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牙科手術(shù)器械包等139項(xiàng)進(jìn)口第一類(lèi)醫(yī)療器械產(chǎn)品備案獲批
發(fā)布日期:2023-05-11 22:11瀏覽次數(shù):1665次
2023年5月11日，國(guó)家藥監(jiān)局發(fā)布《2023年4月進(jìn)口第一類(lèi)醫(yī)療器械產(chǎn)品備案信息》，2023年4月累計(jì)批準(zhǔn)醫(yī)用檢查手套、牙科手術(shù)器械包、呼吸訓(xùn)練器等139項(xiàng)進(jìn)口第一類(lèi)醫(yī)療器械備案事項(xiàng)。詳見(jiàn)正文。

2023年5月11日，國(guó)家藥監(jiān)局發(fā)布《2023年4月進(jìn)口第一類(lèi)醫(yī)療器械產(chǎn)品備案信息》，2023年4月累計(jì)批準(zhǔn)醫(yī)用檢查手套、牙科手術(shù)器械包、呼吸訓(xùn)練器等139項(xiàng)進(jìn)口第一類(lèi)醫(yī)療器械備案事項(xiàng)。詳見(jiàn)正文。

第一類(lèi)醫(yī)療器械產(chǎn)品備案.jpg

2023年4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全自動(dòng)免疫檢驗(yàn)系統(tǒng)用終止液國(guó)械備20160411號(hào)Phadia   ABRapsgatan   7P, P.O. Box 6460, 751 37 Uppsala2023-04-28 變更
2樣本稀釋液國(guó)械備20160409號(hào)Phadia   ABRapsgatan   7P, P.O.Box 6460, 751 37 Uppsala2023-04-28 變更
3清洗液國(guó)械備20160410號(hào)Phadia   ABRapsgatan   7P, P. O. Box 6460, 751 37 Uppsala2023-04-28 變更
4扭力扳手國(guó)械備20230257號(hào)????   ????????   ??? ?????4? 23-32023-04-28 有效
5血細(xì)胞分析用溶血?jiǎng)?/td>國(guó)械備20230256號(hào)シスメックス株式會(huì)社兵庫(kù)県小野市匠臺(tái)17番地2023-04-28 有效
6血細(xì)胞分析用染色液國(guó)械備20230255號(hào)シスメックス株式會(huì)社兵庫(kù)県小野市匠臺(tái)17番地2023-04-28 有效
7醫(yī)用檢查手套國(guó)械備20230254號(hào)Koon   Seng Sdn.Bhd.PTD   16058,KawasanPerindustrian Tangkak,JalanMuar,84900 Tangkak,Johor,Malaysia2023-04-27 有效
8醫(yī)用檢查手套國(guó)械備20230253號(hào)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(shù)器械包國(guó)械備20161359號(hào)CM   Instrumente GmbH G?ns?cker   56，78532 Tuttlingen，Germany2023-04-27 變更
10綁扎膠布國(guó)械備20170250號(hào)3M   Thailand Limited53/1   Soi Sukhapiban 2, Tambol Rahaeng, Amphur, Lardloomkaew, Pathumthani 12140,   Thailand2023-04-27 無(wú)效
11血細(xì)胞分析用染色液國(guó)械備20230252號(hào)シスメックス株式會(huì)社兵庫(kù)県小野市匠臺(tái)17番地2023-04-27 有效
12血細(xì)胞分析用稀釋液國(guó)械備20230251號(hào)シスメックス株式會(huì)社兵庫(kù)県小野市匠臺(tái)17番地2023-04-27 有效
13鼻骨銼國(guó)械備20161945號(hào)Integra   MicroFrance SAS Le   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE; Badstra?e 8, 78532 Tuttlingen,   GERMANY2023-04-27 變更
14CD79a檢測(cè)試劑國(guó)械備20230250號(hào)BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-04-26 有效
15TNFα檢測(cè)試劑國(guó)械備20230249號(hào)BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-04-26 有效
16CD79a檢測(cè)試劑國(guó)械備20230248號(hào)BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-04-26 有效
17全自動(dòng)核酸提取純化儀國(guó)械備20150040號(hào)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(xué)）國(guó)械備20181784號(hào)Agilent   Technologies, Inc.1170   Mark Ave. Carpinteria, CA 93013 United States2023-04-25 變更
19鼻組織鉗國(guó)械備20161696號(hào)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(guó)械備20161942號(hào)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(guó)械備20140221號(hào)bioMérieux   SASite   de Montesquieu – Bordeaux Technopolis 33650 MARTILLAC France2023-04-25 變更
22替代體國(guó)械備20161880號(hào)  DENTSPLY   Implants Manufacturing GmbHAminogatan   1, PO Box 14, 43121 M?lndal，SWEDEN 2023-04-25 變更
23楔子國(guó)械備20181129號(hào)Polydentia   SAVia   Cantonale 47,CH-6805 Mezzovico2023-04-25 變更
24打磨拋光組件國(guó)械備20170149號(hào)Hager   & Meisinger GmbHHansemannstraβe   10, 41468 Neuss Deutschland 2023-04-25 變更
