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国家药监局2024年4月批准进口第一类医疗器械产品备案237项
发布时间:2024-05-16浏览：350

2024年5月15日，国家药监局发布2024年4月进口第一类医疗器械产品备案信息，4月批准口腔科手术器械、基础外科手术器械、持钉器、螺丝起、造口皮肤保护剂、引流袋、造口袋、隐形矫正器的安装调节器械组合包、正畸钳等进口第一类医疗器械产品备案237项，一起看正文。

进口第一类医疗器械产品备案.jpg

2024年4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口腔科手术器械国械备20171161号ORTHOGENT ENGINEERINGToor Abad,Daska Road,Sialkot-51310 - Pakistan 2024-04-30 变更
2基础外科手术器械国械备20171162号ORTHOGENT ENGINEERINGToor Abad,Daska Road,Sialkot-51310-Pakistan2024-04-30 变更
3持钉器国械备20171121号HumanTech Dental GmbHGewerbestrasse 5, 71144 Steinenbronn, Germany2024-04-30 变更
4螺丝起国械备20171123号HumanTech Dental GmbHGewerbestrasse 5, 71144 Steinenbronn, Germany2024-04-30 变更
5造口皮肤保护剂国械备20190695号ConvaTec LimitedHickmans Road, Birkenhead, Wirral CH41 1JH United Kingdom2024-04-30 无效
6引流袋国械备20210078号ConvaTec LimitedCarretera Sánchez, Km. 18.5 Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina, San Cristobal 91000 Dominican Republic.2024-04-30 变更
7造口袋国械备20240027号ConvaTec Inc.Carretera Sanchez, Km. 18.5, Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina, San Cristobal, 91000 Dominican Republic.  Priemyselny Park 3 07101 Michalovce Slovakia2024-04-30 变更
8隐形矫正器的安装调节器械组合包国械备20200152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2024-04-29 变更
9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2024-04-29 变更
10正畸钳国械备20181619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2024-04-29 变更
11基础外科手术器械国械备20240140号WELDON INSTRUMENTSGanjay Wali street Rai Pur Stop, Wazirabad Road, Sialkot, 51310, Pakistan2024-04-29 有效
12足部固定器国械备20171056号Ottobock SE & Co. KGaAMax N?derStra?e 15 37115 Duderstadt,Germany2024-04-29 变更
13血液采集卡国械备20240139号Roche Molecular Systems, Inc.Sandhofer Strasse 116 68305 Mannheim Germany2024-04-28 有效
14试色糊剂国械备20190250号Ivoclar Vivadent AGBendererstrasse 2, 9494 Schaan, Liechtenstein2024-04-28 变更
15矫形外科（骨科）手术器械（包）国械备20180546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2024-04-28 变更
16脊椎固定手术用器械（包）国械备20180556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2024-04-28 变更
17骨髓内钉手术器械（包）国械备20180557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2024-04-28 变更
18颈椎系列手术器械（包）国械备20180568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2024-04-28 变更
19大腿骨系列手术器械（包）国械备20180569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2024-04-28 变更
20钛合金椎笼系统手术器械（包）国械备20180575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2024-04-28 变更
21中空螺钉手术器械（包）国械备20180581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2024-04-28 变更
22血压袖带国械备20181779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 Mexico2024-04-28 变更
23牙科铸造蜡国械备20161609号Renfert GmbHUntere Gieβwiesen 2, 78247 Hilzingen, Germany2024-04-25 变更
24牙科用口外研磨材料国械备20170486号Renfert GmbHUntere Gie?wiesen 2, 78247 Hilzingen, Germany2024-04-25 变更
25牙科分离剂国械备 20151676号Renfert GmbHUntere Gieβwiesen 2, 78247 Hilzingen, Germany2024-04-25 变更
26基础外科手术器械国械备20230562号SURGICAL SOURCES INDUSTRIESUgoki Darbar Road, Near Zoom Petrol Filling Station, Sialkot - Pakistan2024-04-25 变更
27胆囊刮匙国械备20220246号ASIA CARE + TECHPrem Nagar Road, Sialkot Pakistan2024-04-25 变更
28流式细胞分析用溶血素国械备20190471号Becton, Dickinson and Company, BD Biosciences25242 County Road 95 DAVIS, CA USA 956162024-04-25 变更
