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2023年2月總局批準(zhǔn)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案158個(gè)
發(fā)布日期:2023-03-13 19:58瀏覽次數(shù):2209次
2023年3月13日來(lái)自國(guó)家藥監(jiān)局的消息,藥監(jiān)總局2023年2月共批準(zhǔn)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案158個(gè),如醫(yī)用檢查手套、一次性醫(yī)用丁腈橡膠手套、導(dǎo)引針、高速冷凍離心機(jī)、頭戴式放大鏡、干式激光成像儀、壓力繃帶等眾多產(chǎn)品,詳見(jiàn)正文。

2023年3月13日來(lái)自國(guó)家藥監(jiān)局的消息,藥監(jiān)總局2023年2月共批準(zhǔn)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案158個(gè),如醫(yī)用檢查手套、一次性醫(yī)用丁腈橡膠手套、導(dǎo)引針、高速冷凍離心機(jī)、頭戴式放大鏡、干式激光成像儀、壓力繃帶等眾多產(chǎn)品,詳見(jiàn)正文。

第一類醫(yī)療器械產(chǎn)品備案.jpg

2023年2月進(jìn)口第一類醫(yī)療器械產(chǎn)品備案信息

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腕部固定系統(tǒng)手術(shù)器械國(guó)械備20200202號(hào)TriMed,   Inc.27533   Avenue Hopkins, Santa Clarita, CA 91355, USA2023-02-28 變更
2研光器國(guó)械備20230127號(hào)ASA   DENTAL SPAVIA   FIERLA 13-33085 MANIAGO (PN)2023-02-28 有效
3橡皮障支架國(guó)械備20230126號(hào)ASA   DENTAL SPAVIA   FIERLA 13-33085 MANIAGO (PN)2023-02-28 有效
4銀汞合金輸送器國(guó)械備20230125號(hào)ASA   DENTAL SPAVIA   FIERLA 13-33085 MANIAGO (PN)2023-02-28 有效
5牙科用軟組織環(huán)切刀國(guó)械備20230124號(hào)ASA   DENTAL SPAVIA   FIERLA 13-33085 MANIAGO (PN)2023-02-28 有效
6牙骨銼國(guó)械備20230123號(hào)ASA   DENTAL SPAVIA   FIERLA 13-33085 MANIAGO (PN)2023-02-28 有效
7橡皮障夾鉗 國(guó)械備20230122號(hào)ASA   DENTAL SPAVIA   FIERLA 13-33085 MANIAGO (PN)2023-02-28 有效
8橡皮障打孔器國(guó)械備20230121號(hào)ASA   DENTAL SPAVIA   FIERLA 13-33085 MANIAGO (PN)2023-02-28 有效
9成形片國(guó)械備20170117號(hào)Kerr   CorporationVia   Strecce 4 P.O. 272 6934 Bioggio Switzerland2023-02-28 變更
10人工肩關(guān)節(jié)系統(tǒng)手術(shù)器械包國(guó)械備20230120號(hào)Tornier   SAS161   Rue Lavoisier, 38330 Montbonnot-Saint-Martin, FRANCE2023-02-27 有效
11口腔科器械國(guó)械備20191336號(hào)A.Schweickhardt   GmbH&Co.KGTuttlinger   Stra?e 12 78606 Seitingen / Tuttlingen Germany2023-02-27 變更
12牙用充填器國(guó)械備20230119號(hào)ASA   DENTAL SPAVIA   FIERLA 13-33085 MANIAGO (PN)2023-02-24 有效
13牙科骨磨國(guó)械備20230118號(hào)ASA   DENTAL SPAVIA   FIERLA 13-33085 MANIAGO (PN)2023-02-24 有效
14牙用尺國(guó)械備20230117號(hào)ASA   DENTAL SPAVIA   FIERLA 13-33085 MANIAGO (PN)2023-02-24 有效
15牙科輸送器國(guó)械備20230116號(hào)ASA   DENTAL SPAVIA   FIERLA 13-33085 MANIAGO (PN)2023-02-24 有效
16牙科刮治器  國(guó)械備20161891    號(hào)株式會(huì)社YDM埼玉県東松山市今泉28番地2023-02-24 變更
17印模轉(zhuǎn)移桿國(guó)械備20190965號(hào)SHINHUNG   MST CO., LTD.110-2,Donghwagongdan-ro,Munmak-eup,Wonju-si,Gangwon-do,26365,Rep.   of KOREA2023-02-24 變更
18正畸鉗國(guó)械備20161162號(hào)株式會(huì)社YDM埼玉県東松山市今泉28番地2023-02-24 變更
19口腔麻醉手動(dòng)注射架國(guó)械備20230115號(hào)ASA   DENTAL SPAVIA   FIERLA 13-33085 MANIAGO (PN)2023-02-24 有效
