醫(yī)療器械法規(guī)、注冊、臨床、體系認(rèn)證、信息系統(tǒng)一站式服務(wù)
24×7服務(wù)熱線：0571-86198618 簡體中文 ENGLISH
新聞動(dòng)態(tài)
醫(yī)療器械注冊
醫(yī)療器械CE認(rèn)證
醫(yī)療器械臨床試驗(yàn)
醫(yī)療器械經(jīng)營許可
聯(lián)系我們

公眾號(hào)二維碼.jpg

 聯(lián)系電話：0571-86198618手機(jī): 18058734169 (微信同)手機(jī):18868735317（微信同)周一至周日 8:00~22:00
在線客服周一至周日 8:00~22:00

QQ在線客服

 

當(dāng)前位置：網(wǎng)站首頁>新聞動(dòng)態(tài) >國家局7月批準(zhǔn)187項(xiàng)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案
國家局7月批準(zhǔn)187項(xiàng)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案
發(fā)布日期:2023-08-03 20:12瀏覽次數(shù):1438次
2023年8月2日，國家藥監(jiān)局發(fā)布進(jìn)口第一類醫(yī)療器械產(chǎn)品備案數(shù)據(jù)公告，2023年7月，國家局累計(jì)批準(zhǔn)頸椎固定器、醫(yī)用固定帶、脊柱微創(chuàng)手術(shù)工具包、醫(yī)用檢查手套、下肢醫(yī)用外固定支具、鉆針深度停止器、牙科成形片套裝等187項(xiàng)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案。一起看正文。

2023年8月2日，國家藥監(jiān)局發(fā)布進(jìn)口第一類醫(yī)療器械產(chǎn)品備案數(shù)據(jù)公告，2023年7月，國家局累計(jì)批準(zhǔn)頸椎固定器、醫(yī)用固定帶、脊柱微創(chuàng)手術(shù)工具包、醫(yī)用檢查手套、下肢醫(yī)用外固定支具、鉆針深度停止器、牙科成形片套裝等187項(xiàng)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案。一起看正文。

進(jìn)口第一類醫(yī)療器械產(chǎn)品備案.jpg

國家局7月批準(zhǔn)187項(xiàng)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案

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頸椎固定器國械備20170267號(hào)?ssur   hf.Grjotháls   1-5 Reykjavik 110 Iceland2023-07-31 變更
2醫(yī)用固定帶國械備20170246號(hào)?ssur   hf.Grjotháls   1-5 Reykjavik 110 Iceland2023-07-31 變更
3腰椎固定帶國械備20170245號(hào)?ssur   hf.Grjotháls   1-5 Reykjavik 110 Iceland2023-07-31 變更
4腕關(guān)節(jié)固定器國械備20210288號(hào)?ssur   hf.Grjotháls   1-5 Reykjavik 110 Iceland 2023-07-31 變更
5腰部固定器國械備20190176號(hào)?ssur   hfGrjotháls   1-5 Reykjavik 110 Iceland2023-07-31 變更
6肩部固定器國械備20220071號(hào)?ssur   hfGrjotháls   1-5 Reykjavik 110 Iceland2023-07-31 變更
7踝部固定器國械備20220072號(hào)?ssur   hfGrjotháls   1-5 Reykjavik 110 Iceland2023-07-31 變更
8頸部固定器國械備20181375號(hào)Ossur   hfGrjotháls   1-5 Reykjavik 110 Iceland2023-07-31 變更
9胸腰骶固定器國械備20170217號(hào)?ssur   hf.Grjóthálsi   1 - 5, IS-110 Reykjavik, Iceland2023-07-31 變更
10下肢醫(yī)用外固定支具國械備20180444號(hào)Ossur   hfGrjotháls   1-5 Reykjavik 110 Iceland2023-07-31 變更
11宮腔活檢鉗國械備20230361號(hào)CooperSurgical,   Inc.Industriestr.24   D-78532 Tuttlinger Germany2023-07-31 有效
12醫(yī)用檢查手套國械備20210197號(hào)貝格莫特有限公司31,   Jalan Balakong Jaya 4, Taman Industri Balakong Jaya, Seri Kembangan,   Selangor, 43300, Malaysia2023-07-31 變更
13刀頭國械備20200736號(hào)ENDOVISION   Co., Ltd.66-26,   Dongnae-ro, Dong-gu. Daegu, Republic of Korea2023-07-28 變更
14脊柱微創(chuàng)手術(shù)工具包國械備20210050號(hào) ENDOVISION Co., Ltd.66-26,   Dongnae-ro, Dong-gu, Daegu, Republic of Korea2023-07-28 變更
15脊柱手術(shù)工具包國械備20200688號(hào)ENDOVISION   Co., Ltd.66-26,   Dongnae-ro, Dong-gu, Daegu, Republic of Korea2023-07-28 變更
16種植體安裝輔助器械包國械備20230360號(hào)Haenaem   Co., Ltd.194,   Jisan-ro 175beon-gil, Jinwi-myeon, Pyeongtaek-si, Gyeonggi-do, 17718 (Rep. of   KOREA)2023-07-27 有效
17醫(yī)用檢查手套國械備20230253號(hào)Koon   Seng Sdn.Bhd.PTD   16058,Kawasan Perindustrian Tangkak,JalanMuar,84900 Tangkak,Johor,Malaysia2023-07-27 變更