25上/下肢醫(yī)用外固定支具國(guó)械備20230247號(hào)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(guó)械備20230246號(hào)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(guó)械備20210551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2023-04-24 變更
28牙科手術(shù)器械包國(guó)械備20230245號(hào)ABRAHAM   BLACKSMITHAbrona   Street, Small Industrial Estate, Sialkot-51310-Pakistan2023-04-23 有效
29影像板及暗盒國(guó)械備20200585號(hào)PaloDEx   Group OyNahkelantie   160, FI-04300 Tuusula, Finland2023-04-23 變更
30口腔數(shù)字觀察儀國(guó)械備20200629號(hào)WINUS   Technology Co., Ltd5F,   298-7, Gongdan-ro, Gunpo-si, Gyeonggi-do, 15809, KOREA2023-04-23 變更
31膝關(guān)節(jié)手術(shù)器械包國(guó)械備20230244號(hào)Blue   Belt Technologies, Inc.76   South Meridian Ave Oklahoma City Oklahoma 73107-6512 USA2023-04-21 有效
32股骨髓腔對(duì)線手柄套國(guó)械備20152022號(hào)Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-04-21 變更
33骨撬國(guó)械備20152018號(hào)Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-04-21 變更
34 骨拉鉤國(guó)械備20152012號(hào)Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-04-21 變更
35骨錐 國(guó)械備20152024號(hào) Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-04-21 變更
36測(cè)深器國(guó)械備20151879號(hào)Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-04-21 變更
37骨科鉆頭國(guó)械備20152029號(hào)Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
    GERMANY		2023-04-21 變更
38骨鉸刀國(guó)械備20152028號(hào)Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
    GERMANY		2023-04-21 變更
39牙科種植手術(shù)修復(fù)工具包國(guó)械備20230243號(hào)BEGO   Implant Systems GmbH & Co. KGWilhelm-Herbst-Str.   1, 28359 Bremen, Germany2023-04-20 有效
40快接頭國(guó)械備20230242號(hào)Synthes   GmbH4500   Riverside Drive, Palm Beach Gardens, FL 33410, USA2023-04-20 有效
41醫(yī)用檢查手套國(guó)械備20150165號(hào)Hartalega   Sdn. Bhd.7,   Kawasan Perusahaan Suria, 45600 Bestari Jaya, Selangor Malaysia2023-04-20 變更
42手術(shù)剪國(guó)械備20230241號(hào)Georg   Alber GmbHLindenstrasse   13-78603 Renquishausen Germany2023-04-20 有效
43呼吸訓(xùn)練器國(guó)械備20160866號(hào)/C/   Newton, 18-24 08635 Sant Esteve Sesrovires, Barcelona Spain2023-04-20 變更
44成形片夾國(guó)械備20230240號(hào)Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
45拔牙鉗 國(guó)械備20230239號(hào)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(guó)械備20230238號(hào)Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
47口腔止血鉗國(guó)械備20230237號(hào)Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
48上頜竇內(nèi)提升器國(guó)械備20230236號(hào)Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
49牙科器械鉗 國(guó)械備20230235號(hào)Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
50基礎(chǔ)外科用鉗國(guó)械備20230234號(hào)FIRST   CLASS TRADERSP.O.   Box: 1762, Kingra Road, Lageriali, Sialkot-51310-Pakistan2023-04-20 有效
51橡皮障夾鉗 國(guó)械備20230233號(hào)Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
52橡皮障支架國(guó)械備20230232號(hào)Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
53橡皮障夾國(guó)械備20230231號(hào)Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
54橡皮障打孔器國(guó)械備20230230號(hào)Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
55牙挺國(guó)械備20230229號(hào)Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
56牙科用鑷國(guó)械備20230228號(hào)Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
57正畸鉗 國(guó)械備20230227號(hào)Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
58牙科用剪國(guó)械備20230226號(hào)Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
