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2023年8月國家局累計(jì)批準(zhǔn)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案112項(xiàng)
發(fā)布日期:2023-09-07 19:37瀏覽次數(shù):1109次
2023年9月6日，國家藥監(jiān)局發(fā)布數(shù)據(jù)，2023年8月國家局累計(jì)批準(zhǔn)進(jìn)防漏膏、氣管插管固定器、造口護(hù)膚粉、口腔治療器具、鞘液 、眼用剪等進(jìn)口第一類醫(yī)療器械產(chǎn)品備案112項(xiàng)，詳見正文，一起來看看還有哪些進(jìn)口第一類醫(yī)療器械產(chǎn)品。

2023年9月6日，國家藥監(jiān)局發(fā)布數(shù)據(jù)，2023年8月國家局累計(jì)批準(zhǔn)進(jìn)防漏膏、氣管插管固定器、造口護(hù)膚粉、口腔治療器具、鞘液 、眼用剪等進(jìn)口第一類醫(yī)療器械產(chǎn)品備案112項(xiàng)，詳見正文，一起來看看還有哪些進(jìn)口第一類醫(yī)療器械產(chǎn)品。

進(jìn)口第一類醫(yī)療器械產(chǎn)品備案.jpg

2023年8月進(jìn)口第一類醫(yī)療器械產(chǎn)品備案信息

序號產(chǎn)品名稱備案號備案人名稱原文生產(chǎn)地址原文備案日期狀態(tài)
1防漏膏國械備20190580號Hollister   Incorporated 366 Draft Avenue Stuarts Draft, VA 24477 USA2023-08-31 變更
2氣管插管固定器國械備20210478號 Hollister IncorporatedHollister   Incorporated  366 Draft Avenue Stuarts   Draft, VA USA 244772023-08-31 變更
3造口護(hù)膚粉國械備20191349號Hollister   Incorporated 366 Draft Avenue Stuarts Draft, VA 24477 USA2023-08-31 變更
4種植體安裝輔助器械包國械備20230390號Elos   Medtech Pinol A/SEngvej   33 G?rl?se 3330 Denmark2023-08-31 有效
5口腔治療器具國械備20230389號EVERBEST   TRADING CO.S.I.E.,TIPU   ROAD,SIALKOT-PAKISTAN2023-08-31 有效
6鞘液 國械備20160403號Luminex   Corporation12212   Technology Blvd, Austin, Texas 78727 USA2023-08-31 無效
7鞘液國械備20160402號Luminex   Corporation12212 Technology Blvd, Austin, Texas 78727 USA2023-08-31 無效
8眼用剪國械備20220538號KATENA   PRODUCTS, INC.6   CAMPUS DRIVE, SUITE 310, Parsippany, NJ 070542023-08-31 變更
9眼用拉鉤國械備20220547號KATENA   PRODUCTS, INC.6   CAMPUS DRIVE, SUITE 310, Parsippany, NJ 070542023-08-31 變更
10眼用鑷國械備20220536號KATENA   PRODUCTS, INC.6   CAMPUS DRIVE, SUITE 310, Parsippany, NJ 070542023-08-31 變更
11眼用注吸沖洗器國械備20220537號KATENA   PRODUCTS, INC.6   CAMPUS DRIVE, SUITE 310, Parsippany, NJ 070542023-08-31 變更
12眼用剪國械備20220546號KATENA   PRODUCTS, INC.6   CAMPUS DRIVE, SUITE 310, Parsippany, NJ 070542023-08-31 變更
13眼用鑷國械備20220542號KATENA   PRODUCTS, INC.6   CAMPUS DRIVE, SUITE 310, Parsippany, NJ 070542023-08-31 變更
14髖關(guān)節(jié)手術(shù)支撐牽引架國械備20230388號ConMed   Corporation452   Randolph Street, Abington, MA 02351 United States2023-08-31 有效
15負(fù)氣壓式骨折固定保護(hù)氣墊國械備20170145號OPED   GmbHMedizinpark   1 83626 Valley/Oberlaindern GERMANY2023-08-31 變更
16防水創(chuàng)口貼國械備20230387號Young   Chemical Co., Ltd.80-93,   Golden root-ro, Juchon-myeon, Gimhae-si, Gyeongsangnam-do, 50969, Korea2023-08-31 有效
17CD28檢測試劑（流式細(xì)胞儀法）國械備20230386號BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-08-30 有效
18耳鼻喉科手術(shù)器械國械備20181704號SURGICAL   SOURCES INDUSTRIESP.O.Box:1389,Small   Industrial Estate,Sialkot-Pakistan2023-08-29 變更
19止血鉗國械備20181685號SURGICAL   SOURCES INDUSTRIESP.O.Box:1389,Small   Industrial Estate,Sialkot-Pakistan2023-08-29 變更
20牙種植定位桿國械備20160177號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 變更
21種植用手術(shù)導(dǎo)板國械備20160042號Nobel   Biocare ABDimbov?gen   2 SE-691 51 Karlskoga Sweden; 22715 Savi Ranch Parkway Yorba Linda California   92887 USA; 74950 SCIONZIER France2023-08-29 變更
