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2023年5月國(guó)家藥監(jiān)局批準(zhǔn)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案269項(xiàng)
發(fā)布日期:2023-06-07 20:14瀏覽次數(shù):2512次
2023年5月，國(guó)家藥監(jiān)局累計(jì)批準(zhǔn)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案事項(xiàng)269項(xiàng)，好的醫(yī)療器械不一定非得是第三類醫(yī)療器械，不一定非得是第二類醫(yī)療器械，不一定非得是要做臨床試驗(yàn)的器械，許多第一類醫(yī)療器械產(chǎn)品也需要進(jìn)口，需要境外醫(yī)療器械制造商供應(yīng)。

2023年5月，國(guó)家藥監(jiān)局累計(jì)批準(zhǔn)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案事項(xiàng)269項(xiàng)，好的醫(yī)療器械不一定非得是第三類醫(yī)療器械，不一定非得是第二類醫(yī)療器械，不一定非得是要做臨床試驗(yàn)的器械，許多第一類醫(yī)療器械產(chǎn)品也需要進(jìn)口，需要境外醫(yī)療器械制造商供應(yīng)。

第一類醫(yī)療器械產(chǎn)品備案.jpg

2023年5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膝部固定器國(guó)械備20230295號(hào)SIGVARIS   S.A. ul.   Powidzka 50, Gutowo Ma?e, PL/ 62-300 Wrze?nia2023-05-31 有效
2牙科刮治器國(guó)械備20200145號(hào)PRODONT-HOLLIGER   SOCIéTé PAR ACTIONS SIMPLIFIééLieu-dit   La Marnasse, 63880 OLLIERGUES, FRANCE2023-05-31 變更
3高速離心機(jī)國(guó)械備20200714號(hào)Eppendorf   SEPortitzer   Allee 15, 04329 Leipzig, Germany2023-05-30 變更
4低速離心機(jī)國(guó)械備20171118號(hào)Eppendorf   SEBarkhausenweg   1, 22339 Hamburg, Germany2023-05-30 變更
5高速離心機(jī)國(guó)械備20171120號(hào)Eppendorf   SEBarkhausenweg   1, 22339 Hamburg, Germany2023-05-30 變更
6高速冷凍離心機(jī)國(guó)械備20170331號(hào)Eppendorf   SEBarkhausenweg   1, 22339 Hamburg, Germany2023-05-30 變更
7高速離心機(jī)國(guó)械備20180302號(hào)Eppendorf   SEBarkhausenweg   1, 22339 Hamburg, Germany2023-05-30 變更
8高速離心機(jī)國(guó)械備20180864號(hào)Eppendorf   SEPortitzer   Allee 15, 04329 Leipzig, Germany;       175 Freshwater Boulevard, Enfield CT 06082, USA2023-05-30 變更
9低速離心機(jī)國(guó)械備20180863號(hào)Eppendorf   SEPortitzer   Allee 15, 04329 Leipzig, Germany2023-05-30 變更
10高速冷凍離心機(jī)國(guó)械備20210475號(hào)Eppendorf   SEPortitzer   Allee 15, 04329 Leipzig, Germany2023-05-30 變更
11高速離心機(jī)國(guó)械備20190837號(hào)Eppendorf   SEPortitzer   Allee 15, 04329 Leipzig, Germany; 175 Freshwater Boulevard, Enfield CT 06082,   USA2023-05-30 變更
12醫(yī)用干式激光膠片國(guó)械備20230294號(hào)COLENTA   Labortechnik GmbH & Co.KGNeunkirchner   Str.117,A-2700 Wiener Neustadt2023-05-30 有效
13骨科牽引架國(guó)械備20190855號(hào)STERIS   Corporation2720   Gunter Park Drive East, Montgomery, Alabama, 36109, USA2023-05-29 變更
14醫(yī)用超聲波清洗器國(guó)械備20210506號(hào)STERIS   CorporationUnits   7 & 8 Stortford Hall Industrial Park Dunmow Road Bishop’s Stortford   Hertfordshire CM23 5GZ United Kingdom2023-05-29 變更
15骨科牽引架國(guó)械備20200226號(hào)STERIS   SASPutajantie   42 38210 Sastamala, Finland2023-05-29 變更
16ALK抗體試劑（免疫組織化學(xué)）國(guó)械備20220152號(hào)Agilent   Technologies Singapore (International) Pte. Ltd.Produktionsvej   42, Glostrup DK-2600, Denmark2023-05-29 變更
17原位雜交洗脫液國(guó)械備20220149號(hào)Agilent   Technologies Singapore (International) Pte. Ltd.Produktionsvej   42 Glostrup DK-2600 Denmark2023-05-29 變更
