INC.","6 CAMPUS DRIVE, SUITE 310, Parsippany, NJ 07054","2023-09-13 ","变更"]
["90","牙科种植体手术用工具","国械备20230422号","(주)써지덴트","대구광역시 동구 혁신대로 423-7 1층,2층,3층","2023-09-13 ","有效"]
["91","牙科种植体手术用工具","国械备20230421号","(주)써지덴트","대구광역시 동구 혁신대로 423-7 1층,2층,3층","2023-09-13 ","有效"]
["92","光固化牙龈屏障树脂","国械备20230420号","SPIDENT CO., LTD","109, 203, 304, 312, 314, 315, 316 Korea Industrial Complex 722, Gojan-Dong, Namdong-Gu, Incheon, Korea","2023-09-12 ","有效"]
["93","口腔科手术器械","国械备20230419号","MED PLAY INSTRUMENTS","Kacha Shahab Pura Road S. I. E Opposite Mehtab Mosque 51310 Sialkot City-Pakistan","2023-09-12 ","有效"]
["94","手术辅助照明灯","国械备20190736号","安井株式会社","宮崎県東臼杵郡門川町大字加草2725番地","2023-09-12 ","变更"]
["95","牵开器支撑臂","国械备20230418号","Terumo Cardiovascular Systems Corporation","125 Blue Ball Rd Elkton Maryland 21921 USA","2023-09-12 ","有效"]
["96","样本稀释液","国械备20190950号","Randox Laboratories Limited ","55 Diamond Road Crumlin Country Antrim BT29 4QY United Kingdom","2023-09-12 ","变更"]
["97","样本稀释液","国械备20191029号","Randox Laboratories Limited ","55 Diamond Road Crumlin Country Antrim BT29 4QY United Kingdom","2023-09-12 ","变更"]
["98","样本稀释液","国械备20191031号","Randox Laboratories Limited ","55 Diamond Road Crumlin Country Antrim BT29 4QY United Kingdom","2023-09-12 ","变更"]
["99","糖化血红蛋白溶血剂","国械备20191030号","Randox Laboratories Limited ","55 Diamond Road Crumlin Country Antrim BT29 4QY United Kingdom","2023-09-12 ","变更"]
["100","牙科输送器","国械备20230417号","medmix Switzerland AG","Rütistrasse 7, 9469 Haag, Switzerland","2023-09-12 ","有效"]
["101","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","2023-09-12 ","有效"]
["102","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","2023-09-12 ","有效"]
["103","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","2023-09-12 ","有效"]
["104","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","2023-09-12 ","有效"]
["105","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","2023-09-12 ","有效"]
["106","成形片","国械备20170117号","Kerr Italia S.r.l.","Via Strecce 4 P.O. 272 6934 Bioggio Switzerland","2023-09-12 ","变更"]
["107","根管充填器","国械备20160553号","Kerr Corporation","1332 South Lone Hill Avenue Glendora, California 91740 USA;Calle 21 No 1103 AMP CD Industrial Uman Yucatan 97390 Mexico","2023-09-12 ","变更"]
["108","牙科种植体手术用工具","国械备20230411号","(주)써지덴트","대구광역시 동구 혁신대로 423-7 1층,2층,3층","2023-09-12 ","有效"]
["109","牙科种植体手术用工具","国械备20230410号","(주)써지덴트","대구광역시 동구 혁신대로 423-7 1층,2층,3층","2023-09-12 ","有效"]
["110","牙科种植体手术用工具","国械备20230409号","(주)써지덴트","대구광역시 동구 혁신대로 423-7 1층,2층,3층","2023-09-12 ","有效"]
