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国家局2023年12月批准进口第一类医疗器械产品备案123项
发布日期:2024-01-11 16:16浏览次数:487次
来自国家药监局消息，2023年12月，国家药监局累计批准进口第一类医疗器械产品备案123项，包括：肌电导联线、医用离心机、手术辅助照明灯、喉镜、峨眉凿、耳镜、防褥疮垫、种植体安装辅助器械等进口第一类医疗器械备案产品，一起看正文。

来自国家药监局消息，2023年12月，国家药监局累计批准进口第一类医疗器械产品备案123项，包括：肌电导联线、医用离心机、手术辅助照明灯、喉镜、峨眉凿、耳镜、防褥疮垫、种植体安装辅助器械等进口第一类医疗器械备案产品，一起看正文。

进口第一类医疗器械产品备案.jpg

2023年12月批准进口第一类医疗器械备案产品列表

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肌电导联线国械备20210504号Natus   Manufacturing LimitedIDA   Business Park Gort Co.Galway Ireland2023-12-29 变更
2脑电/肌电导联线国械备20210518号Natus   Neurology Incorporated3150   Pleasant View Road Middleton, Wisconsin 53562 USA;IDA Business Park Gort   Co.Galway Ireland.2023-12-29 变更
3医用离心机国械备20230604号Jointechlabs,   Inc421   Lithia Pinecrest Road Brandon, FL 33511 United States of America2023-12-28 有效
4手术辅助照明灯国械备20150129  号XENOSYS   CO., LTD.2F,   2, Venture-ro 100beon-gil, Yeonsu-gu, Incheon2023-12-28 变更
5组合式骨牵引架国械备20220193号ADSM   SAS7b   RUE LAVOISIER 69680 CHASSIEU France2023-12-28 变更
6热塑膜国械备20230603号Orfit   Industries Vosveld 9A 2110 Wijnegem Belgium2023-12-28 有效
7喉镜国械备20230602号HEINE   Optotechnik GmbH & Co. KGDornierstr.   6, 82205 Gilching, Germany2023-12-28 有效
8CD58检测试剂（流式细胞仪法-PE)国械备20230601号BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-12-27 有效
9口腔科器械国械备20230600号FORGEMAN   INSTRUMENTS CO.Near   Masjid Jamal-E-Mustafa, Nasir Road, Sialkot - Pakistan2023-12-27 有效
10峨眉凿国械备20151880号Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg Germany2023-12-27 变更
11骨刮匙国械备20152020号Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-12-27 变更
12骨科手术器械通用手柄国械备20230599号Zimmer   Inc.1800   W. Center Street, Warsaw, Indiana, 46580, USA2023-12-27 有效
13聚酯衬垫国械备20210401号Optomed   OyjYrttipellontie   1 FI-90230 Oulu Finland2023-12-27 无效
14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2023-12-27 变更
15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2023-12-26 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2023-12-26 变更
17引流袋国械备20170603号Serres   OyKeskustie   23, 61850 Kauhajoki As Finland2023-12-26 变更
18耳镜国械备20230598号HEINE   Optotechnik GmbH & Co. KGDornierstr.   6 82205 Gilching Germany2023-12-25 有效
19压力绷带国械备20230597号SIGVARIS   AGGr?blistrasse   8，CH-9014 St. Gallen，Switzerland2023-12-25 有效
20压力绷带国械备20181626号上蕎股份有限公司彰化縣社頭鄉廣興村中興路47號2023-12-25 变更
21样本稀释液国械备20210596号富士レビオ株式会社日本国東京都八王子市小宮町51番地2023-12-22 变更