29正畸钳国械备20151231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2024-04-25 变更
30口角拉钩国械备20170194号Kerr Italia S.r.l.Via Strecce 4 P.O. 272 6934 Bioggio Switzerland2024-04-25 变更
31橡皮障夹国械备20150074号Kerr Italia S.r.l.Via Strecce 4, 6934 Bioggio, Switzerland2024-04-25 变更
32大容量冷冻离心机国械备20161233号J.P. SELECTA, S.A.U.Autovia A2 Km 585.1 08630 Abrera (Barcelona), SPAIN2024-04-24 无效
33CD103检测试剂国械备20240138号Immunotech SAS A Beckman Coulter Company130 Avenue de Lattre de Tassigny BP 177 Marseille, Cedex 9 13276 France2024-04-24 有效
34替代体国械备20200505号GeoMedi Co., Ltd.#702-703, Unit D, Indeokwon IT Valley, 40, Imi-ro, Uiwang-si, Gyeonggi-di, Korea2024-04-23 变更
35种植体扫描体国械备20161395号GeoMedi Co., Ltd.#702-703, Unit D, Indeokwon IT Valley, 40, Imi-ro, Uiwang-si, Gyeonggi-do2024-04-23 变更
36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-do2024-04-23 变更
37造口袋国械备20240105号ConvaTec LimitedPriemyselny Park 3 07101 Michalovce Slovakia2024-04-23 变更
38弹性医用胶布国械备20150483 号/5500 Ooaza-Osanagi, Higashine-shi, Yamagata, 999-3737 Japan2024-04-22 变更
39理疗用体表电极片国械备20170798号姿勻國際有限公司台北縣汐止市福德一路392巷48號4樓2024-04-22 变更
40包埋机国械备20180874号Milestone s.r.l. Via Fatebenefratelli, 1/5 I-24010 Sorisole (BG) Corso Europa,6 I-24030 Valbrembo (BG)2024-04-19 变更
41医用透气胶布国械备20240137号仙峰科技實業有限公司臺中市后里區義里里甲后路一段352巷65號2024-04-19 有效
42髋关节拉钩国械备20210591号Accuratus AGHolligenstrasse 94, CH-3008 Bern2024-04-18 变更
43取出钳国械备20171023号Tecomet, Inc.Hauptstrasse 5,78589 Duerbheim, Germany2024-04-18 变更
44关节手术用手柄国械备20200350号Gauthier Biomedical, Inc. 2221 Washington Street, Grafton, Wisconsin 53024 USA2024-04-18 变更
45打入器国械备20210488号Enztec Limited3/17 Print Place Middleton Christchurch 8024 New Zealand2024-04-18 变更
46固定针国械备20160664号OsteoMed3885 Arapaho Rd Addison Texas 75001 USA2024-04-18 变更
47牙科种植手术工具国械备20180134号Institut Straumann AGPeter Merian-Weg 12，4002 Basel，Switzerland； Les Champs du Clos 2，2613 Villeret，Switzerland； 60 Minuteman Road，Andover，MA，01810，USA2024-04-18 变更
48牙科种植手术工具国械备20170168号Institut Straumann AGPeter Merian-Weg 12，4002 Basel，Switzerland； Les Champs du Clos 2，2613 Villeret，Switzerland； 60 Minuteman Road，Andover，MA，01810，USA2024-04-18 变更
49牙用充填器国械备20240136号株式会社デンテック東京都板橋区清水町５３－５2024-04-18 有效
50多肽纯化试剂 Polypeptide Purification Reagent国械备20150329号Cytori Therapeutics, Inc.Deeside Industrial Park East, Unit 68, Third Avenue, Deeside, CH5 2LA, UK2024-04-18 变更
51医用离心机 国械备20150269号Cytori Therapeutics, Inc.Deeside Industrial Park East, Unit 68, Third Avenue, Deeside, CH5 2LA, UK2024-04-18 变更
52核酸纯化试剂 Nucleic Acid Purification Reagent国械备20150330号Cytori Therapeutics, Inc.Deeside Industrial Park East, Unit 68, Third Avenue, Deeside, CH5 2LA, UK2024-04-18 变更
53牙科种植专用器械包国械备20161332号DIO Corporation66, Centum seo-ro, Haeundae-gu, Busan, REPUBLIC OF KOREA2024-04-17 变更
54种植体扫描体国械备20161179号DIO Corporation66, Centumseo-ro, Haeundae-gu, Busan, REPUBLIC OF KOREA2024-04-17 变更
55琼斯苏木素伊红染色液国械备20240135号Agilent Technologies, Inc.1170 Mark Ave. Carpinteria, California 93013 UNITED STATES2024-04-17 有效
56琼斯核固红染色液国械备20240134号Agilent Technologies, Inc.1170 Mark Ave. Carpinteria, California 93013 UNITED STATES2024-04-17 有效
57胶体铁染色液国械备20240133号Agilent Technologies, Inc.1170 Mark Ave. Carpinteria, California 93013 UNITED STATES2024-04-17 有效