18吸唾管國(guó)械備20170381號(hào)(?)????????   ??? ??? ???109?? 572023-05-26 變更
19牙科充填器國(guó)械備20170371號(hào)(?)????????   ??? ??? ???109?? 572023-05-26 變更
20牙挺國(guó)械備20180608號(hào)(?)????????   ??? ??? ???109?? 572023-05-26 變更
21口鏡國(guó)械備20170391號(hào)(?)????????   ??? ??? ???109?? 572023-05-26 變更
22牙科潔治器國(guó)械備20170823號(hào)(?)????????   ??? ??? ???109?? 572023-05-26 變更
23牙科用分離器國(guó)械備20170834號(hào)(?)????????   ??? ??? ???109?? 572023-05-26 變更
24牙刮匙國(guó)械備20170380號(hào)(?)????????   ??? ??? ???109?? 572023-05-26 變更
25醫(yī)用剪國(guó)械備20151960號(hào)CM   Instrumente GmbHGan   sacker 56 D-78532 Tuttlingen2023-05-26 變更
26顯微止血夾國(guó)械備20150416號(hào)CM   Instrumente GmbH G?ns?cker   56 D-78532 Tuttlingen2023-05-26 變更
27顯微持針鉗國(guó)械備20150406號(hào)CM   Instrumente GmbHG?ns?cker   56 D-78532 Tuttlingen2023-05-26 變更
28牙科骨粉輸送器國(guó)械備20230293號(hào)OSUNG   MND CO., LTD57,   Hwanggeum-ro, 109beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do /#613, 14,   Garam-ro, Seo-gu, Incheon2023-05-25 有效
29手術(shù)刀柄國(guó)械備20180603號(hào)(?)????????   ??? ??? ???109?? 572023-05-25 變更
30呼吸訓(xùn)練器國(guó)械備20150135號(hào)Leventon   S.A.U.C/   Newton, 18-24 08635 Sant Esteve Sesrovires, Barcelona Spain2023-05-25 變更
31呼吸訓(xùn)練器國(guó)械備20160866號(hào)Leventon   S.A.U.C/   Newton, 18-24 08635 Sant Esteve Sesrovires, Barcelona Spain2023-05-25 變更
32上頜竇提升器國(guó)械備20230292號(hào)OSUNG   MND CO., LTD57,   Hwanggeum-ro, 109beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do /#613, 14,   Garam-ro, Seo-gu, Incheon2023-05-25 有效
33醫(yī)用放大鏡國(guó)械備20150130號(hào)XENOSYS   CO., LTD.2F,   2, Venture-ro 100beon-gil, Yeonsu-gu, Incheon2023-05-25 變更
34牙探針國(guó)械備20170835號(hào)(?)????????   ??? ??? ???109?? 572023-05-25 變更
35牙科用骨劈開鑿國(guó)械備20230291號(hào)OSUNG   MND CO., LTD57,   Hwanggeum-ro, 109beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do /#613, 14,   Garam-ro, Seo-gu, Incheon2023-05-25 有效
36咬骨鉗國(guó)械備20170824號(hào)(?)????????   ??? ??? ???109?? 572023-05-25 變更
37唇頰牽開器國(guó)械備20170807號(hào)(?)????????   ??? ??? ???109?? 572023-05-25 變更
38組織拉鉤國(guó)械備20170839號(hào)(?)????????   ??? ??? ???109?? 572023-05-25 變更
39拔牙鉗國(guó)械備20170840號(hào)(?)????????   ??? ??? ???109?? 572023-05-25 變更
40牙齦刀國(guó)械備20180602號(hào)(?)????????   ??? ??? ???109?? 572023-05-25 變更
41上頜竇提升器國(guó)械備20180609號(hào)(?)????????   ??? ??? ???109?? 572023-05-25 變更
42橡皮障器械國(guó)械備20170154號(hào)(?)????????   ??? ??? ???109?? 572023-05-25 變更
43正畸鉗國(guó)械備20181528號(hào)(?)????????   ??? ??? ???109?? 572023-05-25 變更
44牙科用剪國(guó)械備20160966號(hào)(?)?????57,   Hwanggeum-ro 109 beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do, Korea2023-05-25 變更
45牙科用分離器國(guó)械備20160967號(hào)(?)?????57,   Hwanggeum-ro 109 beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do, Korea2023-05-25 變更
46牙骨錘國(guó)械備20170844號(hào)(?)????????   ??? ??? ???109?? 572023-05-25 變更
47牙科去冠器國(guó)械備20230290號(hào)(?)????????   ??? ??? ???109?? 572023-05-25 有效
