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進口第一類醫(yī)療器械產(chǎn)品備案信息(2021年08月)
發(fā)布日期:2021-09-07 23:05瀏覽次數(shù):6251次
盡管資本市場更加看重高風(fēng)險的第三類醫(yī)療器械，但也有許多經(jīng)營一類醫(yī)療器械的企業(yè)取得優(yōu)異經(jīng)營績效。2021年08月，共計123個進口第一類醫(yī)療器械產(chǎn)品備案?獲批，一起來看看有哪些產(chǎn)品。

盡管資本市場更加看重高風(fēng)險的第三類醫(yī)療器械，但也有許多經(jīng)營一類醫(yī)療器械的企業(yè)取得優(yōu)異經(jīng)營績效。2021年08月，共計123個進口第一類醫(yī)療器械產(chǎn)品備案獲批，一起來看看有哪些產(chǎn)品。

進口第一類醫(yī)療器械產(chǎn)品備案.jpg

進口第一類醫(yī)療器械產(chǎn)品備案信息(2021年08月)

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手術(shù)用頭架國械備20161617號pro   med instruments GmbHWaldmatten   6 79224 Umkirch Germany2021-08-31 變更
2醫(yī)用高分子夾板國械備20210464號3M   Deutschland GmbHul.   Kwidzynska 6, 51-416 Wroclaw, Poland2021-08-31 有效
3ERG/TMPRSS2/ETV1/ETV4基因異常檢測試劑盒（原位雜交法）國械備20180783號CytoTest   Inc.9430   Key West Avenue Suite 210 Rockville, MD 20850 USA2021-08-30 變更
4骨髓增生異常綜合征染色體及基因異常檢測試劑盒（原位雜交法）國械備20180744號CytoTest   Inc.9430   Key West Avenue Suite 210 Rockville, MD 20850 USA2021-08-30 變更
5慢性淋巴細胞白血病染色體及基因異常檢測試劑盒（原位雜交法）國械備20180751號CytoTest   Inc.9430   Key West Avenue Suite 210 Rockville, MD 20850 USA2021-08-30 變更
6TERC基因擴增檢測試劑盒（原位雜交法）國械備20180748號CytoTest   Inc.9430   Key West Avenue Suite 210 Rockville, MD 20850 USA2021-08-30 變更
7膀胱癌細胞染色體及基因異常檢測試劑盒（原位雜交法）國械備20180746號CytoTest   Inc.9430   Key West Avenue Suite 210 Rockville, MD 20850 USA2021-08-30 變更
8TOP2A基因擴增檢測試劑盒（原位雜交法）國械備20180750號CytoTest   Inc.9430   Key West Avenue Suite 210 Rockville, MD 20850 USA2021-08-30 變更
9原位雜交藍染染色液國械備20180743號CytoTest   Inc.9430   Key West Avenue Suite 210 Rockville, MD 20850 USA2021-08-30 變更
10肩部手術(shù)固定裝置國械備20210257號ALLEN   MEDICAL SYSTEMS, INC.100   Discovery Way Acton, MA 017202021-08-30 變更
11CD3檢測試劑國械備20210463號Becton,   Dickinson and Company, BD Biosciences2350   Qume Drive, San Jose, California 95131, USA；Vicks Drive, Lot 1 Corner Road   735, Cayey 00736 Puerto Rico2021-08-30 有效
12頸前路鋼板手術(shù)器械國械備20160171號Spineart   SA20   route de pre-bois CP 1813 1215 Geneva(Switzerland)2021-08-27 變更
13菌斑指示劑國械備20170830號Produits   Dentaires SA18   rue des Bosquets,1800 Vevey, Switzerland2021-08-27 變更
14磷酸鹽鑄造包埋材料國械備20170829號Produits   Dentaires SA18   rue des Bosquets,1800 Vevey, Switzerland2021-08-27 變更
15脫脂棉球國械備20170828號Produits   Dentaires SA18   rue des Bosquets,1800 Vevey, Switzerland2021-08-27 變更
16醫(yī)用固定帶國械備20151538號????   ???6，Hwasan-ro   101 beon-gil,Idong-myeon,Cheoin-gu,Yongin-si,Gyeonggi-do2021-08-27 變更
17機用根管螺旋輸送器國械備20181438號Produits   Dentaires SA18   rue des Bosquets CH-1800 Vevey2021-08-27 變更
