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2023年8月國(guó)家局累計(jì)批準(zhǔn)進(jìn)口第一類(lèi)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):1229次
2023年9月6日，國(guó)家藥監(jiān)局發(fā)布數(shù)據(jù)，2023年8月國(guó)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(lèi)醫(yī)療器械產(chǎn)品備案112項(xiàng)，詳見(jiàn)正文，一起來(lái)看看還有哪些進(jìn)口第一類(lèi)醫(yī)療器械產(chǎn)品。

2023年9月6日，國(guó)家藥監(jiān)局發(fā)布數(shù)據(jù)，2023年8月國(guó)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(lèi)醫(yī)療器械產(chǎn)品備案112項(xiàng)，詳見(jiàn)正文，一起來(lái)看看還有哪些進(jìn)口第一類(lèi)醫(yī)療器械產(chǎn)品。

進(jìn)口第一類(lèi)醫(yī)療器械產(chǎn)品備案.jpg

2023年8月進(jìn)口第一類(lèi)醫(yī)療器械產(chǎn)品備案信息

序號(hào)產(chǎn)品名稱(chēng)備案號(hào)備案人名稱(chēng)原文生產(chǎn)地址原文備案日期狀態(tài)
1防漏膏國(guó)械備20190580號(hào)Hollister   Incorporated 366 Draft Avenue Stuarts Draft, VA 24477 USA2023-08-31 變更
2氣管插管固定器國(guó)械備20210478號(hào) Hollister IncorporatedHollister   Incorporated  366 Draft Avenue Stuarts   Draft, VA USA 244772023-08-31 變更
3造口護(hù)膚粉國(guó)械備20191349號(hào)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(guó)械備20230390號(hào)Elos   Medtech Pinol A/SEngvej   33 G?rl?se 3330 Denmark2023-08-31 有效
5口腔治療器具國(guó)械備20230389號(hào)EVERBEST   TRADING CO.S.I.E.,TIPU   ROAD,SIALKOT-PAKISTAN2023-08-31 有效
6鞘液 國(guó)械備20160403號(hào)Luminex   Corporation12212   Technology Blvd, Austin, Texas 78727 USA2023-08-31 無(wú)效
7鞘液國(guó)械備20160402號(hào)Luminex   Corporation12212 Technology Blvd, Austin, Texas 78727 USA2023-08-31 無(wú)效
8眼用剪國(guó)械備20220538號(hào)KATENA   PRODUCTS, INC.6   CAMPUS DRIVE, SUITE 310, Parsippany, NJ 070542023-08-31 變更
9眼用拉鉤國(guó)械備20220547號(hào)KATENA   PRODUCTS, INC.6   CAMPUS DRIVE, SUITE 310, Parsippany, NJ 070542023-08-31 變更
10眼用鑷國(guó)械備20220536號(hào)KATENA   PRODUCTS, INC.6   CAMPUS DRIVE, SUITE 310, Parsippany, NJ 070542023-08-31 變更
11眼用注吸沖洗器國(guó)械備20220537號(hào)KATENA   PRODUCTS, INC.6   CAMPUS DRIVE, SUITE 310, Parsippany, NJ 070542023-08-31 變更
12眼用剪國(guó)械備20220546號(hào)KATENA   PRODUCTS, INC.6   CAMPUS DRIVE, SUITE 310, Parsippany, NJ 070542023-08-31 變更
13眼用鑷國(guó)械備20220542號(hào)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(guó)械備20230388號(hào)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(guó)械備20170145號(hào)OPED   GmbHMedizinpark   1 83626 Valley/Oberlaindern GERMANY2023-08-31 變更
16防水創(chuàng)口貼國(guó)械備20230387號(hào)Young   Chemical Co., Ltd.80-93,   Golden root-ro, Juchon-myeon, Gimhae-si, Gyeongsangnam-do, 50969, Korea2023-08-31 有效
17CD28檢測(cè)試劑（流式細(xì)胞儀法）國(guó)械備20230386號(hào)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(guó)械備20181704號(hào)SURGICAL   SOURCES INDUSTRIESP.O.Box:1389,Small   Industrial Estate,Sialkot-Pakistan2023-08-29 變更
19止血鉗國(guó)械備20181685號(hào)SURGICAL   SOURCES INDUSTRIESP.O.Box:1389,Small   Industrial Estate,Sialkot-Pakistan2023-08-29 變更
20牙種植定位桿國(guó)械備20160177號(hào)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(guó)械備20160042號(hào)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(guó)械備20151914號(hào)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(guó)械備20151418號(hào)Nobel   Biocare AB800   Corporate Drive Mahwah New Jersey 07430, USA 2023-08-29 變更
24牙科輸送頭國(guó)械備20200327號(hào)Pulpdent   Corporation80   Oakland Street, Watertown, MA 02472 United States2023-08-29 變更
