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2023年8月国家局累计批准进口第一类医疗器械产品备案112项
发布日期:2023-09-07 19:37浏览次数:1101次
2023年9月6日，国家药监局发布数据，2023年8月国家局累计批准进防漏膏、气管插管固定器、造口护肤粉、口腔治疗器具、鞘液 、眼用剪等进口第一类医疗器械产品备案112项，详见正文，一起来看看还有哪些进口第一类医疗器械产品。

2023年9月6日，国家药监局发布数据，2023年8月国家局累计批准进防漏膏、气管插管固定器、造口护肤粉、口腔治疗器具、鞘液 、眼用剪等进口第一类医疗器械产品备案112项，详见正文，一起来看看还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

2023年8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防漏膏国械备20190580号Hollister   Incorporated 366 Draft Avenue Stuarts Draft, VA 24477 USA2023-08-31 变更
2气管插管固定器国械备20210478号 Hollister IncorporatedHollister   Incorporated  366 Draft Avenue Stuarts   Draft, VA USA 244772023-08-31 变更
3造口护肤粉国械备20191349号Hollister   Incorporated 366 Draft Avenue Stuarts Draft, VA 24477 USA2023-08-31 变更
4种植体安装辅助器械包国械备20230390号Elos   Medtech Pinol A/SEngvej   33 G?rl?se 3330 Denmark2023-08-31 有效
5口腔治疗器具国械备20230389号EVERBEST   TRADING CO.S.I.E.,TIPU   ROAD,SIALKOT-PAKISTAN2023-08-31 有效
6鞘液 国械备20160403号Luminex   Corporation12212   Technology Blvd, Austin, Texas 78727 USA2023-08-31 无效
7鞘液国械备20160402号Luminex   Corporation12212 Technology Blvd, Austin, Texas 78727 USA2023-08-31 无效
8眼用剪国械备20220538号KATENA   PRODUCTS, INC.6   CAMPUS DRIVE, SUITE 310, Parsippany, NJ 070542023-08-31 变更
9眼用拉钩国械备20220547号KATENA   PRODUCTS, INC.6   CAMPUS DRIVE, SUITE 310, Parsippany, NJ 070542023-08-31 变更
10眼用镊国械备20220536号KATENA   PRODUCTS, INC.6   CAMPUS DRIVE, SUITE 310, Parsippany, NJ 070542023-08-31 变更
11眼用注吸冲洗器国械备20220537号KATENA   PRODUCTS, INC.6   CAMPUS DRIVE, SUITE 310, Parsippany, NJ 070542023-08-31 变更
12眼用剪国械备20220546号KATENA   PRODUCTS, INC.6   CAMPUS DRIVE, SUITE 310, Parsippany, NJ 070542023-08-31 变更
13眼用镊国械备20220542号KATENA   PRODUCTS, INC.6   CAMPUS DRIVE, SUITE 310, Parsippany, NJ 070542023-08-31 变更
14髋关节手术支撑牵引架国械备20230388号ConMed   Corporation452   Randolph Street, Abington, MA 02351 United States2023-08-31 有效
15负气压式骨折固定保护气垫国械备20170145号OPED   GmbHMedizinpark   1 83626 Valley/Oberlaindern GERMANY2023-08-31 变更
16防水创口贴国械备20230387号Young   Chemical Co., Ltd.80-93,   Golden root-ro, Juchon-myeon, Gimhae-si, Gyeongsangnam-do, 50969, Korea2023-08-31 有效
17CD28检测试剂（流式细胞仪法）国械备20230386号BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-08-30 有效
18耳鼻喉科手术器械国械备20181704号SURGICAL   SOURCES INDUSTRIESP.O.Box:1389,Small   Industrial Estate,Sialkot-Pakistan2023-08-29 变更
19止血钳国械备20181685号SURGICAL   SOURCES INDUSTRIESP.O.Box:1389,Small   Industrial Estate,Sialkot-Pakistan2023-08-29 变更
20牙种植定位杆国械备20160177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 France2023-08-29 变更
21种植用手术导板国械备20160042号Nobel   Biocare ABDimbov?gen   2 SE-691 51 Karlskoga Sweden; 22715 Savi Ranch Parkway Yorba Linda California   92887 USA; 74950 SCIONZIER France2023-08-29 变更
22螺丝起国械备20151914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 Denmark;74950 SCIONZIER France;Rue   de Boujean 122 CH-2501 Biel/Bienne2023-08-29 变更
23种植用手术导板国械备20151418号Nobel   Biocare AB800   Corporate Drive Mahwah New Jersey 07430, USA 2023-08-29 变更
24牙科输送头国械备20200327号Pulpdent   Corporation80   Oakland Street, Watertown, MA 02472 United States2023-08-29 变更
