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當(dāng)前位置：網(wǎng)站首頁>新聞動(dòng)態(tài) >2023年11月進(jìn)口第一類醫(yī)療器械產(chǎn)品備案信息
2023年11月進(jìn)口第一類醫(yī)療器械產(chǎn)品備案信息
發(fā)布日期:2023-12-06 17:36瀏覽次數(shù):2988次
2023年12月06日，國家藥監(jiān)局發(fā)布《2023年11月進(jìn)口第一類醫(yī)療器械產(chǎn)品備案信息》，2023年11月累計(jì)批準(zhǔn)180個(gè)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案產(chǎn)品。

2023年12月06日，國家藥監(jiān)局發(fā)布《2023年11月進(jìn)口第一類醫(yī)療器械產(chǎn)品備案信息》，2023年11月累計(jì)批準(zhǔn)180個(gè)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案產(chǎn)品。

進(jìn)口第一類醫(yī)療器械產(chǎn)品備案.jpg

2023年11月進(jìn)口第一類醫(yī)療器械產(chǎn)品備案信息

序號(hào)產(chǎn)品名稱備案號(hào)備案人名稱原文生產(chǎn)地址原文備案日期狀態(tài)
1膝關(guān)節(jié)手術(shù)工具國械備20210189號(hào)DePuy   Ireland UC請(qǐng)見附件“生產(chǎn)地址”。2023-11-30 變更
2肩關(guān)節(jié)全肩肩盂側(cè)工具國械備20230564號(hào)DePuy   Orthopaedics, Inc.8   Matchett Drive, Pierceton, Indiana 46562, USA;   6688 Dixie Hwy., Bridgeport, Michigan   48722, USA;2023-11-30 有效
3動(dòng)力系統(tǒng)配套工具國械備20210630號(hào) Synthes GmbHEimattstrasse   3, 4436 Oberdorf, Switzerland2023-11-30 變更
4肩關(guān)節(jié)手術(shù)工具國械備20230563號(hào)Biomet   Orthopedics56   East Bell Drive, P.O. Box 587,Warsaw, Indiana 46581,USA2023-11-30 有效
5樣本稀釋液國械備20150458號(hào)Medirox   ABStudsvik,   611 82 NYK?PING, Sweden2023-11-30 變更
6基礎(chǔ)外科手術(shù)器械國械備20230562號(hào)SURGICAL   SOURCES INDUSTRIESUgoki   Darbar Road, Near Zoom Petrol Filling Station, Sialkot - Pakistan2023-11-30 有效
7基礎(chǔ)外科手術(shù)器械國械備20230561號(hào)Sehgal's   InstrumentsGhumman   St. Daska Road Pakki Kotli 51340 Sialkot Pakistan.2023-11-30 有效
8瓣膜成形環(huán)測環(huán)器及組件國械備20160017號(hào)Corcym   S.r.l.Via   Crescentino sn 13040 SALUGGIA (VC) ITALY2023-11-30 變更
9牙科種植掃描體國械備20200085號(hào)Zirkonzahn   SrlZona   Industriale Molini di Tures 3 39032 Campo Tures (BZ), Italy2023-11-30 變更
10醫(yī)用嬰兒床國械備20191436號(hào)Advanced   Healthcare Technology Ltd.Northern   Road Sudbury Suffolk CO10 2ZB UK2023-11-30 變更
11剝離器國械備20152132號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-29 變更
12PD-1（CD279）檢測試劑（流式細(xì)胞儀法)國械備20230560號(hào)BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-11-28 有效
13CD9抗體試劑（流式細(xì)胞儀法）國械備20230559號(hào)BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-11-28 有效
14CD41檢測試劑（流式細(xì)胞儀法）國械備20230558號(hào)BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-11-28 有效
15造口皮膚保護(hù)劑國械備20191366號(hào)ConvaTec   LimitedUNIT   22, VALLEY ROAD BUSINESS PARK, BIDSTON, WIRRAL, MERSEYSIDE. CH41 7EL, UNITED   KINGDOM2023-11-28 變更
16顯微剪國械備20161108號(hào)ANTON   HIPP GmbHAnnastr.25/1,78567   Fridingen,Germany2023-11-28 無效
17鼻剪國械備20180399號(hào)ANTON   HIPP GmbHAnnastr.25/1,78567   Fridingen,Germany2023-11-28 無效
18扁桃體剪國械備20180397號(hào)ANTON   HIPP GmbH Annastr.25/1,78567   Fridingen,Germany2023-11-28 無效
19石膏剪國械備20180394號(hào)ANTON   HIPP GmbHAnnastr.25/1,78567   Fridingen,Germany2023-11-28 無效
20組織剪國械備20180395號(hào)ANTON   HIPP GmbHAnnastr.25/1,78567   Fridingen,Germany2023-11-28 無效
21鋼絲剪國械備20180299號(hào)ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 無效
22顯微鉤國械備20180495號(hào)ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 無效
23探針國械備20180499號(hào)ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 無效
24手術(shù)刀國械備20180498號(hào)ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 無效
25骨刮匙國械備20180565號(hào)ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 無效
26顯微剪國械備20180396號(hào)ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 無效
27骨膜剝離器 國械備20180563號(hào)ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 無效
28顯微剝離器國械備20161109號(hào)ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 無效
29椎板牽開器國械備20180496號(hào)ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 無效