20牙科骨粉調(diào)和用金屬容器國(guó)械備20230114號(hào)ASA   DENTAL SPAVIA   FIERLA 13-33085 MANIAGO (PN)2023-02-24 有效
21EMA抗體試劑(免疫組織化學(xué))國(guó)械備20230113號(hào)Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42 DK-2600 Glostrup DENMARK2023-02-23 有效
22bcl-2抗體試劑(免疫組織化學(xué))國(guó)械備20230112號(hào)Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42 DK-2600 Glostrup DENMARK2023-02-23 有效
23Ber-EP4抗體試劑(免疫組織化學(xué))國(guó)械備20230111號(hào)Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42 DK-2600 Glostrup DENMARK2023-02-23 有效
24檢查手套國(guó)械備20181354號(hào)B.   Braun Melsungen AGLatexx   Partners Berhad, Lot 18374, Jalan Perusahaan 3, Kamunting Industrial Estate,   34600 Kamunting, Taiping, Perak, Malaysia2023-02-23 無(wú)效
25牙科種植用延長(zhǎng)器國(guó)械備20161072號(hào)BioHorizons   Implant Systems, Inc.2300   Riverchase Center, Birmingham, Alabama 35244 USA2023-02-23 變更
26試戴體國(guó)械備20161046號(hào)BioHorizons   Implant Systems, Inc.2300   Riverchase Center, Birmingham, Alabama 35244 USA2023-02-23 變更
27牙科骨擠壓器國(guó)械備20160935號(hào)BioHorizons   Implant Systems, Inc.2300   Riverchase Center, Birmingham, Alabama 35244 USA2023-02-23 變更
28牙用尺國(guó)械備20160516號(hào)BioHorizons   Implant Systems, Inc.2300   Riverchase Center Birmingham Alabama 35244 USA2023-02-23 變更
29螺絲起國(guó)械備20161071號(hào)BioHorizons   Implant Systems, Inc.2300   Riverchase Center, Birmingham, Alabama 35244 USA2023-02-23 變更
30基臺(tái)適配器國(guó)械備20170668號(hào)BioHorizons   Implant Systems, Inc.2300   Riverchase Center, Birmingham, Alabama 35244 USA2023-02-23 變更
31種植體內(nèi)螺紋修復(fù)器國(guó)械備20161080號(hào)BioHorizons   Implant Systems, Inc.2300   Riverchase Center, Birmingham, Alabama 35244 USA2023-02-23 變更
32牙科用銼國(guó)械備20161073號(hào)BioHorizons   Implant Systems, Inc.2300   Riverchase Center, Birmingham, Alabama 35244 USA2023-02-23 變更
33轉(zhuǎn)移帽國(guó)械備20161082號(hào)BioHorizons   Implant Systems, Inc.2300   Riverchase Center, Birmingham, Alabama 35244 USA2023-02-23 變更
34種植體旋入止停器國(guó)械備20190692號(hào)BioHorizons   Implant Systems, Inc.  2300   Riverchase Center, Birmingham, Alabama, 35244 USA2023-02-23 變更
35替代體國(guó)械備20190775號(hào)BioHorizons   Implant Systems, Inc.2300   Riverchase Center, Birmingham, Alabama, 35244 USA2023-02-23 變更
36基臺(tái)夾持器國(guó)械備20191276號(hào)BioHorizons   Implant Systems, Inc.2300   Riverchase Center Birmingham Alabama, 35244 USA2023-02-23 變更
37Ber-EP4抗體試劑(免疫組織化學(xué))國(guó)械備20230110號(hào)Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42 DK-2600 Glostrup DENMARK2023-02-23 有效
38ERG抗體試劑(免疫組織化學(xué))國(guó)械備20230109號(hào)Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42 DK-2600 Glostrup DENMARK2023-02-23 有效