48牙科骨粉調(diào)和用金屬容器國(guó)械備20230289號(hào)(?)????????   ??? ??? ???109?? 572023-05-25 有效
49帕巾鉗國(guó)械備20230288號(hào)(?)????????   ??? ??? ???109?? 572023-05-25 有效
50牙科種植用扳手國(guó)械備20230287號(hào)(?)????????   ??? ??? ???109?? 572023-05-25 有效
51口腔正畸用反光鏡國(guó)械備20230286號(hào)(?)????????   ??? ??? ???109?? 572023-05-25 有效
52頭戴式檢查燈國(guó)械備20181596號(hào)Metrex   Research LLC dba Orascoptic3225   Deming Way Suite 190 Middleton,WI USA 535622023-05-25 變更
53根管銼國(guó)械備20160608號(hào)Kerr   Corporation1332   South Lone Hill Avenue Glendora, California 91740 USA; Calle 21 No 1103 AMP   CD Industrial Uman Yucatan 97390 Mexico2023-05-25 變更
54頭戴式檢查燈國(guó)械備20181247號(hào)Metrex   Research LLC dba Orascoptic3225   Deming Way Suite 190 Middleton,WI USA 535622023-05-25 變更
55研光器國(guó)械備20161043號(hào)Kerr   CorporationVia   Strecce 4 P.O. 272 6934 Bioggio Switzerland2023-05-25 變更
56醫(yī)用光學(xué)放大鏡國(guó)械備20190118號(hào)Metrex   Research LLC dba Orascoptic3225   Deming Way Suite 190 Middleton,WI USA 535622023-05-25 變更
57根管充填器國(guó)械備20160554號(hào)Kerr   Corporation1332   South Lone Hill Avenue Glendora, California 91740 USA2023-05-25 變更
58牙科種植系統(tǒng)手術(shù)工具國(guó)械備20181529號(hào)(?)????????   ??? ??? ???109?? 572023-05-25 變更
59持針鉗國(guó)械備20170383號(hào)(?)????????   ??? ??? ???109?? 572023-05-25 變更
60牙科用鑷國(guó)械備20170459號(hào)(?)????????   ??? ??? ???109?? 572023-05-25 變更
61牙用尺國(guó)械備20170845號(hào)(?)????????   ??? ??? ???109?? 572023-05-25 變更
62牙科開口器國(guó)械備20170808號(hào)(?)????????   ??? ??? ???109?? 572023-05-25 變更
63止血鉗國(guó)械備20170370號(hào)(?)????????   ??? ??? ???109?? 572023-05-25 變更
64CD13檢測(cè)試劑國(guó)械備20230055號(hào)Agilent   Technologies Singapore (International) Pte. Ltd.Produktionsvej   42 DK-2600 Glostrup Denmark2023-05-25 變更
65CD103檢測(cè)試劑國(guó)械備20230056號(hào)Agilent   Technologies Singapore (International) Pte. Ltd.Produktionsvej   42 DK-2600 Glostrup Denmark2023-05-25 變更
66CD79a檢測(cè)試劑國(guó)械備20230052號(hào)Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42 DK-2600 Glostrup DENMARK2023-05-25 變更
67CD33檢測(cè)試劑國(guó)械備20230049號(hào)Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42 DK-2600 Glostrup DENMARK2023-05-25 變更
68牙科磷酸鹽鑄造包埋材國(guó)械備20200299號(hào)BEGO   Bremer Goldschl?gerei Wilh. Herbst GmbH & Co. KGWilhelm-Herbst-Str.   1,28359 Bremen, Deutschland2023-05-24 變更
69瓊脂復(fù)制材料國(guó)械備20160406號(hào)BEGO   Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KGWilhelm-Herbst-Str.   1-28359 Bremen, Deutchland2023-05-24 變更
70口角拉鉤國(guó)械備20170194號(hào)Kerr   CorporationVia   Strecce 4 P.O. 272 6934 Bioggio Switzerland2023-05-24 變更
71橡皮障夾國(guó)械備20150074號(hào)Kerr   CorporationVia   Strecce 4, 6934 Bioggio, Switzerland2023-05-24 變更
72研光器國(guó)械備20170116號(hào)Kerr   CorporationVia   Strecce 4 P.O. 272 6934 Bioggio Switzerland2023-05-24 變更
73研光器國(guó)械備20170103號(hào)Kerr   CorporationVia   Strecce 4 P.O. 272 6934 Bioggio Switzerland2023-05-24 變更
