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2023年11月進口第一類醫(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):2990次
2023年12月06日，國家藥監(jiān)局發(fā)布《2023年11月進口第一類醫(yī)療器械產(chǎn)品備案信息》，2023年11月累計批準(zhǔn)180個進口第一類醫(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月進口第一類醫(yī)療器械產(chǎn)品備案信息》，2023年11月累計批準(zhǔn)180個進口第一類醫(yī)療器械產(chǎn)品備案產(chǎn)品。

進口第一類醫(yī)療器械產(chǎn)品備案.jpg

2023年11月進口第一類醫(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”。2023-11-30 變更
2肩關(guān)節(jié)全肩肩盂側(cè)工具國械備20230564號DePuy   Orthopaedics, Inc.8   Matchett Drive, Pierceton, Indiana 46562, USA;   6688 Dixie Hwy., Bridgeport, Michigan   48722, USA;2023-11-30 有效
3動力系統(tǒng)配套工具國械備20210630號 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Advanced   Healthcare Technology Ltd.Northern   Road Sudbury Suffolk CO10 2ZB UK2023-11-30 變更
11剝離器國械備20152132號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造口皮膚保護劑國械備20191366號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ANTON   HIPP GmbHAnnastr.25/1,78567   Fridingen,Germany2023-11-28 無效
17鼻剪國械備20180399號ANTON   HIPP GmbHAnnastr.25/1,78567   Fridingen,Germany2023-11-28 無效
18扁桃體剪國械備20180397號ANTON   HIPP GmbH Annastr.25/1,78567   Fridingen,Germany2023-11-28 無效
19石膏剪國械備20180394號ANTON   HIPP GmbHAnnastr.25/1,78567   Fridingen,Germany2023-11-28 無效
20組織剪國械備20180395號ANTON   HIPP GmbHAnnastr.25/1,78567   Fridingen,Germany2023-11-28 無效
21鋼絲剪國械備20180299號ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 無效
22顯微鉤國械備20180495號ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 無效
23探針國械備20180499號ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 無效
24手術(shù)刀國械備20180498號ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 無效
25骨刮匙國械備20180565號ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 無效
26顯微剪國械備20180396號ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 無效
27骨膜剝離器 國械備20180563號ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 無效
28顯微剝離器國械備20161109號ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 無效
29椎板牽開器國械備20180496號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ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 無效
31 冷凍切片機  國械備20161064號 Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19 69226 Nussloch Germany2023-11-28 變更
32 冷凍切片機 國械備20150367號Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19 69226 Nussloch Germany2023-11-28 變更
33冷凍切片機 國械備20161067號Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19 69226 Nussloch Germany2023-11-28 變更
34冷凍切片機 國械備20180127號 Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19, 69226 Nussloch, Germany2023-11-28 變更
35冷凍切片機國械備20161066號 Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19 69226 Nussloch Germany2023-11-28 變更
36染色機國械備20171212號Leica   Biosystems Nussloch GmbH1750A   Costner Drive Warrington, PA189762023-11-28 變更
37染色機 國械備20151853號 Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19 69226 Nussloch Germany2023-11-28 變更
38真空墊國械備20230557號Qfix 440   Church Road Avondale Pennsylvania 19311 USA2023-11-28 有效
