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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
發(fā)布日期:2023-03-13 19:58瀏覽次數(shù):2452次
2023年3月13日來自國家藥監(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，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，詳見正文。

2023年3月13日來自國家藥監(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，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腕部固定系統(tǒng)手術(shù)器械國械備20200202號TriMed,   Inc.27533   Avenue Hopkins, Santa Clarita, CA 91355, USA2023-02-28 變更
2研光器國械備20230127號ASA   DENTAL SPAVIA   FIERLA 13-33085 MANIAGO (PN)2023-02-28 有效
3橡皮障支架國械備20230126號ASA   DENTAL SPAVIA   FIERLA 13-33085 MANIAGO (PN)2023-02-28 有效
4銀汞合金輸送器國械備20230125號ASA   DENTAL SPAVIA   FIERLA 13-33085 MANIAGO (PN)2023-02-28 有效
5牙科用軟組織環(huán)切刀國械備20230124號ASA   DENTAL SPAVIA   FIERLA 13-33085 MANIAGO (PN)2023-02-28 有效
6牙骨銼國械備20230123號ASA   DENTAL SPAVIA   FIERLA 13-33085 MANIAGO (PN)2023-02-28 有效
7橡皮障夾鉗 國械備20230122號ASA   DENTAL SPAVIA   FIERLA 13-33085 MANIAGO (PN)2023-02-28 有效
8橡皮障打孔器國械備20230121號ASA   DENTAL SPAVIA   FIERLA 13-33085 MANIAGO (PN)2023-02-28 有效
9成形片國械備20170117號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)器械包國械備20230120號Tornier   SAS161   Rue Lavoisier, 38330 Montbonnot-Saint-Martin, FRANCE2023-02-27 有效
11口腔科器械國械備20191336號A.Schweickhardt   GmbH＆Co.KGTuttlinger   Stra?e 12 78606 Seitingen / Tuttlingen Germany2023-02-27 變更
12牙用充填器國械備20230119號ASA   DENTAL SPAVIA   FIERLA 13-33085 MANIAGO (PN)2023-02-24 有效
13牙科骨磨國械備20230118號ASA   DENTAL SPAVIA   FIERLA 13-33085 MANIAGO (PN)2023-02-24 有效
14牙用尺國械備20230117號ASA   DENTAL SPAVIA   FIERLA 13-33085 MANIAGO (PN)2023-02-24 有效
15牙科輸送器國械備20230116號ASA   DENTAL SPAVIA   FIERLA 13-33085 MANIAGO (PN)2023-02-24 有效
16牙科刮治器  國械備20161891    號株式會社YDM埼玉県東松山市今泉28番地2023-02-24 變更
17印模轉(zhuǎn)移桿國械備20190965號SHINHUNG   MST CO., LTD.110-2，Donghwagongdan-ro，Munmak-eup，Wonju-si，Gangwon-do，26365，Rep.   of KOREA2023-02-24 變更
18正畸鉗國械備20161162號株式會社YDM埼玉県東松山市今泉28番地2023-02-24 變更
19口腔麻醉手動注射架國械備20230115號ASA   DENTAL SPAVIA   FIERLA 13-33085 MANIAGO (PN)2023-02-24 有效
20牙科骨粉調(diào)和用金屬容器國械備20230114號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)）國械備20230113號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)）國械備20230112號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)）國械備20230111號Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42 DK-2600 Glostrup DENMARK2023-02-23 有效
24檢查手套國械備20181354號B.   Braun Melsungen AGLatexx   Partners Berhad, Lot 18374, Jalan Perusahaan 3, Kamunting Industrial Estate,   34600 Kamunting, Taiping, Perak, Malaysia2023-02-23 無效
25牙科種植用延長器國械備20161072號BioHorizons   Implant Systems, Inc.2300   Riverchase Center, Birmingham, Alabama 35244 USA2023-02-23 變更
26試戴體國械備20161046號BioHorizons   Implant Systems, Inc.2300   Riverchase Center, Birmingham, Alabama 35244 USA2023-02-23 變更
27牙科骨擠壓器國械備20160935號BioHorizons   Implant Systems, Inc.2300   Riverchase Center, Birmingham, Alabama 35244 USA2023-02-23 變更
28牙用尺國械備20160516號BioHorizons   Implant Systems, Inc.2300   Riverchase Center Birmingham Alabama 35244 USA2023-02-23 變更
29螺絲起國械備20161071號BioHorizons   Implant Systems, Inc.2300   Riverchase Center, Birmingham, Alabama 35244 USA2023-02-23 變更