["111","种植体安装辅助器械","国械备20230408号","(주)써지덴트","대구광역시 동구 혁신대로 423-7 1층,2층,3층","2023-09-12 ","有效"]
["112","骨科手术器械","国械备20230015号","Arthrex, Inc","详见附件3 生产地址","2023-09-11 ","变更"]
["113","楔子","国械备20170236号","Kerr Italia S.r.l.","Via Strecce 4 P.O. 272 6934 Bioggio Switzerland ","2023-09-11 ","变更"]
["114","基础外科手术器械","国械备20230407号","NJ Eeterprises","Block4,Rashid Minhas Road,Small Industrial Estate,Sialkot-Pakitan","2023-09-11 ","有效"]
["115","牙科种植体手术用工具","国械备20230406号","(주)써지덴트","대구광역시 동구 혁신대로 423-7 1층,2층,3층","2023-09-11 ","有效"]
["116","种植体安装辅助器械","国械备20230405号","(주)써지덴트","대구광역시 동구 혁신대로 423-7 1층,2층,3층","2023-09-11 ","有效"]
["117","牙科种植体手术用工具","国械备20230404号","(주)써지덴트","대구광역시 동구 혁신대로 423-7 1층,2층,3층","2023-09-11 ","有效"]
["118","牙科种植体手术用工具","国械备20230403号","(주)써지덴트","대구광역시 동구 혁신대로 423-7 1층,2층,3층","2023-09-11 ","有效"]
["119","造口护理用品","国械备20181590号","Coloplast A/S","Coloplast Hungary KFT, Búzavirág út 15, 2800 Tatabánya, Hungary","2023-09-08 ","变更"]
["120","造口袋","国械备20181571号","Coloplast A/S","Coloplast Hungary KFT, Búzavirág út 15, 2800 Tatabánya, Hungary","2023-09-08 ","变更"]
["121","牙科种植器械限深套","国械备20230402号","(주)써지덴트","대구광역시 동구 혁신대로 423-7 1층,2층,3층","2023-09-08 ","有效"]
["122","牙科用软组织环切刀","国械备20230401号"," (주)써지덴트","대구광역시 동구 혁신대로 423-7 1층,2층,3층","2023-09-08 ","有效"]
["123","拔牙刀","国械备20230400号","(주)써지덴트","대구광역시 동구 혁신대로 423-7 1층,2층,3층","2023-09-08 ","有效"]
["124","种植体安装辅助器械","国械备20230399号","(주)써지덴트","대구광역시 동구 혁신대로 423-7 1층,2층,3층","2023-09-08 ","有效"]
["125","矫形外科（骨科）手术器械","国械备20160556号","Arthrex, Inc.","1370 Creekside Boulevard, Naples, Florida, 34108-1945 USA","2023-09-08 ","变更"]
["126","骨科手术器械","国械备20230398号","NJ Eeterprises","Block4,Rashid Minhas Road,Small Industrial Estate,Sialkot-Pakitan","2023-09-08 ","有效"]
["127","颅骨固定与修复手术器械 ","国械备20180687号","Synthes GmbH","1051 Synthes Avenue, Monument CO 80132, USA; Im Kirchenhürstle 4-6, 79224 Umkirch b. Freiburg, GERMANY; Bohnackerweg 5, 2545 Selzach, SWITZERLAND; 1101 Synthes Avenue, Monument CO 80132, USA; Unter Hasslen 5, 78532 Tuttlingen, Germany; 1200 Synthes Avenue Monument, CO 80132 USA; Industriestrasse 28, 2545 Selzach, SWITZERLAND; 50 Scotland Blvd Bridgewater Massachusetts 02324 USA ","2023-09-07 ","变更"]
["128","手术头灯","国械备20230397号","Sunoptic Technologies, LLC","6018 Bowdendale Ave, Jacksonville, FL 32216 USA","2023-09-07 ","有效"]
["129","骨科外固定支架手术工具","国械备20180144号","Orthofix Srl","Via delle Nazioni, 9, 37012 Bussolengo - VR, Italy","2023-09-07 ","变更"]
["130","长期（口）鼻用微旁流呼气末二氧化碳监测采样及供氧管","国械备20220252号","Covidien LLC","340/1 Moo 6 Bowin Sub-District, Sriracha District Chonburi, Thailand 20230","2023-09-07 ","变更"]