18牙科拋光條國械備20181404號Produits   Dentaires SA18   rue des Bosquets, CH-1800 Vevey2021-08-27 變更
19根管銼國械備20180344號Produits   Dentaires SA18   rue des Bosquets,1800 Vevey, Switzerland2021-08-27 變更
20菌斑指示劑國械備20190173號Produits   Dentaires SA18   rue des Bosquets CH-1800 Vevey2021-08-27 變更
21一次性使用牙科沖洗針國械備20200662號Produits   Dentaires SARue   des Bosquets 18, 1800 Vevey, Switzerland2021-08-27 變更
22螺絲起國械備20151268號Thommen   Medical AGNeckarsulmstrasse   28, 2540 Grenchen, Switzerland2021-08-27 變更
23牙科種植掃描體國械備20181655號Thommen   Medical AGNeckarsulmstrasse   28,2540 Grenchen Switzerland2021-08-26 變更
24替代體國械備20181415號Thommen   Medical AGNeckarsulmstrasse   28,2540 Grenchen Switzerland2021-08-26 變更
25牙科輸送頭國械備20210462號サンメディカル株式會社  滋賀県守山市古高町571-22021-08-26 有效
26髖關(guān)節(jié)手術(shù)工具包國械備20210461號AESCULAP   AGAm   Aesculap-Platz, 78532 Tuttlingen, GERMANY2021-08-26 有效
27膝關(guān)節(jié)手術(shù)工具包國械備20210460號AESCULAP   AGAm   Aesculap-Platz, 78532 Tuttlingen, GERMANY2021-08-26 有效
28咬骨鉗國械備20210459號AESCULAP   AGAm   Aesculap-Platz, 78532 Tuttlingen, GERMANY2021-08-26 有效
29牙科電動抽吸系統(tǒng)國械備20210458號DüRR   DENTAL SEH?pfigheimer   Str.17,74321 Bietigheim-Bissingen,Germany2021-08-26 有效
30置骨器國械備20170916號HumanTech   Dental GmbHGewerbestrasse   5, 71144 Steinenbronn, Germany2021-08-25 變更
31 轉(zhuǎn)移帽國械備20170917號HumanTech   Dental GmbHGewerbestrasse   5,71144 Steinenbronn Germany2021-08-25 變更
32鉆針深度停止器國械備20171122號HumanTech   Dental GmbHGewerbestrasse   5, 71144 Steinenbronn, Germany2021-08-25 變更
33螺絲起國械備20171123號HumanTech   Dental GmbHGewerbestrasse   5, 71144 Steinenbronn, Germany2021-08-25 變更
34高速冷凍離心機國械備20171151號Beckman   Coulter, Inc.5355   West 76th Street Indianapolis, IN 46268 USA2021-08-25 變更
35高速離心機國械備20171152號Beckman   Coulter, Inc.5355   West 76th Street Indianapolis, IN 46268 USA2021-08-25 變更
36持釘器國械備20171121號HumanTech   Dental GmbHGewerbestrasse   5, 71144 Steinenbronn, Germany2021-08-25 變更
37高速冷凍離心機國械備20140268號Beckman   Coulter, Inc.5355   West 76th St. Indianapolis, IN 46268 USA 2021-08-25 變更
38高速冷凍離心機國械備20150131號Beckman   Coulter, Inc.5355   West 76th St. Indianapolis, IN 46268 USA 2021-08-25 變更
39牙科潔治器國械備20210457號POMEE   USA INCMian   Ilam Din Road, Doburji Arian Sialkot, Punjab, 51310, Pakistan2021-08-24 有效
40試色糊劑國械備20210456號Dentsply   Caulk38W.   Clarke Avenue, Milford，Delaware，19963, USA2021-08-24 有效
41牙科輸送頭國械備20200653號Sulzer   Mixpac AGRütistrasse   7, CH-9469 Haag2021-08-24 變更
42超速離心機國械備20170826號Beckman   Coulter, Inc.5355   West 76th Street Indianapolis, IN 46268 USA2021-08-24 變更