58淀粉酶溶液国械备20240132号Agilent Technologies, Inc.1170 Mark Ave. Carpinteria, California 93013 UNITED STATES2024-04-17 有效
59自动加样系统国械备20240131号Becton, Dickinson and Company, BD BiosciencesNeuwiesenstrasse 4, 8222 Beringen, Switzerland2024-04-17 有效
60全自动样品处理系统国械备20240130号株式会社アイディエス1552-1 Aza Kazaana, Oaza Magate, Kikuyo-machi, Kikuchi-gun, Kumamoto-ken, 869-1106 Japan2024-04-17 有效
61防散射滤线栅国械备20240129号JPI Healthcare Co.,Ltd.43, Seonggok-ro 22beon-gil, Danwon-gu Ansan-si, Gyeonggi-do, Korea2024-04-16 有效
62乳腺摄影防散射滤线栅国械备20240128号JPI Healthcare Co.,Ltd.43, Seonggok-ro 22beon-gil, Danwon-gu Ansan-si, Gyeonggi-do, Korea2024-04-16 有效
63放射治疗患者用定位装置国械备20240042号Qfix440 Church Road Avondale Pennsylvania 19311 USA2024-04-16 变更
64定位膜国械备20230556号Qfix440 Church Road Avondale Pennsylvania 19311 USA2024-04-16 变更
65牙科输送头国械备20200072号(?)?????????? ??? ??? 191 ,1?, 4?2024-04-15 变更
66造口底盘国械备20190230号ConvaTec Inc.Carretera Sanchez, Km. 18.5, Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina, San Cristobal, 91000 Dominican Republic.2024-04-15 无效
67手术剪国械备20151004号KLS Martin SE & Co.KGKLS Martin Platz 1, 78532 Tuttlingen, Germany2024-04-15 变更
68手术剪国械备20161654号KLS Martin SE&Co.KGKLS Martin Platz 1, 78532 Tuttlingen, Germany2024-04-15 变更
69牙科输送器国械备20230417号medmix Switzerland AGRütistrasse 7, 9469 Haag, Switzerland2024-04-15 无效
70止血钳国械备20181685号SURGICAL SOURCES INDUSTRIESP.O.Box:1389,Small Industrial Estate,Sialkot-Pakistan2024-04-15 变更
71组织钳国械备20191055号AMICUS ENTERPRISESAmicus Street,Muhammad Pura,Sialkot-51310-Pakistan2024-04-15 变更
72叩诊锤国械备20190206号PANORAMA INTERNATIONALDefence Road,Near China Chowk,Gulshan lqbal Park,Sialkot-51310-Pakistan.2024-04-15 变更
73医用听诊器国械备20220189号ASIA CARE + TECHPrem Nagar Road, Sialkot Pakistan2024-04-15 变更
74基础外科手术器械国械备20220139号ASIA CARE + TECHPrem Nagar Road, Sialkot Pakistan2024-04-15 变更
75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 – Pakistan2024-04-15 变更
76拔牙钳国械备20200098号BLACKSMITH SURGICALNear Noul Chowk，Wazirabad Road，Sialkot-Pakistan2024-04-15 变更
77喉镜国械备20220199号ASIA CARE + TECHPrem Nagar Road, Sialkot Pakistan2024-04-15 变更
78组织镊国械备20200095号BLACKSMITH SURGICALNear Noul Chowk，Wazirabad Road，Sialkot-Pakistan2024-04-15 变更
79手术剪国械备20191056号Care & Cure SurgicoNoal More Roras Road Sialkot Punjab 51310 Pakistan2024-04-15 变更
80组织镊国械备20191038号Care & Cure SurgicoNoal More Roras Road Sialkot Punjab 51310 Pakistan2024-04-15 变更
81口腔科手术器械国械备20191341号BRAVO SURGICALMakki Masjid Street Model Town,Sialkot-Pakistan.2024-04-15 变更
82泌尿肛肠科手术器械国械备20220134号ASIA CARE + TECHPrem Nagar Road, Sialkot Pakistan2024-04-15 变更
83医用放大镜国械备20220213号ASIA CARE + TECHPrem Nagar Road, Sialkot Pakistan2024-04-15 变更
84组织钳国械备20191041号Care & Cure SurgicoNoal More Roras Road Sialkot Punjab 51310 Pakistan2024-04-15 变更
85口腔科手术器械国械备20200541号Rocky Surgimed Mfg Inc.Bismillah Street,Kacha Shahab Pura Behind 18-A,Small Industrial Estate,Sialkot-Pakistan2024-04-15 变更
86耳鼻喉科手术器械国械备20181704号SURGICAL SOURCES INDUSTRIESP.O.Box:1389,Small Industrial Estate,Sialkot-Pakistan2024-04-15 变更
87医用听诊器国械备20190203号PANORAMA INTERNATIONALDefence Road,Near China Chowk,Gulshan lqbal Park,Sialkot-51310-Pakistan. 2024-04-15 变更
88胆囊取石钳国械备20220247号ASIA CARE + TECHPrem Nagar Road, Sialkot Pakistan2024-04-15 变更