25聚酯纤维绷带国械备20181482号BL   TECH CO., LTD.韩国江原道春川市退溪农工路84号2023-08-29 变更
26聚酯衬垫国械备20151171号BL   TECH CO.,LTD. 84,Toegyenonggong-ro, Chuncheon-si,   Gangwon-do, Korea2023-08-29 变更
27医用高分子夹板国械备20181486号BL   TECH CO., LTD84,   Toegyenonggong-ro, Chuncheon-si, Gangwon-do2023-08-29 变更
28鞘液浓缩液国械备20160091号Luminex   Corporation12212   Technology Blvd, Austin, Texas 78727 USA2023-08-28 无效
29根管锉国械备20160922号VDW   GmbHBayerwaldstraβe   15, 81737 München,Germany2023-08-28 变更
30医用退热贴国械备20161526号香港思情用品有限公司香港葵涌健康街18号恒亚中心9楼10-12室2023-08-28 无效
31DAB染色液国械备20150941号Richard-Allan   Scientific LLC46500   Kato Road, Fremont, CA, 94538, United States2023-08-25 变更
32骨科用手术工具国械备20230384号Medtronic   Sofamor Danek USA, Inc.Werftstr.17,   94469 Deggendorf, GERMANY; 4340 Swinnea Road, Memphis TN 38118, USA;   Ulrichsberger Str.17, 94469 Deggendorf, GERMANY 2023-08-24 有效
33创伤外科手术器械包国械备20180944号Synthes   GmbH见附件2023-08-24 变更
34膝关节手术工具国械备20210189号DePuy   Ireland UC请见附件“生产地址”。2023-08-24 变更
35扭力扳手国械备20230383号Elos   Medtech Pinol A/SEngvej   33, G?rl?se 3330, Denmark2023-08-24 有效
36替代体国械备20190301号Zest   Anchors, LLC2875   Loker Avenue East Carlsbad California 92010 USA;2230 Enterprise Street   Escondido California 92029 USA2023-08-24 变更
37止血钳国械备20230382号MICROQORE   MEDICAL GmbHIm   Aachtal 1b D-78267 Aach2023-08-23 有效
38器械钳国械备20230381号MICROQORE   MEDICAL GmbHIm   Aachtal 1b D-78267 Aach2023-08-23 有效
39组织镊国械备20230380号MICROQORE   MEDICAL GmbHIm   Aachtal 1b D-78267 Aach2023-08-23 有效
40手术剪国械备20230379号MICROQORE   MEDICAL GmbHIm   Aachtal 1b D-78267 Aach2023-08-23 有效
41牙科手术器械包国械备20230378号Cowellmedi   Co., Ltd.48,   Hakgam-daero 221beon-gil, Sasang-gu, Busan, Republic of Korea2023-08-23 有效
42牙科种植用测量器国械备20230377号Cowellmedi   Co., Ltd.48,   Hakgam-daero 221beon-gil, Sasang-gu, Busan, Republic of Korea2023-08-23 有效
43牙科工具包国械备20230376号Cowellmedi   Co., Ltd.48,   Hakgam-daero 221beon-gil, Sasang-gu, Busan, Republic of Korea2023-08-23 有效
44种植辅助器械包国械备20230375号Cowellmedi   Co., Ltd.48,   Hakgam-daero 221beon-gil, Sasang-gu, Busan, Republic of Korea2023-08-23 有效
45牙科种植体手术工具包国械备20230374号Cowellmedi   Co., Ltd.48,   Hakgam-daero 221beon-gil, Sasang-gu, Busan, Republic of Korea2023-08-23 有效
46生物显微镜国械备20210399号株式会社エビデント長野県上伊那郡辰野町大字伊那富6666番地2023-08-22 变更
47组织钳国械备20210381号Deusch   Medizintechnik GmbHEsslinger   StraBe 13,78532 Tuttlingen2023-08-22 变更
48牵开器国械备20210383号Deusch   Medizintechnik GmbHEsslinger   StraBe 13,78532 Tuttlingen2023-08-22 变更
49钩针国械备20210444号Deusch   Medizintechnik GmbHEsslinger   StraBe 13,78532 Tuttlingen2023-08-22 变更
50鼻窥器国械备20210384号Deusch   Medizintechnik GmbHEsslinger   StraBe 13,78532 Tuttlingen2023-08-22 变更
51吸引管国械备20210349号Deusch   Medizintechnik GmbHEsslinger   StraBe 13,78532 Tuttlingen2023-08-22 变更
52绑扎胶布国械备20150828号彪仕醫技股份有限公司臺南市南區中華西路一段23號2023-08-22 无效
53医用冰垫国械备20150827号彪仕醫技股份有限公司臺南市南區中華西路一段23號2023-08-22 无效
54颈椎固定带国械备20151041号彪仕醫技股份有限公司臺南市南區中華西路一段23號2023-08-22 无效
55上/下肢医用外固定支具国械备20151045号彪仕醫技股份有限公司臺南市南區中華西路一段23號2023-08-22 无效
56腰椎固定带国械备20151036号彪仕醫技股份有限公司臺南市南區中華西路一段23號2023-08-22 无效