18醫(yī)用檢查手套國械備20230254號(hào)Koon   Seng Sdn.Bhd.PTD   16058,KawasanPerindustrian Tangkak,JalanMuar,84900 Tangkak,Johor,Malaysia2023-07-27 變更
19牙科骨粉輸送器國械備20230359號(hào)Haenaem   Co., Ltd.194,   Jisan-ro 175beon-gil, Jinwi-myeon, Pyeongtaek-si, Gyeonggi-do, 17718 (Rep. of   KOREA)2023-07-27 有效
20鉆針深度停止器國械備20230358號(hào)Haenaem   Co., Ltd.194,   Jisan-ro 175beon-gil, Jinwi-myeon, Pyeongtaek-si, Gyeonggi-do, 17718 (Rep. of   KOREA)2023-07-27 有效
21牙科成形片套裝國械備20160776號(hào)GARRISON   DENTAL SOLUTIONS L.L.C.16673   148th Ave Unit 4 Spring Lake, MI 494562023-07-27 變更
22唇頰牽開器國械備20230357號(hào)Align   Technology, Inc.Aligntech   de Mexico S. de R.L. de C.V.  Boulevard   Independencia 1951, Parque Industrial    Salvacar, Cd. Juarez Chihuahua, MEXICO 325752023-07-27 有效
23手術(shù)輔助照明燈國械備20162066號(hào)Gebrüder   Martin GmbH & Co. KGKLS   Martin Platz 1, 78532 Tuttlingen, Germany2023-07-26 變更
24打磨拋光清潔器具國械備20210507號(hào)Garrison   Dental Solutions LLC19,   Hayezira St., Ra’anana, Israel; Neureutstra?e 6 75210 Keltern Germany2023-07-26 變更
25打入器國械備20150259號(hào)Medos   International SARL Chemin   Blanc, 38 Le Locle, CH-2400, Switzerland2023-07-25 變更
26注射器輔助推進(jìn)槍國械備20230356號(hào)Deusch   Medizintechnik GmbHBregstrasse   34, 78120 Furtwangen2023-07-25 有效
27手術(shù)刀國械備20210443號(hào)Deusch   Medizintechnik GmbHEsslinger   StraBe 13,78532 Tuttlingen2023-07-25 變更
28替代體國械備20181711號(hào)ADIN   DENTAL IMPLANT SYSTEMS LTD.Industrial   Zone, Alon Tavor, Afula POB 1128, Afula 1811101, Israel2023-07-24 變更
29測序反應(yīng)通用試劑盒（測序法）國械備20180410號(hào)Illumina,   Inc.5200   Illumina Way, San Diego, California 92122, USA2023-07-24 變更
30測序反應(yīng)通用試劑盒（測序法）國械備20190416號(hào)Illumina,   Inc.29   Woodlands Industrial Park E1, Northtech, Singapore 7577162023-07-24 變更
31牙科用軟組織環(huán)切刀國械備20200611號(hào)//2023-07-24 變更
32牙用尺國械備20161414號(hào)MIS   Implants Technologies Ltd.Bar   Lev Industrial Park, 2015600 Israel2023-07-24 變更
33種植安裝輔助工具包國械備20190883號(hào)MIS   Implants Technologies Ltd.P.O.   Box 7 Bar Lev Industrial Park, 2015600, Israel 2023-07-24 變更
34唇頰牽開器國械備20220479號(hào)Align   Technology, Inc.Ave.   La Cuspide No.1 Del. Playas de Tijuana, TIJUANA, Baja California Mexico 225002023-07-24 變更
35組織鑷國械備20230355號(hào)BMC-PRIMA   GmbHHerrenbachstr.   17 73066 Uhingen Germany2023-07-24 有效
36牽開器國械備20230354號(hào)BMC-PRIMA   GmbHHerrenbachstr.   17 73066 Uhingen Germany2023-07-24 有效
37血紅蛋白檢測用裝載片國械備20190477號(hào)Fresenius   Kabi AGVon-Cancrin-Straβe   1, 63877 Sailauf ,  Deutschland2023-07-24 變更
38頭戴式檢查燈國械備20230353號(hào)(?)?????????   ?? ?????26? 12 R&D?? 403?2023-07-24 有效
39醫(yī)用放大鏡國械備20230352號(hào)(?)?????????   ?? ?????26? 12 R&D?? 403?2023-07-24 有效
40正畸鉗國械備20180071號(hào)Ortho   Organizers, Inc.1.Ranger   H.Q. Road Cantt, Sialkot – Pakistan；2.3232 N. Rockwell Street, Chicago, IL,   60618, United States；3.Nasir Road, Sialkot-Pakistan2023-07-21 變更