89手术剪国械备20191042号AMICUS ENTERPRISESAmicus Street,Muhammad Pura,Sialkot-51310-Pakistan2024-04-15 变更
90手术剪国械备20200097号BLACKSMITH SURGICALNear Noul Chowk，Wazirabad Road，Sialkot-Pakistan2024-04-15 变更
91听觉检查音叉国械备20190204号PANORAMA INTERNATIONALDefence Road,Near China Chowk,Gulshan lqbal Park,Sialkot-51310-Pakistan. 2024-04-15 变更
92口腔科手术器械国械备20210236号HAWK INSTRUMENTSHEAD MARALA ROAD MURAD PUR SIALKOT-51310 PAKISAN2024-04-15 变更
93耳镜国械备20220198号ASIA CARE + TECHPrem Nagar Road, Sialkot Pakistan2024-04-15 变更
94口腔科手术器械国械备20191247号PRECISION DENTALChah Kakey wali,Jamkiey Road,Daska,Sialkot-Pakistan2024-04-15 变更
95基础外科手术器械国械备20230561号Sehgal's InstrumentsGhumman St. Daska Road Pakki Kotli 51340 Sialkot Pakistan.2024-04-15 变更
96骨科手术器械国械备20220131号ASIA CARE + TECHPrem Nagar Road, Sialkot Pakistan2024-04-15 变更
97口腔科手术器械国械备20230539号SURGICAL SOURCES INDUSTRIESUgoki Darbar Road, Near Zoom Petrol Filling Station, Sialkot - Pakistan2024-04-15 变更
98口腔科手术器械国械备20190202号PANORAMA INTERNATIONALDefence Road,Near China Chowk,Gulshan lqbal Park,Sialkot-51310-Pakistan.2024-04-15 变更
99口腔科手术器械国械备20230555号Sehgal's InstrumentsGhumman St. Daska Road Pakki Kotli 51340 Sialkot Pakistan.2024-04-15 变更
100口腔科手术器械国械备20191340号KING 100 INDUSTRIESNear Usmanya Masjid P.O.Khas Gohadpur,sialkot-Pakistan.2024-04-15 变更
101额戴反光镜国械备20220167号ASIA CARE + TECHPrem Nagar Road, Sialkot Pakistan2024-04-15 变更
102组织钳国械备20200099号BLACKSMITH SURGICALNear Noul Chowk，Wazirabad Road，Sialkot-Pakistan2024-04-15 变更
103神经和心血管手术器械国械备20220138号ASIA CARE + TECHPrem Nagar Road, Sialkot Pakistan2024-04-15 变更
104基础外科手术器械国械备20181462号KUMMAS CORPORATION3-Nishtar Road, Small Industries Estate, Sialkot- Pakistan.2024-04-15 变更
105组织钳国械备20191005号BRENNER INDUSTRIESOffice # C2 Jawad Center Near Javson Hotel, Defence Road, SIALKOT-51310,PAKISTAN.2024-04-15 变更
106基础外科手术器械国械备20190257号SUSTAINABLE INSTRUMENTS8-A,Allama Iqbal Road Small Industrial Estate,P.O.Box 1637,Sialkot-Pakistan2024-04-15 变更
107叩诊锤国械备20220188号ASIA CARE + TECHPrem Nagar Road, Sialkot Pakistan2024-04-15 变更
108组织钳国械备20191248号FALK INTERNATIONALGreen Town,Sublime Chowk,Wazirabad Road Harrar,Sialkot-51310-Pakistan.2024-04-15 变更
109听觉检查音叉国械备20220209号ASIA CARE + TECHPrem Nagar Road, Sialkot Pakistan2024-04-15 变更
110口腔科手术器械国械备20210051号HAWK INSTRUMENTSHEAD MARALA ROAD MURAD PUR SIALKOT-51310 PAKISAN2024-04-15 变更
111组织镊国械备20191039号AMICUS ENTERPRISESAmicus Street,Muhammad Pura,Sialkot-51310-Pakistan2024-04-15 变更
112口腔科手术器械国械备20180821号CARE & CRAFT CORPORATIONNASIR ROAD,SIALKOT-PAKISTAN 2024-04-15 变更
113鼻镜国械备20220168号ASIA CARE + TECHPrem Nagar Road, Sialkot Pakistan2024-04-15 变更
114口腔科手术器械国械备20191249号RAJ IMPEXRoras Road,Muzafar Pur,Sialkot-51310-Pakistan.2024-04-15 变更
115口腔科手术器械国械备20200452号MEDICARE INTERNATIONALPREM NAGAR ROAD 51310 SIALKOT-PAKISTAN2024-04-15 变更
116手术剪国械备20191004号BRENNER INDUSTRIESOffice # C2 Jawad Center Near Javson Hotel, Defence Road, SIALKOT-51310,PAKISTAN.2024-04-15 变更
117口腔科手术器械国械备20220041号SAR SONS SURGICAL PVT LTD.P.O Murad Pur,Mughalpura Road,Sialkot-51360 Pakistan2024-04-15 变更
118口腔科手术器械国械备20191339号AKMO INSTRUMENTSToor Abad Daska Road,Sialkot-51310-Pakistan2024-04-15 变更
119口腔科手术器械国械备20190844号HAWK INSTRUMENTSHEAD MARALA ROAD MURAD PUR SIALKOT-51310 PAKISAN2024-04-15 变更