22全自动免疫检验系统用底物液国械备20160413号富士レビオ株式会社東京都八王子市小宮町５１番地2023-12-22 变更
23研磨材料国械备20160322号Hopf,   Ringleb & Co.GmbH &Cie.Gardeschützenweg   82, 12203 Berlin, Germany2023-12-22 变更
24医用透气胶布国械备20230596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2023-12-21 有效
25防褥疮垫国械备20180526号ROHO,   INC.100   North Florida Avenue, Belleville, Illinois, 62221, US2023-12-21 变更
26唇颊牵开器国械备20230357号Align   Technology, Inc.Aligntech   de Mexico S. de R.L. de C.V.  Boulevard   Independencia 1951, Parque Industrial    Salvacar, Cd. Juarez Chihuahua, MEXICO 325752023-12-21 变更
27髋关节手术工具国械备20210138号Symmetry   Medical Manufacturing, Inc.486   West 350 North, Warsaw, Indiana 46582 USA2023-12-21 变更
28无源手术器械国械备20230595号Ulrich   AGM?venstra?e   12, 9015 St. Gallen,  SCHWEIZ2023-12-21 有效
29MLH1抗体试剂（免疫组织化学）国械备20210583号Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2023-12-21 变更
30MSH6抗体试剂（免疫组织化学）国械备20210599号Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom 2023-12-21 变更
31PMS2抗体试剂（免疫组织化学）国械备20210586号 Leica Biosystems Newcastle Ltd Balliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom 2023-12-21 变更
32MSH2抗体试剂（免疫组织化学）国械备20210584号Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2023-12-21 变更
33髋关节手术工具国械备20190989号Howmedica   Osteonics Corp见附件2023-12-21 变更
34喉镜国械备20210089号SHENZHEN   CHENLI MEDICAL INSTRUMENTSChohan   Street, Mian Shakeel Road, Model Town,Sialkot-Pakistan2023-12-21 变更
35基础外科手术器械国械备20210083号SHENZHEN   CHENLI MEDICAL INSTRUMENTSChohan   Street, Mian Shakeel Road, Model Town,Sialkot-Pakistan2023-12-21 变更
36口腔科手术器械国械备20210081号SHENZHEN   CHENLI MEDICAL INSTRUMENTSChohan   Street, Mian Shakeel Road, Model Town,Sialkot-Pakistan2023-12-21 变更
37耳鼻喉科手术器械国械备20210093号SHENZHEN   CHENLI MEDICAL INSTRUMENTSChohan   Street, Mian Shakeel Road, Model Town,Sialkot-Pakistan2023-12-21 变更
38耳镜国械备20210088号SHENZHEN   CHENLI MEDICAL INSTRUMENTSChohan   Street, Mian Shakeel Road, Model Town,Sialkot-Pakistan2023-12-21 变更
39骨科手术器械国械备20210092号SHENZHEN   CHENLI MEDICAL INSTRUMENTSChohan   Street, Mian Shakeel Road, Model Town,Sialkot-Pakistan2023-12-21 变更
40妇产科手术器械国械备20210082号SHENZHEN   CHENLI MEDICAL INSTRUMENTSChohan   Street, Mian Shakeel Road, Model Town,Sialkot-Pakistan2023-12-21 变更
41种植体安装辅助器械国械备20180987号ALTATEC   GmbHMaybachstr.   5, 71299 Wimsheim, Germany2023-12-19 变更
42Serotonin抗体试剂（免疫组织化学）   BOND Ready-to-Use Primary Antibody
   