43醫(yī)用檢查手套國械備20190238號HARTALEGA   SDN.BHD. No. 7, Kawasan Perusahaan Suria, Bestari   Jaya, 45600 Selangor Darul Ehsan, MALAYSIA 2021-08-24 變更
44基礎(chǔ)外科手術(shù)器械 國械備20210455號Cardio   Surgical Ltd.Clogan,   Stradbally North ,Clarinbridge , Co Galway H91 Y9C9, Ireland2021-08-24 有效
45脛骨托試模國械備20210454號DePuy   Orthopaedics, Inc.47   Episcopal Rd., Berlin, Connecticut 06037 USA2021-08-24 有效
46髖關(guān)節(jié)手術(shù)工具國械備20210453號DePuy   International Limited8   Matchett Drive, Pierceton, Indiana 46562 USA2021-08-24 有效
47手術(shù)刀片國械備20210452號ConMed   Corporation525   French Road Utica, New York 13502, USA2021-08-23 有效
48尿液分析用稀釋液國械備20210451號Medica   Corporation5   Oak Park Drive, Bedford, Massachusetts, 01730, United States2021-08-23 有效
49創(chuàng)口貼國械備20200613號Young   Chemical Co., Ltd80-93,   Golden root-ro, Juchon-myeon, Gimhae-si, Gyeongsangnam-do, Korea2021-08-23 變更
50手術(shù)動力系統(tǒng)工具國械備20210450號AESCULAP   AGAm   Aesculap-Platz, 78532 Tuttlingen, GERMANY2021-08-23 有效
51骨傳導(dǎo)植入式聽力系統(tǒng)植入手術(shù)器械包國械備20210449號Elos   Medtech Pinol A/SEngvej   33, G?rl?se 3330, Denmark2021-08-20 有效
52彈力繃帶國械備20210448號Paul   Hartmann AGLauterstra?e   50, 67752 Wolfstein, GERMANY2021-08-20 有效
53金剛石磨頭國械備20181134號Spiggle   & Theis Medizintechnik GmbHBurghof   14 51491 Overath Germany2021-08-19 變更
54彈力繃帶國械備20210447號Paul   Hartmann AGLauterstra?e   50, 67752 Wolfstein, GERMANY2021-08-19 有效
55牙科輸送頭國械備20200327號Pulpdent   Corporation80   Oakland Street, Watertown, MA 02472 United States2021-08-19 變更
56轉(zhuǎn)移帽國械備20160722號ORNAGHI   LUIGI & C.s.n.c. Via   Santa Margherita,123-20861 BRUGHERIO(MB)-ITALIA2021-08-19 變更
57牙科拋光磨頭國械備20190282號Coltène/Whaledent   AGKanalstrasse   18， 9490 Vaduz, Liechtenstein2021-08-19 變更
58膝關(guān)節(jié)手術(shù)工具國械備20210446號Howmedica   Osteonics Corp.325   Corporate Drive Mahwah, NJ 07430 USA；IDA Industrial Estate Carrigtwohill,   County Cork, Ireland2021-08-17 有效
59造口底盤國械備20190929號Coloplast   A/SColoplast   Hungary KFT, Kerék utca 4, 2800 Tatabánya, Hungary2021-08-17 變更
60彈力套國械備20210445號SIGVARIS   Inc. – Holland Facility13055   Riley St Ste 30, Holland, MI USA 494242021-08-17 有效
61手術(shù)剪國械備20151004號Gebrüder   Martin GmbH & Co. KGKLS   Martin Platz 1, 78532 Tuttlingen, Germany2021-08-17 變更
62組織鑷國械備20151273號Gebrüder   Martin GmbH & Co. KGKLS   Martin Platz 1, 78532 Tuttlingen, Germany2021-08-17 變更
63持針鉗國械備20151311號Gebrüder   Martin GmbH & Co. KGKLS   Martin Platz 1, 78532 Tuttlingen, Germany2021-08-17 變更
64樣本稀釋液國械備20152164號Siemens   Healthcare Diagnostics Inc.333   Coney Street, East Walpole, Massachusetts 02032, USA2021-08-17 變更