120阴道牵开器国械备20200096号BLACKSMITH SURGICALNear Noul Chowk，Wazirabad Road，Sialkot-Pakistan2024-04-15 变更
121妇产科手术器械国械备20220133号ASIA CARE + TECHPrem Nagar Road, Sialkot Pakistan2024-04-15 变更
122口腔科手术器械国械备20191342号HUDENT INTERNATIONALP.O.BOX GOHAD PUR CHOWK,SIALKOT-PAKISTAN.2024-04-15 变更
123耳鼻喉科手术器械国械备20190263号PANORAMA INTERNATIONALDefence Road,Near China Chowk,Gulshan lqbal Park,Sialkot-51310-Pakistan. 2024-04-15 变更
124口腔科手术器械国械备20190869号CLINICAL SURGICALP.O. Gohad Pur, Near lslamia Girls School, Sialkot - 51310 - Punjab - Pakistan2024-04-15 变更
125口腔科手术器械国械备20210371号BROMED SURGICAL（PVT）LTD.Hakeem Street,Rahimpur Khichian,Post Office Bharth,Sialkot-Pakistan2024-04-15 变更
126牙科修整用钨钢车针国械备20190777号Kerr Corporation55 Laurier Drive Morrisburg Ontario KOC 1XO Canada2024-04-15 变更
127口腔科手术器械国械备20190178号ASIA CARE + TECHPrem Nagar Road, Sialkot Pakistan2024-04-15 变更
128基础外科手术器械国械备20191368号BROMED SURGICAL (PVT) LTDHakeem Street,Rahimpur Khichian,Post Office Bharth,Sialkot-Pakistan2024-04-15 变更
129刮匙国械备20200094号BLACKSMITH SURGICALNear Noul Chowk，Wazirabad Road，Sialkot-Pakistan2024-04-15 变更
130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 – Pakistan2024-04-15 变更
131口腔科手术器械国械备20190870号PENTA BROTHERS ENTERPRISESMARALA ROAD, MURAD PUR NEAR SONA BREAD HOUSE, SIALKOT - PAKISTAN.2024-04-15 变更
132口腔科手术器械国械备20190258号SUSTAINABLE INSTRUMENTS8-A,Allama Iqbal Road Small Industrial Estate,P.O.Box 1637,Sialkot-Pakistan2024-04-15 变更
133血红蛋白检测用装载片国械备20190477号Fresenius Kabi AGVon-Cancrin-Straβe 1, 63877 Sailauf ,  Deutschland2024-04-12 变更
134医用离心机国械备20160117号璟明實業股份有限公司新北市三重区中正北路532、534号6楼2024-04-12 变更
135医用离心机国械备20160354号璟明實業股份有限公司新北市三重區中正北路532、534號6樓2024-04-12 变更
136医用检查手套国械备20240127号Careglove Global Sdn. Bhd.Lot 17479, Lorong Senawang 3/2, Off Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan, Malaysia.2024-04-12 有效
137鼻部冲洗器国械备20181445号士康醫療器材有限公司新北市淡水區民权路187巷13号2024-04-12 变更
138一件式牙科种植体系统用配件国械备20161706号台灣植體科技股份有限公司高科分公司高雄市路竹區路科二路63號5樓2024-04-12 变更
139软组织环切刀国械备20161260号台灣植體科技股份有限公司高科分公司高雄市路竹區路科二路63號5樓2024-04-12 变更
140检查用乳胶手套国械备20240126号Careglove Global Sdn. Bhd.Lot 17479, Lorong Senawang 3/2, Off Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan, Malaysia.2024-04-12 有效
141牙科种植手术用器械包国械备20180124号台灣植體科技股份有限公司高科分公司高雄市路竹區路科二路63號5樓2024-04-12 变更
142人工指关节用手术器械国械备20191221号帝人ナカシマメディカル株式会社岡山県岡山市東区上道北方688-12024-04-12 变更
143氧气面罩国械备20160849号太平洋醫材股份有限公司苗栗县铜锣乡自强路19号2024-04-12 变更
144鼻氧管国械备20160397号太平洋醫材股份有限公司苗栗县铜锣乡自强路19号2024-04-12 变更
145组织固定液国械备20151956号Richard-Allan Scientific LLC4481 Campus Drive, Kalamazoo, Michigan 49008, USA2024-04-12 变更
146组织快速脱水试剂国械备20151964号Richard-Allan Scientific LLC4481 Campus Drive, Kalamazoo, Michigan 49008, USA2024-04-12 变更
147集尿袋国械备20162035号太平洋醫材股份有限公司苗栗县铜锣乡自强路19号 2024-04-12 变更
148口腔抽吸管（含刷头）国械备20160537号太平洋醫材股份有限公司苗栗县铜锣乡自强路19号2024-04-12 变更
149苏木素染色液国械备20150245号Ventana Medical Systems, Inc.1910E.Innovation Park Drive Tucson, AZ 85755 USA2024-04-12 变更
150增强液国械备20150346号DiaSorin Italia S.p.A.Von Hevesy-Strasse 3, D-63128 Dietzenbach, Germany2024-04-12 变更
151髋关节手术工具国械备20210057号Viant Medical, LLC4545 Kroemer Road Fort Wayne, IN 46818 USA2024-04-11 变更
152神经和肌肉刺激器用体表电极国械备20200131号Bioness Inc.25103 Rye Canyon Loop Valencia California 91355 USA2024-04-11 无效