25聚酯纖維繃帶國(guó)械備20181482號(hào)BL   TECH CO., LTD.韓國(guó)江原道春川市退溪農(nóng)工路84號(hào)2023-08-29 變更
26聚酯襯墊國(guó)械備20151171號(hào)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(guó)械備20181486號(hào)BL   TECH CO., LTD84,   Toegyenonggong-ro, Chuncheon-si, Gangwon-do2023-08-29 變更
28鞘液濃縮液國(guó)械備20160091號(hào)Luminex   Corporation12212   Technology Blvd, Austin, Texas 78727 USA2023-08-28 無(wú)效
29根管銼國(guó)械備20160922號(hào)VDW   GmbHBayerwaldstraβe   15, 81737 München,Germany2023-08-28 變更
30醫(yī)用退熱貼國(guó)械備20161526號(hào)香港思情用品有限公司香港葵涌健康街18號(hào)恒亞中心9樓10-12室2023-08-28 無(wú)效
31DAB染色液國(guó)械備20150941號(hào)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(guó)械備20230384號(hào)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(guó)械備20180944號(hào)Synthes   GmbH見(jiàn)附件2023-08-24 變更
34膝關(guān)節(jié)手術(shù)工具國(guó)械備20210189號(hào)DePuy   Ireland UC請(qǐng)見(jiàn)附件“生產(chǎn)地址”。2023-08-24 變更
35扭力扳手國(guó)械備20230383號(hào)Elos   Medtech Pinol A/SEngvej   33, G?rl?se 3330, Denmark2023-08-24 有效
36替代體國(guó)械備20190301號(hào)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(guó)械備20230382號(hào)MICROQORE   MEDICAL GmbHIm   Aachtal 1b D-78267 Aach2023-08-23 有效
38器械鉗國(guó)械備20230381號(hào)MICROQORE   MEDICAL GmbHIm   Aachtal 1b D-78267 Aach2023-08-23 有效
39組織鑷國(guó)械備20230380號(hào)MICROQORE   MEDICAL GmbHIm   Aachtal 1b D-78267 Aach2023-08-23 有效
40手術(shù)剪國(guó)械備20230379號(hào)MICROQORE   MEDICAL GmbHIm   Aachtal 1b D-78267 Aach2023-08-23 有效
41牙科手術(shù)器械包國(guó)械備20230378號(hào)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(cè)量器國(guó)械備20230377號(hào)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(guó)械備20230376號(hào)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(guó)械備20230375號(hào)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(guó)械備20230374號(hào)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(guó)械備20210399號(hào)株式會(huì)社エビデント長(zhǎng)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(guó)械備20210381號(hào)Deusch   Medizintechnik GmbHEsslinger   StraBe 13,78532 Tuttlingen2023-08-22 變更
48牽開(kāi)器國(guó)械備20210383號(hào)Deusch   Medizintechnik GmbHEsslinger   StraBe 13,78532 Tuttlingen2023-08-22 變更
49鉤針國(guó)械備20210444號(hào)Deusch   Medizintechnik GmbHEsslinger   StraBe 13,78532 Tuttlingen2023-08-22 變更
50鼻窺器國(guó)械備20210384號(hào)Deusch   Medizintechnik GmbHEsslinger   StraBe 13,78532 Tuttlingen2023-08-22 變更
51吸引管國(guó)械備20210349號(hào)Deusch   Medizintechnik GmbHEsslinger   StraBe 13,78532 Tuttlingen2023-08-22 變更
52綁扎膠布國(guó)械備20150828號(hào)彪仕醫(yī)技股份有限公司臺(tái)南市南區(qū)中華西路一段23號(hào)2023-08-22 無(wú)效
53醫(yī)用冰墊國(guó)械備20150827號(hào)彪仕醫(yī)技股份有限公司臺(tái)南市南區(qū)中華西路一段23號(hào)2023-08-22 無(wú)效
54頸椎固定帶國(guó)械備20151041號(hào)彪仕醫(yī)技股份有限公司臺(tái)南市南區(qū)中華西路一段23號(hào)2023-08-22 無(wú)效
55上/下肢醫(yī)用外固定支具國(guó)械備20151045號(hào)彪仕醫(yī)技股份有限公司臺(tái)南市南區(qū)中華西路一段23號(hào)2023-08-22 無(wú)效
56腰椎固定帶國(guó)械備20151036號(hào)彪仕醫(yī)技股份有限公司臺(tái)南市南區(qū)中華西路一段23號(hào)2023-08-22 無(wú)效
57牙科種植輔助器械包國(guó)械備20180988號(hào)ALTATEC   GmbHMaybachstr.   5, 71299 Wimsheim, Germany2023-08-21 變更
58口腔燈國(guó)械備20170125號(hào)?   ????(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(guó)械備20230373號(hào)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(guó)械備20200676號(hào)Luminex   Corporation12212   Technology Blvd. Austin TX 78727 USA2023-08-18 變更
