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2024年1月国家局批准进口第一类医疗器械产品备案125项
发布日期:2024-02-18 18:16浏览次数:838次
从我的认识来看，一类医疗器械备案产品在临床上扮演了重要且广泛的角色，在临床应用上帮助到许多患者和临床工作者们，因此，我是几乎每月都会为大家介绍国家药监局批准的进口第一类医疗器械产品备案事项，一起来看2024年1月有哪些进口第一类医疗器械产品。

从我的认识来看，一类医疗器械备案产品在临床上扮演了重要且广泛的角色，在临床应用上帮助到许多患者和临床工作者们，因此，我是几乎每月都会为大家介绍国家药监局批准的进口第一类医疗器械产品备案事项，一起来看2024年1月有哪些进口第一类医疗器械产品。

进口第一类医疗器械产品备案.jpg

2024年1月国家局批准进口第一类医疗器械产品备案125项

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医用检查手套国械备20161386号Ansell   Healthcare Europe NVLot   6129, Jalan Haji Abdul Manan, Batu 5 1/4, Off Jalan Meru 41050 Klang,   Malaysia2024-01-31 变更
2缓冲液国械备20160496号Siemens   Healthcare Diagnostics Products GmbHEmil-von-Behring-Str.   76, 35041 Marburg, Germany2024-01-31 无效
3软轴牵开器国械备20161616号pro   med instruments GmbHBoetzinger   Strasse 38 79111 Freiburg Germany2024-01-31 变更
4手术用头架国械备20161617号pro   med instruments GmbHWaldmatten   6 79224 Umkirch Germany2024-01-31 变更
5脊柱手术器械包国械备20171186号冠亞生技股份有限公司 新北市新店区复兴里复兴路43号（1楼）2024-01-31 变更
6放射治疗患者用定位装置国械备20240042号Qfix440   Church Road Avondale Pennsylvania 19311 USA2024-01-31 有效
7手术辅助移动式手术照明灯国械备20230017号Vivo   Surgical Private Limited67   Ayer Rajah Crescent #01-01/02 Singapore 1399502024-01-30 变更
8血管钳国械备20240041号Surgivet   Instruments CompanyWazirabad   Road, Sialkot - Pakistan2024-01-30 有效
9腰椎固定器国械备20151241号Aspen   Medical Products,Inc.6481   Oak Canyon Irvine,CA 926182024-01-30 变更
10胸腰骶固定器国械备20151193号Aspen   Medical Products,Inc.6481   Oak Canyon Irvine,CA 926182024-01-30 变更
11手术剪国械备20240040号Surgivet   Instruments CompanyWazirabad   Road, Sialkot - Pakistan2024-01-30 有效
12手术刀国械备20240039号Surgivet   Instruments CompanyWazirabad   Road, Sialkot - Pakistan2024-01-30 有效
13器械钳国械备20240038号Surgivet   Instruments CompanyWazirabad   Road, Sialkot - Pakistan2024-01-30 有效
14牵开器国械备20240037号Surgivet   Instruments CompanyWazirabad   Road, Sialkot - Pakistan2024-01-30 有效
15医用镊国械备20240036号Surgivet   Instruments CompanyWazirabad   Road, Sialkot - Pakistan2024-01-30 有效
16剥离器国械备20240035号Surgivet   Instruments CompanyWazirabad   Road, Sialkot - Pakistan2024-01-30 有效
17持钉器国械备20240034号MCTBIO46,   Chobu-ro, Mohyeon-myeon, Cheoin-gu, Yongin-si, Gyeonggi-do, Korea Rep.2024-01-29 有效
18冷冻包埋剂国械备20240033号SAKURA   FINETEK U.S.A., INC.1750   W 214th St TORRANCE, CA USA 905012024-01-29 有效
19全自动免疫检验系统用底物液国械备20150154号Siemens   Healthcare Diagnostics Inc.500   GBC Drive, Mailstop 514 P.O.Box 6101 Newark, DE 19714 United States2024-01-29 无效
20全自动免疫检验系统用底物液国械备20150161号Siemens   Healthcare Diagnostics Inc.500   GBC Drive, Mailstop 514 P.O.Box 6101 Newark, DE 19714 United States2024-01-29 无效
21牙科用镊国械备20230193号PRODONT-HOLLIGER   SOCIETE PAR ACTIONS SIMPLIFIEELieu-dit   La Marnasse,63880 Olliergues,France2024-01-29 变更