153显微镊国械备20150527号FEHLING INSTRUMENTS GmbH & Co. KGHanauer Landstraβe 7A, 63791 Karlstein, Germany2024-04-10 变更
154血管钳国械备20150528号FEHLING INSTRUMENTS GmbH & Co. KGHanauer Landstraβe 7A, 63791 Karlstein, Germany2024-04-10 变更
155外科牵开器国械备20151609号FEHLING INSTRUMENTS GmbH & Co. KGHanauer Landstraβe 7A D-63791 Karlstein2024-04-10 变更
156义齿修复工具国械备20161964号Zest Anchors, LLC2230 Enterprise Street, Escondido, California, 92029, USA2024-04-10 变更
157种植辅助材料国械备20191381号Valoc AGCH-4434 H?lstein2024-04-10 变更
158口腔科抛光保护帽国械备20220347号Institut Straumann AG见附页2024-04-10 变更
159替代体国械备20220227号Institut Straumann AGB?chler Feintech AG, Ribigasse 7 CH-4434 H?lstein; MEDENTiKA GmbH, Hammweg 8-10, 76549 Hügelsheim, Deutschland2024-04-10 变更
160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32024-04-10 变更
161硅橡胶复制材料国械备20191118号DMP Dental Industry S.A.Kalyvion Avenue, Markopoulo Industrial Zone, Attiki 19003, Greece2024-04-10 无效
162牙钻延长器国械备20200656号Institut Straumann AGPeter 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, Germany2024-04-09 变更
163牙科塑料基底国械备20181407号Institut Straumann AGPeter Merian-Weg 12，4002 Basel，SWITZERLAND；Les Champs du Clos 2，2613 Villeret，SWITZERLAND；60 Minuteman Road，Andover，MA，01810，USA.2024-04-09 变更
164牙科工具清洁刷国械备20181226号Institut Straumann AGRudolf-Diesel-Straβe 17, 91572 Bechhofen, GERMANY2024-04-09 变更
165牙科种植修复用工具包国械备20180704号Institut Straumann AGCH-4434 H?lstein2024-04-09 变更
166牙科种植体丝攻国械备20171227号Institut Straumann AGPeter Merian-Weg 12，4002 Basel，Switzerland； Les Champs du Clos 2，2613 Villeret，Switzerland； 60 Minuteman Road，Andover，MA，01810，USA2024-04-09 变更
167种植用手术导板国械备20170735号Institut Straumann AGBirmannsgasse 3, 4055, Basel, Swizerland2024-04-09 变更
168牙科镊国械备20161299号Institut Straumann AGOstlandstraβe 36, 78234 Engen, Germany2024-04-09 变更
169牙科种植扫描定位件国械备20161413号Institut Straumann AGInstitut 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 2024-04-09 变更
170替代体国械备20161864号Institut Straumann AGInstitut 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，USA2024-04-09 变更
171种植体安装器械国械备20162041号Institut Straumann AGInstitut 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 2024-04-09 变更
172种植辅助器械国械备20170066号Institut Straumann AGPeter Merian-Weg 12，4002 Basel，Switzerland； Les Champs du Clos 2，2613 Villeret，Switzerland； 60 Minuteman Road，Andover，MA，01810，USA2024-04-09 变更
173牙用尺国械备20170166号Institut Straumann AGPeter Merian-Weg 12，4002 Basel，Switzerland； Les Champs du Clos 2，2613 Villeret，Switzerland； 60 Minuteman Road，Andover，MA，01810，USA2024-04-09 变更
174牙科镊国械备20170454号Institut Straumann AGInstitut 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 2024-04-09 变更
175牙科种植体手术用工具国械备20170650号Institut Straumann AGPeter Merian-Weg 12，4002 Basel，Switzerland； Les Champs du Clos 2，2613 Villeret，Switzerland； 60 Minuteman Road，Andover，MA，01810，USA2024-04-09 变更
176牙科镊国械备20161298号Institut Straumann AGWürttemberger Strβe 23 78567 Fridingen, Deutschland2024-04-09 变更
177口腔用钳国械备20190531号ELITE INTERNATIONALPlot2, Block 2, S.I.E., Sialkot2024-04-09 变更
178牙探针国械备20190423号/Plot2, Block 2, S.I.E., Sialkot 2024-04-09 变更
179牙挺国械备20190434号ELITE INTERNATIONALPlot2, Block 2, S.I.E., Sialkot 2024-04-09 变更
180口腔科手术器械国械备20190655号ELITE INTERNATIONAL  Plot2, Block 2, S.I.E., Sialkot 2024-04-09 变更