39醫(yī)用外固定支具國(guó)械備20230108號(hào)DJO,LLCNo.143,   Sec.2, Zhangxin Rd., Hemei Township, Changhua County 50854, Taiwan (R.O.C.)2023-02-23 有效
40導(dǎo)航定位系統(tǒng)工具國(guó)械備20230078號(hào)Medtronic   Navigation, Inc.826   Coal Creek Circle Louisville, CO 80027 United States of America2023-02-23 變更
41CD21抗體試劑(免疫組織化學(xué))國(guó)械備20230107號(hào)Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42 DK-2600 Glostrup DENMARK2023-02-22 有效
42巨細(xì)胞病毒抗體試劑(免疫組織化學(xué))國(guó)械備20230106號(hào)Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42 DK-2600 Glostrup DENMARK2023-02-22 有效
43巨細(xì)胞病毒抗體試劑(免疫組織化學(xué))國(guó)械備20230105號(hào)Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42 DK-2600 Glostrup DENMARK2023-02-22 有效
44CD7抗體試劑(免疫組織化學(xué))國(guó)械備20230104號(hào)Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42 DK-2600 Glostrup DENMARK2023-02-22 有效
45bcl-6抗體試劑(免疫組織化學(xué))國(guó)械備20230103號(hào)Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42 DK-2600 Glostrup DENMARK2023-02-22 有效
46牙科種植材料取出器國(guó)械備20151824號(hào)Nobel   Biocare ABDimbov?gen   2 SE-691 51 Karlskoga Sweden;22715 Savi Ranch Parkway Yorba Linda California   92887 USA;Engvej 33, 3330 G?rl?se, Denmark;74950 SCIONZIER France;Trophagener   Weg 25, 32657 Lemgo Deutschland;3233 W. Harvard Street, Santa Ana,   California, 92704,USA2023-02-22 變更
47牙科用軟組織環(huán)切刀國(guó)械備20151961號(hào)Nobel   Biocare ABDimbovagen   2 SE-691 51 Karlskoga Sweden;22715 Savi Ranch Parkway Yorba Linda California   92887 USA;Engvej 33, 3330 G?rl?se, Denmark;3233 W. Harvard Street, Santa Ana,   California, 92704,USA2023-02-22 變更
48牙科器械鉗國(guó)械備20230102號(hào)ASA   DENTAL SPAVIA   FIERLA 13-33085 MANIAGO (PN)2023-02-22 有效
49截石位手術(shù)體位固定架國(guó)械備20160606號(hào)ALLEN   MEDICAL SYSTEMS,INC.100   Discovery Way Acton,MA 017202023-02-22 變更
50牙科用鑷國(guó)械備20230101號(hào)ASA   DENTAL SPA VIA   FIERLA 13-33085 MANIAGO (PN)2023-02-22 有效
51牙科用剪國(guó)械備20230100號(hào)ASA   DENTAL SPAVIA   FIERLA 13-33085 MANIAGO (PN)2023-02-22 有效
52硅橡膠復(fù)制材料包國(guó)械備20210231號(hào)DETAX   GmbHCarl-Zeiss-Straβe   4, 76275 Ettlingen, Germany2023-02-22 變更
53X射線膠片顯影液國(guó)械備20230099號(hào)Carestream   Health,Inc.1049   West Ridge Road,Rochester, NY USA 146152023-02-22 有效
54X射線膠片顯影液和定影液國(guó)械備20230098號(hào)Caretsream   Health,Inc.1049   West Ridge Road,Rochester,NY USA 146152023-02-22 有效
55X射線膠片定影液國(guó)械備20230097號(hào)Carestream   Health,Inc.1049   West Ridge Road,Rochester, NY USA 146152023-02-22 有效
56拔牙鉗國(guó)械備20230096號(hào)ASA   DENTAL SPAVIA   FIERLA 13-33085 MANIAGO (PN)2023-02-22 有效