39顯微針國械備20180564號ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 無效
40定位膜國械備20230556號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號新廣業(yè)股份有限公司臺中市神岡區(qū)社口里中山路312號2023-11-27 變更
43關(guān)節(jié)假體夾持器國械備20152021號 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W&H   Dentalwerk Bürmoos GmbHCarl-Zeiss-Strasse   16, 77656 Offenburg, Germany2023-11-27 有效
56全自動血沉分析儀國械備20230541號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Zimmer   CAS75   Queen Street, Suite 3300, Montreal, Quebec H3C 2N6, Canada2023-11-24 有效
58頭燈國械備20160035號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RZ   Medizintechnik GmbHUnter   Hasslen 20 78532 Tuttlingen Germany2023-11-23 變更
61顯微剪國械備20170856號RZ   Medizintechnik GmbHUnter   Hasslen 20 78532 Tuttlingen Germany2023-11-23 變更
62顯微持針鑷國械備20170855號RZ   Medizintechnik GmbHUnter   Hasslen 20 78532 Tuttlingen Germany2023-11-23 變更
63顯微止血夾國械備20170848號RZ   Medizintechnik GmbHUnter   Hasslen 20 78532 Tuttlingen Germany2023-11-23 變更
64顯微鑷國械備20170009號RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
65吸引管國械備20160141號RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
66口腔開口器國械備20160034號RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
67鉤針國械備20160033號RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
68骨錘國械備20160030號RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
69探針國械備20160028號RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
70手術(shù)刀國械備20152117號RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
71外科牽開器國械備20152120號RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
72 支撐喉鏡國械備20180222號RZ   Medizintechnik GmbHUnter   Hasslen 20 78532 Tuttlingen Germany 2023-11-23 變更
73醫(yī)用鑷國械備20152116號RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
74骨銼國械備20152119號RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
75鼻窺器國械備20152118號RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
76骨鑿 國械備20152131號RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
77刮匙國械備20151685號RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
78醫(yī)用剪國械備20151641號RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 變更
79止血鉗 國械備20151642號RZ   Medizintechnik GmbHUnter   Hasslen 20 D-78532 Tuttlingen2023-11-23 變更
80組織鉗國械備20150692號RZ   Medizintechnik GmbHUnter   Hasslen 20 D-78532 Tuttlingen2023-11-23 變更
81持針鉗國械備20150693號RZ   Medizintechnik GmbHUnter   Hasslen 20 D-78532 Tuttlingen2023-11-23 變更
82咬骨鉗國械備20150690號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ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-23 無效
85顯微鑷國械備20161111號ANTON   HIPP GmbHAnnastr.25/1,78567   Fridingen,Germany2023-11-23 無效
86咬骨鉗國械備20161156號ANTON   HIPP GmbH Annastr.25/1,78567   Fridingen,Germany2023-11-23 無效
87紗布繃帶剪國械備20180298號ANTON   HIPP GmbHAnnastr.25/1,78567   Fridingen,Germany2023-11-23 無效
88顯微持針鉗國械備20161110號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Integra   LifeSciences Production Corporation/2023-11-23 變更
90夾持鉗國械備20210024號グンゼ株式會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號グンゼ株式會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Synthes   GmbH詳見附件2023-11-20 變更