41醫(yī)用檢查手套國械備20170208號(hào)Henry   Schein Services GmbHLot   1365, Batu 17, Jalan Sungai Sembilang, Jeram, Kuala Selangor, Selangor Darul   Ehsan 45800 Malaysia2023-07-21 變更
42正畸鉗國械備20160817號(hào)Ormco   Corporation1)   1332 South Lone Hill Avenue, Glendora, California,  91740, USA;
   
    2) Circuito Sur No.31, Parque Industrial Nelson, Mexicali, B.C. C.P. 21395,   Mexico
   
    3) Calle Industrial Del Acero No.18, parque Industrial EL Vigia Mexicali,   Baja California Mexico 21397		2023-07-21 變更
43股骨干手術(shù)工具國械備20230351號(hào)SERF85   Avenue des Bruyères，69150 DECINES-CHARPIEU，F(xiàn)RANCE2023-07-21 有效
44CD28檢測試劑(流式細(xì)胞儀法)國械備20230350號(hào)BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-07-20 有效
45骨測量器國械備20200173號(hào)Rebstock   Instruments GmbHIn   Weiher Weiher?cker 7 78589 D Dürbheim Germany2023-07-20 無效
46骨測量器國械備20230349號(hào)Rebstock   Instruments GmbHIn   Weiher?cker 7 78589 Dürbheim, Germany2023-07-20 有效
47CD28檢測試劑(流式細(xì)胞儀法)國械備20230348號(hào)BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-07-20 有效
48瑞氏染色液   ADVIA Autoslide Modified Wright Stain國械備20151834號(hào)Siemens   Healthcare Diagnostics Inc.4481   Campus Drive, Kalamazoo, Michigan 49008 USA2023-07-20 變更
49緩沖液   ADVIA Autoslide Modified Wright Buffer國械備20151129號(hào)Siemens   Healthcare Diagnostics Inc.4481   Campus Drive, Kalamazoo, Michigan 49008, USA2023-07-20 變更
50CD28檢測試劑（流式細(xì)胞儀法）國械備20230347號(hào)BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-07-20 有效
51洗板機(jī)國械備20190496號(hào)Agilent   Technologies, Inc.100   Tigan Street Highland Park Winooski, VT 05404-0998 USA2023-07-20 變更
52洗板機(jī)國械備20190874號(hào)Agilent   Technologies, Inc.100   Tigan Street Highland Park Winooski, VT 05404-0998 USA2023-07-20 變更
53洗板機(jī)國械備20181472號(hào)Agilent   Technologies, Inc.100   Tigan Street Highland Park Winooski, VT 05404-0998 USA2023-07-20 變更
54骨關(guān)節(jié)手術(shù)器械國械備20170306號(hào)DePuy   Mitek325   Paramount Drive Raynham, MA 02767 USA2023-07-20 變更
55干式激光成像儀國械備20230346號(hào)COLENTA   Labortechnik GmbH & Co.KGNeunkirchner   Str.117,2700 Wiener Neustadt, Austria2023-07-20 有效
56肌電導(dǎo)聯(lián)線國械備20210504號(hào)Natus   Manufacturing LimitedIDA   Business Park Gort Co.Galway Ireland2023-07-20 變更
57電極導(dǎo)聯(lián)線國械備20220096號(hào)Natus   Neurology Incorporated3150   Pleasant View Road Middleton Wisconsin 53562 USA； IDA Business Park Gort Co.   Galway Ireland； 250 Okgucheondong-ro Siheung-si Gyeongi-do 15084 Republic of   Korea2023-07-20 變更
58腦電/肌電導(dǎo)聯(lián)線國械備20210518號(hào)Natus   Neurology Incorporated3150   Pleasant View Road Middleton, Wisconsin 53562 USA;IDA Business Park Gort   Co.Galway Ireland.2023-07-20 變更
59口腔數(shù)字觀察儀國械備20200038號(hào)ModJaw   SAS354   Voie Magellan 73800 Sainte-Hélène-du-Lac France2023-07-20 變更
60造口袋國械備20190171號(hào)ConvaTec   Inc.Carretera   Sanchez, Km. 18.5, Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina,   San Cristobal, 91000 Dominican Republic.2023-07-19 變更
61橡皮障器械國械備20171011號(hào)Kentzler-Kaschner   Dental GmbHMühlgraben   36,73479 Ellwangen/Jagst,Germany2023-07-19 變更
