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2023年5月國家藥監(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):3593次
2023年5月，國家藥監(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膝部固定器國械備20230295號SIGVARIS   S.A. ul.   Powidzka 50, Gutowo Ma?e, PL/ 62-300 Wrze?nia2023-05-31 有效
2牙科刮治器國械備20200145號PRODONT-HOLLIGER   SOCIéTé PAR ACTIONS SIMPLIFIééLieu-dit   La Marnasse, 63880 OLLIERGUES, FRANCE2023-05-31 變更
3高速離心機(jī)國械備20200714號Eppendorf   SEPortitzer   Allee 15, 04329 Leipzig, Germany2023-05-30 變更
4低速離心機(jī)國械備20171118號Eppendorf   SEBarkhausenweg   1, 22339 Hamburg, Germany2023-05-30 變更
5高速離心機(jī)國械備20171120號Eppendorf   SEBarkhausenweg   1, 22339 Hamburg, Germany2023-05-30 變更
6高速冷凍離心機(jī)國械備20170331號Eppendorf   SEBarkhausenweg   1, 22339 Hamburg, Germany2023-05-30 變更
7高速離心機(jī)國械備20180302號Eppendorf   SEBarkhausenweg   1, 22339 Hamburg, Germany2023-05-30 變更
8高速離心機(jī)國械備20180864號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)國械備20180863號Eppendorf   SEPortitzer   Allee 15, 04329 Leipzig, Germany2023-05-30 變更
10高速冷凍離心機(jī)國械備20210475號Eppendorf   SEPortitzer   Allee 15, 04329 Leipzig, Germany2023-05-30 變更
11高速離心機(jī)國械備20190837號Eppendorf   SEPortitzer   Allee 15, 04329 Leipzig, Germany; 175 Freshwater Boulevard, Enfield CT 06082,   USA2023-05-30 變更
12醫(yī)用干式激光膠片國械備20230294號COLENTA   Labortechnik GmbH & Co.KGNeunkirchner   Str.117,A-2700 Wiener Neustadt2023-05-30 有效
13骨科牽引架國械備20190855號STERIS   Corporation2720   Gunter Park Drive East, Montgomery, Alabama, 36109, USA2023-05-29 變更
14醫(yī)用超聲波清洗器國械備20210506號STERIS   CorporationUnits   7 & 8 Stortford Hall Industrial Park Dunmow Road Bishop’s Stortford   Hertfordshire CM23 5GZ United Kingdom2023-05-29 變更
15骨科牽引架國械備20200226號STERIS   SASPutajantie   42 38210 Sastamala, Finland2023-05-29 變更
16ALK抗體試劑（免疫組織化學(xué)）國械備20220152號Agilent   Technologies Singapore (International) Pte. Ltd.Produktionsvej   42, Glostrup DK-2600, Denmark2023-05-29 變更
17原位雜交洗脫液國械備20220149號Agilent   Technologies Singapore (International) Pte. Ltd.Produktionsvej   42 Glostrup DK-2600 Denmark2023-05-29 變更
18吸唾管國械備20170381號(?)????????   ??? ??? ???109?? 572023-05-26 變更
19牙科充填器國械備20170371號(?)????????   ??? ??? ???109?? 572023-05-26 變更
20牙挺國械備20180608號(?)????????   ??? ??? ???109?? 572023-05-26 變更
21口鏡國械備20170391號(?)????????   ??? ??? ???109?? 572023-05-26 變更
22牙科潔治器國械備20170823號(?)????????   ??? ??? ???109?? 572023-05-26 變更
23牙科用分離器國械備20170834號(?)????????   ??? ??? ???109?? 572023-05-26 變更
24牙刮匙國械備20170380號(?)????????   ??? ??? ???109?? 572023-05-26 變更
25醫(yī)用剪國械備20151960號CM   Instrumente GmbHGan   sacker 56 D-78532 Tuttlingen2023-05-26 變更
26顯微止血夾國械備20150416號CM   Instrumente GmbH G?ns?cker   56 D-78532 Tuttlingen2023-05-26 變更
27顯微持針鉗國械備20150406號CM   Instrumente GmbHG?ns?cker   56 D-78532 Tuttlingen2023-05-26 變更
28牙科骨粉輸送器國械備20230293號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)刀柄國械備20180603號(?)????????   ??? ??? ???109?? 572023-05-25 變更
30呼吸訓(xùn)練器國械備20150135號Leventon   S.A.U.C/   Newton, 18-24 08635 Sant Esteve Sesrovires, Barcelona Spain2023-05-25 變更
31呼吸訓(xùn)練器國械備20160866號Leventon   S.A.U.C/   Newton, 18-24 08635 Sant Esteve Sesrovires, Barcelona Spain2023-05-25 變更
32上頜竇提升器國械備20230292號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)用放大鏡國械備20150130號XENOSYS   CO., LTD.2F,   2, Venture-ro 100beon-gil, Yeonsu-gu, Incheon2023-05-25 變更
34牙探針國械備20170835號(?)????????   ??? ??? ???109?? 572023-05-25 變更
35牙科用骨劈開鑿國械備20230291號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咬骨鉗國械備20170824號(?)????????   ??? ??? ???109?? 572023-05-25 變更
37唇頰牽開器國械備20170807號(?)????????   ??? ??? ???109?? 572023-05-25 變更
38組織拉鉤國械備20170839號(?)????????   ??? ??? ???109?? 572023-05-25 變更