74楔子國(guó)械備20170236號(hào)Kerr   CorporationVia   Strecce 4 P.O. 272 6934 Bioggio Switzerland 2023-05-24 變更
75研光器國(guó)械備20200550號(hào)Kerr   CorporationLot   3, Jalan CJ 1/6, Kawasan Perusahaan Cheras Jaya, Jalan Balakong, Batu 11,   Cheras, Selangor Malaysia 432002023-05-24 變更
76骨銼國(guó)械備20170847號(hào)(?)????????   ??? ??? ???109?? 572023-05-24 變更
77持骨鉗國(guó)械備20170853號(hào)(?)????????   ??? ??? ???109?? 572023-05-24 變更
78牙骨鑿國(guó)械備20170382號(hào)(?)????????   ??? ??? ???109?? 572023-05-24 變更
79皮膚組織鉆孔器國(guó)械備20170854號(hào)(?)????????   ??? ??? ???109?? 572023-05-24 變更
80牙科修整用金剛砂車針國(guó)械備20200064號(hào)(?)????????   ??? ??? ???109?? 57, ????? ?? ??? 14, 613?2023-05-24 變更
81口腔麻醉注射架國(guó)械備20170846號(hào)(?)????????   ??? ??? ???109?? 572023-05-24 變更
82研光器國(guó)械備20161935號(hào)Kerr   CorporationVia   Strecce 4 P.O. 272 6934 Bioggio Switzerland2023-05-24 變更
83頭戴式放大鏡國(guó)械備20140236號(hào)Metrex   Research LLC dba Orascoptic3225   Deming Way Suite 190 Middleton, WI 53562 2023-05-24 變更
84根管銼國(guó)械備20151818號(hào)Kerr   Corporation1332   South Lone Hill Avenue Glendora, California 91740 USA;Calle 21 No 1103 AMP CD   Industrial Uman Yucatan 97390 Mexico2023-05-24 變更
85頭戴式放大鏡國(guó)械備20140247號(hào)Metrex   Research LLC dba Orascoptic3225   Deming Way Suite 190 Middleton, WI 53562 2023-05-24 變更
86研光器國(guó)械備20170118號(hào)Kerr   CorporationVia   Strecce 4 P.O. 272 6934 Bioggio Switzerland2023-05-24 變更
87根管銼國(guó)械備20160552號(hào)Kerr   Corporation1332   South Lone Hill Avenue Glendora, California 91740 USA; Calle 21 No 1103 AMP   CD Industrial Uman Yucatan 97390 Mexico2023-05-24 變更
88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 USA2023-05-24 變更
89光固化牙齦屏障樹脂國(guó)械備20230285號(hào)SANCTUARY   HEALTH SDN. BHD.No.16,   Persiaran Perindustrian Kanthan 1, Kawasan Perindustrian Kanthan, 31200   Chemor, Perak, Malaysia.2023-05-24 有效
90牙科輸送器國(guó)械備20230284號(hào)(?)????????   ??? ??? ???109?? 572023-05-23 有效
91緩沖液國(guó)械備20180713號(hào)HYPHEN   BioMed155   rue d’Eragny, 95000 Neuville-sur-Oise, France2023-05-23 變更
92骨科用螺絲刀國(guó)械備20170294號(hào)movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 變更
93剪斷器國(guó)械備20170291號(hào)movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 變更
94螺釘取出器國(guó)械備20170293號(hào)movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 變更
95打入器國(guó)械備20170292號(hào)movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 變更
96醫(yī)用尺國(guó)械備   20152121號(hào)Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
    GERMANY		2023-05-23 變更
97骨鉆國(guó)械備20170287號(hào)movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 變更
98肩鎖關(guān)節(jié)手術(shù)工具國(guó)械備20170285號(hào)movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 變更
99打入器國(guó)械備20170283號(hào)movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 變更
100跟腱手術(shù)工具國(guó)械備20170263號(hào)movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 變更
101骨鉆國(guó)械備20170286號(hào)movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 變更