57牙科用牽開(kāi)器國(guó)械備20230095號(hào)ASA   DENTAL SPAVIA   FIERLA 13-33085 MANIAGO (PN)2023-02-22 有效
58牙科用刀國(guó)械備20230094號(hào)ASA   DENTAL SPA VIA FIERLA 13-33085 MANIAGO (PN)2023-02-22 有效
59硅橡膠復(fù)制材料國(guó)械備20190650號(hào)DETAX   GmbHCarl-Zeiss-Straβe   4, 76275 Ettlingen, Germany2023-02-21 變更
60模型樹(shù)脂包國(guó)械備20190744號(hào)DETAX   GmbHCarl-Zeiss-Straβe   4, 76275 Ettlingen, Germany2023-02-21 變更
61微生物比濁儀國(guó)械備20230093號(hào)Beckman   Coulter, Inc.25   Bradley Drive, Westbrook, Maine 04092, USA2023-02-21 有效
62自粘彈力繃帶國(guó)械備20161076號(hào)3M   Company601   22nd Ave. South Brookings, South Dakota, 57006, USA2023-02-21 變更
63自粘彈力繃帶 國(guó)械備20150894號(hào)3M   Company3M   Brookings, 601 22ND AVE. South Brookings, South Dakota, 57006, USA2023-02-21 變更
64醫(yī)用退熱凝膠國(guó)械備20210308號(hào)SACRUM   ALGAE株式會(huì)社東京都足立區(qū)梅田六丁目9番6號(hào)2023-02-21 變更
65人體定位墊國(guó)械備20230092號(hào)Philips   Medical Systems Nederland B.V.Veenpluis   6, 5684 PC Best, The Netherlands2023-02-21 有效
66非接觸裂隙燈前置鏡國(guó)械備20210237號(hào)VOLK   OPTICAL INC.7893   ENTERPRISE DR. Mentor, OH USA 440602023-02-21 變更
67種植體清潔刷國(guó)械備20200167號(hào) 光弘生醫(yī)科技股份有限公司桃園市蘆竹區(qū)內(nèi)厝里大豐街21號(hào)2023-02-20 變更
68創(chuàng)傷手術(shù)器械包國(guó)械備20151190號(hào)Zimmer   Switzerland Manufacturing GmbHSulzerallee   8, Winterthur, 8404, Switzerland2023-02-20 變更
69肱骨髓內(nèi)釘手術(shù)工具國(guó)械備20210174號(hào)Zimmer   Switzerland Manufacturing GmbHSulzerallee   8, Winterthur 8404 Switzerland2023-02-20 變更
70手術(shù)托架 國(guó)械備20220036號(hào)ミズホ株式會(huì)社新潟県五泉市赤海3631番14,千葉県佐倉(cāng)市太田2173番地132023-02-17 變更
71腹腔用拉鉤裝置器國(guó)械備20160311號(hào)Max   Hauser Süddeutsche Chirurgiemechanik GmbHF?hrenstra?e   33,78532 Tuttlingen Germany2023-02-17 變更
72牙科骨磨國(guó)械備20230091號(hào)A.Schweickhardt   GmbH & Co.KGTuttlinger   Stra?e 12 78606 Seitingen/ Tuttlingen Germany2023-02-17 有效
73注射器輔助推進(jìn)槍國(guó)械備20230090號(hào)Owen   Mumford LimitedPrimsdown   Industrial Estate, Worcester Road, Chipping Norton, Oxfordshire,OX7 5XP,   United Kingdom2023-02-17 有效
74藥敏接種培養(yǎng)液國(guó)械備20230089號(hào)Remel,   Inc12076   Santa Fe Trail Drive Lenexa Kansas 66215 USA2023-02-16 有效
75肉湯培養(yǎng)基國(guó)械備20230088號(hào)Remel,   Inc12076   Santa Fe Trail Drive Lenexa Kansas 66215 USA2023-02-16 有效
76清洗液國(guó)械備   20170375號(hào)EKF-diagnostic   GmbHEbendorfer   Chaussee 3, 39179 Barleben, GERMANY2023-02-16 變更
77樣本稀釋液國(guó)械備20150741號(hào)Wallac   OyMustionkatu   6, FI-20750 Turku, Finland2023-02-16 無(wú)效
78上肢醫(yī)用外固定支具國(guó)械備20170269號(hào)?ssur   hf.Grjotháls   1-5 Reykjavik 110 Iceland2023-02-15 變更
79糞便檢驗(yàn)預(yù)處理裝置國(guó)械備20151619號(hào)EIKEN   CHEMICAL CO., LTD.3585,   Kando, Yoshida-cho, Haibara-gun, Shizuoka, 421-0304 JAPAN2023-02-15 變更