30基臺適配器國械備20170668號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)器國械備20161080號BioHorizons   Implant Systems, Inc.2300   Riverchase Center, Birmingham, Alabama 35244 USA2023-02-23 變更
32牙科用銼國械備20161073號BioHorizons   Implant Systems, Inc.2300   Riverchase Center, Birmingham, Alabama 35244 USA2023-02-23 變更
33轉(zhuǎn)移帽國械備20161082號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械備20190692號BioHorizons   Implant Systems, Inc.  2300   Riverchase Center, Birmingham, Alabama, 35244 USA2023-02-23 變更
35替代體國械備20190775號BioHorizons   Implant Systems, Inc.2300   Riverchase Center, Birmingham, Alabama, 35244 USA2023-02-23 變更
36基臺夾持器國械備20191276號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)）國械備20230110號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)）國械備20230109號Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42 DK-2600 Glostrup DENMARK2023-02-23 有效
39醫(yī)用外固定支具國械備20230108號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)工具國械備20230078號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)）國械備20230107號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)）國械備20230106號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)）國械備20230105號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)）國械備20230104號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)）國械備20230103號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械備20151824號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)切刀國械備20151961號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牙科器械鉗國械備20230102號ASA   DENTAL SPAVIA   FIERLA 13-33085 MANIAGO (PN)2023-02-22 有效
49截石位手術(shù)體位固定架國械備20160606號ALLEN   MEDICAL SYSTEMS,INC.100   Discovery Way Acton,MA 017202023-02-22 變更
50牙科用鑷國械備20230101號ASA   DENTAL SPA VIA   FIERLA 13-33085 MANIAGO (PN)2023-02-22 有效
51牙科用剪國械備20230100號ASA   DENTAL SPAVIA   FIERLA 13-33085 MANIAGO (PN)2023-02-22 有效
52硅橡膠復(fù)制材料包國械備20210231號DETAX   GmbHCarl-Zeiss-Straβe   4, 76275 Ettlingen, Germany2023-02-22 變更
53X射線膠片顯影液國械備20230099號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械備20230098號Caretsream   Health,Inc.1049   West Ridge Road,Rochester,NY USA 146152023-02-22 有效
55X射線膠片定影液國械備20230097號Carestream   Health,Inc.1049   West Ridge Road，Rochester, NY USA 146152023-02-22 有效
56拔牙鉗國械備20230096號ASA   DENTAL SPAVIA   FIERLA 13-33085 MANIAGO (PN)2023-02-22 有效
57牙科用牽開器國械備20230095號ASA   DENTAL SPAVIA   FIERLA 13-33085 MANIAGO (PN)2023-02-22 有效
58牙科用刀國械備20230094號ASA   DENTAL SPA VIA FIERLA 13-33085 MANIAGO (PN)2023-02-22 有效
59硅橡膠復(fù)制材料國械備20190650號DETAX   GmbHCarl-Zeiss-Straβe   4, 76275 Ettlingen, Germany2023-02-21 變更
60模型樹脂包國械備20190744號DETAX   GmbHCarl-Zeiss-Straβe   4, 76275 Ettlingen, Germany2023-02-21 變更
61微生物比濁儀國械備20230093號Beckman   Coulter, Inc.25   Bradley Drive, Westbrook, Maine 04092, USA2023-02-21 有效
62自粘彈力繃帶國械備20161076號3M   Company601   22nd Ave. South Brookings, South Dakota, 57006, USA2023-02-21 變更
63自粘彈力繃帶 國械備20150894號3M   Company3M   Brookings, 601 22ND AVE. South Brookings, South Dakota, 57006, USA2023-02-21 變更
64醫(yī)用退熱凝膠國械備20210308號SACRUM   ALGAE株式會社東京都足立區(qū)梅田六丁目9番6號2023-02-21 變更
