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当前位置：网站首页>新闻动态 >2023年5月国家药监局批准进口第一类医疗器械产品备案269项
2023年5月国家药监局批准进口第一类医疗器械产品备案269项
发布日期:2023-06-07 20:14浏览次数:4842次
2023年5月，国家药监局累计批准进口第一类医疗器械产品备案事项269项，好的医疗器械不一定非得是第三类医疗器械，不一定非得是第二类医疗器械，不一定非得是要做临床试验的器械，许多第一类医疗器械产品也需要进口，需要境外医疗器械制造商供应。

2023年5月，国家药监局累计批准进口第一类医疗器械产品备案事项269项，好的医疗器械不一定非得是第三类医疗器械，不一定非得是第二类医疗器械，不一定非得是要做临床试验的器械，许多第一类医疗器械产品也需要进口，需要境外医疗器械制造商供应。

第一类医疗器械产品备案.jpg

2023年5月进口第一类医疗器械产品备案信息

序号产品名称备案号备案人名称原文生产地址原文备案日期状态
1膝部固定器国械备20230295号SIGVARIS   S.A. ul.   Powidzka 50, Gutowo Ma?e, PL/ 62-300 Wrze?nia2023-05-31 有效
2牙科刮治器国械备20200145号PRODONT-HOLLIGER   SOCIéTé PAR ACTIONS SIMPLIFIééLieu-dit   La Marnasse, 63880 OLLIERGUES, FRANCE2023-05-31 变更
3高速离心机国械备20200714号Eppendorf   SEPortitzer   Allee 15, 04329 Leipzig, Germany2023-05-30 变更
4低速离心机国械备20171118号Eppendorf   SEBarkhausenweg   1, 22339 Hamburg, Germany2023-05-30 变更
5高速离心机国械备20171120号Eppendorf   SEBarkhausenweg   1, 22339 Hamburg, Germany2023-05-30 变更
6高速冷冻离心机国械备20170331号Eppendorf   SEBarkhausenweg   1, 22339 Hamburg, Germany2023-05-30 变更
7高速离心机国械备20180302号Eppendorf   SEBarkhausenweg   1, 22339 Hamburg, Germany2023-05-30 变更
8高速离心机国械备20180864号Eppendorf   SEPortitzer   Allee 15, 04329 Leipzig, Germany;       175 Freshwater Boulevard, Enfield CT 06082, USA2023-05-30 变更
9低速离心机国械备20180863号Eppendorf   SEPortitzer   Allee 15, 04329 Leipzig, Germany2023-05-30 变更
10高速冷冻离心机国械备20210475号Eppendorf   SEPortitzer   Allee 15, 04329 Leipzig, Germany2023-05-30 变更
11高速离心机国械备20190837号Eppendorf   SEPortitzer   Allee 15, 04329 Leipzig, Germany; 175 Freshwater Boulevard, Enfield CT 06082,   USA2023-05-30 变更
12医用干式激光胶片国械备20230294号COLENTA   Labortechnik GmbH & Co.KGNeunkirchner   Str.117,A-2700 Wiener Neustadt2023-05-30 有效
13骨科牵引架国械备20190855号STERIS   Corporation2720   Gunter Park Drive East, Montgomery, Alabama, 36109, USA2023-05-29 变更
14医用超声波清洗器国械备20210506号STERIS   CorporationUnits   7 & 8 Stortford Hall Industrial Park Dunmow Road Bishop’s Stortford   Hertfordshire CM23 5GZ United Kingdom2023-05-29 变更
15骨科牵引架国械备20200226号STERIS   SASPutajantie   42 38210 Sastamala, Finland2023-05-29 变更
16ALK抗体试剂（免疫组织化学）国械备20220152号Agilent   Technologies Singapore (International) Pte. Ltd.Produktionsvej   42, Glostrup DK-2600, Denmark2023-05-29 变更
17原位杂交洗脱液国械备20220149号Agilent   Technologies Singapore (International) Pte. Ltd.Produktionsvej   42 Glostrup DK-2600 Denmark2023-05-29 变更
18吸唾管国械备20170381号(?)????????   ??? ??? ???109?? 572023-05-26 变更
19牙科充填器国械备20170371号(?)????????   ??? ??? ???109?? 572023-05-26 变更
20牙挺国械备20180608号(?)????????   ??? ??? ???109?? 572023-05-26 变更
21口镜国械备20170391号(?)????????   ??? ??? ???109?? 572023-05-26 变更
22牙科洁治器国械备20170823号(?)????????   ??? ??? ???109?? 572023-05-26 变更
23牙科用分离器国械备20170834号(?)????????   ??? ??? ???109?? 572023-05-26 变更
24牙刮匙国械备20170380号(?)????????   ??? ??? ???109?? 572023-05-26 变更
25医用剪国械备20151960号CM   Instrumente GmbHGan   sacker 56 D-78532 Tuttlingen2023-05-26 变更
26显微止血夹国械备20150416号CM   Instrumente GmbH G?ns?cker   56 D-78532 Tuttlingen2023-05-26 变更
27显微持针钳国械备20150406号CM   Instrumente GmbHG?ns?cker   56 D-78532 Tuttlingen2023-05-26 变更
28牙科骨粉输送器国械备20230293号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手术刀柄国械备20180603号(?)????????   ??? ??? ???109?? 572023-05-25 变更
30呼吸训练器国械备20150135号Leventon   S.A.U.C/   Newton, 18-24 08635 Sant Esteve Sesrovires, Barcelona Spain2023-05-25 变更
31呼吸训练器国械备20160866号Leventon   S.A.U.C/   Newton, 18-24 08635 Sant Esteve Sesrovires, Barcelona Spain2023-05-25 变更