94骨科手術(shù)器械國械備20200275號Synthes   GmbH見附件。2023-11-20 變更
95醫(yī)用檢查手套國械備20230538號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MIHHA   ENTERPRISESNizam   Street, Kotli Behram, Sialkot-Pakistan2023-11-20 有效
98醫(yī)用檢查手套國械備20170895號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COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-17 變更
100醫(yī)用退熱貼 國械備20171169號新タック化成株式會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COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 變更
102牙科剪國械備20191259號COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 變更
103阻生齒牙挺國械備20191264號COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 變更
104牙探針國械備20191285號COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 變更
105口腔麻醉劑手動助推器國械備20191345號COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 變更
106牙骨膜分離器國械備20191265號COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 變更
107橡皮膏 國械備20151099號Lohmann   & Rauscher International GmbH & Co.KGWesterwaldstraβe   4,56579 Rengsdorf GERMANY2023-11-16 無效
108頸部固定器國械備20170969號Ottobock   SE & Co. KGaAMax   N?derStra?e 15 37115 Duderstadt,Germany2023-11-16 變更
109位置定位器國械備20160638號Dentis   Co., Ltd#99,   Seongseoseo-Ro, Dalseo-Gu, Daegu, Korea2023-11-16 變更
110牙用尺國械備20160637號Dentis   Co., Ltd#99,   Seongseoseo-Ro, Dalseo-Gu, Daegu, Korea2023-11-16 變更
111轉(zhuǎn)移帽國械備20160639號Dentis   Co., Ltd#99,   Seongseoseo-Ro, Dalseo-Gu, Daegu, Korea2023-11-16 變更
112螺絲起國械備20160640號Dentis   Co., Ltd#99,   Seongseoseo-Ro, Dalseo-Gu, Daegu, Korea2023-11-16 變更
113牙科種植定位器國械備20160653號Dentis   Co., Ltd#99,   Seongseoseo-Ro, Dalseo-Gu, Daegu, Korea2023-11-16 變更
114轉(zhuǎn)移帽國械備20161044號Dentis   Co., Ltd#99,   Seongseoseo-Ro, Dalseo-Gu, Daegu, Korea2023-11-16 變更
115代型材料國械備20170121號Dentis   Co., Ltd.#99,   Seongseoseo-Ro, Dalseo-Gu, Daegu, Korea2023-11-16 變更
116口鏡國械備20191279號COMMIC   SURGICO羅拉絲路，諾切區(qū)，錫亞爾科特市，郵編51310，巴基斯坦2023-11-16 變更
117牙用充填器國械備20191260號COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 變更
118橡皮障夾國械備20191291號COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 變更
119牙用鑷國械備20191263號COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 變更
120成形片夾國械備20191262號COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 變更
121牙科器械鉗國械備20191258號COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 變更
122正畸鉗國械備20191254號COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 變更
123脫鈣液國械備20230535號Milestone   s.r.l.Via   Fatebenefratelli,1/5 IT-24010 SORISOLE (BG) Corso Europa,6 IT-24030 Valbrembo   (BG)2023-11-16 有效
124扭力扳手國械備20230257號????   ????????   ??? ?????4? 23-32023-11-15 變更
125足托固定器國械備20161906號Ottobock   SE & Co. KGaAMax-N?der-Stra?e   15, 37115 Duderstadt, Germany2023-11-15 變更
126肩關(guān)節(jié)固定器國械備20171259號Ottobock   SE & Co. KGaAMax   N?derStra?e 15 37115 Duderstadt,Germany2023-11-15 變更
127創(chuàng)傷外科手術(shù)器械包國械備20180944號Synthes   GmbH見附件2023-11-15 變更
128一件式造口袋國械備20200123號ConvaTec   LimitedCarretera   Sanchez, Km. 18.5, Parque Industrial Itabo S.A. Buildings 23, 29, 30 Haina,   San Cristobal, 91000 Dominican Republic.2023-11-15 變更