57牙科种植辅助器械包国械备20180988号ALTATEC   GmbHMaybachstr.   5, 71299 Wimsheim, Germany2023-08-21 变更
58口腔灯国械备20170125号?   ????(Baekseok-dong,   Ilsan technotown),1003-1, 1003, 138, Ilsan-ro, Ilsandong-gu, Goyang-si,   Gyeonggi-do, Korea2023-08-21 变更
59鼻部冲洗器国械备20230373号FLAEM   NUOVA SPAVIA   COLLI STORICI 221/223/225 25015 SAN MARTINO DELLA BATTAGLIA (BS) ITALY2023-08-21 有效
60鞘液浓缩液国械备20200676号Luminex   Corporation12212   Technology Blvd. Austin TX 78727 USA2023-08-18 变更
61鞘液国械备20200675号Luminex   Corporation 12212   Technology Blvd. Austin TX 78727 USA2023-08-18 变更
62鞘液国械备20200650号Luminex   Corporation12212   Technology Blvd. Austin TX 78727 USA2023-08-18 变更
63给药指套国械备20220363号H.Dam   K?rgaard A/SBorupvang   9，2750 Ballerup，Denmark2023-08-18 变更
64固定用弹力束带国械备20190925号Bauerfeind   AGTriebeser   Stra?e 16 07937 Zeulenroda-Triebes Germany2023-08-18 变更
65种植体安装辅助工具国械备20190673号(?)??????   ??? ???  ???? 474  , 4? 411?, 4? 412?(????, ??????????)2023-08-17 变更
66种植辅助材料国械备20190062号(?)??????   ??? ??? ???? 474 , 4? 411?, 4? 412? (????, ??????????)2023-08-17 变更
67种植体螺丝起国械备20190674号(?)??????   ??? ???  ???? 474  , 4? 411?, 4? 412?(????, ??????????)2023-08-17 变更
68膝关节固定器国械备20170278号?ssur   hf.Grjotháls   1-5 Reykjavik 110 Iceland2023-08-17 变更
69热塑膜国械备20230372号MACROMEDICS   BVOostbaan   670, 2841ML Moordrecht, The Netherlands2023-08-16 有效
70显微外科手术器械国械备20170838号Synovis   Micro Companies Alliance，Inc439   Industrial Lane, Birmingham, Alabama 35211 USA2023-08-16 变更
71牙科输送器国械备20181637号DMG   Chemisch-Pharmazeutische Fabrik GmbHElbgaustraβe   248 22547 Hamburg Germany2023-08-15 变更
72造口底盘国械备20200155号Welland   Medical LimitedHydehurst   Lane, Crawley, West Sussex, RH10 9AS, United Kingdom2023-08-15 变更
73造口护理用品国械备20200116号Welland   Medical LimitedHydehurst   Lane, Crawley, West Sussex, RH10 9AS, United Kingdom2023-08-15 变更
74造口袋国械备20200157号Welland   Medical LimitedHydehurst   Lane, Crawley, West Sussex, RH10 9AS, United Kingdom2023-08-15 变更
75造口袋国械备20190372号Welland   Medical LimitedHydehurst   Lane, Crawley, West Sussex, RH10 9AS, United Kingdom2023-08-14 变更
76造口底盘国械备20190401号Welland   Medical LimitedHydehurst   Lane, Crawley, West Sussex, RH10 9AS, United Kingdom2023-08-14 变更
77造口袋国械备20190402号Welland   Medical LimitedHydehurst   Lane, Crawley, West Sussex, RH10 9AS, United Kingdom2023-08-14 变更
78病人推床国械备20161127号Hill-Rom,   Inc.Avenida   Del Telefono No.200 Huinala, Apodaca Nuevo Leon C.P. 66640 Mexico2023-08-14 变更
79医用放大镜国械备20181539号(?)?????????,???   ?? ???? 592023-08-14 变更
80集尿袋国械备20170831号//2023-08-14 变更
81洗板机国械备20181472号Agilent   Technologies, Inc.100   Tigan Street Highland Park Winooski, VT 05404-0998 USA2023-08-14 无效
82洗板机国械备20190496号Agilent   Technologies, Inc.100   Tigan Street Highland Park Winooski, VT 05404-0998 USA2023-08-14 无效
83洗板机国械备20190874号Agilent   Technologies, Inc.100   Tigan Street Highland Park Winooski, VT 05404-0998 USA2023-08-14 无效
84凝血分析用稀释液国械备20150936号DIAGNOSTICA   STAGOIDA   Business Park, Bary CO. WICKLOW IRELAND2023-08-14 变更
85代型材料国械备20170964号Ivoclar   Vivadent AG Bendererstrasse   2, 9494 Schaan, Liechtenstein 2023-08-11 变更