80骨科手術(shù)器械國(guó)械備20191138號(hào)Limacorporate   S.p.A.Via   Nazionale, 52 33038 Villanova San Daniele del Friuli (UDINE) ITALY2023-02-15 變更
81醫(yī)用檢查手套國(guó)械備20230087號(hào)UG   GLOBAL RESOURCES SDN. BHD.Lot   62 & 63, Lorong Senawang 3/2,Kawasan Perindustrian Senawang, 70450   Seremban, Negeri Sembilan Darul Khusus, Malaysia2023-02-15 有效
82醫(yī)用支撐腿架國(guó)械備20230086號(hào)MAQUET   GmbHKehler   Straβe 31, 76437 Rastatt, Germany2023-02-14 有效
83手術(shù)剪國(guó)械備20230085號(hào)Berger   Surgical Medical Products GmbHTake-off-Gewerbepark   4 D-78579 Neuhausen ob Eck2023-02-14 有效
84肛門鏡國(guó)械備20230084號(hào)Berger   Surgical Medical Products GmbHTake-off-Gewerbepark   4 D-78579 Neuhausen ob Eck2023-02-14 有效
85外耳道擴(kuò)張器國(guó)械備20230083號(hào) Berger Surgical Medical Products GmbHTake-off-Gewerbepark   4 D-78579 Neuhausen ob Eck2023-02-14 有效
86壓板國(guó)械備20230082號(hào)Berger   Surgical Medical Products GmbHTake-off-Gewerbepark   4 D-78579 Neuhausen ob Eck 2023-02-14 有效
87種植輔助器械包國(guó)械備20180112號(hào)ALTATEC   GmbHMaybachstr.   5,71299 Wimsheim, Germany2023-02-13 變更
88牙科模型材料國(guó)械備20161677號(hào)ALTATEC   GmbHMaybachstr.5,   71299 Wimsheim, GERMANY2023-02-13 變更
89轉(zhuǎn)移帽國(guó)械備20180208號(hào)ALTATEC   GmbHMaybachstr.   5,71299 Wimsheim, Germany2023-02-13 變更
90種植體安裝輔助器械國(guó)械備20190350號(hào)ALTATEC   GmbHMaybachstr.   5, 71299 Wimsheim, GERMANY2023-02-13 變更
91種植體安裝輔助器械國(guó)械備20180987號(hào)ALTATEC   GmbHMaybachstr.   5, 71299 Wimsheim, Germany2023-02-13 變更
92牙科種植輔助器械包國(guó)械備20180988號(hào)ALTATEC   GmbHMaybachstr.   5, 71299 Wimsheim, Germany2023-02-13 變更
93種植輔助材料國(guó)械備20181551號(hào)ALTATEC   GmbHMaybachstr.   5, 71299 Wimsheim, GERMANY2023-02-13 變更
94牙科骨擠壓器國(guó)械備20170960號(hào)ALTATEC   GmbHMaybachstr.   5,71299 Wimsheim, Germany2023-02-13 變更
95夾板及固定帶國(guó)械備20190059號(hào)VAR?TEKS   ORTOPED? SANAY? A.?.Maltepe   Mah, Aile Bah?e Sok., Litros Yolu, No: 10, 34010, Zeytinburnu, ?stanbul,   Turkey2023-02-13 變更
96踝部固定器國(guó)械備20230081號(hào)PAVIS   S.P.A.Via   G.Rossini, 11/B - 21020 Buguggiate (VA), Italy2023-02-10 有效
97麥?zhǔn)媳葷嵊?jì)國(guó)械備20220077號(hào)Trek   Diagnostic Systems LtdViking   House Ellingham Way Ashford TN23 6NF United Kingdom2023-02-10 變更
98髖關(guān)節(jié)手術(shù)器械國(guó)械備20151787號(hào)Smith   & Nephew,Inc1450   Brooks Road, Memphis, Tennessee, 38116, USA;
   
    Alemannenstraβe 14, D-78532, Tuttlingen, 78532, Germany;
   
    2 lengkok Teluk Kumbar 1, Jalan Teluk Kumbar, 11920 Bayan Lepas, Penang,   MALAYSIA;
   
    Schachenallee 29, 5001 Aarau, SWITZERLAND;
   
    Boulevard Héctor Terán #20120, Ciudad Industrial, Tijuana, B.C. 22444,   Mexico.