102肩袖手術(shù)工具國(guó)械備20170284號(hào)movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 變更
103后交叉韌帶手術(shù)工具國(guó)械備20170295號(hào)movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 變更
104前交叉韌帶手術(shù)工具國(guó)械備20170397號(hào)movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 變更
105骨定位針國(guó)械備20170288號(hào)movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 變更
106髓腔擴(kuò)大器國(guó)械備20152142號(hào)Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-05-23 變更
107髖關(guān)節(jié)拉鉤國(guó)械備   20152073號(hào)Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-05-23 變更
108 咬骨剪國(guó)械備   20152125號(hào) Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
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109扭斷器國(guó)械備20152130號(hào)Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-05-23 變更
110顏面系列手術(shù)器械（包）國(guó)械備20180582號(hào)亞太醫(yī)療器材科技股份有限公司彰化縣伸港鄉(xiāng)溪底村工三路二號(hào)2023-05-23 變更
111取出鉗國(guó)械備20152126號(hào)Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-05-23 變更
112骨用牽開器國(guó)械備20152127號(hào)Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-05-23 變更
113耳用鑷國(guó)械備20230282號(hào)MED-EL   Elektromedizinische Ger?te GmbHFürstenweg   77A，6020 Innsbruck，Austria2023-05-22 有效
114陰道環(huán)放置器國(guó)械備20170451號(hào)N.V.OrganonVeilingweg   24, 2651 BE, Berkel en Rodenrijs, The Netherlands2023-05-22 變更
115醫(yī)用透氣膠帶國(guó)械備20200150號(hào)ニチバン株式會(huì)社福岡県朝倉(cāng)郡筑前町野町字禪門橋1713番地2023-05-22 變更
116全自動(dòng)紅細(xì)胞沉降率測(cè)定儀國(guó)械備20220074號(hào)DIESSE   Diagnostica Senese S.p.A.Strada   dei Laghi 39, 53035 Monteriggioni (SI) Italy2023-05-22 變更
117全自動(dòng)紅細(xì)胞沉降率測(cè)定儀國(guó)械備20220076號(hào)DIESSE   Diagnostica Senese S.p.A.Strada   dei Laghi 39, 53035 Monteriggioni (SI) Italy2023-05-22 變更
118腰部固定器國(guó)械備20190176號(hào)?ssur   hfGrjotháls   1-5 Reykjavik 110 Iceland2023-05-19 變更
119施夾鉗(不帶夾)國(guó)械備20200365號(hào)PETERS   SURGICAL 見附件22023-05-19 變更
120膝關(guān)節(jié)手術(shù)工具國(guó)械備20181669號(hào)Meril   Healthcare Pvt. Ltd.First   Floor, H1-H3, Meril Park, Survey No 135/2/B & 174/2, Muktanand Marg,   Chala,Vapi, Gujarat, India - 3961912023-05-19 變更
121全自動(dòng)核酸提取儀國(guó)械備20230281號(hào)臺(tái)灣圓點(diǎn)奈米技術(shù)股份有限公司333桃園市龜山區(qū)文禾路188號(hào)4樓2023-05-19 有效
122封片機(jī)國(guó)械備20230280號(hào)Shandon   Diagnostics Limited, a subsidiary of EprediaTudor   Road, Manor Park, Runcorn, WA7 1TA Cheshire, United Kingdom2023-05-19 有效
123矯形外科（骨科）手術(shù)器械（包）國(guó)械備20180546號(hào)亞太醫(yī)療器材科技股份有限公司彰化縣伸港鄉(xiāng)溪底村工三路二號(hào)2023-05-19 變更
124中空螺釘手術(shù)器械（包）國(guó)械備20180581號(hào)亞太醫(yī)療器材科技股份有限公司彰化縣伸港鄉(xiāng)溪底村工三路二號(hào)2023-05-19 變更
125牙科用毛刷國(guó)械備20191097號(hào)SDI   Limited3-15   Brunsdon Street, Bayswater, Victoria 3153, Australia2023-05-19 變更
126銀汞調(diào)合器國(guó)械備20170059號(hào)SDI   Limited3-15   Brunsdon Street Bayswater, Victoria 3153 Australia2023-05-19 變更
