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牙科手術器械包等139項進口第一類醫療器械產品備案獲批
發布日期:2023-05-11 22:11瀏覽次數:1845次
2023年5月11日，國家藥監局發布《2023年4月進口第一類醫療器械產品備案信息》，2023年4月累計批準醫用檢查手套、牙科手術器械包、呼吸訓練器等139項進口第一類醫療器械備案事項。詳見正文。

2023年5月11日，國家藥監局發布《2023年4月進口第一類醫療器械產品備案信息》，2023年4月累計批準醫用檢查手套、牙科手術器械包、呼吸訓練器等139項進口第一類醫療器械備案事項。詳見正文。

第一類醫療器械產品備案.jpg

2023年4月進口第一類醫療器械產品備案信息

序號產品名稱備案號備案人名稱原文生產地址原文備案日期狀態
1全自動免疫檢驗系統用終止液國械備20160411號Phadia   ABRapsgatan   7P, P.O. Box 6460, 751 37 Uppsala2023-04-28 變更
2樣本稀釋液國械備20160409號Phadia   ABRapsgatan   7P, P.O.Box 6460, 751 37 Uppsala2023-04-28 變更
3清洗液國械備20160410號Phadia   ABRapsgatan   7P, P. O. Box 6460, 751 37 Uppsala2023-04-28 變更
4扭力扳手國械備20230257號????   ????????   ??? ?????4? 23-32023-04-28 有效
5血細胞分析用溶血劑國械備20230256號シスメックス株式會社兵庫県小野市匠臺17番地2023-04-28 有效
6血細胞分析用染色液國械備20230255號シスメックス株式會社兵庫県小野市匠臺17番地2023-04-28 有效
7醫用檢查手套國械備20230254號Koon   Seng Sdn.Bhd.PTD   16058,KawasanPerindustrian Tangkak,JalanMuar,84900 Tangkak,Johor,Malaysia2023-04-27 有效
8醫用檢查手套國械備20230253號Koon   Seng Sdn.Bhd.PTD   16058,Kawasan Perindustrian Tangkak,JalanMuar,84900 Tangkak,Johor,Malaysia2023-04-27 有效
9脊柱外科手術器械包國械備20161359號CM   Instrumente GmbH G?ns?cker   56，78532 Tuttlingen，Germany2023-04-27 變更
10綁扎膠布國械備20170250號3M   Thailand Limited53/1   Soi Sukhapiban 2, Tambol Rahaeng, Amphur, Lardloomkaew, Pathumthani 12140,   Thailand2023-04-27 無效
11血細胞分析用染色液國械備20230252號シスメックス株式會社兵庫県小野市匠臺17番地2023-04-27 有效
12血細胞分析用稀釋液國械備20230251號シスメックス株式會社兵庫県小野市匠臺17番地2023-04-27 有效
13鼻骨銼國械備20161945號Integra   MicroFrance SAS Le   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE; Badstra?e 8, 78532 Tuttlingen,   GERMANY2023-04-27 變更
14CD79a檢測試劑國械備20230250號BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-04-26 有效
15TNFα檢測試劑國械備20230249號BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-04-26 有效
16CD79a檢測試劑國械備20230248號BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-04-26 有效
17全自動核酸提取純化儀國械備20150040號HAMILTON   BONADUZ AGVia   Crusch 8 CH-7402 Bonaduz Switzerland2023-04-26 變更
18AMACR/p504s抗體試劑（免疫組織化學）國械備20181784號Agilent   Technologies, Inc.1170   Mark Ave. Carpinteria, CA 93013 United States2023-04-25 變更
19鼻組織鉗國械備20161696號Integra   MicroFrance SASLe   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE; 31 Rue Malaingre, 52800   Nogent, France; Schlo??ckerweg 6/1, 78582 Balgheim, Germany2023-04-25 變更
20顯微持針鉗國械備20161942號Integra   MicroFrance SAS Le   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE2023-04-25 變更
21 革蘭染色液 Color Gram 2 (COLOR GRAM 2-F) 國械備20140221號bioMérieux   SASite   de Montesquieu – Bordeaux Technopolis 33650 MARTILLAC France2023-04-25 變更
22替代體國械備20161880號  DENTSPLY   Implants Manufacturing GmbHAminogatan   1, PO Box 14, 43121 M?lndal，SWEDEN 2023-04-25 變更
23楔子國械備20181129號Polydentia   SAVia   Cantonale 47,CH-6805 Mezzovico2023-04-25 變更
24打磨拋光組件國械備20170149號Hager   & Meisinger GmbHHansemannstraβe   10, 41468 Neuss Deutschland 2023-04-25 變更