   
   
2023-02-09 變更
99小骨關(guān)節(jié)植入物手術(shù)器械包國(guó)械備20160867號(hào)Wright   Medical Technology, Inc.11576   Memphis Arlington Road, Arlington, Tennessee, 38002, USA2023-02-09 變更
100空心加壓螺釘系統(tǒng)手術(shù)器械包國(guó)械備20160475號(hào)Wright   Medical Technology, Inc.11576   Memphis Arlington Road, Arlington, Tennessee, 38002, USA2023-02-09 變更
101足踝系統(tǒng)用手術(shù)器械包國(guó)械備20161099號(hào)Wright   Medical Technology, Inc.11576   Memphis Arlington Road, Arlington, Tennessee, 38002, USA2023-02-09 變更
102骨折固定系統(tǒng)手術(shù)器械包國(guó)械備20160931號(hào)Wright   Medical Technology, Inc.11576   Memphis Arlington Road, Arlington, Tennessee, 38002, USA2023-02-09 變更
103足踝釘板系統(tǒng)用手術(shù)器械包國(guó)械備20191102號(hào)Wright   Medical Technology, Inc.11576   Memphis Arlington Road, Arlington, Tennessee, 38002, USA2023-02-09 變更
104模型樹(shù)脂國(guó)械備20180695號(hào)VERICOM   CO., LTD48,Toegyegongdan   1-gil,Chuncheon-si, Gangwon-do, 200-944,Republic of KOREA2023-02-09 變更
105骨鉸刀國(guó)械備20191045號(hào)Wright   Medical Technology, Inc.11576   Memphis Arlington Road, Arlington, Tennessee, 38002, USA2023-02-09 變更
106足踝釘板系統(tǒng)手術(shù)器械包國(guó)械備20190267號(hào)Wright   Medical Technology, Inc11576   Memphis Arlington Road, Arlington, Tennessee, 38002, USA2023-02-09 變更
107足踝髓內(nèi)釘系統(tǒng)手術(shù)器械包國(guó)械備20161201號(hào)Wright   Medical Technology, Inc.11576   Memphis Arlington Road, Arlington, Tennessee, 38002, USA2023-02-09 變更
108全踝關(guān)節(jié)手術(shù)器械包國(guó)械備20161100號(hào)Wright   Medical Technology, Inc.11576   Memphis Arlington Road, Arlington, Tennessee, 38002, USA2023-02-09 變更
109壓力繃帶國(guó)械備20230080號(hào)SIGVARIS   Inc.13055   Riley St., Suite 30 Holland, Michigan 49424 USA2023-02-09 有效
110肘關(guān)節(jié)手術(shù)器械包國(guó)械備20160724號(hào)Wright   Medical Technology, Inc.11576   Memphis Arlington Road, Arlington, Tennessee, 38002, USA2023-02-09 變更
111壓力繃帶國(guó)械備20230079號(hào)SIGVARIS   Inc.13055   Riley St., Suite 30 Holland, Michigan 49424 USA2023-02-09 有效
112全踝關(guān)節(jié)手術(shù)器械包國(guó)械備20191444號(hào)Wright   Medical Technology, Inc.11576   Memphis Arlington Road, Arlington, Tennessee, 38002, USA2023-02-09 變更
113骨鉸刀國(guó)械備20191100號(hào)Wright   Medical Technology, Inc.11576   Memphis Arlington Road, Arlington, Tennessee, 38002, USA2023-02-09 變更
114全踝關(guān)節(jié)手術(shù)器械包國(guó)械備20200188號(hào)Wright   Medical Technology, Inc.11576   Memphis Arlington Road, Arlington, Tennessee, 38002, USA2023-02-09 變更
115骨科定位片國(guó)械備20191061號(hào)Wright   Medical Technology, Inc.11576   Memphis Arlington Road, Arlington, Tennessee, 38002, USA2023-02-09 變更
116導(dǎo)航定位系統(tǒng)工具國(guó)械備20230078號(hào)Medtronic   Navigation, Inc.826   Coal Creek Circle Louisville, CO 80027 United States of America2023-02-09 有效
117超聲探頭穿刺架國(guó)械備20230077號(hào)GE   ヘルスケア?ジャパン株式會(huì)社〒191-8503   東京都日野市旭が丘 4-7-1272023-02-08 有效