39拔牙鉗國械備20170840號(?)????????   ??? ??? ???109?? 572023-05-25 變更
40牙齦刀國械備20180602號(?)????????   ??? ??? ???109?? 572023-05-25 變更
41上頜竇提升器國械備20180609號(?)????????   ??? ??? ???109?? 572023-05-25 變更
42橡皮障器械國械備20170154號(?)????????   ??? ??? ???109?? 572023-05-25 變更
43正畸鉗國械備20181528號(?)????????   ??? ??? ???109?? 572023-05-25 變更
44牙科用剪國械備20160966號(?)?????57,   Hwanggeum-ro 109 beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do, Korea2023-05-25 變更
45牙科用分離器國械備20160967號(?)?????57,   Hwanggeum-ro 109 beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do, Korea2023-05-25 變更
46牙骨錘國械備20170844號(?)????????   ??? ??? ???109?? 572023-05-25 變更
47牙科去冠器國械備20230290號(?)????????   ??? ??? ???109?? 572023-05-25 有效
48牙科骨粉調(diào)和用金屬容器國械備20230289號(?)????????   ??? ??? ???109?? 572023-05-25 有效
49帕巾鉗國械備20230288號(?)????????   ??? ??? ???109?? 572023-05-25 有效
50牙科種植用扳手國械備20230287號(?)????????   ??? ??? ???109?? 572023-05-25 有效
51口腔正畸用反光鏡國械備20230286號(?)????????   ??? ??? ???109?? 572023-05-25 有效
52頭戴式檢查燈國械備20181596號Metrex   Research LLC dba Orascoptic3225   Deming Way Suite 190 Middleton,WI USA 535622023-05-25 變更
53根管銼國械備20160608號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頭戴式檢查燈國械備20181247號Metrex   Research LLC dba Orascoptic3225   Deming Way Suite 190 Middleton,WI USA 535622023-05-25 變更
55研光器國械備20161043號Kerr   CorporationVia   Strecce 4 P.O. 272 6934 Bioggio Switzerland2023-05-25 變更
56醫(yī)用光學(xué)放大鏡國械備20190118號Metrex   Research LLC dba Orascoptic3225   Deming Way Suite 190 Middleton,WI USA 535622023-05-25 變更
57根管充填器國械備20160554號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)工具國械備20181529號(?)????????   ??? ??? ???109?? 572023-05-25 變更
59持針鉗國械備20170383號(?)????????   ??? ??? ???109?? 572023-05-25 變更
60牙科用鑷國械備20170459號(?)????????   ??? ??? ???109?? 572023-05-25 變更
61牙用尺國械備20170845號(?)????????   ??? ??? ???109?? 572023-05-25 變更
62牙科開口器國械備20170808號(?)????????   ??? ??? ???109?? 572023-05-25 變更
63止血鉗國械備20170370號(?)????????   ??? ??? ???109?? 572023-05-25 變更
64CD13檢測試劑國械備20230055號Agilent   Technologies Singapore (International) Pte. Ltd.Produktionsvej   42 DK-2600 Glostrup Denmark2023-05-25 變更
65CD103檢測試劑國械備20230056號Agilent   Technologies Singapore (International) Pte. Ltd.Produktionsvej   42 DK-2600 Glostrup Denmark2023-05-25 變更
66CD79a檢測試劑國械備20230052號Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42 DK-2600 Glostrup DENMARK2023-05-25 變更
67CD33檢測試劑國械備20230049號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械備20200299號BEGO   Bremer Goldschl?gerei Wilh. Herbst GmbH & Co. KGWilhelm-Herbst-Str.   1,28359 Bremen, Deutschland2023-05-24 變更
69瓊脂復(fù)制材料國械備20160406號BEGO   Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KGWilhelm-Herbst-Str.   1-28359 Bremen, Deutchland2023-05-24 變更
70口角拉鉤國械備20170194號Kerr   CorporationVia   Strecce 4 P.O. 272 6934 Bioggio Switzerland2023-05-24 變更
71橡皮障夾國械備20150074號Kerr   CorporationVia   Strecce 4, 6934 Bioggio, Switzerland2023-05-24 變更
72研光器國械備20170116號Kerr   CorporationVia   Strecce 4 P.O. 272 6934 Bioggio Switzerland2023-05-24 變更
73研光器國械備20170103號Kerr   CorporationVia   Strecce 4 P.O. 272 6934 Bioggio Switzerland2023-05-24 變更
74楔子國械備20170236號Kerr   CorporationVia   Strecce 4 P.O. 272 6934 Bioggio Switzerland 2023-05-24 變更
75研光器國械備20200550號Kerr   CorporationLot   3, Jalan CJ 1/6, Kawasan Perusahaan Cheras Jaya, Jalan Balakong, Batu 11,   Cheras, Selangor Malaysia 432002023-05-24 變更
76骨銼國械備20170847號(?)????????   ??? ??? ???109?? 572023-05-24 變更
77持骨鉗國械備20170853號(?)????????   ??? ??? ???109?? 572023-05-24 變更
78牙骨鑿國械備20170382號(?)????????   ??? ??? ???109?? 572023-05-24 變更
79皮膚組織鉆孔器國械備20170854號(?)????????   ??? ??? ???109?? 572023-05-24 變更
80牙科修整用金剛砂車針國械備20200064號(?)????????   ??? ??? ???109?? 57, ????? ?? ??? 14, 613?2023-05-24 變更