25上/下肢醫用外固定支具國械備20230247號JC   OrthoHeal Private LimitedJC   OrthoHeal Private Limited GF-33/34, Classic Towers,Near Akota Garden,   Akota,Vadodara, Gujarat-390020，India2023-04-25 有效
26放射治療患者用固定裝置國械備20230246號Medtec,   LLC dba CIVCO Radiotherapy1401   8th St. SE, Orange City, IA, 51041, United States2023-04-25 有效
27生物顯微鏡國械備20210551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2023-04-24 變更
28牙科手術器械包國械備20230245號ABRAHAM   BLACKSMITHAbrona   Street, Small Industrial Estate, Sialkot-51310-Pakistan2023-04-23 有效
29影像板及暗盒國械備20200585號PaloDEx   Group OyNahkelantie   160, FI-04300 Tuusula, Finland2023-04-23 變更
30口腔數字觀察儀國械備20200629號WINUS   Technology Co., Ltd5F,   298-7, Gongdan-ro, Gunpo-si, Gyeonggi-do, 15809, KOREA2023-04-23 變更
31膝關節手術器械包國械備20230244號Blue   Belt Technologies, Inc.76   South Meridian Ave Oklahoma City Oklahoma 73107-6512 USA2023-04-21 有效
32股骨髓腔對線手柄套國械備20152022號Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-04-21 變更
33骨撬國械備20152018號Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-04-21 變更
34 骨拉鉤國械備20152012號Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-04-21 變更
35骨錐 國械備20152024號 Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-04-21 變更
36測深器國械備20151879號Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-04-21 變更
37骨科鉆頭國械備20152029號Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
    GERMANY		2023-04-21 變更
38骨鉸刀國械備20152028號Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
    GERMANY		2023-04-21 變更
39牙科種植手術修復工具包國械備20230243號BEGO   Implant Systems GmbH & Co. KGWilhelm-Herbst-Str.   1, 28359 Bremen, Germany2023-04-20 有效
40快接頭國械備20230242號Synthes   GmbH4500   Riverside Drive, Palm Beach Gardens, FL 33410, USA2023-04-20 有效
41醫用檢查手套國械備20150165號Hartalega   Sdn. Bhd.7,   Kawasan Perusahaan Suria, 45600 Bestari Jaya, Selangor Malaysia2023-04-20 變更
42手術剪國械備20230241號Georg   Alber GmbHLindenstrasse   13-78603 Renquishausen Germany2023-04-20 有效
43呼吸訓練器國械備20160866號/C/   Newton, 18-24 08635 Sant Esteve Sesrovires, Barcelona Spain2023-04-20 變更
44成形片夾國械備20230240號Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
45拔牙鉗 國械備20230239號Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
46口腔麻醉注射架國械備20230238號Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
47口腔止血鉗國械備20230237號Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
48上頜竇內提升器國械備20230236號Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
49牙科器械鉗 國械備20230235號Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
50基礎外科用鉗國械備20230234號FIRST   CLASS TRADERSP.O.   Box: 1762, Kingra Road, Lageriali, Sialkot-51310-Pakistan2023-04-20 有效
51橡皮障夾鉗 國械備20230233號Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
52橡皮障支架國械備20230232號Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
53橡皮障夾國械備20230231號Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
54橡皮障打孔器國械備20230230號Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
55牙挺國械備20230229號Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
56牙科用鑷國械備20230228號Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