32上颌窦提升器国械备20230292号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医用放大镜国械备20150130号XENOSYS   CO., LTD.2F,   2, Venture-ro 100beon-gil, Yeonsu-gu, Incheon2023-05-25 变更
34牙探针国械备20170835号(?)????????   ??? ??? ???109?? 572023-05-25 变更
35牙科用骨劈开凿国械备20230291号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咬骨钳国械备20170824号(?)????????   ??? ??? ???109?? 572023-05-25 变更
37唇颊牵开器国械备20170807号(?)????????   ??? ??? ???109?? 572023-05-25 变更
38组织拉钩国械备20170839号(?)????????   ??? ??? ???109?? 572023-05-25 变更
39拔牙钳国械备20170840号(?)????????   ??? ??? ???109?? 572023-05-25 变更
40牙龈刀国械备20180602号(?)????????   ??? ??? ???109?? 572023-05-25 变更
41上颌窦提升器国械备20180609号(?)????????   ??? ??? ???109?? 572023-05-25 变更
42橡皮障器械国械备20170154号(?)????????   ??? ??? ???109?? 572023-05-25 变更
43正畸钳国械备20181528号(?)????????   ??? ??? ???109?? 572023-05-25 变更
44牙科用剪国械备20160966号(?)?????57,   Hwanggeum-ro 109 beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do, Korea2023-05-25 变更
45牙科用分离器国械备20160967号(?)?????57,   Hwanggeum-ro 109 beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do, Korea2023-05-25 变更
46牙骨锤国械备20170844号(?)????????   ??? ??? ???109?? 572023-05-25 变更
47牙科去冠器国械备20230290号(?)????????   ??? ??? ???109?? 572023-05-25 有效
48牙科骨粉调和用金属容器国械备20230289号(?)????????   ??? ??? ???109?? 572023-05-25 有效
49帕巾钳国械备20230288号(?)????????   ??? ??? ???109?? 572023-05-25 有效
50牙科种植用扳手国械备20230287号(?)????????   ??? ??? ???109?? 572023-05-25 有效
51口腔正畸用反光镜国械备20230286号(?)????????   ??? ??? ???109?? 572023-05-25 有效
52头戴式检查灯国械备20181596号Metrex   Research LLC dba Orascoptic3225   Deming Way Suite 190 Middleton,WI USA 535622023-05-25 变更
53根管锉国械备20160608号Kerr   Corporation1332   South Lone Hill Avenue Glendora, California 91740 USA; Calle 21 No 1103 AMP   CD Industrial Uman Yucatan 97390 Mexico2023-05-25 变更
54头戴式检查灯国械备20181247号Metrex   Research LLC dba Orascoptic3225   Deming Way Suite 190 Middleton,WI USA 535622023-05-25 变更
55研光器国械备20161043号Kerr   CorporationVia   Strecce 4 P.O. 272 6934 Bioggio Switzerland2023-05-25 变更
56医用光学放大镜国械备20190118号Metrex   Research LLC dba Orascoptic3225   Deming Way Suite 190 Middleton,WI USA 535622023-05-25 变更
57根管充填器国械备20160554号Kerr   Corporation1332   South Lone Hill Avenue Glendora, California 91740 USA2023-05-25 变更
58牙科种植系统手术工具国械备20181529号(?)????????   ??? ??? ???109?? 572023-05-25 变更
59持针钳国械备20170383号(?)????????   ??? ??? ???109?? 572023-05-25 变更
60牙科用镊国械备20170459号(?)????????   ??? ??? ???109?? 572023-05-25 变更
61牙用尺国械备20170845号(?)????????   ??? ??? ???109?? 572023-05-25 变更
62牙科开口器国械备20170808号(?)????????   ??? ??? ???109?? 572023-05-25 变更
63止血钳国械备20170370号(?)????????   ??? ??? ???109?? 572023-05-25 变更
64CD13检测试剂国械备20230055号Agilent   Technologies Singapore (International) Pte. Ltd.Produktionsvej   42 DK-2600 Glostrup Denmark2023-05-25 变更
65CD103检测试剂国械备20230056号Agilent   Technologies Singapore (International) Pte. Ltd.Produktionsvej   42 DK-2600 Glostrup Denmark2023-05-25 变更
66CD79a检测试剂国械备20230052号Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42 DK-2600 Glostrup DENMARK2023-05-25 变更
67CD33检测试剂国械备20230049号Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42 DK-2600 Glostrup DENMARK2023-05-25 变更
68牙科磷酸盐铸造包埋材国械备20200299号BEGO   Bremer Goldschl?gerei Wilh. Herbst GmbH & Co. KGWilhelm-Herbst-Str.   1,28359 Bremen, Deutschland2023-05-24 变更
69琼脂复制材料国械备20160406号BEGO   Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KGWilhelm-Herbst-Str.   1-28359 Bremen, Deutchland2023-05-24 变更
70口角拉钩国械备20170194号Kerr   CorporationVia   Strecce 4 P.O. 272 6934 Bioggio Switzerland2023-05-24 变更