181基础外科手术器械国械备20190420号/Plot2, Block 2, S.I.E., Sialkot 2024-04-09 变更
182牙科手术器械包国械备20180108号DENTSPLY Implants Manufacturing GmbH见附页。2024-04-09 变更
183口腔科手术器械国械备20240125号Dr. Frigz International Pvt. Ltd. Airport Road, Gohad Pur, Sialkot, Pakistan.2024-04-09 有效
184位置定位器国械备20170701号DENTSPLY Implants Manufacturing GmbHAminogatan 1, PO Box 14, 431 21 M?lndal,SWEDEN2024-04-09 变更
185牙科种植体种植工具国械备20170702号DENTSPLY Implants Manufacturing GmbHAminogatan 1, PO Box 14, 43121 M?lndal，SWEDEN 2024-04-09 变更
186机用螺丝刀国械备20170338号DENTSPLY Implants Manufacturing GmbHAminogatan 1, PO Box 14, 43121 M?lndal,SWEDEN2024-04-08 变更
187牙用尺国械备20160570号  DENTSPLY Implants Manufacturing GmbHAminogatan 1, PO Box 14, 43121 M?lndal，SWEDEN 2024-04-08 变更
188转移帽国械备20160991号DENTSPLY Implants Manufacturing GmbHAminogatan 1, PO Box 14, 43121 M?lndal，SWEDEN 2024-04-08 变更
189肩关节手术工具国械备20240124号Biomet Orthopedics56 East Bell Drive, P.O. Box 587, Warsaw, Indiana 46581, USA2024-04-08 有效
190位置定位器国械备20160960号  DENTSPLY Implants Manufacturing GmbHAminogatan 1, PO Box 14, 43121 M?lndal，SWEDEN 2024-04-08 变更
191替代体国械备20161880号  DENTSPLY Implants Manufacturing GmbHAminogatan 1, PO Box 14, 43121 M?lndal，SWEDEN 2024-04-08 变更
192医用橡胶检查手套国械备20240123号PT. UNIVERSAL GLOVESJI. Pertahanan No.17,Patumbak Deli Serdang-Sumatera Utara(20361 ) Indonesia2024-04-08 有效
193牙科种植体种植工具国械备20220574号DENTSPLY Implants Manufacturing GmbHAminogatan 1, 431 53 M?lndal, SWEDEN2024-04-08 变更
194医用橡胶检查手套国械备20240122号PT. UNIVERSAL GLOVESJI. Pertahanan No.17,Patumbak Deli Serdang-Sumatera Utara(20361 ) Indonesia2024-04-08 有效
195牙骨锤国械备20161441号  DENTSPLY Implants Manufacturing GmbHAminogatan 1, PO Box 14, 43121 M?lndal，SWEDEN 2024-04-08 变更
196缓冲液国械备20240121号Abbott Ireland Diagnostics DivisionFinisklin Business Park, Sligo, Ireland2024-04-08 有效
197缓冲液国械备20240120号Abbott Ireland Diagnostics DivisionFinisklin Business Park, Sligo, Ireland2024-04-08 有效
198理疗用体表电极国械备20181740号YOUNG-IN biotech Co., Ltdundefined.394,Nambusunhwan-ro,Yangcheon-gu,Seoul,Republic of Korea2024-04-07 无效
199人体定位垫国械备20240119号ァルケァ株式会社千葉県千葉市花見川区千種町 289-42024-04-07 有效
200持钉器国械备20161198号ADIN DENTAL IMPLANT SYSTEMS LTD.Industrial Zone, Alon Tavor, Afula POB 1128, Afula 1811101, Israel2024-04-03 变更
201扭力扳手国械备20161146号ADIN DENTAL IMPLANT SYSTEMS LTD.Industrial Zone, Alon Tavor, Afula POB 1128, Afula 1811101, Israel2024-04-03 变更
202牙用尺国械备20161147号ADIN DENTAL IMPLANT SYSTEMS LTD.Industrial Zone, Alon Tavor, Afula POB 1128, Afula 1811101, Israel2024-04-03 变更
203种植辅助材料 国械备20220029号ADIN DENTAL IMPLANT SYSTEMS LTD.Industrial Zone Alon Tavor, POB 1128 Afula, 1811101 Israel2024-04-03 变更
204种植辅助材料国械备20210201号ADIN DENTAL IMPLANT SYSTEMS LTD.Industrial Zone Alon Tavor, POB 1128 Afula, 1811101 Israel2024-04-03 变更
205CD3检测试剂国械备20240118号BioLegend,Inc.8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212024-04-03 有效
206种植体安装辅助器械国械备20240117号BASIC DENTAL IMPLANT SYSTEMS.INC.103 NM HIGHWAY 528 NE Ste B3，Rio Rancho NM 87124 USA2024-04-03 有效
207转移帽国械备20161183号ADIN DENTAL IMPLANT SYSTEMS LTD.Industrial Zone, Alon Tavor, Afula POB 1128, Afula 1811101, Israel2024-04-02 变更
208螺丝起国械备20161200号ADIN DENTAL IMPLANT SYSTEMS LTD.Industrial Zone, Alon Tavor, Afula POB 1128, Afula 1811101, Israel2024-04-02 变更