65造口底盤國械備20190932號Coloplast   A/SColoplast   Hungary KFT, Kerék utca 4, 2800 Tatabánya, Hungary2021-08-17 變更
66鉤針國械備20210444號Deusch   Medizintechnik GmbHEsslinger   StraBe 13,78532 Tuttlingen2021-08-17 有效
67手術(shù)刀國械備20210443號Deusch   Medizintechnik GmbHEsslinger   StraBe 13,78532 Tuttlingen2021-08-17 有效
68骨科手術(shù)器械包國械備20180204號MAKO   SURGICAL CORP.見申請表附件2021-08-16 變更
69成人和兒童骨科手術(shù)器械國械備20210442號best   medical GmbHHeudorfer   Straβe 32 78576 Emmingen-Liptingen Germany2021-08-16 有效
70牙科輸送頭國械備20210441號ネオ製藥工業(yè)株式會社長野県松本市大字和田4010番172021-08-16 有效
71成人和兒童顯微外科手術(shù)器械國械備20210440號best   medical GmbHHeudorfer   Straβe 32 78576 Emmingen-Liptingen Germany2021-08-16 有效
72蘇木素-伊紅染色液（H-E）國械備20210439號Leica   Biosystems Richmond, Inc.5205   Route 12 P.O.Box 528 Richmond Illinois 60071 USA2021-08-16 有效
73口腔科用定位桿國械備20210438號Osstem   Implant Co.,Ltd.66-16,   Bansong-ro, 513beon-gil, Haeundae-gu, Busan2021-08-16 有效
74前處理緩沖液B國械備20190668號Kreatech   Biotechnology B.V.Vlierweg   20, 1032 LG Amsterdam, The Netherlands2021-08-16 變更
75沖洗緩沖液V國械備20190667號Kreatech   Biotechnology B.V.Vlierweg   20, 1032 LG Amsterdam, The Netherlands2021-08-16 變更
76TERC基因擴增探針試劑（原位雜交法）國械備20181384號KREATECH   Biotechnology BVVlierweg   20, 1032 LG Amsterdam, The Netherlands2021-08-16 變更
77TOP2A基因擴增探針試劑（原位雜交法）國械備20181383號KREATECH   Biotechnology BVVlierweg   20, 1032 LG Amsterdam, The Netherlands2021-08-16 變更
78替代體國械備20181180號ORNAGHI   LUIGI & C.S.n.c.Via   Santa Margherita, 123-20861 BRUGHERIO (MB)2021-08-13 變更
79替代體國械備20181179號ORNAGHI   LUIGI & C.S.n.c.Via   Santa Margherita, 123-20861 BRUGHERIO (MB)2021-08-13 變更
80替代體國械備20181178號ORNAGHI   LUIGI & C.S.n.c.Via   Santa Margherita, 123-20861 BRUGHERIO (MB)2021-08-13 變更
81牙科種植用延長器國械備20200258號ORNAGHI   LUIGI & C. S.n.c.Via   S. Margherita, 131 - 20861 BRUGHERIO (MB) - ITALIA2021-08-13 變更
82膝關(guān)節(jié)手術(shù)工具國械備20160144號SOCIETA   AZIONARIA MATERIALE OSPEDALIERO-S.A.M.O.S.P.A.Via   G. Matteotti, 37 40057 Cadriano di Granarolo Emilia BO Italia/Via   Buozzi,13-15-40057 Cadriano,Granarolo,Bologna,ITALY2021-08-13 變更
83髖關(guān)節(jié)手術(shù)工具國械備20161334號SOCIETA   AZIONARIA MATERIALE OSPEDALIERO-S.A.M.O.S.p.a.Via   G. Matteotti, 37  40057 Cadriano di   Granarolo Emilia BO Italia2021-08-13 變更
84醫(yī)用手持式壓力泵國械備20160976號VBM   Medizintechnik GmbHEinsteinstr.   1, 72172 Sulz a. N. Germany2021-08-12 變更
85膝關(guān)節(jié)手術(shù)工具國械備20181367號Zimmer   Inc. 1800   W. Center Street, Warsaw, Indiana 46580 USA2021-08-12 變更