127封片機(jī)國(guó)械備20230279號(hào)Shandon   Diagnostics Limited, a subsidiary of EprediaTudor   Road, Manor Park, Runcorn, WA7 1TA Cheshire, United Kingdom2023-05-18 有效
128肌電導(dǎo)聯(lián)線國(guó)械備20210504號(hào)Natus   Manufacturing LimitedIDA   Business Park Gort Co.Galway Ireland2023-05-18 變更
129成形片國(guó)械備20210269號(hào)Kerr   CorporationVia   Passanti, 174 Scafati Salerno 84018 Italy2023-05-18 變更
130成形片國(guó)械備20170117號(hào)Kerr   CorporationVia   Strecce 4 P.O. 272 6934 Bioggio Switzerland2023-05-18 變更
131CD19抗體試劑（免疫組織化學(xué)）國(guó)械備20230278號(hào)Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2023-05-18 有效
132CD23抗體試劑（免疫組織化學(xué)）國(guó)械備20230277號(hào)Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2023-05-18 有效
133CD5抗體試劑（免疫組織化學(xué)）國(guó)械備20230276號(hào)Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2023-05-18 有效
134鉆針深度停止器國(guó)械備20160172號(hào)Nobel   Biocare AB22715   Savi Ranch Parkway Yorba Linda California 92887 USA；Dimbov?gen 2 SE-691 51   Karlskoga Sweden；Engvej 33, 3330 G?rl?se, Denmark2023-05-18 變更
135種植用手術(shù)導(dǎo)板國(guó)械備20160302號(hào)Nobel   Biocare AB  Dimbov?gen   2 SE-691 51 Karlskoga Sweden; 22715 Savi Ranch Parkway Yorba Linda California   92887 USA; 74950 SCIONZIER France.2023-05-18 變更
136印模帽國(guó)械備20160363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； 1701 Earhart Court, La Verne, CA   91750 USA2023-05-18 變更
137替代體國(guó)械備20181219號(hào)Nobel   Biocare ABDimbov?gen   2, 691 51 Karlskoga Sweden;22715 Savi Ranch Parkway Yorba Linda California   92887 USA;16 rue des Horlogers 74950 Scionzier France;3233 W. Harvard Street,   Santa Ana, California 92704, USA;Engvej 33, G?rl?se 3330, Denmark;2023-05-18 變更
138鉆針引導(dǎo)器國(guó)械備20160301號(hào)Nobel   Biocare AB22715   Savi Ranch Parkway Yorba Linda California 92887 USA; Dimbov?gen 2 SE-691 51   Karlskoga Sweden; Engvej 33, 3330 G?rl?se, Denmark2023-05-18 變更
139骨髓內(nèi)釘手術(shù)器械（包）國(guó)械備20180557號(hào)亞太醫(yī)療器材科技股份有限公司彰化縣伸港鄉(xiāng)溪底村工三路二號(hào)2023-05-18 變更
140大腿骨系列手術(shù)器械（包）國(guó)械備20180569號(hào)亞太醫(yī)療器材科技股份有限公司彰化縣伸港鄉(xiāng)溪底村工三路二號(hào)2023-05-18 變更
141骨科手術(shù)器械國(guó)械備20210435號(hào)Cardio   Surgical Ltd.Clogan,   Stradbally North ,Clarinbridge , Co Galway H91 Y9C9, Ireland2023-05-18 變更
142基礎(chǔ)外科手術(shù)器械 國(guó)械備20210455號(hào)Cardio   Surgical Ltd.Clogan,   Stradbally North ,Clarinbridge , Co Galway H91 Y9C9, Ireland2023-05-18 變更
143神經(jīng)和心血管手術(shù)器械國(guó)械備20210436號(hào)Cardio   Surgical Ltd.Clogan,   Stradbally North ,Clarinbridge , Co Galway H91 Y9C9, Ireland2023-05-18 變更
144PMS2抗體試劑（免疫組織化學(xué)）國(guó)械備20230275號(hào)Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42 DK-2600 Glostrup DENMARK2023-05-17 有效
145MSH6抗體試劑（免疫組織化學(xué)）國(guó)械備20230274號(hào)Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42 DK-2600 Glostrup DENMARK2023-05-17 有效
146MSH2抗體試劑（免疫組織化學(xué)）國(guó)械備20230273號(hào)Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42 DK-2600 Glostrup DENMARK2023-05-17 有效