["131","长期新生儿鼻用微旁流呼气末二氧化碳监测采样管","国械备20220226号","Covidien LLC","340/1 Moo 6 Bowin Sub-District, Sriracha District Chonburi, Thailand 20230","2023-09-07 ","变更"]
["132","短期儿童（口）鼻用微旁流呼气末二氧化碳监测采样及供氧管","国械备20220251号","Covidien LLC","340/1 Moo 6 Bowin Sub-District, Sriracha District Chonburi, Thailand 20230","2023-09-07 ","变更"]
["133","短期通用型（口）鼻用微旁流呼气末二氧化碳监测采样与供氧管","国械备20220253号","Covidien LLC","340/1 Moo 6 Bowin Sub-District, Sriracha District Chonburi, Thailand 20230","2023-09-07 ","变更"]
["134","长期新生儿/婴儿/儿童（口）鼻用微旁流呼气末二氧化碳监测采样及供氧管","国械备20220052号","Covidien LLC","340/1 Moo 6 Bowin Sub-District, Sriracha District Chonburi, Thailand 20230","2023-09-07 ","变更"]
["135","全自动染色封片一体机","国械备20230396号","Leica Biosystems Nussloch GmbH","Heidelberger Strasse 17-19, 69226 Nussloch, Germany","2023-09-07 ","有效"]
["136","通用型消化内镜用微旁流呼气末二氧化碳监测采样及供氧管","国械备20220245号","Covidien LLC","340/1 Moo 6 Bowin Sub-District, Sriracha District Chonburi, Thailand 20230","2023-09-07 ","变更"]
["137","短期新生儿/婴儿/儿童（口）鼻用微旁流呼气末二氧化碳监测采样管","国械备20220244号","Covidien LLC","340/1 Moo 6 Bowin Sub-District, Sriracha District Chonburi, Thailand 20230","2023-09-07 ","变更"]
["138","鼻用微旁流呼气末二氧化碳监测采样管及附件","国械备20220254号","Covidien LLC","340/1 Moo 6 Bowin Sub-District, Sriracha District Chonburi, Thailand 20230","2023-09-07 ","变更"]
["139","短期（口）鼻用微旁流呼气末二氧化碳监测采样及供氧管","国械备20220255号","Covidien LLC","340/1 Moo 6 Bowin Sub-District, Sriracha District Chonburi, Thailand 20230.    Avenue Henequen No. 1181, Park Industrial Salvarcar, 32573 Ciudad Juarez, Chihuahua, MEXICO","2023-09-07 ","变更"]
["140","口腔数字观察仪 ","国械备20191286号 "," DXM Co.,Ltd. ","No . 1003, llsantechnotown Bldg.,138, llsan -ro, llsandong-gu, Goyang-si,Gyeonggi-do, Korea","2023-09-07 ","无效"]
["141","脊柱用手术工具","国械备20220323号","Medtronic Sofamor Danek USA, Inc","4340 Swinnea Road Memphis, TN 38118, USA; 2500 Silveus Crossing Warsaw, IN 46582, USA","2023-09-07 ","变更"]
["142","牙科种植专用器械包","国械备20161332号","DIO Corporation","66, Centum seo-ro, Haeundae-gu, Busan, REPUBLIC OF KOREA","2023-09-06 ","变更"]
["143","手术放大镜","国械备20230395号","OCULUS Optikgeräte GmbH","Münchholzhäuser Str.29, 35582 Wetzlar, GERMANY","2023-09-06 ","有效"]
["144","牙科种植体手术工具","国械备20140142号","DIO Corporation","66, Centumseo-ro, Haeundae-gu, Busan 612-020, REPUBLIC OF KOREA","2023-09-06 ","变更"]
["145","上肢医用外固定支具","国械备20150242号","彪仕醫技股份有限公司","台南市南区中华西路一段23号","2023-09-05 ","变更"]
["146","下肢医用外固定支具","国械备20150243号","彪仕醫技股份有限公司","台南市南区中华西路一段23号","2023-09-05 ","变更"]
["147","腰椎固定器","国械备20150246号","彪仕醫技股份有限公司","台南市南区中华西路一段23号","2023-09-05 ","变更"]