62正畸自鎖托槽開啟器國械備20210533號(hào)GNI   Co., Ltd.5F   501, 63-12, Dongtancheomdansaneop 1-ro, Hwaseong-si, Gyeonggi-do, Republic of   Korea2023-07-19 變更
63醫(yī)用退熱貼 國械備20230345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2023-07-19 有效
64 骨關(guān)節(jié)手術(shù)器械 國械備20140151號(hào)DePuy   Mitek325   Paramount Drive , Raynham, MA 02767 , USA；Puits Godet 20 NeuchatelCH-2000   Switzerland；Kibbutz GaatonKibbutz Gaaton25130 Israel2023-07-18 變更
65CD8抗體試劑（免疫組織化學(xué)）國械備20230344號(hào)Ventana   Medical Systems, Inc.1910   East Innovation Park Drive, Tucson AZ 85755, USA2023-07-18 有效
66醫(yī)用外固定支具國械備20170130號(hào)THUASNE118/120,   rue Marius Aufan BP 243 FR-92307 LEVALLOIS-PERRET; 4615 Shepard St.   Bakersfield, CA 93313;Im Steinkamp 12, 30938 Burgwedel 2023-07-18 變更
67自粘彈力繃帶國械備20161076號(hào)3M   Company601   22nd Ave. South Brookings, South Dakota, 57006, USA2023-07-17 變更
68口腔麻醉劑手動(dòng)助推器國械備20220200號(hào)SEPTODONT3,   rue Jean-Jacques Rousseau B.P. 282 - Aussillon Mazamet Cedex 81207 France2023-07-17 變更
69測瓣器/測環(huán)器/持環(huán)器連接手柄國械備20230343號(hào)Medtronic,   Inc.1851   E. Deere Avenue, Santa Ana, CA 92705, USA2023-07-17 有效
70手術(shù)頭燈國械備20230342號(hào)(?)????????????   166 102? 304?(???,???????)2023-07-17 有效
71牙科種植定位器國械備20150163號(hào)Dentium   Co., Ltd.150,   Eondong-ro, Giheung-gu, Yongin-si, Gyeonggi-do2023-07-17 變更
72測瓣器/測環(huán)器/持環(huán)器連接手柄國械備20230341號(hào)Medtronic,   Inc.1851   E. Deere Avenue, Santa Ana, CA 92705, USA2023-07-13 有效
73造口袋國械備20190931號(hào)Coloplast   A/SColoplast   Hungary KFT, Kerék utca 4, 2800 Tatabánya, Hungary2023-07-13 變更
74醫(yī)用放大鏡國械備20160791號(hào)Volk   Optical Inc.7893   Enterprise Drive, Mentor, OH, 44060, USA2023-07-13 變更
75醫(yī)用放大鏡國械備20161239號(hào)VOLK   OPTICAL INC.7893   Enterprise Drive, Mentor, OH, 44060, USA2023-07-13 變更
76非接觸眼底鏡國械備20210238號(hào)VOLK   OPTICAL INC.7893   ENTERPRISE DR. Mentor, OH USA 440602023-07-13 變更
77非接觸裂隙燈前置鏡國械備20210237號(hào)VOLK   OPTICAL INC.7893   ENTERPRISE DR. Mentor, OH USA 440602023-07-13 變更
78非接觸式眼底廣角觀察鏡國械備20162009號(hào)Volk   Optical Inc.7893   Enterprise Dr. Mentor, Ohio 440602023-07-13 變更
79非接觸式眼底廣角觀察鏡國械備20170162號(hào)Volk   Optical Inc.7893   Enterprise Dr. Mentor, Ohio 440602023-07-13 變更
80倒像鏡及裝置國械備20151251號(hào)Volk   Optical Inc.7893   Enterprise Drive, Mentor, OH, 44060, USA2023-07-13 變更
81倒像鏡及裝置國械備20170209號(hào)Volk   Optical Inc.7893   Enterprise Dr. Mentor, Ohio 440602023-07-13 變更
82眼科手術(shù)器械手柄國械備20220211號(hào)VOLK   OPTICAL INC.7893   ENTERPRISE DR. Mentor, OH USA 440602023-07-13 變更
83角膜接觸鏡片固定環(huán)國械備20220507號(hào)VOLK   OPTICAL INC.7893   ENTERPRISE DR. Mentor, OH USA 440602023-07-13 變更
84眼科手術(shù)器械包國械備20170174號(hào)MICROSURGICAL   TECHNOLOGY. INC.8415   154TH AVE NE REDMOND, WA USA 980522023-07-13 變更
85虹膜拉鉤國械備20181048號(hào)MICROSURGICAL   TECHNOLOGY, INC.8415   154th Ave Ne Redmond, WA 980522023-07-13 變更
86眼科手術(shù)刀國械備20171192號(hào)MICROSURGICAL   TECHNOLOGY, INC.3222   Phoenixville Pike, Malvern, PA USA 193352023-07-13 變更