71橡皮障夹国械备20150074号Kerr   CorporationVia   Strecce 4, 6934 Bioggio, Switzerland2023-05-24 变更
72研光器国械备20170116号Kerr   CorporationVia   Strecce 4 P.O. 272 6934 Bioggio Switzerland2023-05-24 变更
73研光器国械备20170103号Kerr   CorporationVia   Strecce 4 P.O. 272 6934 Bioggio Switzerland2023-05-24 变更
74楔子国械备20170236号Kerr   CorporationVia   Strecce 4 P.O. 272 6934 Bioggio Switzerland 2023-05-24 变更
75研光器国械备20200550号Kerr   CorporationLot   3, Jalan CJ 1/6, Kawasan Perusahaan Cheras Jaya, Jalan Balakong, Batu 11,   Cheras, Selangor Malaysia 432002023-05-24 变更
76骨锉国械备20170847号(?)????????   ??? ??? ???109?? 572023-05-24 变更
77持骨钳国械备20170853号(?)????????   ??? ??? ???109?? 572023-05-24 变更
78牙骨凿国械备20170382号(?)????????   ??? ??? ???109?? 572023-05-24 变更
79皮肤组织钻孔器国械备20170854号(?)????????   ??? ??? ???109?? 572023-05-24 变更
80牙科修整用金刚砂车针国械备20200064号(?)????????   ??? ??? ???109?? 57, ????? ?? ??? 14, 613?2023-05-24 变更
81口腔麻醉注射架国械备20170846号(?)????????   ??? ??? ???109?? 572023-05-24 变更
82研光器国械备20161935号Kerr   CorporationVia   Strecce 4 P.O. 272 6934 Bioggio Switzerland2023-05-24 变更
83头戴式放大镜国械备20140236号Metrex   Research LLC dba Orascoptic3225   Deming Way Suite 190 Middleton, WI 53562 2023-05-24 变更
84根管锉国械备20151818号Kerr   Corporation1332   South Lone Hill Avenue Glendora, California 91740 USA;Calle 21 No 1103 AMP CD   Industrial Uman Yucatan 97390 Mexico2023-05-24 变更
85头戴式放大镜国械备20140247号Metrex   Research LLC dba Orascoptic3225   Deming Way Suite 190 Middleton, WI 53562 2023-05-24 变更
86研光器国械备20170118号Kerr   CorporationVia   Strecce 4 P.O. 272 6934 Bioggio Switzerland2023-05-24 变更
87根管锉国械备20160552号Kerr   Corporation1332   South Lone Hill Avenue Glendora, California 91740 USA; Calle 21 No 1103 AMP   CD Industrial Uman Yucatan 97390 Mexico2023-05-24 变更
88头戴式放大镜国械备20162018号Metrex   Research LLC dba Orascoptic3225   Deming Way Suite 190 Middleton Wisconsin 53562 USA2023-05-24 变更
89光固化牙龈屏障树脂国械备20230285号SANCTUARY   HEALTH SDN. BHD.No.16,   Persiaran Perindustrian Kanthan 1, Kawasan Perindustrian Kanthan, 31200   Chemor, Perak, Malaysia.2023-05-24 有效
90牙科输送器国械备20230284号(?)????????   ??? ??? ???109?? 572023-05-23 有效
91缓冲液国械备20180713号HYPHEN   BioMed155   rue d’Eragny, 95000 Neuville-sur-Oise, France2023-05-23 变更
92骨科用螺丝刀国械备20170294号movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 变更
93剪断器国械备20170291号movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 变更
94螺钉取出器国械备20170293号movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 变更
95打入器国械备20170292号movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 变更
96医用尺国械备   20152121号Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
    GERMANY		2023-05-23 变更
97骨钻国械备20170287号movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 变更
98肩锁关节手术工具国械备20170285号movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 变更
99打入器国械备20170283号movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 变更
100跟腱手术工具国械备20170263号movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 变更
101骨钻国械备20170286号movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 变更
102肩袖手术工具国械备20170284号movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 变更
103后交叉韧带手术工具国械备20170295号movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 变更
104前交叉韧带手术工具国械备20170397号movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 变更
105骨定位针国械备20170288号movmedix5   rue de la Fontaine 21560 ARC SUR TILLE FRANCE2023-05-23 变更
106髓腔扩大器国械备20152142号Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-05-23 变更