147骨刀 國(guó)械備 20152051號(hào) Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
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148拔出器 國(guó)械備20152044號(hào)Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
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149骨測(cè)量器國(guó)械備20152049   號(hào)Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
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150膝關(guān)節(jié)拉鉤國(guó)械備   20152122號(hào)Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
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151折彎鉗國(guó)械備   20152123號(hào) Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
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152固定針國(guó)械備20152047號(hào) Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
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153導(dǎo)鉆 國(guó)械備20152045號(hào)Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-05-17 變更
154骨科定位片 國(guó)械備20152031號(hào) Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-05-17 變更
155打拔器國(guó)械備20152033號(hào) Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
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156 咬骨鉗 國(guó)械備20152124號(hào)   Waldemar Link GmbH & Co.KG Barkhausenweg   10 22339 Hamburg GERMANY2023-05-17 變更
157牙科骨內(nèi)植入物附件包國(guó)械備20190057號(hào)亞太醫(yī)療器材科技股份有限公司彰化縣伸港鄉(xiāng)溪底村工三路二號(hào)2023-05-17 變更
158牙科矯正器械包國(guó)械備20180128號(hào)亞太醫(yī)療器材科技股份有限公司彰化縣伸港鄉(xiāng)溪底村工三路二號(hào)2023-05-17 變更
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160牙科成形片及配套工具國(guó)械備20230271號(hào)Ultradent   Products, Inc.505   West Ultradent Drive (10200 South), South Jordan, Utah 84095, USA2023-05-16 有效
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165成形片夾國(guó)械備20230270號(hào)株式會(huì)社デンテック東京都板橋區(qū)清水町５３－５2023-05-16 有效
166醫(yī)用硅膠壓敏膠帶國(guó)械備20200630號(hào)3M   Deutschland GmbHPlant   Kamen EDISONSTRASSE 6 KAMEN,Nordrhein-Westfalen GERMANY 591742023-05-16 變更
167脊柱外科手術(shù)器械包國(guó)械備20151522號(hào)Medos   International SARLChemin   Blanc, 38 Le Locle, CH-2400, Switzerland; 325 Paramount Drive Raynham,   Massachusetts 02767, USA; 50 Scotland Blvd, Bridgewater Massachusetts, 02767   USA 2023-05-16 變更
168脊柱截骨手術(shù)器械（包）國(guó)械備20161782號(hào)Medos   International SARL50   Scotland Blvd, Bridgewater Massachusetts, 02324 USA  2023-05-16 變更
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171種植體安裝器械國(guó)械備20170766號(hào)(?)????????   ??? ??? 75? 5 1??? 40B 4-10L2023-05-15 變更
172口腔科拋光保護(hù)帽國(guó)械備20230269號(hào)(?)????????   ??? ???75? 5 ????? ??? ???75? 92023-05-15 有效
173牙科種植手術(shù)工具國(guó)械備20230268號(hào)(?)????????   ??? ???75? 5 ????? ??? ???75? 92023-05-15 有效
174牙科種植掃描體國(guó)械備20230267號(hào)(?)????????   ??? ???75? 5 ????? ??? ???75? 92023-05-15 有效
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176一次性使用牙科毛刷國(guó)械備20230265號(hào)Ultradent   Products, Inc.505   West Ultradent Drive (10200 South) South Jordan, Utah 84095, USA.2023-05-15 有效