59牙科用牽開(kāi)器國(guó)械備20230225號(hào)Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
60牙科去冠器 國(guó)械備20230224號(hào)Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-20 有效
61視力表燈箱國(guó)械備20230223號(hào)Good-Lite   Company1155   Jansen Farm Drive Elgin, IL 601232023-04-19 有效
62CD5抗體試劑（免疫組織化學(xué)）國(guó)械備20180756號(hào)Agilent   Technologies, Inc.1170   Mark Ave. Carpinteria, CA 93013 United States2023-04-18 變更
63阿利辛藍(lán)－過(guò)碘酸雪夫氏染色液國(guó)械備20230222號(hào)Agilent   Technologies,Inc.1170   Mark Ave. Carpinteria, California 93013 UNITED STATES2023-04-18 有效
64吸唾管國(guó)械備20160481號(hào)Henry   Schein Inc.VIA   DELL'ARTIGIANATO 7-36030 MONTECCHIO PRECALCINO(VI) ITALY2023-04-18 變更
65橡皮障國(guó)械備20160823號(hào)Henry   Schein Inc.No   16, Persiaran Perindustrian Kanthan 1, Kawansan Perindustrian Kanthan, 31200   Chemor, Perak, Malaysia2023-04-18 變更
66醫(yī)用檢查手套國(guó)械備20220660號(hào)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(guó)械備20180501號(hào)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(guó)械備20140355號(hào)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(guó)械備20181007號(hào)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(kāi)啟器國(guó)械備20230221號(hào)3M   Unitek Corporation3232   N. Rockwell Street, Chicago, IL, 60618, United States2023-04-17 有效
71扭力扳手國(guó)械備20140364號(hào)Alpha-Bio   Tec Ltd.7   Hatnufa St.,Kiryat Arye, POB3936, Petach Tikva, 4951025 Israel2023-04-17 變更
72牙用尺 國(guó)械備20180520號(hào)Alpha-Bio   Tec Ltd7   Hatnufa St., Kiryat Arye, POB 3936 Petach Tikva, 4951025 Israel2023-04-17 變更
73檢查手套國(guó)械備20170549號(hào)Mexpo   International Inc.馬來(lái)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(shù)器械國(guó)械備20230220號(hào)Medos   International SARL見(jiàn)附件。2023-04-17 有效
75脊柱手術(shù)器械國(guó)械備20210227號(hào)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(nèi)鏡清洗機(jī)國(guó)械備20220223號(hào)STEELCO   SPAVIA   BALEGANTE 27-31039 RIESE PIO X(TV)-Italy2023-04-17 變更
77口鏡國(guó)械備20230219號(hào)Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-17 有效
78牙刮匙國(guó)械備20230218號(hào)Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-17 有效
79牙科潔治器國(guó)械備20230217號(hào)Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-17 有效
80牙骨膜分離器國(guó)械備20230216號(hào)Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-17 有效
81脊柱固定系統(tǒng)手術(shù)工具國(guó)械備20160103號(hào)Pioneer   Surgical Technology,Inc.375   River Park Circle,Marquette,MI 498552023-04-16 無(wú)效
82顯微鑷國(guó)械備20150527號(hào)FEHLING   INSTRUMENTS GmbH & Co. KGHanauer   Landstraβe 7A, 63791 Karlstein, Germany2023-04-14 變更
83清洗脫蠟液國(guó)械備20230215號(hào)Agilent   Technologies,Inc.1170   Mark Ave. Carpinteria, California 93013 UNITED STATES2023-04-14 有效
84細(xì)胞角蛋白8&18抗體試劑(免疫組織化學(xué))國(guó)械備20230214號(hào)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(xué)）國(guó)械備20230213號(hào)Agilent   Technologies,Inc.1170   Mark Ave. Carpinteria, California 93013 UNITED STATES2023-04-14 有效
86牙周探針國(guó)械備20230212號(hào)Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-14 有效
87剔挖器國(guó)械備20230211號(hào)Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-14 有效
88牙用充填器 國(guó)械備20230210號(hào)Ray-Bright   IndustriesNear   Asghar Awan Attari,Marjan Road,Ugoki,Sialkot 51310 Pakistan2023-04-14 有效
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