87手術(shù)放大鏡國械備20140260號(hào)Keeler   Ltd.Clewer   Hill Rd., Windsor, Berkshire, SL4 4AA2023-07-13 變更
88醫(yī)用頭燈國械備20181337號(hào)Keeler   LtdClewer   Hill Road, Windsor, Berkshire, United Kingdom2023-07-13 變更
89鞏膜壓迫器國械備20220163號(hào)Keeler   LtdClewer   Hill Road, Windsor, Berkshire, SL4 4AA UK2023-07-13 變更
90耳鏡國械備20190791號(hào)Rudolf   Riester GmbHBruckstraβe   31, 72417 Jungingen, Germany2023-07-13 變更
91檢耳鏡國械備20180752號(hào)Rudolf   Riester GmbHBruckstraβe   31, 72417 Jungingen, Germany2023-07-13 變更
92耳鏡國械備20210416號(hào)Rudolf   Riester GmbHBruckstraβe   31, 72417 Jungingen, Germany2023-07-13 變更
93 二用聽診器 國械備20150317號(hào)Rudolf   Riester GmbHBruckstraβe   31 72417 Jungingen, Germany2023-07-13 變更
94手術(shù)放大鏡國械備20151134號(hào)Rudolf   Riester GmbHClewer   Hill Road, Windsor, Berkshire SL4 4AA, United Kingdom2023-07-13 變更
95雙翼陰道擴(kuò)張器國械備20160356號(hào)Rudolf   Riester GmbHSmall   Industrial Estate, Sialkot-Pakistan2023-07-13 變更
96眼科手術(shù)輔助用鉤國械備20160346號(hào)MICROSURGICAL   TECHNOLOGY, INC8415   154th Ave Ne Redmond. WA 980522023-07-13 變更
97聽覺檢查音叉國械備20170546號(hào)Rudolf   Riester GmbHBruckstra?e   31, 72417 Jungingen, Germany2023-07-13 變更
98頭戴式檢查燈國械備20190369號(hào)Rudolf   Riester GmbHBruckstraβe   31, 72417 Jungingen, Germany2023-07-13 變更
99醫(yī)用檢查燈國械備20190355號(hào)Rudolf   Riester GmbHBruckstraβe   31, 72417 Jungingen, Germany2023-07-13 變更
100試戴體國械備20181127號(hào)Alpha-Bio   Tec Ltd.7   Hatnufa St., Kiryat Arye, POB 3936 Petach Tikva, 4951025 Israel2023-07-13 變更
101替代體國械備20210225號(hào)//2023-07-13 變更
102牙科種植定位器國械備20140366號(hào)Alpha-Bio   Tec Ltd.7   Hatnufa St., Kiryat Arye, POB 3936, PetachTikva, 4951025 Israel2023-07-13 變更
103種植體掃描體國械備20180895號(hào)Alpha-Bio   Tec Ltd.7   Hatnufa St., Kiryat Arye POB 3936, Petach Tikva 4951025 Israel2023-07-13 變更
104電動(dòng)移位機(jī)國械備20200720號(hào)ArjoHuntleigh   ABul.ks.Wawrzyniaka   2, 62-052 Komorniki, Poland2023-07-13 變更
105電動(dòng)移位機(jī)國械備20200703號(hào)ArjoHuntleigh   AB2001,   rue Tanguay Magog Québec J1X 5Y5 Canada2023-07-13 變更
106干式激光成像儀國械備20180692號(hào)Bermedi   Medical Solutions GmbHB?lschestra?e   27, 12587 Berlin, Germany2023-07-13 變更
107牙科刮治器國械備20150700號(hào)LM-Instruments   OyNorrbyn   rantatie 8, 21600 Parainen, Finland2023-07-13 變更
108牙科潔治器國械備20150691號(hào)LM-Instruments   OyNorrbyn   rantatie 8, 21600 Parainen, Finland2023-07-13 變更
109牙用充填器國械備20151675號(hào)LM-Instruments   OYNorrbyn   rantatie 8, 21600 Parainen, Finland2023-07-13 變更
110方絲扭轉(zhuǎn)器國械備20170010號(hào)LM-Instruments   OyNorrbyn   rantatie 8, 21600 Parainen,FINLAND2023-07-13 變更
111電動(dòng)移位機(jī)國械備20200573號(hào)ArjoHuntleigh   ABul.ks.Wawrzyniaka   2, 62-052 Komorniki, Poland2023-07-13 變更
112電動(dòng)移位機(jī)國械備20190552號(hào)ArjoHuntleigh   AB2001,   rue Tanguay Magog Québec J1X 5Y5 Canada2023-07-13 變更
113顯微鉗國械備20190351號(hào)株式會(huì)社高山醫(yī)療機(jī)械製作所東京都臺(tái)東區(qū)谷中3-4-42023-07-12 變更
114顯微鉤國械備20190352號(hào)株式會(huì)社高山醫(yī)療機(jī)械製作所東京都臺(tái)東區(qū)谷中3-4-42023-07-12 變更