129骨科保護支具國械備20230534號Bort   GmbHAm   Schweizerbach 1, 71384 Weinstadt-Benzach，Germany2023-11-15 有效
130返藍染色液國械備20151291號Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42, DK-2600 Glostrup Denmark2023-11-14 變更
131眼用鑷國械備20230533號Vortex   Surgical, Inc.4   Research Park, Suite 124 St. Charles, MO 63304 USA 2023-11-14 有效
132清洗液   Artisan 50x Wash Solution國械備20150166號Agilent   Technologies, Inc.6392   Via Real Carpinteria, CA 930132023-11-14 變更
133創(chuàng)口貼國械備20230532號Beiersdorf   AGCtra.de   Mataró a Granollers P .Km 5,6,08310 Argentona (Barcelona) ,Spanien2023-11-14 有效
134防水創(chuàng)可貼國械備20230531號Beiersdorf   AGCtra.de   Mataró a Granollers P .Km 5,6,08310 Argentona (Barcelona) ,Spanien2023-11-14 有效
135創(chuàng)口貼國械備20230530號Beiersdorf   AGCtra.de   Mataró a Granollers P .Km 5,6,08310 Argentona (Barcelona) ,Spanien2023-11-14 有效
136醫(yī)用壓敏膠帶國械備20230529號Beiersdorf   AGCtra.de   Mataró a Granollers P .Km 5,6,08310 Argentona (Barcelona) ,Spanien2023-11-14 有效
137引流袋系統(tǒng)國械備20230528號怡安醫(yī)療器材股份有限公司臺灣省臺中市梧棲區(qū)經(jīng)三路39號2023-11-14 有效
138全自動核酸提取純化儀國械備20230527號Promega   Corporation1017,   A Building Gangseo-Hangang-Xi Tower 401, Yangcheon-ro Gangseo-gu Seoul 07528   Republic of Korea2023-11-14 有效
139核酸提取或純化試劑國械備20230526號Promega   Corporation2800   Woods Hollow Road Madison Wisconsin 53711-5399 USA2023-11-14 有效
140核酸提取或純化試劑國械備20230525號Promega   Corporation2800   Woods Hollow Road Madison Wisconsin 53711-5399 USA2023-11-14 有效
141螺絲起國械備20150871號???????(?)66-16,   Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2023-11-13 變更
142牙用尺國械備20150781號Osstem   Implant Co.,Ltd.66-16,   Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2023-11-13 變更
143扭力扳手國械備20150782號Osstem   Implant Co.,Ltd.66-16,   Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2023-11-13 變更
144縫隙封閉糊劑國械備20190276號 Ultradent Products, Inc. 505   West Ultradent Drive (10200 South), South Jordan, Utah 84095, USA2023-11-13 變更
145牙科成形片套裝國械備20230524號AFRZ   CORPORATIONRoras   Road, Near Makki Masjid, Sialkot - Pakistan2023-11-09 有效
146牙科拋光器械國械備20230523號AFRZ   CORPORATIONRoras   Road, Near Makki Masjid, Sialkot - Pakistan2023-11-09 有效
147血細(xì)胞分析用稀釋液國械備20230522號シスメックス株式會社17   Takumidai, Ono, Hyogo 675-1322, Japan2023-11-09 有效
148血細(xì)胞分析用溶血劑國械備20230521號シスメックス株式會社17   Takumidai, Ono, Hyogo 675-1322, Japan2023-11-09 有效
149CD79a檢測試劑國械備20230520號BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-11-09 有效
150CD79a檢測試劑國械備20230519號BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-11-09 有效
151CD103檢測試劑國械備20230518號BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-11-09 有效
152漏斗胸手術(shù)器械包國械備20161051號Biomet   Microfixation見附件2023-11-08 變更
153增強液（免疫組化法）國械備20190911號Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42, DK-2600 Glostrup, Denmark;1170 Mark Ave. Carpinteria, CA 93013 United   States2023-11-08 變更
154增強液  EnVision FLEX+ Rabbit LINKER (Dako Omnis)國械備20140028號Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42, DK-2600 Glostrup Denmark2023-11-08 變更