    Serotonin (Polyclonal)		国械备20190091号Leica   Biosystems Newcastle LtdBalliol   Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom2023-12-19 无效
43Thyroid   Stimulating Hormone抗体试剂（免疫组织化学）国械备20190632号Leica   Biosystems Newcastle Ltd.Balliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom.2023-12-19 无效
44ZAP-70抗体试剂（免疫组织化学）国械备20190813号Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2023-12-19 无效
45CD33抗体试剂（免疫组织化学法）国械备20230594号 Leica Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom 2023-12-19 有效
46切片机国械备20180641号大和光機工業株式会社埼玉県朝霞市膝折町二丁目14番43号2023-12-19 无效
47牙用探针国械备20151312号Cortex   Dental Implants Industries Ltd.
2023-12-19 变更
48螺丝起国械备20140226号/
2023-12-19 变更
49口腔手术器械国械备20181405号Cortex   Dental Implants Industries Ltd.Shlomi   Industrial Zone, Ya’ara Street26, P.O.Box125,2283202,Israel2023-12-19 变更
50牙科塑料基底国械备20200406号 Cortex Dental Implants Industries Ltd.Shlomi   Industrial Zone, Ya' ara Street 26, P.O.Box 125, 2283202, Israel2023-12-19 变更
51扭力扳手 国械备20140227 号Cortex   Dental Implants Industries LTDShlomi   Industrial Zone Ya’ara street 26.P.O.BOX 125,22832, Israel2023-12-19 变更
52牙科种植体手术工具包国械备20161141号Cortex   Dental Implants Industries LTDShlomi   Industrial Zone Ya’ara street 26.P.O.BOX 125,22832, Israel2023-12-19 变更
53种植体手术工具国械备20151307号/
2023-12-19 变更
54牙科种植定位器国械备20151313号Cortex   Dental Implants Industries Ltd.
2023-12-19 变更
55种植体扫描体国械备20171019号Cortex   Dental Implants Industries Ltd.Shlomi   Industrial Zone, Ya’ara Street26, P.O.Box125,2283202,Israel2023-12-19 变更
56扭力扳手国械备20160092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, Denmark2023-12-19 变更
57超声波清洗机国械备20230593号STEELCO   SPA31039   RIESE PIO X (TV) –VIA BALEGANTE 27 (ITA) –Italy2023-12-19 有效
58助行器国械备20210323号James   Leckey Design LtdBallinderry   Road, Lisburn, Antrim BT28 2SA United Kingdom2023-12-18 变更
59医用放大镜国械备20230592号I.C.LERCHER-Selation   GmbHIm   Sagenloh 8 78333 Stockach2023-12-18 有效
60眼用刮匙国械备20230591号KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-12-18 有效
61显微刀国械备20161096号Integra   MicroFrance SAS Le   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE; 31 Rue Malaingre, 52800   Nogent, France 2023-12-15 变更
62显微针国械备20160808号Integra   MicroFrance SASLe   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE2023-12-15 变更
63基础外科手术器械包国械备20162039号Integra   MicroFrance SAS/2023-12-15 变更
64显微镊国械备20161698号Integra   MicroFrance SASLe   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE; Badstra?e 8, 78532 Tuttlingen,   GERMANY2023-12-15 变更
65支撑喉镜国械备20160933号Integra   MicroFrance SASLe   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE2023-12-15 变更
66耳钳国械备20161931号Integra   MicroFrance SAS Le   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE 2023-12-15 变更
67鼻中隔咬骨钳国械备20161934号Integra   MicroFrance SAS Le   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE; Bischof-Sproll-Stra?e 2, 78532   Tuttlingen, Germany; 31 Rue Malaingre, 52800 Nogent, France; Lehrstrasse 11,   78589 Dürbheim, DEUTSCHLAND; G?ns?cker 15, 78532 Tuttlingen, DEUTSCHLAND  2023-12-15 变更
68拉钩国械备20160889号Integra   MicroFrance SASLe   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE; Bischof-Sproll-Stra?e 2, 78532   Tuttlingen, Germany; Badstra?e 8, 78532 Tuttlingen, GERMANY2023-12-15 变更
69耳用骨凿国械备20162029号Integra   MicroFrance SAS Le   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE2023-12-15 变更
70五官科吸引管国械备20161283号Integra   MicroFrance SAS  Le   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE; Rue du Grand-Pré 10, 1007   Lausanne, Switzerland2023-12-15 变更
71探针国械备20160623号Integra   MicroFrance SASLe   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE; 31 Rue Malaingre, 52800   Nogent, France2023-12-15 变更
72鼻腔撑开器国械备20162036号Integra   MicroFrance SAS Le   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE; Bischof-Sproll-Stra?e 2, 78532   Tuttlingen, Germany; G?ns?cker 15, 78532 Tuttlingen, DEUTSCHLAND; Gotenstra?e   5, 78532 Tuttlingen, Deutschland 2023-12-15 变更
73显微剪国械备20160807号Integra   MicroFrance SASLe   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE2023-12-15 变更
74显微钩国械备20160596号Integra   MicroFrance SASLe   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE2023-12-15 变更
75手术剪国械备20161968号Integra   MicroFrance SAS Le   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE；31 Rue Malaingre, 52800 Nogent,   France；Weilheimerstrasse 20, Wurmlingen Baden-Wurttemberg, GERMANY 785732023-12-15 变更
76乳突牵开器国械备20160597号Integra   MicroFrance SASLe   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE; Am Eichbühl 70-72, 78532   Tuttlingen, Deutschland; Lehrstrasse 11, 78589 Dürbheim, GERMANY2023-12-15 变更
77耳科手术压平器国械备20171215号Integra   MicroFrance SASLe   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE2023-12-15 变更
78鼻骨凿国械备20161967号Integra   MicroFrance SAS Le   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE2023-12-15 变更
79显微喉钳国械备20161095号Integra   MicroFrance SAS Le   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE;31 Rue Malaingre, 52800 Nogent,   France2023-12-15 变更
80显微剥离器国械备20161282号Integra   MicroFrance SAS Le   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE; 31 Rue Malaingre, 52800   Nogent, France; Badstra?e 8, 78532 Tuttlingen, GERMANY2023-12-15 变更
81脊柱外科手术器械包国械备20151700号Synthes   GmbH1051   Synthes Avenue, Monument, CO 80132, USA; 35 Airport
   