57正畸鉗 國械備20230227號Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
58牙科用剪國械備20230226號Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
59牙科用牽開器國械備20230225號Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
60牙科去冠器 國械備20230224號Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
61視力表燈箱國械備20230223號Good-Lite   Company1155   Jansen Farm Drive Elgin, IL 601232023-04-19 有效
62CD5抗體試劑（免疫組織化學）國械備20180756號Agilent   Technologies, Inc.1170   Mark Ave. Carpinteria, CA 93013 United States2023-04-18 變更
63阿利辛藍－過碘酸雪夫氏染色液國械備20230222號Agilent   Technologies,Inc.1170   Mark Ave. Carpinteria, California 93013 UNITED STATES2023-04-18 有效
64吸唾管國械備20160481號Henry   Schein Inc.VIA   DELL'ARTIGIANATO 7-36030 MONTECCHIO PRECALCINO(VI) ITALY2023-04-18 變更
65橡皮障國械備20160823號Henry   Schein Inc.No   16, Persiaran Perindustrian Kanthan 1, Kawansan Perindustrian Kanthan, 31200   Chemor, Perak, Malaysia2023-04-18 變更
66醫用檢查手套國械備20220660號Henry   Schein Inc.189,   Moo 7, Phlai Wat, Kanchanadit, Surat Thani 84160, THAILAND2023-04-18 變更
67核酸提取或純化試劑國械備20180501號BIOMERIEUX   S.A.Centre   Christophe Merieux-5 rue des Berges-38024 GRENOBLE  CEDEX 01-FRANCE2023-04-18 變更
68放射治療患者用固定裝置國械備20140355號Medtec,   LLC dba CIVCO Radiotherapy1401   8th St. SE, Orange City, IA, 51041, United States2023-04-18 變更
69放射治療患者用固定裝置國械備20181007號Medtec,   LLC dba CIVCO Radiotherapy1401   8TH ST. S.E. Orange City, IA USA 510412023-04-18 變更
70正畸自鎖托槽開啟器國械備20230221號3M   Unitek Corporation3232   N. Rockwell Street, Chicago, IL, 60618, United States2023-04-17 有效
71扭力扳手國械備20140364號Alpha-Bio   Tec Ltd.7   Hatnufa St.,Kiryat Arye, POB3936, Petach Tikva, 4951025 Israel2023-04-17 變更
72牙用尺 國械備20180520號Alpha-Bio   Tec Ltd7   Hatnufa St., Kiryat Arye, POB 3936 Petach Tikva, 4951025 Israel2023-04-17 變更
73檢查手套國械備20170549號Mexpo   International Inc.馬來西亞，雪蘭州，巴生，奧夫嘉蘭馬路，巴圖5，嘉蘭特拉泰，5091地段2023-04-17 變更
74脊柱手術器械國械備20230220號Medos   International SARL見附件。2023-04-17 有效
75脊柱手術器械國械備20210227號Avalign   Technologies, Inc.8727   Clinton Park Dr, Fort Wayne, IN USA 46825; 8414 Clinton Park Dr, Fort Wayne,   IN USA 46825; 626 Cooper Ct, Schaumburg, IL USA 601732023-04-17 變更
76內鏡清洗機國械備20220223號STEELCO   SPAVIA   BALEGANTE 27-31039 RIESE PIO X(TV)-Italy2023-04-17 變更
77口鏡國械備20230219號Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-17 有效
78牙刮匙國械備20230218號Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-17 有效
79牙科潔治器國械備20230217號Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-17 有效
80牙骨膜分離器國械備20230216號Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-17 有效
81脊柱固定系統手術工具國械備20160103號Pioneer   Surgical Technology,Inc.375   River Park Circle,Marquette,MI 498552023-04-16 無效
82顯微鑷國械備20150527號FEHLING   INSTRUMENTS GmbH & Co. KGHanauer   Landstraβe 7A, 63791 Karlstein, Germany2023-04-14 變更
83清洗脫蠟液國械備20230215號Agilent   Technologies,Inc.1170   Mark Ave. Carpinteria, California 93013 UNITED STATES2023-04-14 有效
84細胞角蛋白8&18抗體試劑(免疫組織化學)國械備20230214號Agilent   Technologies, Inc.1170   Mark Ave. Carpinteria, California 93013 UNITED STATES2023-04-14 有效