22螺絲起國械備20151914號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 變更
23種植用手術(shù)導(dǎo)板國械備20151418號Nobel   Biocare AB800   Corporate Drive Mahwah New Jersey 07430, USA 2023-08-29 變更
24牙科輸送頭國械備20200327號Pulpdent   Corporation80   Oakland Street, Watertown, MA 02472 United States2023-08-29 變更
25聚酯纖維繃帶國械備20181482號BL   TECH CO., LTD.韓國江原道春川市退溪農(nóng)工路84號2023-08-29 變更
26聚酯襯墊國械備20151171號BL   TECH CO.,LTD. 84,Toegyenonggong-ro, Chuncheon-si,   Gangwon-do, Korea2023-08-29 變更
27醫(yī)用高分子夾板國械備20181486號BL   TECH CO., LTD84,   Toegyenonggong-ro, Chuncheon-si, Gangwon-do2023-08-29 變更
28鞘液濃縮液國械備20160091號Luminex   Corporation12212   Technology Blvd, Austin, Texas 78727 USA2023-08-28 無效
29根管銼國械備20160922號VDW   GmbHBayerwaldstraβe   15, 81737 München,Germany2023-08-28 變更
30醫(yī)用退熱貼國械備20161526號香港思情用品有限公司香港葵涌健康街18號恒亞中心9樓10-12室2023-08-28 無效
31DAB染色液國械備20150941號Richard-Allan   Scientific LLC46500   Kato Road, Fremont, CA, 94538, United States2023-08-25 變更
32骨科用手術(shù)工具國械備20230384號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創(chuàng)傷外科手術(shù)器械包國械備20180944號Synthes   GmbH見附件2023-08-24 變更
34膝關(guān)節(jié)手術(shù)工具國械備20210189號DePuy   Ireland UC請見附件“生產(chǎn)地址”。2023-08-24 變更
35扭力扳手國械備20230383號Elos   Medtech Pinol A/SEngvej   33, G?rl?se 3330, Denmark2023-08-24 有效
36替代體國械備20190301號Zest   Anchors, LLC2875   Loker Avenue East Carlsbad California 92010 USA;2230 Enterprise Street   Escondido California 92029 USA2023-08-24 變更
37止血鉗國械備20230382號MICROQORE   MEDICAL GmbHIm   Aachtal 1b D-78267 Aach2023-08-23 有效
38器械鉗國械備20230381號MICROQORE   MEDICAL GmbHIm   Aachtal 1b D-78267 Aach2023-08-23 有效
39組織鑷國械備20230380號MICROQORE   MEDICAL GmbHIm   Aachtal 1b D-78267 Aach2023-08-23 有效
40手術(shù)剪國械備20230379號MICROQORE   MEDICAL GmbHIm   Aachtal 1b D-78267 Aach2023-08-23 有效
41牙科手術(shù)器械包國械備20230378號Cowellmedi   Co., Ltd.48,   Hakgam-daero 221beon-gil, Sasang-gu, Busan, Republic of Korea2023-08-23 有效
42牙科種植用測量器國械備20230377號Cowellmedi   Co., Ltd.48,   Hakgam-daero 221beon-gil, Sasang-gu, Busan, Republic of Korea2023-08-23 有效
43牙科工具包國械備20230376號Cowellmedi   Co., Ltd.48,   Hakgam-daero 221beon-gil, Sasang-gu, Busan, Republic of Korea2023-08-23 有效
44種植輔助器械包國械備20230375號Cowellmedi   Co., Ltd.48,   Hakgam-daero 221beon-gil, Sasang-gu, Busan, Republic of Korea2023-08-23 有效
45牙科種植體手術(shù)工具包國械備20230374號Cowellmedi   Co., Ltd.48,   Hakgam-daero 221beon-gil, Sasang-gu, Busan, Republic of Korea2023-08-23 有效
46生物顯微鏡國械備20210399號株式會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 變更
47組織鉗國械備20210381號Deusch   Medizintechnik GmbHEsslinger   StraBe 13,78532 Tuttlingen2023-08-22 變更
48牽開器國械備20210383號Deusch   Medizintechnik GmbHEsslinger   StraBe 13,78532 Tuttlingen2023-08-22 變更
49鉤針國械備20210444號Deusch   Medizintechnik GmbHEsslinger   StraBe 13,78532 Tuttlingen2023-08-22 變更
50鼻窺器國械備20210384號Deusch   Medizintechnik GmbHEsslinger   StraBe 13,78532 Tuttlingen2023-08-22 變更