    Road, Horseheads, NY 14845, USA; 1303 Goshen Parkway,
   
    West Chester, PA 19380, USA; ImBifang 6,4614 H?gendorf,
   
    Switzerland ; Via Cavazz 5, 6805 Mezzovico, Switzerland;
   
    Muracherstrasse 3,2544 Bettlach, Switzerland;
   
    Dornacherstrasse 20, 4710 Balsthal, Switzerland;
   
    Kanalstrasse West 30, 3942 Raron, Switzerland;
   
    Solothurnstrasse 186, 2540 Grenchen, Switzerland;
   
    ImKirchenhürstle 4-6, 79224 Umkirchb.Freiburg, Germany;
   
    Karolingerstrasse 16, 5020 Salzburg, Austria;
   
    Eimattstrasse 3,4436 Oberdorf, Switzerland;
   
    Bohnackerweg 5, 2545 Selzach, Switzerland
   
   		2023-12-15 变更
82种植体辅助安装套装国械备20200268号//2023-12-15 无效
83清洗液国械备20220544号DiaSorin   Italia S.p.A.Von   Hevesy-Str. 3, 63128 Dietzenbach, Germany2023-12-15 变更
84增强液国械备20200322号DiaSorin   Italia S.p.A.Von-Hevesy-Str.   3, 63128 Dietzenbach, Germany2023-12-15 变更
85清洗液国械备20151113号Roche   Diagnostics GmbHSandhofer   Strasse 116， 68305 Mannheim，Germany2023-12-14 变更
86眼用扩张器国械备20230590号KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-12-14 有效
87眼用注入器国械备20230589号KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-12-14 有效
88开睑器国械备20230588号KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-12-14 有效
89弹性绷带国械备20230587号LUROPAS   del Dott. Molinari & C. S.r.l.Via   Antonio Vivaldi, 4 - 24040 Calvenzano (BG) - Italy2023-12-13 有效
90超声洁牙机工作尖国械备20191244号//2023-12-13 变更
91组织脱水机国械备20230586号Milestone   S.r.l.Via   Fatebenefratelli, 1/5 24010 SORISOLE (BG) Corso Europa Unita, 6 IT – 24030   VALBREMBO (BG) 2023-12-12 有效
92耳镜国械备20190465号Tyto   Care Ltd.12   Haomanut Street Netanya,4250445,Israel2023-12-12 变更
93样本稀释液国械备20160414号富士レビオ株式会社東京都八王子市小宮町51番地2023-12-12 变更
94清洗液国械备20151528号富士レビオ株式会社1.   東京都八王子市小宮町５１番地; 2. 福井県敦賀市東洋町10番地24号2023-12-11 变更
95医用头灯国械备20230585号(?)??????????   ?? ???? 592023-12-11 有效
96膝关节手术工具国械备20230584号Zimmer   CAS75   Queen Street, Suite 3300, Montreal, Quebec, H3C 2N6, Canada2023-12-08 有效
97眼用冲吸器及手柄国械备20220537号KATENA   PRODUCTS, INC.6   CAMPUS DRIVE, SUITE 310, Parsippany, NJ 070542023-12-08 变更
98开睑器国械备20230583号KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-12-08 有效
99眼用固位器国械备20230582号KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-12-08 有效
100眼用固位器国械备20230581号KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-12-08 有效
101眼科用测量器国械备20230579号KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-12-08 有效
102标记环国械备20230578号KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-12-08 有效
103肩关节手术工具国械备20230576号DePuy   Ireland UC见附件2023-12-07 有效
104脊柱手术器械国械备20181275号Synthes   GmbH见附件(附件链接：http://125.35.24.156/upload/yfzl/1535188913104.docx)2023-12-07 变更
105脊柱手术器械包国械备20191117号Synthes   GmbH见附件2023-12-07 变更
106人体定位垫国械备20230575号 Orfit IndustriesVosveld   9A 2110 Wijnegem Belgium2023-12-07 有效
107人体定位垫国械备20230574号Orfit   Industries Vosveld 9A 2110 Wijnegem Belgium2023-12-07 有效
108脊柱外科手术器械包国械备20180006号寶楠生技股份有限公司臺北市內湖區瑞光路258巷50號3樓2023-12-06 变更
109染色机国械备20160809号Shandon   Diagnostics Limited, a subsidiary of Epredia Tudor Road, Manor Park, Runcorn, Cheshire,   WA7 1TA, UNITED KINGDOM2023-12-05 变更
110样本稀释液国械备20140356号Siemens   Healthcare Diagnostics Inc.333   Coney Street, East Walpole, Massachusetts 02032, USA2023-12-04 无效
111样本释放剂国械备20151865号Siemens   Healthcare Diagnostics Inc.333   Coney Street, East Walpole, Massachusetts 02032, USA2023-12-04 无效
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