["148","医用外固定躯干支具","国械备20160884号","彪仕醫技股份有限公司","台南市南区中华西路一段23号","2023-09-05 ","变更"]
["149","医用外固定四肢及关节支具","国械备20160885号","彪仕醫技股份有限公司","台南市南区中华西路一段23号","2023-09-05 ","变更"]
["150","颈托","国械备20150158号","彪仕醫技股份有限公司","台南市南区中华西路一段23号","2023-09-05 ","变更"]
["151","手臂吊带","国械备20140115号","彪仕醫技股份有限公司","台南市南区中华西路一段23号","2023-09-05 ","变更"]
["152","绑扎胶布","国械备20150156号","彪仕醫技股份有限公司","台南市南区中华西路一段23号","2023-09-05 ","变更"]
["153","牙科开口器","国械备20230394号","Ultradent Products, Inc.","505 West Ultradent Drive (10200 South), South Jordan, Utah 84095, USA","2023-09-05 ","有效"]
["154","疝脱支撑器","国械备20140067号","彪仕醫技股份有限公司","台南市南区中华西路一段23号","2023-09-05 ","变更"]
["155","荷包钳","国械备20180061号","Johnson & Johnson MEDICAL GmbH","Robert-Koch-Strasse 1, 22851 Norderstedt, GERMANY;Sauerbruchstr. 7 25479 Ellerau Deutschland","2023-09-05 ","变更"]
["156","施夹器","国械备20150332号","Ethicon Endo-Surgery, LLC","25 Plant Avenue, Hauppauge, NY 11788 USA","2023-09-05 ","变更"]
["157","踝部固定器","国械备20230393号","Becker Orthopedic Appliance Co.","635 Executive Drive, Troy, Michigan, 48083, United States","2023-09-05 ","有效"]
["158","测瓣器及其组件","国械备20230392号","Abbott Medical ","177 County Road B East St. Paul Minnesota 55117 USA","2023-09-04 ","有效"]
["159","手术拉钩","国械备20150082号","FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH","Prager Ring 70, 52070 Aachen, Germany","2023-09-04 ","变更"]
["160","消化内镜用微旁流呼气末二氧化碳监测采样及供氧管","国械备20220038号","Covidien LLC","340/1 Moo 6 Bowin Sub-District, Sriracha District Chonburi, Thailand 20230","2023-09-04 ","变更"]
["161","样本稀释液","国械备20161020号","キヤノンメディカルシステムズ株式会社","新潟県五泉市南本町1-2-2","2023-09-01 ","变更"]
["162","清洗液","国械备20181340号","キヤノンメディカルシステムズ株式会社","1-2-2 Minami-honcho, Gosen-shi, Niigata 959-1695, Japan","2023-09-01 ","变更"]
["163","清洗液","国械备20181343号","キヤノンメディカルシステムズ株式会社","1-2-2 Minami-honcho, Gosen-shi, Niigata 959-1695, Japan","2023-09-01 ","变更"]
["164","清洗液","国械备20181342号","キヤノンメディカルシステムズ株式会社","1-2-2 Minami-honcho, Gosen-shi, Niigata 959-1695, Japan","2023-09-01 ","变更"]
["165","清洗液","国械备20181341号","キヤノンメディカルシステムズ株式会社","1-2-2 Minami-honcho, Gosen-shi, Niigata 959-1695, Japan","2023-09-01 ","变更"]
["166","医用检查手套","国械备20230391号","PROFESSIONAL LATEX SDN. BHD. ","Lot 52, Jalan Logam 2, Kamunting Raya Industrial, 34600 Kamunting, Perak Darul Ridzuan, MALAYSIA","2023-09-01 ","有效"]
["167","腹部手术牵开器","国械备20170805号","ulrich GmbH & Co. KG","Buchbrunnenweg 12, 89081 Ulm, GERMANY","2023-09-01 ","无效"]
["168","全自动核酸纯化仪","国械备20151784号","MP Biomedicals Asia Pacific Pte Ltd","台湾235 新北市中和区桥和路122号2楼之2 ","2023-09-14 ","无效"]
["169","LP手臂吊带 (未灭菌)","国械备20140114号"," 彪仕醫技股份有限公司","臺南市南區中華西路一段23號","2023-09-05 ","无效"]