65人體定位墊國械備20230092號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械備20210237號VOLK   OPTICAL INC.7893   ENTERPRISE DR. Mentor, OH USA 440602023-02-21 變更
67種植體清潔刷國械備20200167號 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2023-02-20 變更
68創(chuàng)傷手術(shù)器械包國械備20151190號Zimmer   Switzerland Manufacturing GmbHSulzerallee   8, Winterthur, 8404, Switzerland2023-02-20 變更
69肱骨髓內(nèi)釘手術(shù)工具國械備20210174號Zimmer   Switzerland Manufacturing GmbHSulzerallee   8, Winterthur 8404 Switzerland2023-02-20 變更
70手術(shù)托架 國械備20220036號ミズホ株式會社新潟県五泉市赤海3631番14，千葉県佐倉市太田2173番地132023-02-17 變更
71腹腔用拉鉤裝置器國械備20160311號Max   Hauser Süddeutsche Chirurgiemechanik GmbHF?hrenstra?e   33，78532 Tuttlingen Germany2023-02-17 變更
72牙科骨磨國械備20230091號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)槍國械備20230090號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)液國械備20230089號Remel,   Inc12076   Santa Fe Trail Drive Lenexa Kansas 66215 USA2023-02-16 有效
75肉湯培養(yǎng)基國械備20230088號Remel,   Inc12076   Santa Fe Trail Drive Lenexa Kansas 66215 USA2023-02-16 有效
76清洗液國械備   20170375號EKF-diagnostic   GmbHEbendorfer   Chaussee 3, 39179 Barleben, GERMANY2023-02-16 變更
77樣本稀釋液國械備20150741號Wallac   OyMustionkatu   6, FI-20750 Turku, Finland2023-02-16 無效
78上肢醫(yī)用外固定支具國械備20170269號?ssur   hf.Grjotháls   1-5 Reykjavik 110 Iceland2023-02-15 變更
79糞便檢驗(yàn)預(yù)處理裝置國械備20151619號EIKEN   CHEMICAL CO., LTD.3585,   Kando, Yoshida-cho, Haibara-gun, Shizuoka, 421-0304 JAPAN2023-02-15 變更
80骨科手術(shù)器械國械備20191138號Limacorporate   S.p.A.Via   Nazionale, 52 33038 Villanova San Daniele del Friuli (UDINE) ITALY2023-02-15 變更
81醫(yī)用檢查手套國械備20230087號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)用支撐腿架國械備20230086號MAQUET   GmbHKehler   Straβe 31, 76437 Rastatt, Germany2023-02-14 有效
83手術(shù)剪國械備20230085號Berger   Surgical Medical Products GmbHTake-off-Gewerbepark   4 D-78579 Neuhausen ob Eck2023-02-14 有效
84肛門鏡國械備20230084號Berger   Surgical Medical Products GmbHTake-off-Gewerbepark   4 D-78579 Neuhausen ob Eck2023-02-14 有效
85外耳道擴(kuò)張器國械備20230083號 Berger Surgical Medical Products GmbHTake-off-Gewerbepark   4 D-78579 Neuhausen ob Eck2023-02-14 有效
86壓板國械備20230082號Berger   Surgical Medical Products GmbHTake-off-Gewerbepark   4 D-78579 Neuhausen ob Eck 2023-02-14 有效
87種植輔助器械包國械備20180112號ALTATEC   GmbHMaybachstr.   5,71299 Wimsheim, Germany2023-02-13 變更
88牙科模型材料國械備20161677號ALTATEC   GmbHMaybachstr.5,   71299 Wimsheim, GERMANY2023-02-13 變更
89轉(zhuǎn)移帽國械備20180208號ALTATEC   GmbHMaybachstr.   5,71299 Wimsheim, Germany2023-02-13 變更
90種植體安裝輔助器械國械備20190350號ALTATEC   GmbHMaybachstr.   5, 71299 Wimsheim, GERMANY2023-02-13 變更
91種植體安裝輔助器械國械備20180987號ALTATEC   GmbHMaybachstr.   5, 71299 Wimsheim, Germany2023-02-13 變更
92牙科種植輔助器械包國械備20180988號ALTATEC   GmbHMaybachstr.   5, 71299 Wimsheim, Germany2023-02-13 變更
93種植輔助材料國械備20181551號ALTATEC   GmbHMaybachstr.   5, 71299 Wimsheim, GERMANY2023-02-13 變更
94牙科骨擠壓器國械備20170960號ALTATEC   GmbHMaybachstr.   5,71299 Wimsheim, Germany2023-02-13 變更
95夾板及固定帶國械備20190059號VAR?TEKS   ORTOPED? SANAY? A.?.Maltepe   Mah, Aile Bah?e Sok., Litros Yolu, No: 10, 34010, Zeytinburnu, ?stanbul,   Turkey2023-02-13 變更