118牙科橡皮障楔線國(guó)械備20160116號(hào)Dent4You   AG235   Ascot Parkway Cuyahoga Falls, OH 44223 United States of America2023-02-08 變更
119骨科手術(shù)器械國(guó)械備20191433號(hào)Limacorporate   S.p.A.Via   Nazionale, 52 33038 Villanova San Daniele del Friuli (UDINE) ITALY2023-02-08 變更
120骨科手術(shù)器械國(guó)械備20200331號(hào)HPF   S.r.l.Via   Pinzano, 24 - 33030 Flagogna di Forgaria nel Friuli (UD) - Italy2023-02-08 變更
121下肢醫(yī)用外固定支具國(guó)械備20150418號(hào)Breg   Inc.Calzada   Presidnte Venustiano Carrnza #33, C.P.21385, Mexicali, Baja California,   Mexico2023-02-08 變更
122上肢醫(yī)用外固定支具國(guó)械備20150417號(hào)Breg   Inc.Calzada   Presidnte Venustiano Carrnza #33, C.P.21385, Mexicali, Baja California,   Mexico2023-02-08 變更
123踝部固定器國(guó)械備20180276號(hào)Breg   Inc見(jiàn)附件2023-02-08 變更
124醫(yī)用外固定支具國(guó)械備20180274號(hào)Breg   IncCalzada   Presidnte Venustiano Carrnza #33, C.p.21385, Mexicali, Baja California,   Mexico.2023-02-08 變更
125橡皮障支架國(guó)械備20160478號(hào)Dent4You   AG235   Ascot Parkway Cuyahoga Falls OH 44223 United States Of America2023-02-07 變更
126橡皮障打孔器國(guó)械備20160375號(hào)Dent4You   AG235   Ascot Parkway Cuyahoga Falls OH 44223 United States Of America2023-02-07 變更
127牙刮匙國(guó)械備20230076號(hào)ASA   DENTAL SPAVIA   FIERLA 13-33085 MANIAGO (PN)2023-02-07 有效
128醫(yī)用彈力貼布國(guó)械備20191353號(hào)ニチバン株式會(huì)社日本福岡県朝倉(cāng)郡筑前町野町字禪門橋17132023-02-06 變更
129婦產(chǎn)科手術(shù)器械國(guó)械備20200043號(hào)DELMONT   IMAGING390   Avenue du Mistral, 13600 La Ciotat, France2023-02-06 變更
130橡皮障夾鉗國(guó)械備20160376號(hào)Dent4You   AG235   Ascot Parkway Cuyahoga Falls OH 44223 United States Of America2023-02-06 變更
131橡皮障夾國(guó)械備20151720號(hào)Dent4You   AG235   Ascot Parkway Cuyahoga Falls, OH 44223 United States of America2023-02-06 變更
132口腔科手術(shù)器械國(guó)械備20230075號(hào)ASAS   AND BROTHERS ENTERPRISESMODEL   TOWN,UGOKI,SIALKOT,PAKISTAN2023-02-06 有效
133異硫氰酸熒光素(FITC)標(biāo)記的兔抗人C3c(含伊文氏蘭)國(guó)械備20200399號(hào)EUROIMMUN   Medizinische Labordiagnostika AGWerkstraβe   1, 23942 Dassow, Germany 2023-02-06 變更
134異硫氰酸熒光素(FITC)標(biāo)記的羊抗人IgG(含碘化丙啶)國(guó)械備20200400號(hào)EUROIMMUN   Medizinische Labordiagnostika AGWerkstraβe   1, 23942 Dassow, Germany2023-02-06 變更
135異硫氰酸熒光素(FITC)標(biāo)記的羊抗人IgM(含伊文氏蘭)國(guó)械備20200398號(hào)EUROIMMUN   Medizinische Labordiagnostika AGWerkstraβe   1, 23942 Dassow, Germany 2023-02-06 變更
136干式激光成像儀國(guó)械備20151260號(hào)コニカミノルタ株式會(huì)社埼玉県狹山市広瀬臺(tái)二丁目2番1號(hào) 2-2-1,   Hirosedai,Sayama-shi,Saitama2023-02-06 變更
137干式激光成像儀國(guó)械備20170398號(hào)コニカミノルタ株式會(huì)社1   Sakura-machi,Hino-shi,Tokyo,Japan;2-2-1,   Hirosedai,Sayama-shi,Saitama,Japan 2023-02-06 變更
138醫(yī)用檢查手套國(guó)械備20230074號(hào)GLOMAXES   LATEX GLOVE MANUFACTURER SDN.BHD.No.153,Jalan   4,Kawasan Perindustrian Olak Lempit,42700 Banting,Selangor Darul   Ehsan,Malaysia.2023-02-06 有效