107髋关节拉钩国械备   20152073号Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-05-23 变更
108 咬骨剪国械备   20152125号 Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
    GERMANY		2023-05-23 变更
109扭断器国械备20152130号Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-05-23 变更
110颜面系列手术器械（包）国械备20180582号亞太醫療器材科技股份有限公司彰化縣伸港鄉溪底村工三路二號2023-05-23 变更
111取出钳国械备20152126号Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-05-23 变更
112骨用牵开器国械备20152127号Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-05-23 变更
113耳用镊国械备20230282号MED-EL   Elektromedizinische Ger?te GmbHFürstenweg   77A，6020 Innsbruck，Austria2023-05-22 有效
114阴道环放置器国械备20170451号N.V.OrganonVeilingweg   24, 2651 BE, Berkel en Rodenrijs, The Netherlands2023-05-22 变更
115医用透气胶带国械备20200150号ニチバン株式会社福岡県朝仓郡筑前町野町字禅門橋1713番地2023-05-22 变更
116全自动红细胞沉降率测定仪国械备20220074号DIESSE   Diagnostica Senese S.p.A.Strada   dei Laghi 39, 53035 Monteriggioni (SI) Italy2023-05-22 变更
117全自动红细胞沉降率测定仪国械备20220076号DIESSE   Diagnostica Senese S.p.A.Strada   dei Laghi 39, 53035 Monteriggioni (SI) Italy2023-05-22 变更
118腰部固定器国械备20190176号?ssur   hfGrjotháls   1-5 Reykjavik 110 Iceland2023-05-19 变更
119施夹钳(不带夹)国械备20200365号PETERS   SURGICAL 见附件22023-05-19 变更
120膝关节手术工具国械备20181669号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 变更
121全自动核酸提取仪国械备20230281号台灣圓點奈米技術股份有限公司333桃園市龜山區文禾路188號4樓2023-05-19 有效
122封片机国械备20230280号Shandon   Diagnostics Limited, a subsidiary of EprediaTudor   Road, Manor Park, Runcorn, WA7 1TA Cheshire, United Kingdom2023-05-19 有效
123矫形外科（骨科）手术器械（包）国械备20180546号亞太醫療器材科技股份有限公司彰化縣伸港鄉溪底村工三路二號2023-05-19 变更
124中空螺钉手术器械（包）国械备20180581号亞太醫療器材科技股份有限公司彰化縣伸港鄉溪底村工三路二號2023-05-19 变更
125牙科用毛刷国械备20191097号SDI   Limited3-15   Brunsdon Street, Bayswater, Victoria 3153, Australia2023-05-19 变更
126银汞调合器国械备20170059号SDI   Limited3-15   Brunsdon Street Bayswater, Victoria 3153 Australia2023-05-19 变更
127封片机国械备20230279号Shandon   Diagnostics Limited, a subsidiary of EprediaTudor   Road, Manor Park, Runcorn, WA7 1TA Cheshire, United Kingdom2023-05-18 有效
128肌电导联线国械备20210504号Natus   Manufacturing LimitedIDA   Business Park Gort Co.Galway Ireland2023-05-18 变更
129成形片国械备20210269号Kerr   CorporationVia   Passanti, 174 Scafati Salerno 84018 Italy2023-05-18 变更
130成形片国械备20170117号Kerr   CorporationVia   Strecce 4 P.O. 272 6934 Bioggio Switzerland2023-05-18 变更
131CD19抗体试剂（免疫组织化学）国械备20230278号Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2023-05-18 有效
132CD23抗体试剂（免疫组织化学）国械备20230277号Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2023-05-18 有效
133CD5抗体试剂（免疫组织化学）国械备20230276号Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2023-05-18 有效
134钻针深度停止器国械备20160172号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 变更
135种植用手术导板国械备20160302号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 变更
136印模帽国械备20160363号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 变更
137替代体国械备20181219号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 变更
138钻针引导器国械备20160301号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 变更
139骨髓内钉手术器械（包）国械备20180557号亞太醫療器材科技股份有限公司彰化縣伸港鄉溪底村工三路二號2023-05-18 变更
140大腿骨系列手术器械（包）国械备20180569号亞太醫療器材科技股份有限公司彰化縣伸港鄉溪底村工三路二號2023-05-18 变更
141骨科手术器械国械备20210435号Cardio   Surgical Ltd.Clogan,   Stradbally North ,Clarinbridge , Co Galway H91 Y9C9, Ireland2023-05-18 变更
142基础外科手术器械 国械备20210455号Cardio   Surgical Ltd.Clogan,   Stradbally North ,Clarinbridge , Co Galway H91 Y9C9, Ireland2023-05-18 变更
143神经和心血管手术器械国械备20210436号Cardio   Surgical Ltd.Clogan,   Stradbally North ,Clarinbridge , Co Galway H91 Y9C9, Ireland2023-05-18 变更