115手術(shù)剪國械備20230340號(hào)BMC-PRIMA   GmbHHerrenbachstr.   17 73066 Uhingen Germany2023-07-12 有效
116吸引管國械備20230338號(hào)BMC-PRIMA   GmbHHerrenbachstr.   17 73066 Uhingen Germany2023-07-12 有效
117醫(yī)用墊單國械備20220319號(hào)PAUL   HARTMANN AG見附件2023-07-11 變更
118鈦籠安裝專用工具包國械備20190607號(hào)Mediox   Orvosi Muszergyarto Kft3324   Fels?tárkány, 2473 hrsz. Hungary2023-07-11 變更
119頸椎前路鋼板系統(tǒng)手術(shù)工具包國械備20171256號(hào)Mediox   Orvosi M?szergyártó Kft.3324   Fels?tárkány, 2473 hrsz. Hungary2023-07-11 變更
120椎間融合器系統(tǒng)專用工具包國械備20190618號(hào)Mediox   Orvosi Muszergyarto Kft3324   Fels?tárkány, 2473 hrsz. Hungary2023-07-11 變更
121脊柱釘棒固定系統(tǒng)專用工具包國械備20190440號(hào)Mediox   Orvosi Muszergyarto Kft3324   Fels?tárkány, 2473 hrsz. Hungary2023-07-11 變更
122髓內(nèi)釘系統(tǒng)專用工具包國械備20220117號(hào)Mediox   Orvosi Müszergyártó Kft.3324   Fels?tárkány, 2473 hrsz. Hungary2023-07-11 變更
123空心螺釘系統(tǒng)專用工具包國械備20210411號(hào)Mediox   Orvosi Muszergyarto Kft3324   Fels?tárkány, 2473 hrsz. Hungary2023-07-11 變更
124脊柱后路鋼板系統(tǒng)專用工具包國械備20190556號(hào)Mediox   Orvosi Muszergyarto Kft3324   Fels?tárkány, 2473 hrsz. Hungary2023-07-11 變更
125鎖定金屬接骨板系統(tǒng)專用工具包國械備20220082號(hào)Mediox   Orvosi Müszergyártó Kft.3324   Fels?tárkány, 2473 hrsz. Hungary2023-07-11 變更
126二氧化碳吸收器國械備20230337號(hào)Intersurgical   Ltd.Crane   House, Molly Millars Lane, Wokingham, Berkshire, RG41 2RZ, UK2023-07-11 有效
127器械鉗國械備20230336號(hào)BMC-PRIMA   GmbHHerrenbachstr.   17 73066 Uhingen Germany2023-07-11 有效
128楔子國械備20161730號(hào)LM-Instruments   OyNorrbyn   rantatie 8, 21600 Parainen,FINLAND2023-07-10 變更
129口鏡國械備20161901號(hào)LM-Instruments   OyNorrbyn   rantatie 8, 21600 Parainen,FINLAND2023-07-10 變更
130正畸結(jié)扎器國械備20170011號(hào)LM-Instruments   OyNorrbyn   rantatie 8, 21600 Parainen,FINLAND2023-07-10 變更
131牙科輸送器國械備20160984號(hào)LM-Instruments   OyNorrbyn   rantatie 8, 21600 Parainen,FINLAND2023-07-10 變更
132剔挖器國械備20160694號(hào)LM-Instruments   OyNorrbyn   rantatie 8, 21600 Parainen,FINLAND2023-07-10 變更
133牙科種植定位器國械備20171115號(hào)LM-Instruments   OyNorrbyn   rantatie 8, 21600 Parainen,FINLAND2023-07-10 變更
134牙科去冠器國械備20170377號(hào)LM-Instruments   OyNorrbyn   rantatie 8, 21600 Parainen,FINLAND2023-07-10 變更
135牙釉鑿國械備20160044號(hào)LM-Instruments   OyNorrbyn   rantatie 8, 21600 Parainen, FINLAND2023-07-10 變更
136牙科用刀國械備20160045號(hào)LM-Instruments   OyNorrbyn   rantatie 8, 21600 Parainen,FINLAND2023-07-10 變更
137牙刮匙國械備20160262號(hào)LM-Instruments   OyNorrbyn   rantatie 8, 21600 Parainen,FINLAND2023-07-10 變更
138牙科石膏 國械備20181361號(hào)ZHERMACK   S.p.A.Via   Bovazecchino, 100 45021 Badia Polesine (RO) Italy2023-07-10 無效
139牙科石膏國械備20230335號(hào)ZHERMACK   S.p.AVia   Bovazecchino100, 45021 Badia Polesine (RO), ITALY2023-07-10 有效
140放射治療患者用固定裝置國械備20230334號(hào)Medtec,   LLC dba CIVCO Radiotherapy1401   8th St.SE,Orange City,IA,51041,United States2023-07-10 有效
141醫(yī)用檢查手套國械備20190681號(hào)Mexpo   International Inc.Lot   4969,Jalan Teratai, Batu 6, Off Jalan Meru, 41050 Klang, Selangor Darul   Ehsan, Malaysia2023-07-10 變更