155醫(yī)用干式激光膠片國械備20230517號COLENTA   Labortechnik GmbH & Co.KGNeunkirchner   Straβe 117,2700 Wiener Neustadt, Austria2023-11-08 有效
156膝關(guān)節(jié)手術(shù)器械包國械備20190071號MAKO   SURGICAL CORP.見附件。2023-11-07 變更
157眼科手術(shù)非接觸觀察裝置國械備20230516號OCULUS   Optikger?te GmbHMünchholzh?user   Str.29, 35582 Wetzlar, GERMANY2023-11-07 有效
158樣本萃取液及流動相溶劑包(串聯(lián)質(zhì)譜法)國械備20140120號Wallac   OyMustionkatu   6, FI-20750 Turku, Finland2023-11-07 變更
159清洗液國械備20140011號Wallac   OyMustionkatu   6, FI-20750 Turku, Finland2023-11-07 變更
160誘導(dǎo)劑國械備20151616號Wallac   Oy華萊克有限公司2023-11-07 變更
161誘導(dǎo)劑國械備20150676號Wallac   OyMustionkatu   6, FI-20750 Turku, Finland2023-11-07 變更
162樣本稀釋液國械備20150733號Wallac   OyMustionkatu   6, FI-20750 Turku, Finland2023-11-07 變更
163增強液國械備20151617號Wallac   OyMustionkatu   6, FI-20750 Turku, Finland2023-11-07 變更
164清洗液國械備20140370號Wallac   OyMustionkatu   6, FI-20750 Turku, Finland2023-11-07 變更
165樣本稀釋液國械備20150740號Wallac   OyMustionkatu   6, FI-20750 Turku, Finland2023-11-07 變更
166腰部固定器國械備20190176號?ssur   hfGrjotháls   1-5 Reykjavik 110 Iceland2023-11-06 變更
167骨科手術(shù)器械國械備20180816號Synthes   GmbH見附件。2023-11-06 變更
168倒置生物顯微鏡國械備20230515號株式會社二コン471,   Nagaodai-Cho, Sakae-Ku, Yokohama, Kanagawa, 244-8533, Japan2023-11-03 有效
169高速離心機國械備20180864號Eppendorf   SEPortitzer   Allee 15, 04329 Leipzig, Germany;       175 Freshwater Boulevard, Enfield CT 06082, USA2023-11-03 變更
170導(dǎo)航手術(shù)工具國械備20190893號Medtronic   Navigation, Inc.826   Coal Creek Circle Louisville, CO 80027 United States of America2023-11-02 變更
171套管國械備20200001號Medtronic   Powered Surgical Solutions4620   North Beach Street Fort Worth Texas 76137 USA2023-11-02 變更
172口腔科器械國械備20230514號Easy   Source SurgicalHouse   No.7/4,Mohaliah Rang Pura,PindiArayian,Sialkot-51310,Pakistan2023-11-01 有效
173人工晶狀體植入器國械備20210234號Johnson   & Johnson Surgical Vision, Inc.8600   Evergreen Boulevard, Minneapolis MN 55433, USA2023-11-01 變更
174核酸提取試劑國械備20171233號MP   Biomedicals Asia Pacific Pte Ltd2F.-2,   No.122, Qiaohe Rd., Zhonghe Dist., New Taipei City 235, Taiwan（R.O.C.）2023-11-02 無效
175核酸提取試劑國械備20160566號MP   Biomedicals Asia Pacific Pte Ltd2F.-2,   No.122, Qiaohe Rd., Zhonghe Dist., New Taipei City 235, Taiwan（R.O.C.）2023-11-02 無效
176核酸提取試劑國械備20160040號MP   Biomedicals Asia Pacific Pte Ltd2F.-2,   No.122, Qiaohe Rd., Zhonghe Dist., New Taipei City 235, Taiwan（R.O.C.）2023-11-02 無效
177核酸提取試劑國械備20160127號MP   Biomedicals Asia Pacific Pte Ltd2F.-2,   No.122, Qiaohe Rd., Zhonghe Dist., New Taipei City 235, Taiwan（R.O.C.）2023-11-02 無效
178核酸提取試劑國械備20160126號MP   Biomedicals Asia Pacific Pte Ltd2F.-2,   No.122, Qiaohe Rd., Zhonghe Dist., New Taipei City 235, Taiwan（R.O.C.）2023-11-02 無效
179核酸提取試劑國械備20160487號MP   Biomedicals Asia Pacific Pte Ltd2F.-2,   No.122, Qiaohe Rd., Zhonghe Dist., New Taipei City 235, Taiwan（R.O.C.）2023-11-02 無效
180聚左旋乳酸可吸收骨固定系統(tǒng)配套工具國械備20140081號グンゼ株式會社京都府綾部市青野町棗之市462023-11-22 無效

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