86成人和兒童耳鼻喉科手術(shù)器械國械備20210437號best   medical GmbHHeudorfer   Straβe 32 78576 Emmingen-Liptingen Germany2021-08-11 有效
87手術(shù)刀國械備20151355號LandangerZI   La Vendue,FR-52906 Chaumont Cedex 92021-08-11 變更
88神經(jīng)和心血管手術(shù)器械國械備20210436號Cardio   Surgical Ltd.Clogan,   Stradbally North ,Clarinbridge , Co Galway H91 Y9C9, Ireland2021-08-11 有效
89骨科手術(shù)器械國械備20210435號Cardio   Surgical Ltd.Clogan,   Stradbally North ,Clarinbridge , Co Galway H91 Y9C9, Ireland2021-08-11 有效
90刮匙國械備20210434號FENTEXmedical   GmbHtake-off   Gewerbepark 2 78579 Neuhausen Ob Eck Germany2021-08-10 有效
91鋼絲穿引器國械備20152023號 Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
    GERMANY		2021-08-10 變更
92鋼絲鉗國械備20152043號Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2021-08-10 變更
93起子國械備20180206號MAKO   Surgical Corp.130   Durham Dr., Athens, AL 35611, USA2021-08-10 變更
94股骨假體試模國械備20210433號DePuy   Orthopaedics, Inc. 486   West 350 North, Warsaw, Indiana 46582 USA; 811 Northwoods Blvd., Vandalia,   Ohio 45377 USA2021-08-10 有效
95膝關(guān)節(jié)手術(shù)導(dǎo)板國械備20210432號DePuy   International Limited486   West 350 North, Warsaw, Indiana 46582 USA2021-08-10 有效
96膝關(guān)節(jié)手術(shù)工具國械備20160853號Biomet   Orthopedics56   East Bell Drive,P.O.Box 587, Warsaw Indiana 46581 USA2021-08-10 變更
97膝關(guān)節(jié)手術(shù)工具包國械備20160975號Biomet   Orthopedics56   East Bell Drive,P.O.Box 587, Warsaw Indiana 46581 USA2021-08-10 變更
98試模國械備20180022號MAKO   Surgical Corp.2555   Davie Road Fort Lauderdale, Florida 333172021-08-09 變更
99打入器國械備20180202號MAKO   SURGICAL CORP.2429   North Burdick St. Kalamazoo, MI 490072021-08-09 變更
100外科手術(shù)固定裝置國械備20190115號MAKO   SURGICAL CORP.見附件。2021-08-09 變更
101CD45檢測試劑國械備20210431號BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-08-09 有效
102CD33檢測試劑國械備20210430號BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-08-09 有效
103CD23檢測試劑國械備20210429號BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-08-09 有效
104CD11b檢測試劑國械備20210428號BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-08-09 有效
105快裝手柄國械備20210427號愛派司生技股份有限公司新北市中和區(qū)橋和路120號2樓之22021-08-09 有效
106骨定位針國械備20210426號愛派司生技股份有限公司新北市中和區(qū)橋和路120號2樓之22021-08-09 有效
107骨科鉆頭國械備20210425號愛派司生技股份有限公司新北市中和區(qū)橋和路120號2樓之22021-08-09 有效
108一次性使用末梢采血管國械備20210424號NEOTERYX,   LLC421   Amapola Avenue Torrance, CA USA 905012021-08-09 有效
109肋骨固定板國械備20161361號Chrisofix   Hungary Kft.Grassalkovich   út 272-274. 1239 Budapest Hungary2021-08-09 變更
110醫(yī)用高分子夾板國械備20150041號Chrisofix   Hungary Kft.Grassalkovichút   272. 1239 Budapest Hungary2021-08-09 變更
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