144PMS2抗体试剂（免疫组织化学）国械备20230275号Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42 DK-2600 Glostrup DENMARK2023-05-17 有效
145MSH6抗体试剂（免疫组织化学）国械备20230274号Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42 DK-2600 Glostrup DENMARK2023-05-17 有效
146MSH2抗体试剂（免疫组织化学）国械备20230273号Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42 DK-2600 Glostrup DENMARK2023-05-17 有效
147骨刀 国械备 20152051号 Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
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148拔出器 国械备20152044号Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
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149骨测量器国械备20152049   号Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
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150膝关节拉钩国械备   20152122号Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
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151折弯钳国械备   20152123号 Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
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152固定针国械备20152047号 Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
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153导钻 国械备20152045号Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-05-17 变更
154骨科定位片 国械备20152031号 Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-05-17 变更
155打拔器国械备20152033号 Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
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156 咬骨钳 国械备20152124号   Waldemar Link GmbH & Co.KG Barkhausenweg   10 22339 Hamburg GERMANY2023-05-17 变更
157牙科骨内植入物附件包国械备20190057号亞太醫療器材科技股份有限公司彰化縣伸港鄉溪底村工三路二號2023-05-17 变更
158牙科矫正器械包国械备20180128号亞太醫療器材科技股份有限公司彰化縣伸港鄉溪底村工三路二號2023-05-17 变更
159手术头架国械备20230272号medical   bees GmbHFriedrich-W?hler-Straβe   13 78576 Emmingen Deutschland2023-05-17 有效
160牙科成形片及配套工具国械备20230271号Ultradent   Products, Inc.505   West Ultradent Drive (10200 South), South Jordan, Utah 84095, USA2023-05-16 有效
161牙科模型材料国械备20151947号BEGO   Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KGWilhelm-Herbst-Str.   1,28359 Bremen, Deutchland2023-05-16 变更
162口腔观察仪国械备20161762号KaVo   Dental  GmbHBismarckring   39, 88400 Biberach, Germany; Bahnhofstraβe 20, 88447 Warthausen, Germany2023-05-16 变更
163口腔灯国械备20151288号KaVo   Dental GmbHBismarckring   39 D-88400 Biberach,Germany;    Bahnhofstraβe 20 D-88447 Warthausen,Germany2023-05-16 变更
164快接头国械备20190456号KaVo   Dental GmbHBahnhofstra?e   20 88447 Warthausen, Germany2023-05-16 变更
165成形片夹国械备20230270号株式会社デンテック東京都板橋区清水町５３－５2023-05-16 有效
166医用硅胶压敏胶带国械备20200630号3M   Deutschland GmbHPlant   Kamen EDISONSTRASSE 6 KAMEN,Nordrhein-Westfalen GERMANY 591742023-05-16 变更
167脊柱外科手术器械包国械备20151522号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 变更
168脊柱截骨手术器械（包）国械备20161782号Medos   International SARL50   Scotland Blvd, Bridgewater Massachusetts, 02324 USA  2023-05-16 变更
169防漏膏国械备20190302号B.   Braun Hospicare Ltd2055   Luna Road, #126, Carrollton Texas 75006 USA2023-05-16 无效
170种植辅助器械包国械备20200058号(?)????????   ??? ???75? 5, ????? ??? ????64? 542023-05-15 变更
171种植体安装器械国械备20170766号(?)????????   ??? ??? 75? 5 1??? 40B 4-10L2023-05-15 变更
172口腔科抛光保护帽国械备20230269号(?)????????   ??? ???75? 5 ????? ??? ???75? 92023-05-15 有效
173牙科种植手术工具国械备20230268号(?)????????   ??? ???75? 5 ????? ??? ???75? 92023-05-15 有效
174牙科种植扫描体国械备20230267号(?)????????   ??? ???75? 5 ????? ??? ???75? 92023-05-15 有效
175定位螺丝国械备20230266号(?)????????   ??? ???75? 5 ????? ??? ???75? 92023-05-15 有效