30顯微沖洗吸引管國械備20161155號(hào)ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 無效
31 冷凍切片機(jī)  國械備20161064號(hào) Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19 69226 Nussloch Germany2023-11-28 變更
32 冷凍切片機(jī) 國械備20150367號(hào)Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19 69226 Nussloch Germany2023-11-28 變更
33冷凍切片機(jī) 國械備20161067號(hào)Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19 69226 Nussloch Germany2023-11-28 變更
34冷凍切片機(jī) 國械備20180127號(hào) Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19, 69226 Nussloch, Germany2023-11-28 變更
35冷凍切片機(jī)國械備20161066號(hào) Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19 69226 Nussloch Germany2023-11-28 變更
36染色機(jī)國械備20171212號(hào)Leica   Biosystems Nussloch GmbH1750A   Costner Drive Warrington, PA189762023-11-28 變更
37染色機(jī) 國械備20151853號(hào) Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19 69226 Nussloch Germany2023-11-28 變更
38真空墊國械備20230557號(hào)Qfix 440   Church Road Avondale Pennsylvania 19311 USA2023-11-28 有效
39顯微針國械備20180564號(hào)ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 無效
40定位膜國械備20230556號(hào)Qfix440   Church Road Avondale Pennsylvania 19311 USA2023-11-28 有效
41口腔科手術(shù)器械國械備20230555號(hào)Sehgal's   InstrumentsGhumman   St. Daska Road Pakki Kotli 51340 Sialkot Pakistan.2023-11-27 有效
42輸氧面罩國械備20210258號(hào)新廣業(yè)股份有限公司臺(tái)中市神岡區(qū)社口里中山路312號(hào)2023-11-27 變更
43關(guān)節(jié)假體夾持器國械備20152021號(hào) Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-11-27 變更
44牙科吸潮紙尖國械備20230554號(hào)C?ng   ty TNHH Gapadent Vi?t NamL?   B-B4 C?m c?ng nghi?p Hà Lam - Ch? ???c, x? Bình Ph?c, huy?n Th?ng Bình, t?nh   Qu?ng Nam, Vi?t Nam2023-11-27 有效
45眼科植入物及輔助器械國械備20230553號(hào)KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-11-27 有效
46眼用沖吸器及手柄國械備20230552號(hào)KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-11-27 有效
47眼科用鏟國械備20230551號(hào)KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-11-27 有效
48眼用碎核器國械備20230550號(hào)KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-11-27 有效
49眼用碎核器國械備20230549號(hào)KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-11-27 有效
50角膜標(biāo)記環(huán)國械備20230548號(hào)KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-11-27 有效
51角膜標(biāo)記環(huán)國械備20230546號(hào)KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-11-27 有效
52 鉆石手術(shù)刀國械備20230545號(hào)KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-11-27 有效
53眼用鑷國械備20220542號(hào)KATENA   PRODUCTS, INC.6   CAMPUS DRIVE, SUITE 310, Parsippany, NJ 070542023-11-27 變更
54鉆石手術(shù)刀國械備20230544號(hào)KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-11-27 有效
55拋光清潔器具國械備20230543號(hào)W&H   Dentalwerk Bürmoos GmbHCarl-Zeiss-Strasse   16, 77656 Offenburg, Germany2023-11-27 有效
56全自動(dòng)血沉分析儀國械備20230541號(hào)ALIFAX   S.r.l.Via   Merano 30 33045 Nimis (UD) Italy2023-11-24 有效
57醫(yī)學(xué)圖像體外定位貼國械備20230540號(hào)Zimmer   CAS75   Queen Street, Suite 3300, Montreal, Quebec H3C 2N6, Canada2023-11-24 有效
58頭燈國械備20160035號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
59醫(yī)用檢查音叉國械備20171244號(hào)RZ   Medizintechnik GmnHUnter   Hasslen 20 78532 Tuttlingen Germany2023-11-23 變更
60手外科固定復(fù)位鑷國械備20171154號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20 78532 Tuttlingen Germany2023-11-23 變更
61顯微剪國械備20170856號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20 78532 Tuttlingen Germany2023-11-23 變更
62顯微持針鑷國械備20170855號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20 78532 Tuttlingen Germany2023-11-23 變更
63顯微止血夾國械備20170848號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20 78532 Tuttlingen Germany2023-11-23 變更
64顯微鑷國械備20170009號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
65吸引管國械備20160141號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