142替代體國械備20181126號(hào)Alpha-Bio   Tec Ltd.7   Hatnufa St., Kiryat Arye, POB 3936 Petach Tikva, 4951025 Israel2023-07-07 變更
143螺絲起國械備20140371號(hào)Alpha-Bio   Tec Ltd.7   Hatnufa St., Kiryat Arye, POB3936, Petach Tikva, 4951025 Israel2023-07-07 變更
144扭力扳手國械備20140364號(hào)Alpha-Bio   Tec Ltd.7   Hatnufa St.,Kiryat Arye, POB3936, Petach Tikva, 4951025 Israel2023-07-07 變更
145螺絲起國械備20170255號(hào)Alpha-Bio   Tec.LTD7   Hatnufa St.,Kiryat Arye, POB 3936,Petach-TiKva,4951025,Israel2023-07-07 變更
146上頜竇提升器國械備20140365號(hào)Alpha-Bio   Tec Ltd.7   Hatnufa St., Kiryat Arye, POB 3936, Petach Tikva, 4951025 Israel2023-07-07 變更
147螺絲起國械備20190885號(hào)Alpha-Bio   Tec Ltd. 7   Hatnufa St.,Kiryat Arye POB 3936， Petach Tikva 4951025 Israel2023-07-07 變更
148牙用尺 國械備20180520號(hào)Alpha-Bio   Tec Ltd7   Hatnufa St., Kiryat Arye, POB 3936 Petach Tikva, 4951025 Israel2023-07-07 變更
149牙科塑料基底國械備20190159號(hào)Alpha-Bio   Tec Ltd.7   Hatnufa St., Kiryat Arye, POB 3936 Petach Tikva, 4951025 Israel2023-07-07 變更
150醫(yī)用放大鏡國械備20230333號(hào)(?)????????????   166 102? 304?(???,???????)2023-07-07 有效
151牙科用軟組織環(huán)切刀國械備20180519號(hào)Alpha-Bio   Tec Ltd.7   Hatnufa St., Kiryat Arye, POB 3936 Petach Tikva, 4951025 Israel2023-07-07 變更
152鉆針深度停止器國械備20171119號(hào)Alpha-Bio   Tec. Ltd.7   Hatnufa St., Kiryat Arye, POB 3936, Petach-TiKva, 4951025, Irsael2023-07-07 變更
153轉(zhuǎn)移帽國械備20180560號(hào)Alpha-Bio   Tec Ltd.7   Hatnufa St.,Kiryat Arye,POB 3936 Petach Tikva,4951025,Israel2023-07-07 變更
154一次性吸引管國械備20230332號(hào)Neuro   Enterprises, LLC2550   N Lakeview Ave. S-301 Chicago, IL 60614 Untied States of America2023-07-06 有效
155基礎(chǔ)外科手術(shù)器械國械備20161074號(hào)Spiggle   & Theis Medizintechnik GmbH Burghof   14 51491 Overath Germany2023-07-06 變更
156耳鼻喉科手術(shù)器械國械備20160604號(hào)Spiggle   & Theis Medizintechnik GmbHBurghof   14 51491 Overath Germany2023-07-06 變更
157牙科輸送頭國械備20170727號(hào)Coltène/Whaledent   AGFeldwiesenstrasse   20, 9450 Altst?tten, Switzerland2023-07-04 變更
158CD2檢測試劑國械備20181498號(hào)Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2023-07-04 變更
159CD2檢測試劑國械備20181499號(hào)Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2023-07-04 變更
160組織鉗國械備20230331號(hào)BMC-PRIMA   GmbHHerrenbachstr.   17 73066 Uhingen Germany2023-07-04 有效
161手術(shù)刀柄國械備20230330號(hào)Otto   Leibinger GmbHGriesweg   27 78570 Mühlheim Germany2023-07-04 有效
162口腔X射線攝片架國械備20170032號(hào)Kerr   CorporationVia   Strecce 4 P.O. 272 6934 Bioggio Switzerland2023-07-04 變更
163三用聽診器國械備20161053號(hào)3M   Company5400   Paris Rd Columbia, MO USA 652022023-07-04 變更
164口腔材料注射頭國械備20170501號(hào)Kerr   Corporation also trading as Pentron ClinicalRuetistrasse   7 Haag, Sankt Gallen Switzerland 94692023-07-04 變更
165橡皮障國械備20170006號(hào)Kerr   CorporationVia   Strecce 4 P.O. 272 6934 Bioggio Switzerland2023-07-04 變更
166正畸彈簧國械備20190772號(hào)Ormco   Corporation見附頁2023-07-04 變更
167試色糊劑國械備20181138號(hào)Kerr   Corporation1717   West Collins Avenue Orange California 92867 USA2023-07-04 變更