51吸引管國械備20210349號Deusch   Medizintechnik GmbHEsslinger   StraBe 13,78532 Tuttlingen2023-08-22 變更
52綁扎膠布國械備20150828號彪仕醫(yī)技股份有限公司臺南市南區(qū)中華西路一段23號2023-08-22 無效
53醫(yī)用冰墊國械備20150827號彪仕醫(yī)技股份有限公司臺南市南區(qū)中華西路一段23號2023-08-22 無效
54頸椎固定帶國械備20151041號彪仕醫(yī)技股份有限公司臺南市南區(qū)中華西路一段23號2023-08-22 無效
55上/下肢醫(yī)用外固定支具國械備20151045號彪仕醫(yī)技股份有限公司臺南市南區(qū)中華西路一段23號2023-08-22 無效
56腰椎固定帶國械備20151036號彪仕醫(yī)技股份有限公司臺南市南區(qū)中華西路一段23號2023-08-22 無效
57牙科種植輔助器械包國械備20180988號ALTATEC   GmbHMaybachstr.   5, 71299 Wimsheim, Germany2023-08-21 變更
58口腔燈國械備20170125號?   ????(Baekseok-dong,   Ilsan technotown),1003-1, 1003, 138, Ilsan-ro, Ilsandong-gu, Goyang-si,   Gyeonggi-do, Korea2023-08-21 變更
59鼻部沖洗器國械備20230373號FLAEM   NUOVA SPAVIA   COLLI STORICI 221/223/225 25015 SAN MARTINO DELLA BATTAGLIA (BS) ITALY2023-08-21 有效
60鞘液濃縮液國械備20200676號Luminex   Corporation12212   Technology Blvd. Austin TX 78727 USA2023-08-18 變更
61鞘液國械備20200675號Luminex   Corporation 12212   Technology Blvd. Austin TX 78727 USA2023-08-18 變更
62鞘液國械備20200650號Luminex   Corporation12212   Technology Blvd. Austin TX 78727 USA2023-08-18 變更
63給藥指套國械備20220363號H.Dam   K?rgaard A/SBorupvang   9，2750 Ballerup，Denmark2023-08-18 變更
64固定用彈力束帶國械備20190925號Bauerfeind   AGTriebeser   Stra?e 16 07937 Zeulenroda-Triebes Germany2023-08-18 變更
65種植體安裝輔助工具國械備20190673號(?)??????   ??? ???  ???? 474  , 4? 411?, 4? 412?(????, ??????????)2023-08-17 變更
66種植輔助材料國械備20190062號(?)??????   ??? ??? ???? 474 , 4? 411?, 4? 412? (????, ??????????)2023-08-17 變更
67種植體螺絲起國械備20190674號(?)??????   ??? ???  ???? 474  , 4? 411?, 4? 412?(????, ??????????)2023-08-17 變更
68膝關(guān)節(jié)固定器國械備20170278號?ssur   hf.Grjotháls   1-5 Reykjavik 110 Iceland2023-08-17 變更
69熱塑膜國械備20230372號MACROMEDICS   BVOostbaan   670, 2841ML Moordrecht, The Netherlands2023-08-16 有效
70顯微外科手術(shù)器械國械備20170838號Synovis   Micro Companies Alliance，Inc439   Industrial Lane, Birmingham, Alabama 35211 USA2023-08-16 變更
71牙科輸送器國械備20181637號DMG   Chemisch-Pharmazeutische Fabrik GmbHElbgaustraβe   248 22547 Hamburg Germany2023-08-15 變更
72造口底盤國械備20200155號Welland   Medical LimitedHydehurst   Lane, Crawley, West Sussex, RH10 9AS, United Kingdom2023-08-15 變更
73造口護(hù)理用品國械備20200116號Welland   Medical LimitedHydehurst   Lane, Crawley, West Sussex, RH10 9AS, United Kingdom2023-08-15 變更
74造口袋國械備20200157號Welland   Medical LimitedHydehurst   Lane, Crawley, West Sussex, RH10 9AS, United Kingdom2023-08-15 變更
75造口袋國械備20190372號Welland   Medical LimitedHydehurst   Lane, Crawley, West Sussex, RH10 9AS, United Kingdom2023-08-14 變更
76造口底盤國械備20190401號Welland   Medical LimitedHydehurst   Lane, Crawley, West Sussex, RH10 9AS, United Kingdom2023-08-14 變更
77造口袋國械備20190402號Welland   Medical LimitedHydehurst   Lane, Crawley, West Sussex, RH10 9AS, United Kingdom2023-08-14 變更
78病人推床國械備20161127號Hill-Rom,   Inc.Avenida   Del Telefono No.200 Huinala, Apodaca Nuevo Leon C.P. 66640 Mexico2023-08-14 變更