22口内塑形刀国械备20230194号PRODONT-HOLLIGER   SOCIETE PAR ACTIONS SIMPLIFIEELieu-dit   La Marnasse,63880 Olliergues,France2024-01-29 变更
23种植体安装辅助器械国械备20181502号Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 变更
24牙科种植扫描定位件国械备20181322号Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 变更
25种植体安装辅助器械国械备20181501号Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 变更
26牙科塑料基底国械备20181324号Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 变更
27牙科种植器械限深套国械备20200124号Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 变更
28扭力扳手国械备20170185号Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 变更
29种植辅助材料国械备20181132号Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 变更
30种植辅助器械国械备20170978号Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 变更
31转移帽国械备20170216号Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 变更
32螺丝起国械备20150871号???????(?)66-16,   Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2024-01-29 变更
33试戴体国械备20200271号Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE 2024-01-29 变更
34种植手术工具包国械备20181582号Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 变更
35牙用刀国械备20170979号Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 变更
36牙科手术通用器械包国械备20180323号Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 变更
37牙科种植手术工具包国械备20171180号Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 变更
38牙用尺国械备20171039号Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE2024-01-29 变更
39血型及配血离心孵育工作组国械备20140148号Ortho-Clinical   Diagnostics2400   Millbrook Drive, Buffalo Grove, IL 60089, USA2024-01-29 变更
40固定用弹力束带国械备20181484号Bauerfeind   AGTriebeser   Straβe 16 07937 Zeulenroda- Triebes Germany2024-01-26 变更
41眼科手术器械国械备20240032号KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692024-01-26 有效
42眼科泪囊手术器械国械备20240031号KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692024-01-26 有效
43眼用咬除器国械备20240030号KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692024-01-26 有效
44髋关节手术支撑牵引架国械备20230388号ConMed   Corporation452   Randolph Street, Abington, MA 02351 United States2024-01-26 变更
45射频治疗仪用耦合剂国械备20240029号Solta   Medical, Inc.286   Eldridge Road Fairfield New Jersey 07004 USA2024-01-26 有效
46膝关节固定器国械备20240028号豐利國際股份有限公司南投縣南投市福興里永興路13號2、3樓2024-01-26 有效
47防漏膏国械备20190264号ConvaTec   Inc.Carretera   Sanchez, Km. 18.5, Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina,   San Cristobal, 91000 Dominican Republic.2024-01-25 变更
48造口袋国械备20190930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   Slovakia.2024-01-25 变更
49造口袋国械备20190171号ConvaTec   Inc.Carretera   Sanchez, Km. 18.5, Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina,   San Cristobal, 91000 Dominican Republic.2024-01-25 变更
50造口袋国械备20190594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   Slovakia.2024-01-25 变更