139止血鉗國(guó)械備20150031號(hào)Max   Hauser Süddeutsche Chirurgiemechanik GmbHF?hrenstra?e   33,78532 Tuttlingen Germany2023-02-03 變更
140超聲潔牙機(jī)工作尖國(guó)械備20191244號(hào)//2023-02-03 變更
141醫(yī)用干式銀鹽膠片國(guó)械備20230073號(hào)AGFA   NVSeptestraat   27, 2640 Mortsel , Belgium  1658 Bushy   Park Road, Goose Creek, South Carolina 29445, USA2023-02-03 有效
142高速冷凍離心機(jī)國(guó)械備20150368號(hào)Thermo   Electron LED GmbH Zweigniederlassung OsterodeAm   Kalkberg, 37520 Osterode am Harz, Germany2023-02-03 變更
143種植輔助材料國(guó)械備20230072號(hào)A.B.   Dental Devices Ltd.19   Hayahalomim Street Ashdod 7761117 Israel2023-02-03 有效
144藥敏接種培養(yǎng)液國(guó)械備20140220號(hào)Remel,   Inc12076   Santa Fe Trail Drive , Lenexa, Kansas 66215, USA2023-02-02 變更
145頭戴式放大鏡國(guó)械備20162018號(hào)Metrex   Research LLC dba Orascoptic3225   Deming Way Suite 190 Middleton Wisconsin 53562 USA2023-02-02 變更
146CD36檢測(cè)試劑國(guó)械備20230071號(hào)BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-02-02 有效
147CD71檢測(cè)試劑國(guó)械備20230070號(hào)BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-02-02 有效
148虹膜拉鉤國(guó)械備20181048號(hào)MICROSURGICAL   TECHNOLOGY, INC.8415   154th Ave Ne Redmond, WA 980522023-02-02 變更
149導(dǎo)引針國(guó)械備20171015號(hào)Boston   Scientific Corporation10700   Bren Road West, Minnetonka, MN USA 553432023-02-01 變更
150器械鉗國(guó)械備20171065號(hào)Boston   Scientific Corporation10700   Bren Road West, Minnetonka, MN USA 553432023-02-01 變更
151削切刀國(guó)械備20151269號(hào)Gebr.   Brasseler GmbH & Co. KGTrophagener   Weg 25 32657 Lemgo Deutschland2023-02-01 無(wú)效
152骨鉸刀國(guó)械備20150482號(hào)Gebr.   Brasseler GmbH & Co. KGTrophagener   Weg 25 32657 Lemgo Deutschland2023-02-01 無(wú)效
153鋸片國(guó)械備20151270號(hào)Gebr.   Brasseler GmbH & Co. KGTrophagener   Weg 25 32657 Lemgo Deutschland2023-02-01 無(wú)效
154一次性醫(yī)用丁腈橡膠手套國(guó)械備20230069號(hào)GLOMAXES   LATEX GLOVE MANUFACTURER SDN.BHD.No.153,Jalan   4,Kawasan Perindustrian Olak Lempit,42700 Banting,Selangor Darul   Ehsan,Malaysia.2023-02-01 有效
155醫(yī)用檢查手套國(guó)械備20230068號(hào)GLOMAXES   LATEX GLOVE MANUFACTURER SDN.BHD.No.153,Jalan   4,Kawasan Perindustrian Olak Lempit,42700 Banting,Selangor Darul   Ehsan,Malaysia.2023-02-01 有效
156成像板暗盒國(guó)械備20170460號(hào)コニカミノルタ株式會(huì)社日本國(guó)東京都日野市さくら町1番地;日本國(guó)埼玉県狹山市広瀬臺(tái)2-2-12023-02-27 無(wú)效
157成像板暗盒國(guó)械備20170461號(hào)コニカミノルタ株式會(huì)社日本國(guó)東京都日野市さくら町1番地;日本國(guó)埼玉県狹山市広瀬臺(tái)2-2-12023-02-27 無(wú)效
158檢查手套國(guó)械備20151388號(hào)B.   Braun Melsungen AG110   Kanjanavanit Road, Pahtong, Hatyai, Songkhla 90230, Thailand2023-02-23 無(wú)效

眾多進(jìn)口第一類醫(yī)療器械產(chǎn)品備案獲批,也說(shuō)明第一類醫(yī)療器械產(chǎn)品在國(guó)內(nèi)也有大的市場(chǎng),也說(shuō)明生產(chǎn)第一類醫(yī)療器械還有許多機(jī)會(huì)。


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