81口腔麻醉注射架國械備20170846號(?)????????   ??? ??? ???109?? 572023-05-24 變更
82研光器國械備20161935號Kerr   CorporationVia   Strecce 4 P.O. 272 6934 Bioggio Switzerland2023-05-24 變更
83頭戴式放大鏡國械備20140236號Metrex   Research LLC dba Orascoptic3225   Deming Way Suite 190 Middleton, WI 53562 2023-05-24 變更
84根管銼國械備20151818號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頭戴式放大鏡國械備20140247號Metrex   Research LLC dba Orascoptic3225   Deming Way Suite 190 Middleton, WI 53562 2023-05-24 變更
86研光器國械備20170118號Kerr   CorporationVia   Strecce 4 P.O. 272 6934 Bioggio Switzerland2023-05-24 變更
87根管銼國械備20160552號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頭戴式放大鏡國械備20162018號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械備20230285號SANCTUARY   HEALTH SDN. BHD.No.16,   Persiaran Perindustrian Kanthan 1, Kawasan Perindustrian Kanthan, 31200   Chemor, Perak, Malaysia.2023-05-24 有效
90牙科輸送器國械備20230284號(?)????????   ??? ??? ???109?? 572023-05-23 有效
91緩沖液國械備20180713號HYPHEN   BioMed155   rue d’Eragny, 95000 Neuville-sur-Oise, France2023-05-23 變更
92骨科用螺絲刀國械備20170294號movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 變更
93剪斷器國械備20170291號movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 變更
94螺釘取出器國械備20170293號movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 變更
95打入器國械備20170292號movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 變更
96醫(yī)用尺國械備   20152121號Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
    GERMANY		2023-05-23 變更
97骨鉆國械備20170287號movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 變更
98肩鎖關(guān)節(jié)手術(shù)工具國械備20170285號movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 變更
99打入器國械備20170283號movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 變更
100跟腱手術(shù)工具國械備20170263號movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 變更
101骨鉆國械備20170286號movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 變更
102肩袖手術(shù)工具國械備20170284號movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 變更
103后交叉韌帶手術(shù)工具國械備20170295號movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 變更
104前交叉韌帶手術(shù)工具國械備20170397號movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 變更
105骨定位針國械備20170288號movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 變更
106髓腔擴(kuò)大器國械備20152142號Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-05-23 變更
107髖關(guān)節(jié)拉鉤國械備   20152073號Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-05-23 變更
108 咬骨剪國械備   20152125號 Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
    GERMANY		2023-05-23 變更
109扭斷器國械備20152130號Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-05-23 變更
110顏面系列手術(shù)器械（包）國械備20180582號亞太醫(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2023-05-23 變更
111取出鉗國械備20152126號Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-05-23 變更
112骨用牽開器國械備20152127號Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-05-23 變更
113耳用鑷國械備20230282號MED-EL   Elektromedizinische Ger?te GmbHFürstenweg   77A，6020 Innsbruck，Austria2023-05-22 有效
114陰道環(huán)放置器國械備20170451號N.V.OrganonVeilingweg   24, 2651 BE, Berkel en Rodenrijs, The Netherlands2023-05-22 變更
115醫(yī)用透氣膠帶國械備20200150號ニチバン株式會社福岡県朝倉郡筑前町野町字禪門橋1713番地2023-05-22 變更
116全自動紅細(xì)胞沉降率測定儀國械備20220074號DIESSE   Diagnostica Senese S.p.A.Strada   dei Laghi 39, 53035 Monteriggioni (SI) Italy2023-05-22 變更
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125牙科用毛刷國械備20191097號SDI   Limited3-15   Brunsdon Street, Bayswater, Victoria 3153, Australia2023-05-19 變更
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132CD23抗體試劑（免疫組織化學(xué)）國械備20230277號Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2023-05-18 有效
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