176一次性使用牙科毛刷国械备20230265号Ultradent   Products, Inc.505   West Ultradent Drive (10200 South) South Jordan, Utah 84095, USA.2023-05-15 有效
177染色机国械备20161037号DAGATRONICS   CORPORATION(Deogi-dong),   177, Tanjung-ro, I1sanseo-gu Goyang-si, Gyeonggi-do, Korea2023-05-15 变更
178人体定位垫国械备20220550号Orfit   IndustriesVosveld   9a 2110 Wijnegem Belgium2023-05-15 变更
179定位膜国械备20160834号Orfit   IndustriesVosveld   9A 2110 Wijnegem Belgium2023-05-15 变更
180放射治疗托架国械备20210107号Orfit   IndustriesVosveld   9a 2110 Wijnegem Belgium2023-05-15 变更
181放射治疗托架国械备20220007号Orfit   IndustriesVosveld   9a 2110 Wijnegem Belgium2023-05-15 变更
182放射治疗托架国械备20220008号Orfit   IndustriesVosveld   9a 2110 Wijnegem Belgium2023-05-15 变更
183热塑膜国械备20200470号Orfit   IndustriesVosveld   9a 2110 Wijnegem Belgium2023-05-15 变更
184人体定位垫国械备20150605号Orfit   IndustriesVosveld   9A 2110 Wijnegem Belgium2023-05-15 变更
185人体定位垫国械备20150606号Orfit   IndustriesVosveld   9A 2110 Wijnegem Belgium2023-05-15 变更
186人体定位垫国械备20160832号Orfit   IndustriesVosveld   9A 2110 Wijnegem Belgium2023-05-15 变更
187人体定位垫国械备20160833号Orfit   IndustriesVosveld   9A 2110 Wijnegem Belgium2023-05-15 变更
188人体定位垫国械备20150288号Orfit   IndustriesVosveld   9A 2110 Wijnegem Belgium2023-05-15 变更
189人体定位垫国械备20150428号Orfit   IndustriesVosveld   9A 2110 Wijnegem Belgium2023-05-15 变更
190全自动血沉分析仪国械备20230264号ALIFAX   S.r.l.Via   Merano 30, 33045 Nimis(UD), ITALY 2023-05-12 有效
191检查头灯国械备20230263号ULTRALIGHT   OPTICS INC.7200   Hazard Ave Westminster, CA USA 926832023-05-12 有效
192脑电(肌电)导联线国械备20170600号SPES   MEDICA SPAVia   Europa Zona Industriale 84091 Battipaglia SA Italia2023-05-12 变更
193神经和肌肉刺激器用体表电极国械备20200082号SPES   MEDICA SPAVia   Europa Zona Industriale 84091 Battipaglia (SA) Italia2023-05-12 变更
194医用放大镜国械备20230262号ULTRALIGHT   OPTICS INC.7200   Hazard Ave Westminster, CA USA 926832023-05-12 有效
195牙科用镊国械备20151693号SABMEDP.O.Box   1131, Khadim Ali Road, Sialkot-Pakistan2023-05-11 变更
196骨膜剥离器国械备20152048号Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-05-11 变更
197持钉钳国械备20152046号Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
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198骨锤国械备20152052号Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-05-11 变更
199免疫显色试剂国械备20190912号Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42, DK-2600 Glostrup, Denmark2023-05-11 变更
200钢丝钳国械备20152043号Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-05-11 变更
201转移帽 国械备20152147号Cowellmedi   co., Ltd.48,   Hakgam-daero 221 beon-gil, Sasang-gu, Busan, Republic of Korea2023-05-11 变更
202牙科种植定位器国械备20160170号Cowellmedi   co.,Ltd.48,   Hakgam-daero 221 beon-gil, Sasang-gu, Busan, Republic of Korea2023-05-11 变更
203牙用尺国械备20152146号Cowellmedi   co., Ltd.48,   Hakgam-daero 221 beon-gil, Sasang-gu, Busan, Republic of Korea2023-05-11 变更
204口垫国械备20180138号Cowellmedi   co.,Ltd.48,   Hakgam-daero 221 beon-gil, Sasang-gu, Busan, Republic of Korea2023-05-11 变更
205髂骨取出器国械备20180136号Cowellmedi   co.,Ltd.48,   Hakgam-daero 221 beon-gil, Sasang-gu, Busan, Republic of Korea2023-05-11 变更
206软组织环切刀国械备20160008号Cowellmedi   co.,Ltd.48,   Hakgam-daero 221 beon-gil, Sasang-gu, Busan, Republic of Korea2023-05-11 变更
207钻针深度停止器国械备20152154号Cowellmedi   co., Ltd.48,   Hakgam-daero 221 beon-gil, Sasang-gu, Busan, Republic of Korea2023-05-11 变更
208牙科种植工具国械备20151813号Cowellmedi   co., Ltd.48,   Hakgam-daero 221beon-gil, Sasang-gu, Busan,617-801, Republic of Korea2023-05-11 变更
209口腔科器械国械备20200178号Cowellmedi   co.,Ltd.48,   Hakgam-daero 221beon-gil, Sasang-gu, Busan, Republic  of Korea2023-05-11 变更