79醫(yī)用放大鏡國械備20181539號(?)?????????,???   ?? ???? 592023-08-14 變更
80集尿袋國械備20170831號//2023-08-14 變更
81洗板機(jī)國械備20181472號Agilent   Technologies, Inc.100   Tigan Street Highland Park Winooski, VT 05404-0998 USA2023-08-14 無效
82洗板機(jī)國械備20190496號Agilent   Technologies, Inc.100   Tigan Street Highland Park Winooski, VT 05404-0998 USA2023-08-14 無效
83洗板機(jī)國械備20190874號Agilent   Technologies, Inc.100   Tigan Street Highland Park Winooski, VT 05404-0998 USA2023-08-14 無效
84凝血分析用稀釋液國械備20150936號DIAGNOSTICA   STAGOIDA   Business Park, Bary CO. WICKLOW IRELAND2023-08-14 變更
85代型材料國械備20170964號Ivoclar   Vivadent AG Bendererstrasse   2, 9494 Schaan, Liechtenstein 2023-08-11 變更
86子彈型光固化樹脂輸送器國械備20230371號Ivoclar   Vivadent AGBendererstrasse   2, 9494 Schaan, LIECHTENSTEIN；Schweizersbildstrasse 57, 8200 Schaffhausen,   Switzerland2023-08-11 有效
87CD27檢測試劑(流式細(xì)胞儀法)國械備20230370號BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-08-10 有效
88CD27檢測試劑（流式細(xì)胞儀法）國械備20230369號BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-08-10 有效
89CD41檢測試劑（流式細(xì)胞儀法）國械備20230368號BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-08-10 有效
90CD9抗體試劑（流式細(xì)胞儀法）國械備20230367號BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-08-10 有效
91CD81檢測試劑（流式細(xì)胞儀法）國械備20230366號BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-08-10 有效
92髖關(guān)節(jié)手術(shù)工具國械備20230365號SERF85   Avenue des Bruyères，69150 DECINES-CHARPIEU，F(xiàn)RANCE2023-08-10 有效
93吸潮紙尖國械備20140199號META   BIOMED CO., LTD.136,   Mochung-ro, Heungdeok-gu Cheongju -si, Chungcheongbuk-do2023-08-10 變更
94注射器輔助推進(jìn)槍國械備20230090號Owen   Mumford LimitedPrimsdown   Industrial Estate, Worcester Road, Chipping Norton, Oxfordshire,OX7 5XP,   United Kingdom2023-08-10 變更
95液體敷料國械備20181717號LABORATOIRES   URGO   Parc   Excellence 2000-2 avenue de Strasbourg-21800 CHEVIGNY SAINT SAUVEUR-FRANCE2023-08-10 無效
96髖關(guān)節(jié)手術(shù)工具國械備20210150號DePuy   Ireland UC請見附件“生產(chǎn)地址”。2023-08-08 變更
97唾液樣本采集管（DNA自采集工作包，ORAcollect）國械備20170939號DNA   Genotek Inc.3000-500   Palladium Drive Ottawa Ontario K2V 1C2 Canada2023-08-08 變更
98一次性使用唾液采集器國械備20230045號DNA   Genotek Inc.3000   - 500 Palladium Drive; Ottawa, ON; K2V1C2 CANADA2023-08-08 變更
99唾液樣本采集管（DNA自采集工作包，Oragene）國械備20170946號DNA   Genotek Inc.3000-500   Palladium Drive Ottawa Ontario K2V 1C2 Canada2023-08-08 變更
100糞便DNA采樣包國械備20171075號DNA   Genotek Inc.3000-500   Palladium Drive, Ottawa, Ontario, Canada K2V 1C22023-08-08 變更
101放射治療患者用固定裝置國械備20230364號Medtec,   LLC dba CIVCO Radiotherapy1401   8th St.SE,Orange City,IA,51041,United States2023-08-04 有效
102牙科刮治器國械備20230363號株式會社YDM埼玉県東松山市今泉28番地2023-08-03 有效
103動力系統(tǒng)配套工具國械備20210407號The   Anspach Effort, Inc4500   Riverside Drive,Palm Beach Gardens,FL 334102023-08-03 變更
104骨科手術(shù)器械國械備20180814號Synthes   GmbH見附件。2023-08-03 變更
105夾頭國械備20230362號Stryker   Instruments250W   KENSINGER DR STE 400 Cranberry Township,PA USA 160662023-08-03 有效
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