66口腔開口器國械備20160034號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
67鉤針國械備20160033號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
68骨錘國械備20160030號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
69探針國械備20160028號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
70手術(shù)刀國械備20152117號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
71外科牽開器國械備20152120號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
72 支撐喉鏡國械備20180222號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20 78532 Tuttlingen Germany 2023-11-23 變更
73醫(yī)用鑷國械備20152116號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
74骨銼國械備20152119號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
75鼻窺器國械備20152118號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
76骨鑿 國械備20152131號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
77刮匙國械備20151685號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
78醫(yī)用剪國械備20151641號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
79止血鉗 國械備20151642號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20 D-78532 Tuttlingen2023-11-23 變更
80組織鉗國械備20150692號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20 D-78532 Tuttlingen2023-11-23 變更
81持針鉗國械備20150693號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20 D-78532 Tuttlingen2023-11-23 變更
82咬骨鉗國械備20150690號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
83口腔科手術(shù)器械國械備20230539號(hào)SURGICAL   SOURCES INDUSTRIESUgoki   Darbar Road, Near Zoom Petrol Filling Station, Sialkot - Pakistan2023-11-23 有效
84顱骨牽引器國械備20180497號(hào)ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-23 無效
85顯微鑷國械備20161111號(hào)ANTON   HIPP GmbHAnnastr.25/1,78567   Fridingen,Germany2023-11-23 無效
86咬骨鉗國械備20161156號(hào)ANTON   HIPP GmbH Annastr.25/1,78567   Fridingen,Germany2023-11-23 無效
87紗布繃帶剪國械備20180298號(hào)ANTON   HIPP GmbHAnnastr.25/1,78567   Fridingen,Germany2023-11-23 無效
88顯微持針鉗國械備20161110號(hào)ANTON   HIPP GmbHAnnastr.25/1,78567   Fridingen,Germany2023-11-23 無效
89耳鼻喉科手術(shù)器械包國械備20170904號(hào)Integra   LifeSciences Production Corporation/2023-11-23 變更
90夾持鉗國械備20210024號(hào)グンゼ株式會(huì)社京都府綾部市青野町棗ヶ市462023-11-22 無效
91聚左旋乳酸可吸收骨固定系統(tǒng)配套工具國械備20181627號(hào)グンゼ株式會(huì)社京都府綾部市青野町棗ヶ市462023-11-22 無效
92牙科種植手術(shù)工具國械備20170168號(hào)Institut   Straumann AGPeter   Merian-Weg 12，4002 Basel，Switzerland； Les Champs du Clos 2，2613   Villeret，Switzerland； 60 Minuteman Road，Andover，MA，01810，USA2023-11-21 變更
93創(chuàng)傷外科手術(shù)器械包國械備20220635號(hào)Synthes   GmbH詳見附件2023-11-20 變更
94骨科手術(shù)器械國械備20200275號(hào)Synthes   GmbH見附件。2023-11-20 變更
95醫(yī)用檢查手套國械備20230538號(hào)Sri   Trang Gloves (Thailand) Public Company Limited110/19   Ban Khao Mai Daeng, Moo 7, Phlai Wat, Kanchanadit, Surat Thani 84160,   THAILAND2023-11-20 有效
96醫(yī)用檢查手套國械備20230537號(hào)Sri   Trang Gloves (Thailand) Public Company Limited110/19   Ban Khao Mai Daeng, Moo 7, Phlai Wat, Kanchanadit, Surat Thani 84160,   THAILAND2023-11-20 有效
97牙科手術(shù)器械包國械備20230536號(hào)MIHHA   ENTERPRISESNizam   Street, Kotli Behram, Sialkot-Pakistan2023-11-20 有效
98醫(yī)用檢查手套國械備20170895號(hào)Sri   Trang Gloves (Thailand) Public Company Limited110   Kanjanavanit Road, Pahtong, Hatyai, Songkhla 90230, Thailand2023-11-20 變更
99橡皮障夾鉗國械備20191288號(hào)COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-17 變更
100醫(yī)用退熱貼 國械備20171169號(hào)新タック化成株式會(huì)社香川県三豊市豊中町上高野4148番地2023-11-16 變更
101拔牙鉗國械備20191261號(hào)COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 變更
102牙科剪國械備20191259號(hào)COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 變更
103阻生齒牙挺國械備20191264號(hào)COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 變更
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