210牙科手术工具国械备20170763号Cowellmedi   co.,Ltd.48,   Hakgam-daero 221 beon-gil, Sasang-gu, Busan, Republic of Korea2023-05-11 变更
211口外研磨材料国械备20160634号BEGO   Bremer Goldschl?gerei Wilh. Herbst GmbH & Co. KGWilhelm-Herbst-Str.   1-28359 Bremen, Deutchland2023-05-11 变更
212电动移位机国械备20181692号ArjoHuntleigh   AB2001,   rue Tanguay Magog Québec J1X 5Y5 Canada2023-05-11 变更
213牙科种植辅助工具国械备20170765号Cowellmedi   co.,Ltd.48,   Hakgam-daero 221 beon-gil, Sasang-gu, Busan, Republic of Korea2023-05-11 变更
214牙科用咬骨钳国械备20180536号OSUNG   MND Co., Ltd.57,   Hwanggeum-ro 109beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do2023-05-10 变更
215牙科刮治器国械备20180541号OSUNG   MND Co., Ltd.57,   Hwanggeum-ro 109beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do2023-05-10 变更
216牙用镊国械备20180525号OSUNG   MND Co., Ltd.57,   Hwanggeum-ro 109beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do2023-05-09 变更
217牙科剪国械备20180347号OSUNG   MND Co., Ltd.57,   Hwanggeum-ro 109beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do2023-05-09 变更
218骨粉调和用金属容器国械备20190298号(?)?????57,   Hwanggeum-ro 109beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do2023-05-09 变更
219刀片夹持器国械备20180324号OSUNG   MND Co., Ltd.57,   Hwanggeum-ro 109beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do2023-05-09 变更
220吸引头国械备20180468号OSUNG   MND Co., Ltd.57,   Hwanggeum-ro 109beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do2023-05-09 变更
221旋入扳手国械备20151817号Ormco   Corporation1332   South Lone Hill Avenue Glendora, California 91740, USA2023-05-09 变更
222牙用尺国械备20180639号(?)????? ???   ??? ??? ??? 109?? 57 2023-05-09 变更
223牙骨凿国械备20180550号OSUNG   MND Co., Ltd.57,   Hwanggeum-ro 109beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do2023-05-09 变更
224牙骨锤国械备20180549号OSUNG   MND Co., Ltd.57,   Hwanggeum-ro 109beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do2023-05-09 变更
225脊柱内固定手术器械（包）国械备20190807号Medos   International SARL 50   Scotland Blvd, Bridgewater Massachusetts, 02324 USA2023-05-09 变更
226脊柱手术器械国械备20181275号Synthes   GmbH见附件(附件链接：http://125.35.24.156/upload/yfzl/1535188913104.docx)2023-05-09 变更
227脊柱内固定手术器械（包）国械备20170641号Medos   International SARL50   Scotland Blvd, Bridgewater, Massachusetts, 02324 USA2023-05-09 变更
228抗酸染色液   PREVI Fluo TB国械备20150070号bioMérieux   SAMontesquieu   – Bordeaux Technopolis 33650 MARTILLAC, France2023-05-09 变更
229 革兰染色液 Color Gram 2 (COLOR GRAM 2-F) 国械备20140221号bioMérieux   SASite   de Montesquieu – Bordeaux Technopolis 33650 MARTILLAC France2023-05-09 变更
230牙科修整用钨钢车针国械备20190777号Beavers   Dental55   Laurier Drive Morrisburg Ontario KOC 1XO Canada2023-05-09 变更
231二氧化碳吸收剂国械备20230261号Molecular   Products, Inc.633   CTC Boulevard, Suite 200 Louisville, CO USA2023-05-09 有效
232导航手术工具国械备20200654号Brainlab   AGOlof-Palme-Stra?e   9, 81829 München,Germany2023-05-09 变更
233转移帽国械备20180208号ALTATEC   GmbHMaybachstr.   5,71299 Wimsheim, Germany2023-05-08 变更
234组织镊国械备20180524号OSUNG   MND Co., Ltd.57,   Hwanggeum-ro 109beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do2023-05-08 变更
235注射助推器国械备20180269号OSUNG   MND Co., Ltd.57,   Hwanggeum-ro 109beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do2023-05-08 变更
236牙刮匙国械备20180540号OSUNG   MND Co., Ltd.57,   Hwanggeum-ro 109beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do2023-05-08 变更
237吸引管国械备20180467号OSUNG   MND Co., Ltd.57,   Hwanggeum-ro 109beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do2023-05-08 变更
238牙刮匙国械备20180382号OSUNG   MND Co., Ltd.57,   Hwanggeum-ro 109beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do2023-05-08 变更