61鞘液國(guó)械備20200675號(hào)Luminex   Corporation 12212   Technology Blvd. Austin TX 78727 USA2023-08-18 變更
62鞘液國(guó)械備20200650號(hào)Luminex   Corporation12212   Technology Blvd. Austin TX 78727 USA2023-08-18 變更
63給藥指套國(guó)械備20220363號(hào)H.Dam   K?rgaard A/SBorupvang   9，2750 Ballerup，Denmark2023-08-18 變更
64固定用彈力束帶國(guó)械備20190925號(hào)Bauerfeind   AGTriebeser   Stra?e 16 07937 Zeulenroda-Triebes Germany2023-08-18 變更
65種植體安裝輔助工具國(guó)械備20190673號(hào)(?)??????   ??? ???  ???? 474  , 4? 411?, 4? 412?(????, ??????????)2023-08-17 變更
66種植輔助材料國(guó)械備20190062號(hào)(?)??????   ??? ??? ???? 474 , 4? 411?, 4? 412? (????, ??????????)2023-08-17 變更
67種植體螺絲起國(guó)械備20190674號(hào)(?)??????   ??? ???  ???? 474  , 4? 411?, 4? 412?(????, ??????????)2023-08-17 變更
68膝關(guān)節(jié)固定器國(guó)械備20170278號(hào)?ssur   hf.Grjotháls   1-5 Reykjavik 110 Iceland2023-08-17 變更
69熱塑膜國(guó)械備20230372號(hào)MACROMEDICS   BVOostbaan   670, 2841ML Moordrecht, The Netherlands2023-08-16 有效
70顯微外科手術(shù)器械國(guó)械備20170838號(hào)Synovis   Micro Companies Alliance，Inc439   Industrial Lane, Birmingham, Alabama 35211 USA2023-08-16 變更
71牙科輸送器國(guó)械備20181637號(hào)DMG   Chemisch-Pharmazeutische Fabrik GmbHElbgaustraβe   248 22547 Hamburg Germany2023-08-15 變更
72造口底盤(pán)國(guó)械備20200155號(hào)Welland   Medical LimitedHydehurst   Lane, Crawley, West Sussex, RH10 9AS, United Kingdom2023-08-15 變更
73造口護(hù)理用品國(guó)械備20200116號(hào)Welland   Medical LimitedHydehurst   Lane, Crawley, West Sussex, RH10 9AS, United Kingdom2023-08-15 變更
74造口袋國(guó)械備20200157號(hào)Welland   Medical LimitedHydehurst   Lane, Crawley, West Sussex, RH10 9AS, United Kingdom2023-08-15 變更
75造口袋國(guó)械備20190372號(hào)Welland   Medical LimitedHydehurst   Lane, Crawley, West Sussex, RH10 9AS, United Kingdom2023-08-14 變更
76造口底盤(pán)國(guó)械備20190401號(hào)Welland   Medical LimitedHydehurst   Lane, Crawley, West Sussex, RH10 9AS, United Kingdom2023-08-14 變更
77造口袋國(guó)械備20190402號(hào)Welland   Medical LimitedHydehurst   Lane, Crawley, West Sussex, RH10 9AS, United Kingdom2023-08-14 變更
78病人推床國(guó)械備20161127號(hào)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(guó)械備20181539號(hào)(?)?????????,???   ?? ???? 592023-08-14 變更
80集尿袋國(guó)械備20170831號(hào)//2023-08-14 變更
81洗板機(jī)國(guó)械備20181472號(hào)Agilent   Technologies, Inc.100   Tigan Street Highland Park Winooski, VT 05404-0998 USA2023-08-14 無(wú)效
82洗板機(jī)國(guó)械備20190496號(hào)Agilent   Technologies, Inc.100   Tigan Street Highland Park Winooski, VT 05404-0998 USA2023-08-14 無(wú)效
83洗板機(jī)國(guó)械備20190874號(hào)Agilent   Technologies, Inc.100   Tigan Street Highland Park Winooski, VT 05404-0998 USA2023-08-14 無(wú)效
84凝血分析用稀釋液國(guó)械備20150936號(hào)DIAGNOSTICA   STAGOIDA   Business Park, Bary CO. WICKLOW IRELAND2023-08-14 變更
85代型材料國(guó)械備20170964號(hào)Ivoclar   Vivadent AG Bendererstrasse   2, 9494 Schaan, Liechtenstein 2023-08-11 變更
86子彈型光固化樹(shù)脂輸送器國(guó)械備20230371號(hào)Ivoclar   Vivadent AGBendererstrasse   2, 9494 Schaan, LIECHTENSTEIN；Schweizersbildstrasse 57, 8200 Schaffhausen,   Switzerland2023-08-11 有效
87CD27檢測(cè)試劑(流式細(xì)胞儀法)國(guó)械備20230370號(hào)BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-08-10 有效
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