86子弹型光固化树脂输送器国械备20230371号Ivoclar   Vivadent AGBendererstrasse   2, 9494 Schaan, LIECHTENSTEIN；Schweizersbildstrasse 57, 8200 Schaffhausen,   Switzerland2023-08-11 有效
87CD27检测试剂(流式细胞仪法)国械备20230370号BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-08-10 有效
88CD27检测试剂（流式细胞仪法）国械备20230369号BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-08-10 有效
89CD41检测试剂（流式细胞仪法）国械备20230368号BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-08-10 有效
90CD9抗体试剂（流式细胞仪法）国械备20230367号BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-08-10 有效
91CD81检测试剂（流式细胞仪法）国械备20230366号BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-08-10 有效
92髋关节手术工具国械备20230365号SERF85   Avenue des Bruyères，69150 DECINES-CHARPIEU，FRANCE2023-08-10 有效
93吸潮纸尖国械备20140199号META   BIOMED CO., LTD.136,   Mochung-ro, Heungdeok-gu Cheongju -si, Chungcheongbuk-do2023-08-10 变更
94注射器辅助推进枪国械备20230090号Owen   Mumford LimitedPrimsdown   Industrial Estate, Worcester Road, Chipping Norton, Oxfordshire,OX7 5XP,   United Kingdom2023-08-10 变更
95液体敷料国械备20181717号LABORATOIRES   URGO   Parc   Excellence 2000-2 avenue de Strasbourg-21800 CHEVIGNY SAINT SAUVEUR-FRANCE2023-08-10 无效
96髋关节手术工具国械备20210150号DePuy   Ireland UC请见附件“生产地址”。2023-08-08 变更
97唾液样本采集管（DNA自采集工作包，ORAcollect）国械备20170939号DNA   Genotek Inc.3000-500   Palladium Drive Ottawa Ontario K2V 1C2 Canada2023-08-08 变更
98一次性使用唾液采集器国械备20230045号DNA   Genotek Inc.3000   - 500 Palladium Drive; Ottawa, ON; K2V1C2 CANADA2023-08-08 变更
99唾液样本采集管（DNA自采集工作包，Oragene）国械备20170946号DNA   Genotek Inc.3000-500   Palladium Drive Ottawa Ontario K2V 1C2 Canada2023-08-08 变更
100粪便DNA采样包国械备20171075号DNA   Genotek Inc.3000-500   Palladium Drive, Ottawa, Ontario, Canada K2V 1C22023-08-08 变更
101放射治疗患者用固定装置国械备20230364号Medtec,   LLC dba CIVCO Radiotherapy1401   8th St.SE,Orange City,IA,51041,United States2023-08-04 有效
102牙科刮治器国械备20230363号株式会社YDM埼玉県東松山市今泉28番地2023-08-03 有效
103动力系统配套工具国械备20210407号The   Anspach Effort, Inc4500   Riverside Drive,Palm Beach Gardens,FL 334102023-08-03 变更
104骨科手术器械国械备20180814号Synthes   GmbH见附件。2023-08-03 变更
105夹头国械备20230362号Stryker   Instruments250W   KENSINGER DR STE 400 Cranberry Township,PA USA 160662023-08-03 有效
106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, korea2023-08-03 变更
107显微眼用镊国械备20151247号D.O.R.C.   Dutch Ophthalmic Research Center (International) B.V.Scheijdelveweg   2 3214 VN Zuidland The Netherlands2023-08-01 变更
108干式激光成像仪国械备20200021号Bermedi   Medical Solutions GmbHB?lschestra?e   27, 12587 Berlin, Germany2023-08-01 变更
109牙科输送器国械备20160919号Osstem   Implant Co.,Ltd.66-16,   Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2023-08-01 变更
110显微眼用剪国械备20151163号D.O.R.C.   Dutch Ophthalmic Research Center (International) B.V.Scheijdelveweg   2 3214 VN Zuidland The Netherlands2023-08-01 变更
111骨科手术器械国械备20170643号ulrich   GmbH & Co. KGBuchbrunnenweg   12, 89081 Ulm, GERMANY2023-08-31 无效
112咬骨钳国械备20170804号ulrich   GmbH & Co. KGBuchbrunnenweg   12, 89081 Ulm, GERMANY2023-08-31 无效

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