51造口底盘国械备20181394号ConvaTec   Inc.Carretera   Sanchez, Km. 18.5 Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina,   San Cristobal 91000 Dominican Republic2024-01-25 变更
52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.2024-01-25 变更
53造口袋国械备20181323号ConvaTec   Inc.Carretera   Sanchez, Km. 18.5 qarque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina,   San Cristobal 91000 Dominican Republic2024-01-25 变更
54造口袋国械备20190626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   Slovakia.2024-01-25 变更
55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 Slovakia2024-01-25 有效
56骨科钻头国械备20240026号ConMed   Corporation11311   Concept Boulevard LARGO, FL USA 337732024-01-25 有效
57钻针引导器国械备20160301号Nobel   Biocare AB22715   Savi Ranch Parkway Yorba Linda California 92887 USA; Dimbov?gen 2 SE-691 51   Karlskoga Sweden; Engvej 33, 3330 G?rl?se, Denmark2024-01-25 变更
58牙用尺国械备20152150号Nobel   Biocare ABDimbov?gen   2 SE-691 51 Karlskoga Sweden;22715 Savi Ranch Parkway Yorba Linda California   92887 USA2024-01-25 变更
59基础外科手术器械国械备20240025号First   Class TradersOpposite   Oxford High School Kingra Road Langeraiali Sialkot - Pakistan2024-01-25 有效
60基础外科手术器械国械备20240024号Brotra   International117   Ghazi Defence, Officer Colony, Sialkot - 51310, Pakistan2024-01-25 有效
61替代体国械备20181194号OSSTEM   IMPLANT Co., Ltd. 66-16,   Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2024-01-25 变更
62一次性使用样本收集器国械备20240023号HemoCue   ABKuvettgatan   1, SE-26271 Angelholm, Sweden2024-01-25 有效
63口腔观察仪国械备20160921号SOPROAvenue   des Genévriers, ZAC Athélia IV, 13705 LA CIOTAT2024-01-24 变更
64牙科刮治器国械备20191351号Prodont-holliger   société par actions simplifiéeLieu-dit   La Marnasse, 63880 OLLIERGUES, FRANCE2024-01-24 变更
65口腔观察仪国械备20160146号SOPROZAC   Athelia IV, Avenue des Genevriers, 13705 LA CIOTAT CEDEX FRANCE2024-01-24 变更
66耳钳国械备20240022号FRIEDEN   MEDICAL INSTRUMENTS Mughal   Pura，Gohad Pur, 51310，Sialkot-Pakistan2024-01-23 有效
67刮治器国械备20151442号Hu-Friedy   Mfg.Co.,LLC3232   N. Rockwell Street, Chicago, IL 60618, United States2024-01-23 变更
68脊柱用手术工具国械备20230172号Medtronic   Sofamor Danek USA, Inc.8347   N Steven Road, Milwaukee WI 53223, USA2024-01-23 变更
69造口袋国械备20190949号Coloplast   A/SKerék   utca 4, 2800 Tatabánya, Hungary2024-01-23 变更
70造口袋国械备20190945号Coloplast   A/SKerék   utca 4, 2800 Tatabánya, Hungary2024-01-23 变更
71膝关节手术工具国械备20210189号DePuy   Ireland UC请见附件“生产地址”。2024-01-22 变更
72种植体手术辅助工具国械备20240021号BIOTEM   CO., LTD.422,   Sasang-ro, Sasang-gu, Busan-si, Republic of Korea2024-01-22 有效
73螺丝起国械备20240020号BIOTEM   CO., LTD.422,   Sasang-ro, Sasang-gu, Busan-si, Republic of Korea2024-01-22 有效
74替代体国械备20240019号Biotem   Co., Ltd.422,   Sasang-ro, Sasang-gu, Busan-si, Republic of Korea2024-01-22 有效
75医用检查手套国械备20191018号Hartalega   NGC Sdn. Bhd.No.   1, Persiaran Tanjung Kawasan Perindustrian Tanjung 43900 Sepang, Selangor   Darul Ehsan MALAYSIA2024-01-22 变更