239免疫组化抗原修复缓冲液EnVision   FLEX Target Retrieval Solution, High pH(50×)国械备20161500号Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42, DK-2600 Glostrup, Denmark2023-05-08 变更
240免疫显色试剂   EnVision FLEX, High pH(Dako Omnis)EnVision FLEX Mini Kit, High pH(Dako Omnis)国械备20140301号Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42, DK-2600 Glostrup Denmark2023-05-08 变更
241免疫显色试剂   EnVision FLEX+, Mouse, High pH, (Link)国械备20171083号Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42, DK-2600 Glostrup, Denmark; 1170 Mark Ave, Carpinteria, CA 93013 United   States2023-05-08 变更
242免疫显色试剂   EnVision FLEX Mini Kit, High pH (Link)国械备20181783号Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42, DK-2600 Glostrup, Denmark；1170 Mark Ave, Carpinteria, CA 93013 United   States2023-05-08 变更
243免疫显色试剂EnVision   FLEX, High pH (Link)国械备20181785号Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42, DK-2600 Glostrup, Denmar；1170 Mark Ave, Carpinteria, CA 93013 United   States2023-05-08 变更
244帕巾钳国械备20180535号OSUNG   MND Co., Ltd.57,   Hwanggeum-ro 109beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do2023-05-08 变更
245免疫组化抗原修复缓冲液   EnVision FLEX Target Retrieval Solution, High pH (50x) (Dako Omnis)国械备20140002号Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42, DK-2600 Glostrup Denmark2023-05-08 变更
246光固化牙龈屏障树脂国械备20191157号(?)?????????   ??? ??? ??? 134 1210?2023-05-08 变更
247拔牙钳国械备20180828号Otto   Leibinger GmbHGriesweg   27 78570 Mühlheim Germany2023-05-08 变更
248口镜国械备20181734号Otto   Leibinger GmbHGriesweg   27 78570 Mühlheim Germany2023-05-08 变更
249牙科电动抽吸系统国械备20230260号?  ?10-3,   Deogugongdan 2-gil, Bongdam-eup, Hwaseong-si, Gyeonggi-do, Korea2023-05-06 有效
250骨科牵引架国械备20230259号Allen   Medical Systems, Inc.100   Discovery Way Acton, MA 01720 USA2023-05-06 有效
251口镜国械备20180325号OSUNG   MND Co., Ltd.57,   Hwanggeum-ro 109beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do2023-05-05 变更
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253牙用分离器国械备20180212号OSUNG   MND Co., Ltd.57,   Hwanggeum-ro 109beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do2023-05-05 变更
254唇颊牵开器国械备20180211号OSUNG   MND Co., Ltd.57,   Hwanggeum-ro 109beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do2023-05-05 变更
255持针钳国械备20180151号OSUNG   MND Co., Ltd.57,   Hwanggeum-ro 109beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do2023-05-05 变更
256样本保存液   Mucolexx国械备20151955号Richard-Allan   Scientific LLC4481   Campus Drive, Kalamazoo, Michigan 49008, USA2023-05-05 变更
257医用放大镜国械备20170086号ION   VISION, INC.40W548   Settlement Dr Campton Hills ,  IL  USA 601752023-05-05 变更
258楔形保护片国械备20161760号Directa   ABFinvids   v?g 8, Box 723, SE-194 27 Upplands V?sby (Sweden)2023-05-04 变更
259成形片国械备20170259号Directa   ABFinvids   v?g 8, Box 723, SE-194 27 Upplands V?sby (Sweden)2023-05-04 变更
260成形片国械备20152155号Directa   ABFinvids   vag 8, Box 723, SE-194 27 Upplands Vasby (Sweden)2023-05-04 变更
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262肢体固定器国械备20150218号Baxter   Medical Systems GmbH + Co. KGCarl-Zeiss-Strasse   7-9 07318 Saalfeld Germany2023-05-04 变更
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264口镜国械备20230258号賈雷格斯實業有限公司臺中市潭子區豐栗路100巷88弄8號2023-05-04 有效
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267牙科用软组织环切刀国械备20220577号BASIC   DENTAL IMPLANT SYSTEMS,INC.3321   COLUMBIA Dr. N.E. ALBUQUERQUE, NM USA 871072023-05-04 变更
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