168測瓣器/持瓣器連接手柄國械備20230329號(hào)Medtronic,   Inc.1851   E. Deere Avenue, Santa Ana, CA 92705, USA2023-07-03 有效
169口腔給藥器國械備20220183號(hào)Sópipa   Pharma Kft.1146   Budapest, Francia u. 57/c.2023-07-03 變更
170口腔治療器具國械備20230328號(hào)NAWAZ   SURGICAL Co. Wahid   Street, Deen Pura, Capital Road, Sialkot -51310 Pakistan.2023-07-03 有效
171醫(yī)用激光膠片國械備20171024號(hào)コニカミノルタ株式會(huì)社8124   Pacific Avenue White City，Oregen USA 97503；日本埼玉県久喜市菖蒲町三箇6201-62023-07-03 變更
172醫(yī)用干式激光膠片國械備20180691號(hào)Bermedi   Medical Solutions GmbHB?lschestra?e   27, 12587 Berlin, Germany2023-07-03 變更
173燒傷（整形）科手術(shù)器械國械備20180012號(hào)Mill   Medical Instruments B.V.UNIT   801B 8/F TREND CTR 29 CHEUNG LEE ST CHAI WAN，HONG KONG2023-07-27 無效
174計(jì)劃生育手術(shù)器械國械備20180011號(hào)Mill   Medical Instruments B.V.UNIT   801B 8/F TREND CTR 29 CHEUNG LEE ST CHAI WAN，HONG KONG2023-07-27 無效
175婦產(chǎn)科用手術(shù)器械國械備20180002號(hào)Mill   Medical Instruments B.V.UNIT   801B 8/F TREND CTR 29 CHEUNG LEE ST CHAI WAN，HONG KONG2023-07-27 無效
176泌尿肛腸外科手術(shù)器械國械備20180001號(hào)Mill   Medical Instruments B.V.UNIT   801B 8/F TREND CTR 29 CHEUNG LEE ST CHAI WAN，HONG KONG2023-07-27 無效
177矯形外科（骨科）手術(shù)器械國械備20171254號(hào)Mill   Medical Instruments B.V.UNIT   801B 8/F TREND CTR 29 CHEUNG LEE ST CHAI WAN，HONG KONG2023-07-27 無效
178耳鼻喉科手術(shù)器械 國械備20171242號(hào)Mill   Medical Instruments B.V.UNIT   801B 8/F TREND CTR 29 CHEUNG LEE ST CHAI WAN，HONG KONG2023-07-27 無效
179腹部外科手術(shù)器械國械備20171251號(hào)Mill   Medical Instruments B.V.UNIT   801B 8/F TREND CTR 29 CHEUNG LEE ST CHAI WAN，HONG KONG2023-07-27 無效
180基礎(chǔ)外科手術(shù)器械國械備20170581號(hào)Mill   Medical Instruments B.V.Unit   801B 8/F Trend Ctr 29 Cheung Lee St Chai Wan,Hong Kong2023-07-27 無效
181無針注射推進(jìn)器國械備20171210號(hào)Mill   Medical Instruments B.V.UNIT   801B 8/F TREND CTR 29 CHEUNG LEE ST CHAI WAN，HONG KONG2023-07-27 無效
182胸腔心血管外科手術(shù)器械國械備20171239號(hào)Mill   Medical Instruments B.V.UNIT   801B 8/F TREND CTR 29 CHEUNG LEE ST CHAI WAN，HONG KONG2023-07-27 無效
183顯微外科手術(shù)器械國械備20171219號(hào)Mill   Medical Instruments B.V.UNIT   801B 8/F TREND CTR 29 CHEUNG LEE ST CHAI WAN，HONG KONG2023-07-27 無效
184口腔科手術(shù)器械國械備20171229號(hào)Mill   Medical Instruments B.V.UNIT   801B 8/F TREND CTR 29 CHEUNG LEE ST CHAI WAN，HONG KONG2023-07-27 無效
185眼科手術(shù)器械國械備20171234號(hào)Mill   Medical Instruments B.V.UNIT   801B 8/F TREND CTR 29 CHEUNG LEE ST CHAI WAN，HONG KONG2023-07-27 無效
186神經(jīng)外科手術(shù)器械國械備20171228號(hào)Mill   Medical Instruments B.V.UNIT   801B 8/F TREND CTR 29 CHEUNG LEE ST CHAI WAN，HONG KONG2023-07-27 無效
187基礎(chǔ)外科手術(shù)器械國械備20180031號(hào)Mill   Medical Instruments B.V.UNIT   801B 8/F TREND CTR 29 CHEUNG LEE ST CHAI WAN，HONG KONG.2023-07-27 無效

更多進(jìn)口第一類醫(yī)療器械產(chǎn)品備案服務(wù)需求，歡迎您隨時(shí)方便與杭州證標(biāo)客醫(yī)藥技術(shù)咨詢有限公司聯(lián)絡(luò)，聯(lián)系人：葉工，電話：18058734169，微信同。

Copyright © 2018 醫(yī)療器械注冊技術(shù)咨詢 浙ICP備18025678號(hào) 技術(shù)支持：熙和網(wǎng)絡(luò)