76检查手套国械备20151767号Hartalega   NGC Sdn. Bhd.No.   1, Persiaran Tanjung, Kawasan Perindustrian Tanjung, 43900 Sepang, Selangor   Darul Ehsan Malaysia2024-01-22 变更
77弹力绷带国械备20240018号LUROPAS   del Dott. Molinari & C. S.r.l.Via   Antonio Vivaldi, 4 - 24040 Calvenzano (BG) - Italy2024-01-22 有效
78关节假体试模    国械备20240017号Zimmer   Inc.1800   W. Center Street, Warsaw, Indiana 46580, USA2024-01-19 有效
79替代体国械备20181320号MegaGen   Implant Co.,Ltd.45,   Secheon-ro 7-gil, Dasa-eup, Dalseong-gun, Daegu2024-01-19 变更
80牙周探针国械备20230182号PRODONT-HOLLIGER   SOCIETE PAR ACTIONS SIMPLIFIEELieu-dit   La Marnasse,63880 Olliergues,France2024-01-18 变更
81银汞合金充填器国械备20230180号PRODONT-HOLLIGER   SOCIETE PAR ACTIONS SIMPLIFIEELieu-dit   La Marnasse,63880 Olliergues,France2024-01-18 变更
82牙用充填器国械备20230181号PRODONT-HOLLIGER   SOCIETE PAR ACTIONS SIMPLIFIEELieu-dit   La Marnasse,63880 Olliergues,France2024-01-18 变更
83牙科模型材料国械备20240016号BEGO   Bremer Goldschl?gerei Wilh. Herbst GmbH & Co. KGWilhelm-Herbst-Str.   1-28359 Bremen, Deutschland2024-01-18 有效
84口镜国械备20190571号PRODONT-HOLLIGER   SOCIéTé PAR ACTIONS SIMPLIFIéELieu-dit   La Marnasse 63880 Olliergues France2024-01-18 变更
85牙探针国械备20190542号PRODONT-HOLLIGER   SOCIéTé PAR ACTIONS SIMPLIFIéELieu-dit   La Marnasse 63880 Olliergues France2024-01-18 变更
86牙科骨挤压器国械备20190570号PRODONT-HOLLIGER   SOCIéTé PAR ACTIONS SIMPLIFIéE Lieu-dit La Marnasse 63880 Olliergues   France 2024-01-18 变更
87牙科刮治器国械备20200145号PRODONT-HOLLIGER   SOCIéTé PAR ACTIONS SIMPLIFIééLieu-dit   La Marnasse, 63880 OLLIERGUES, FRANCE2024-01-17 变更
88牙科刮治器国械备20210597号PRODONT-HOLLIGER   SOCIETE PAR ACTIONSLieu-dit   La Marnasse,63880 OLLIERGUES,France2024-01-17 变更
89种植体螺丝起国械备20151826号Nobel   Biocare AB Dimbov?gen   2 SE-691 51 Karlskoga Sweden；  22715   Savi Ranch Parkway Yorba Linda California 92887 USA；Engvej 33, 3330 G?rl?se,   Denmark；74950 SCIONZIER France2024-01-17 变更
90担架国械备20190694号MEDIROL   s.r.o.Dolní   Dubňany 58, 671 73 Tule?ice2024-01-17 变更
91清洗液国械备20180471号Siemens   Healthcare Diagnostics Inc.Emil-von-Behring-Str.76,   35041 Marburg, Germany2024-01-17 无效
92疝脱支撑器国械备20140070号彪仕醫技股份有限公司台南市南区中华西路一段23号2024-01-16 变更
93牙科吸潮纸尖国械备20240015号（?）?????????   ??? ??? ??? ????4? 162024-01-15 有效
94基础外科手术器械国械备20240014号ARTIFIED   INTERNATIONALMUGHAL   PURA MAIN STREET, AIRPORT ROAD,SIALKOT-51310, PAKISTAN2024-01-12 有效
95转移体国械备20200349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, USA2024-01-12 变更
96替代体国械备20181463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.2024-01-12 变更
97口腔科手术器械国械备20240013号ARTIFIED   INTERNATIONALMUGHAL   PURA MAIN STREET, AIRPORT ROAD,SIALKOT-51310, PAKISTAN2024-01-12 有效
98种植体螺丝起国械备20191350号GNI   co., ltd5F   501, 63-12, Dongtancheomdansaneop 1-ro, Hwaseong-si, Gyeonggi-do, 18469, Rep.   of KOREA2024-01-12 变更