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186人體定位墊國(guó)械備20160832號(hào)Orfit   IndustriesVosveld   9A 2110 Wijnegem Belgium2023-05-15 變更
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190全自動(dòng)血沉分析儀國(guó)械備20230264號(hào)ALIFAX   S.r.l.Via   Merano 30, 33045 Nimis(UD), ITALY 2023-05-12 有效
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193神經(jīng)和肌肉刺激器用體表電極國(guó)械備20200082號(hào)SPES   MEDICA SPAVia   Europa Zona Industriale 84091 Battipaglia (SA) Italia2023-05-12 變更
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225脊柱內(nèi)固定手術(shù)器械（包）國(guó)械備20190807號(hào)Medos   International SARL 50   Scotland Blvd, Bridgewater Massachusetts, 02324 USA2023-05-09 變更
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228抗酸染色液   PREVI Fluo TB國(guó)械備20150070號(hào)bioMérieux   SAMontesquieu   – Bordeaux Technopolis 33650 MARTILLAC, France2023-05-09 變更
229 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 France2023-05-09 變更
230牙科修整用鎢鋼車針國(guó)械備20190777號(hào)Beavers   Dental55   Laurier Drive Morrisburg Ontario KOC 1XO Canada2023-05-09 變更
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239免疫組化抗原修復(fù)緩沖液EnVision   FLEX Target Retrieval Solution, High pH(50×)國(guó)械備20161500號(hào)Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42, DK-2600 Glostrup, Denmark2023-05-08 變更
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246光固化牙齦屏障樹脂國(guó)械備20191157號(hào)(?)?????????   ??? ??? ??? 134 1210?2023-05-08 變更
247拔牙鉗國(guó)械備20180828號(hào)Otto   Leibinger GmbHGriesweg   27 78570 Mühlheim Germany2023-05-08 變更
248口鏡國(guó)械備20181734號(hào)Otto   Leibinger GmbHGriesweg   27 78570 Mühlheim Germany2023-05-08 變更
249牙科電動(dòng)抽吸系統(tǒng)國(guó)械備20230260號(hào)?  ?10-3,   Deogugongdan 2-gil, Bongdam-eup, Hwaseong-si, Gyeonggi-do, Korea2023-05-06 有效
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251口鏡國(guó)械備20180325號(hào)OSUNG   MND Co., Ltd.57,   Hwanggeum-ro 109beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do2023-05-05 變更
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261拔牙刀國(guó)械備20180101號(hào)Directa   ABFinvids   v?g 8, Box 723, SE-194 27 Upplands V?sby, Sweden2023-05-04 變更
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264口鏡國(guó)械備20230258號(hào)賈雷格斯實(shí)業(yè)有限公司臺(tái)中市潭子區(qū)豐栗路100巷88弄8號(hào)2023-05-04 有效
265負(fù)壓引流器國(guó)械備20150347號(hào)CG   Bio Co., Ltd.35-14,   Jeyakgongdan 4-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do2023-05-04 變更
266牙科種植體種植工具國(guó)械備20220576號(hào)BASIC   DENTAL IMPLANT SYSTEMS,INC.3321   COLUMBIA Dr. N.E. ALBUQUERQUE, NM USA 871072023-05-04 變更
267牙科用軟組織環(huán)切刀國(guó)械備20220577號(hào)BASIC   DENTAL IMPLANT SYSTEMS,INC.3321   COLUMBIA Dr. N.E. ALBUQUERQUE, NM USA 871072023-05-04 變更
268種植輔助材料國(guó)械備20220573號(hào)BASIC   DENTAL IMPLANT SYSTEMS,INC.3321   COLUMBIA Dr. N.E. ALBUQUERQUE, NM USA 871072023-05-04 變更
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