96踝部固定器國械備20230081號PAVIS   S.P.A.Via   G.Rossini, 11/B - 21020 Buguggiate (VA), Italy2023-02-10 有效
97麥?zhǔn)媳葷嵊?jì)國械備20220077號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)器械國械備20151787號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)器械包國械備20160867號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)器械包國械備20160475號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)器械包國械備20161099號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)器械包國械備20160931號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)器械包國械備20191102號Wright   Medical Technology, Inc.11576   Memphis Arlington Road, Arlington, Tennessee, 38002, USA2023-02-09 變更
104模型樹脂國械備20180695號VERICOM   CO., LTD48，Toegyegongdan   1-gil，Chuncheon-si, Gangwon-do, 200-944,Republic of KOREA2023-02-09 變更
105骨鉸刀國械備20191045號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)器械包國械備20190267號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)器械包國械備20161201號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)器械包國械備20161100號Wright   Medical Technology, Inc.11576   Memphis Arlington Road, Arlington, Tennessee, 38002, USA2023-02-09 變更
109壓力繃帶國械備20230080號SIGVARIS   Inc.13055   Riley St., Suite 30 Holland, Michigan 49424 USA2023-02-09 有效
110肘關(guān)節(jié)手術(shù)器械包國械備20160724號Wright   Medical Technology, Inc.11576   Memphis Arlington Road, Arlington, Tennessee, 38002, USA2023-02-09 變更
111壓力繃帶國械備20230079號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)器械包國械備20191444號Wright   Medical Technology, Inc.11576   Memphis Arlington Road, Arlington, Tennessee, 38002, USA2023-02-09 變更
113骨鉸刀國械備20191100號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)器械包國械備20200188號Wright   Medical Technology, Inc.11576   Memphis Arlington Road, Arlington, Tennessee, 38002, USA2023-02-09 變更
115骨科定位片國械備20191061號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)工具國械備20230078號Medtronic   Navigation, Inc.826   Coal Creek Circle Louisville, CO 80027 United States of America2023-02-09 有效
117超聲探頭穿刺架國械備20230077號GE   ヘルスケア?ジャパン株式會社〒191-8503   東京都日野市旭が丘 4-7-1272023-02-08 有效
118牙科橡皮障楔線國械備20160116號Dent4You   AG235   Ascot Parkway Cuyahoga Falls, OH 44223 United States of America2023-02-08 變更
119骨科手術(shù)器械國械備20191433號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)器械國械備20200331號HPF   S.r.l.Via   Pinzano, 24 - 33030 Flagogna di Forgaria nel Friuli (UD) - Italy2023-02-08 變更
121下肢醫(yī)用外固定支具國械備20150418號Breg   Inc.Calzada   Presidnte Venustiano Carrnza #33, C.P.21385, Mexicali, Baja California,   Mexico2023-02-08 變更
122上肢醫(yī)用外固定支具國械備20150417號Breg   Inc.Calzada   Presidnte Venustiano Carrnza #33, C.P.21385, Mexicali, Baja California,   Mexico2023-02-08 變更
123踝部固定器國械備20180276號Breg   Inc見附件2023-02-08 變更
124醫(yī)用外固定支具國械備20180274號Breg   IncCalzada   Presidnte Venustiano Carrnza #33, C.p.21385, Mexicali, Baja California,   Mexico.2023-02-08 變更
125橡皮障支架國械備20160478號Dent4You   AG235   Ascot Parkway Cuyahoga Falls OH 44223 United States Of America2023-02-07 變更
126橡皮障打孔器國械備20160375號Dent4You   AG235   Ascot Parkway Cuyahoga Falls OH 44223 United States Of America2023-02-07 變更
127牙刮匙國械備20230076號ASA   DENTAL SPAVIA   FIERLA 13-33085 MANIAGO (PN)2023-02-07 有效