99放射治疗托架国械备20240012号Orfit   IndustriesVosveld   9A 2110 Wijnegem Belgium2024-01-11 有效
100医用检查手套国械备20240011号Henry   Schein Inc.110   Kanjanavanit Road, Pahtong, Hat Yai, Songkhla 90230, THAILAND2024-01-11 有效
101造口袋国械备20210159号ConvaTec   Inc.Carretera   Sanchez, Km. 18.5 Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina,   San Cristobal 91000 Dominican Republic2024-01-11 变更
102口腔科手术器械国械备20190790号MEDIFACE   INSTRUMENTSShahab   Pura Road,Opp.Tajdar-e-Madina Masjid,Sialkot-51340-Pakistan2024-01-10 变更
103种植体安装辅助器械国械备20190350号ALTATEC   GmbHMaybachstr.   5, 71299 Wimsheim, GERMANY2024-01-10 变更
104医用胶布国械备20240010号永全纖維有限公司臺南市關廟區埤頭裏關新路二段51巷68棟18號2樓2024-01-10 有效
105腰椎固定器国械备20170965号Disk   Dr. Co., Ltd.(Seongsu-dong   2(i)-ga, Motor City Bldg.), #601, 49, Gwangnaru-ro 6-gil, Seongdong-gu, Seoul2024-01-10 变更
106口腔数字观察仪国械备20230147号SOPRO   A Company of ACTEON GroupZAC   Athélia IV – Avenue des Genévriers 13705 LA CIOTAT CEDEX FRANCE2024-01-10 变更
107种植辅助材料国械备20170167号Institut   Straumann AGPeter   Merian-Weg 12，4002 Basel，Switzerland； Les Champs du Clos 2，2613   Villeret，Switzerland； 60 Minuteman Road，Andover，MA，01810，USA2024-01-09 变更
108测瓣器套件国械备20210033号On-X   Life Technologies, Inc.1300   East Anderson Ln, Bldg B, Austin, Texas 78752, USA2024-01-05 变更
109骨科手术器械国械备20240009号Arthrex,   Inc.见附件3。2024-01-05 有效
110口腔科手术器械国械备20240008号Zhongba   Medical InstrumentsCapital   Road,Model Town,Sialkot,Pakistan2024-01-05 有效
111妇产科手术器械国械备20240007号Zhongba   Medical InstrumentsCapital   Road,Model Town,Sialkot,Pakistan2024-01-05 有效
112基础外科手术器械国械备20240006号Zhongba   Medical InstrumentsCapital   Road,Model Town,Sialkot,Pakistan2024-01-05 有效
113牙科用剪国械备20240005号B&L   Biotech, Inc. #502,   95, Gwangdeokdong-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Korea 154622024-01-05 有效
114牙科用镊国械备20240004号B&L   Biotech, Inc. #502,   95, Gwangdeokdong-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Korea 154622024-01-05 有效
115腰椎固定器国械备20150356号彪仕醫技股份有限公司台南市南区中华西路一段23号2024-01-04 变更
116上肢医用外固定支具国械备20150354号彪仕醫技股份有限公司台南市南区中华西路一段23号2024-01-04 变更
117腕部固定带国械备20181491号彪仕醫技股份有限公司臺南市南區中華西路一段23號2024-01-04 变更
118肘关节固定带国械备20181511号彪仕醫技股份有限公司臺南市南區中華西路一段23號2024-01-04 变更
119下肢医用外固定支具国械备20150357号彪仕醫技股份有限公司台南市南区中华西路一段23号2024-01-04 变更
120医用固定带国械备20181489号彪仕醫技股份有限公司臺南市南區中華西路一段23號2024-01-04 变更
121手臂吊带国械备20140113号彪仕醫技股份有限公司台南市南区中华西路一段23号2024-01-04 变更
122颈托国械备20150355号彪仕醫技股份有限公司台南市南区中华西路一段23号2024-01-04 变更
123下肢支具国械备20181490号彪仕醫技股份有限公司臺南市南區中華西路一段23號2024-01-03 变更
124牵开器支撑臂适配夹国械备20240002号Terumo   Cardiovascular Systems Corporation125   Blue Ball Rd Elkton Maryland 21921 USA2024-01-03 有效
125瓣膜持瓣器连接手柄国械备20240001号Medtronic,   Inc.3800   Annapolis Lane, Minneapolis MN 55447, USA2024-01-02 有效

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