85 MC抗體試劑（免疫組織化學）國械備20230213號Agilent   Technologies,Inc.1170   Mark Ave. Carpinteria, California 93013 UNITED STATES2023-04-14 有效
86牙周探針國械備20230212號Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-14 有效
87剔挖器國械備20230211號Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-14 有效
88牙用充填器 國械備20230210號Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-14 有效
89牙探針國械備20230209號Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-14 有效
90比濁儀國械備20210523號Becton，Dickinson   and Company100   Dayton Avenue, Ames, IA 50010, USA2023-04-14 變更
91CD1a抗體試劑（免疫組織化學）國械備20230208號Agilent   Technologies,Inc.1170   Mark Ave. Carpinteria, California 93013 UNITED STATES2023-04-13 有效
92Smooth   Muscle Myosin抗體試劑（免疫組織化學）國械備20230207號Agilent   Technologies,Inc.1170   Mark Ave. Carpinteria, California 93013 UNITED STATES2023-04-13 有效
93血管鉗國械備20150528號FEHLING   INSTRUMENTS GmbH & Co. KGHanauer   Landstraβe 7A, 63791 Karlstein, Germany2023-04-13 變更
94咬骨鉗國械備20190134號FEHLING   INSTRUMENTS GmbH & Co. KG Hanauer Landstra?e 7A, 63791 Karlstein   Germany2023-04-13 變更
95樣本稀釋液國械備20191257號Siemens   Healthcare Diagnostics Inc.333   Coney Street, East Walpole, MA, 02032, United States2023-04-13 變更
96樣本釋放劑國械備20191256號Siemens   Healthcare Diagnostics Inc.333   Coney Street, East Walpole, MA, 02032, United States2023-04-13 變更
97樣本稀釋液國械備20160737號Ortho-Clinical   DiagnosticsFelindre   Meadows PENCOED, BRIDGEND CF35 5PZ UNITED KINGDOM2023-04-13 變更
98樣本稀釋液國械備20150458號Medirox   ABStudsvik,   611 82 NYK?PING, Sweden2023-04-13 變更
99一次性醫用丁腈橡膠手套國械備20230206號MEDICAL   GLOVE CO.,LTD288   Moo 7, T.Lam Thap, A.Lam Thap, Krabi 81190 Thailand2023-04-13 有效
100醫用橡膠檢查手套國械備20230205號MEDICAL   GLOVE CO.,LTD288   Moo 7, T.Lam Thap, A.Lam Thap, Krabi 81190 Thailand2023-04-13 有效
101p120抗體試劑（免疫組織化學）   BOND Ready-to-Use Primary Antibody p120 Catenin (EP66)國械備20190013號Leica   Biosystems Newcastle LtdBalliol   Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom2023-04-13 變更
102生物顯微鏡國械備20220063號株式會社二コン244-8533　日本神奈川県橫浜市栄區長尾臺町4712023-04-12 變更
103組織染色機國械備20140169號MEDITE   Medical GmbH國械備201401692023-04-12 變更
104輪轉式切片機國械備20140038號MEDITE   Medical GmbHWollenweberstrasse   12, 31303 Burgdorf2023-04-12 變更
105冷凍切片機 國械備20150255號MEDITE   Medical GmbHWollenweberstrasse   12, 31303 Burgdorf2023-04-12 變更
106醫用檢查手套國械備20230204號HARTALEGA   SDN.BHD.NO.7,KAWASAN   PERUSAHAAN SURIA,45600 2023-04-11 有效
107雙移動髖臼杯系統手術工具國械備20230203號SERF85   Avenue des Bruyères，69150 DECINES-CHARPIEU，FRANCE2023-04-11 有效
108CD43抗體試劑（免疫組織化學）國械備20190634號Leica   Biosystems Newcastle Ltd.Balliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom.2023-04-11 變更
109PMS2抗體試劑（免疫組織化學）國械備20210586號 Leica Biosystems Newcastle Ltd Balliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom 2023-04-11 變更
110MSH6抗體試劑（免疫組織化學）國械備20210599號Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom 2023-04-11 變更
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