209机用螺丝刀国械备20161240号ADIN DENTAL IMPLANT SYSTEMS LTD.Industrial Zone, Alon Tavor, Afula POB 1128, Afula 1811101, Israel2024-04-02 变更
210种植用手术导板国械备20161182号ADIN DENTAL IMPLANT SYSTEMS LTD.Industrial Zone, Alon Tavor, Afula POB 1128, Afula 1811101, Israel2024-04-02 变更
211上颌窦提升器国械备20161197号ADIN DENTAL IMPLANT SYSTEMS LTD.Industrial Zone, Alon Tavor, Afula POB 1128, Afula 1811101, Israel2024-04-02 变更
212替代体国械备20181711号ADIN DENTAL IMPLANT SYSTEMS LTD.Industrial Zone, Alon Tavor, Afula POB 1128, Afula 1811101, Israel2024-04-02 变更
213牙科种植体种植工具国械备20161166号ADIN DENTAL IMPLANT SYSTEMS LTD.Industrial Zone, Alon Tavor, Afula POB 1128, Afula 1811101, Israel2024-04-02 变更
214牙科种植定位器国械备20161167号ADIN DENTAL IMPLANT SYSTEMS LTD.Industrial Zone, Alon Tavor, Afula POB 1128, Afula 1811101, Israel2024-04-02 变更
215钻针深度停止器国械备20161168号ADIN DENTAL IMPLANT SYSTEMS LTD.Industrial Zone, Alon Tavor, Afula POB 1128, Afula 1811101, Israel2024-04-02 变更
216种植体扫描体国械备20161169号ADIN DENTAL IMPLANT SYSTEMS LTD.Industrial Zone, Alon Tavor, Afula POB 1128, Afula 1811101, Israel2024-04-02 变更
217种植安装辅助工具国械备20210202号ADIN DENTAL IMPLANT SYSTEMS LTD.Industrial Zone Alon Tavor, POB 1128 Afula, 1811101 Israel2024-04-02 变更
218种植体安装辅助器械国械备20220043号Adin Dental Implant Systems Ltd.Industrial Zone Alon Tavor, POB 1128 Afula, 1811101 Israel2024-04-02 变更
219牙科开口器国械备20240116号Pro-Options ABBr?nnkyrkagatan 94, 117 26 Stockholm, Sweden2024-04-02 有效
220探针  国械备20191418号ASANUS Medizintechnik GmbHtake off Gewerbepark 2, 78579 Neuhausen ob Eck, Germany2024-04-02 变更
221牵开器  国械备20191068号ASANUS Medizintechnik GmbHtake off Gewerbepark 2, 78579 Neuhausen ob Eck, Germany2024-04-02 变更
222压力绷带国械备20240115号Paul Hartmann AGLauterstraβe 50, 67752 Wolfstein, GERMANY2024-04-02 有效
223器械钳   国械备20191196号ASANUS Medizintechnik GmbHtake off Gewerbepark 2, 78579 Neuhausen ob Eck, Germany2024-04-02 变更
224医用剪  国械备20180850号ASANUS Medizintechnik GmbHtake off Gewerbepark 2, 78579 Neuhausen ob Eck, Germany2024-04-02 变更
225拉钩国械备20160138号KLS Martin SE&Co.KGKLS Martin Platz 1, 78532 Tuttlingen, Germany2024-04-02 变更
226造口袋国械备20240114号Coloplast A/SColoplast Hungary KFT, Búzavirág út 15, 2800 Tatabánya, Hungary2024-04-02 有效
227矫形外科（骨科）手术器械包国械备20171178号KLS Martin SE & Co.KGKLS Martin Platz 1, 78532 Tuttlingen, Germany2024-04-02 变更
228刮匙国械备20160703号KLS Martin SE&Co.KGKLS Martin Platz 1, 78532 Tuttlingen, Germany2024-04-02 变更
229医用镊  国械备20181005号ASANUS Medizintechnik GmbHtake off Gewerbepark 2, 78579 Neuhausen ob Eck, Germany2024-04-01 变更
230持针钳  国械备20181013号ASANUS Medizintechnik GmbHtake off Gewerbepark 2, 78579 Neuhausen ob Eck, Germany2024-04-01 变更
231吸引管  国械备20191420号ASANUS Medizintechnik GmbHtake off Gewerbepark 2, 78579 Neuhausen ob Eck, Germany2024-04-01 变更
232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2024-04-01 变更
233骨科手术工具国械备20240113号Zimmer CAS75 Queen Street, Suite 3300 Montreal, Quebec, H3C 2N6, Canada2024-04-01 有效
234造口皮肤保护剂国械备20190017号アルケア株式会社千葉県千葉市花見川区千種町36-22024-04-01 变更
235造口减压环国械备20151614号ConvaTec Limited1405 Dogwood Way, Mebane, NC  27302, USA2024-04-15 无效
236包埋机国械备20170146号サクラ精機株式会社長野県千曲市大字鋳物師屋75－52024-04-02 无效
237包埋机国械备20171001号サクラ精機株式会社長野県千曲市大字鋳物師屋75-52024-04-02 无效


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