128醫(yī)用彈力貼布國械備20191353號ニチバン株式會社日本福岡県朝倉郡筑前町野町字禪門橋17132023-02-06 變更
129婦產(chǎn)科手術(shù)器械國械備20200043號DELMONT   IMAGING390   Avenue du Mistral, 13600 La Ciotat, France2023-02-06 變更
130橡皮障夾鉗國械備20160376號Dent4You   AG235   Ascot Parkway Cuyahoga Falls OH 44223 United States Of America2023-02-06 變更
131橡皮障夾國械備20151720號Dent4You   AG235   Ascot Parkway Cuyahoga Falls, OH 44223 United States of America2023-02-06 變更
132口腔科手術(shù)器械國械備20230075號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）國械備20200399號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）國械備20200400號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）國械備20200398號EUROIMMUN   Medizinische Labordiagnostika AGWerkstraβe   1, 23942 Dassow, Germany 2023-02-06 變更
136干式激光成像儀國械備20151260號コニカミノルタ株式會社埼玉県狹山市広瀬臺二丁目2番1號　2-2-1，   Hirosedai，Sayama-shi，Saitama2023-02-06 變更
137干式激光成像儀國械備20170398號コニカミノルタ株式會社1   Sakura-machi，Hino-shi，Tokyo，Japan；2-2-1，   Hirosedai，Sayama-shi，Saitama，Japan 2023-02-06 變更
138醫(yī)用檢查手套國械備20230074號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止血鉗國械備20150031號Max   Hauser Süddeutsche Chirurgiemechanik GmbHF?hrenstra?e   33，78532 Tuttlingen Germany2023-02-03 變更
140超聲潔牙機(jī)工作尖國械備20191244號//2023-02-03 變更
141醫(yī)用干式銀鹽膠片國械備20230073號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)國械備20150368號Thermo   Electron LED GmbH Zweigniederlassung OsterodeAm   Kalkberg, 37520 Osterode am Harz, Germany2023-02-03 變更
143種植輔助材料國械備20230072號A.B.   Dental Devices Ltd.19   Hayahalomim Street Ashdod 7761117 Israel2023-02-03 有效
144藥敏接種培養(yǎng)液國械備20140220號Remel,   Inc12076   Santa Fe Trail Drive , Lenexa, Kansas 66215, USA2023-02-02 變更
145頭戴式放大鏡國械備20162018號Metrex   Research LLC dba Orascoptic3225   Deming Way Suite 190 Middleton Wisconsin 53562 USA2023-02-02 變更
146CD36檢測試劑國械備20230071號BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-02-02 有效
147CD71檢測試劑國械備20230070號BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-02-02 有效
148虹膜拉鉤國械備20181048號MICROSURGICAL   TECHNOLOGY, INC.8415   154th Ave Ne Redmond, WA 980522023-02-02 變更
149導(dǎo)引針國械備20171015號Boston   Scientific Corporation10700   Bren Road West, Minnetonka, MN USA 553432023-02-01 變更
150器械鉗國械備20171065號Boston   Scientific Corporation10700   Bren Road West, Minnetonka, MN USA 553432023-02-01 變更
151削切刀國械備20151269號Gebr.   Brasseler GmbH & Co. KGTrophagener   Weg 25 32657 Lemgo Deutschland2023-02-01 無效
152骨鉸刀國械備20150482號Gebr.   Brasseler GmbH & Co. KGTrophagener   Weg 25 32657 Lemgo Deutschland2023-02-01 無效
153鋸片國械備20151270號Gebr.   Brasseler GmbH & Co. KGTrophagener   Weg 25 32657 Lemgo Deutschland2023-02-01 無效
154一次性醫(yī)用丁腈橡膠手套國械備20230069號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)用檢查手套國械備20230068號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成像板暗盒國械備20170460號コニカミノルタ株式會社日本國東京都日野市さくら町1番地；日本國埼玉県狹山市広瀬臺2-2-12023-02-27 無效
157成像板暗盒國械備20170461號コニカミノルタ株式會社日本國東京都日野市さくら町1番地；日本國埼玉県狹山市広瀬臺2-2-12023-02-27 無效
158檢查手套國械備20151388號B.   Braun Melsungen AG110   Kanjanavanit Road, Pahtong, Hatyai, Songkhla 90230, Thailand2023-02-23 無效

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


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