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BEUDAMED

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2,581 results · 38ms · Sources: EU EUDAMED, US FDA

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FDA registration 1k FDA UDI 998 FDA 510(k) 187 Device 105 Basic UDI-DI 80 Manufacturer 74 FDA classification 64 FDA Pre-Market Approval 38 Authorized representative 9 Importer 7 Certificate 2 + More Filters

Country

United States 1k Vietnam 292 China 161 India 133 Taiwan 104 Hong Kong 77 Egypt 67 Mexico 52 Pakistan 47 Thailand 37 Germany 35 Türkiye 32 Belgium 30 Japan 30 France 28 Cambodia 19 Italy 18 Finland 15 United Kingdom 11 Canada 10 + More Countries

Manufacturer

Xiamen Boson Biotech Co., Ltd. 86 Koba Vision 30 Instrumentation Laboratory Sp A 16 Thermo Fisher Scientific Oy 15 Mauna Kea Technologies 9 Kowa Company, Ltd. Chofu Factory 7 Biochemical Diagnostics, Inc 6 Maccura Biotechnology Co., Ltd. 4 Align Technology Ltd. 3 Diamond Diagnostics Inc 3 Huayi Isotopes Co. (A Division Of Jiangsu Huayi Technology Co., Ltd.) 3 Scy Tek Laboratories Inc. 3 Antitoxin Gmb H 2 Beijing Diagreat Biotechnologies Co., Ltd. 2 Bio Teke Corporation（Wuxi）Co., Ltd 2 Dentmate Technology 2 Foshan Snyder Medical Equipment Co.,Ltd 2 Hangzhou Laihe Biotech Co., Ltd. 2 Jiangsu Mole Bioscience Co., Ltd. 2 Nanjing Kangni Smart Technology Co.,Ltd 2 + More Manufacturers

Competent Authority

Ministry Of Health, Welfare And Sports 98 De/Ca20, Bezirksregierung Düsseldorf Dezernat 24 79 Federal Agency For Medicines And Health Products / / Health Products Division 30 Ministry Of Health Directorate General Of Medical Devices And Pharmaceutical Services 20 Finnish Medicines Agency, Supervision And Licences, Medical Device Unit 15 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 11 Malta Medicines Authority 6 De/Ca22 Bezirksregierung Münster 3 Nemzeti Népegészségügyi és Gyógyszerészeti Központ 3 De/Ca21 Bezirksregierung Köln Dezernat 24 2 De/Ca38 Regierungspräsidium Karlsruhe 2 The Medicines And Healthcare Products Regulatory Agency 2 Turkish Medicine And Medical Devices Agency 2 Agencia Española De Medicamentos Y Productos Sanitarios 1 Cyprus Medical Devices Authority, Medical And Public Health Services, Ministry Of Health 1 Danish Medicines Agency, Pharmacovigilance & Medical Devices 1 Health Products Regulatory Authority, Medical Devices Department 1 + More Competent Authorities

Kind

Professional Testing 73 Reagent 73 Kit 68 Single Use 45 Human Tissues 20 Animal Tissues 7 Sterilization 7 Active 2 Sterile 2 Measuring Function 1 + More Kinds

Classification

FDA Class 2 137 Eu Ivd General 107 FDA Class 1 102 FDA Class 3 41 Eu Md Class 1 36 Eu Ivd Class B 16 Eu Md Class 2a 12 Eu Ivd Class A 7 Eu Ivd Class C 7 FDA Not Classified 7 + More Classifications

Notified Body

Tüv Rheinland Lga Products Gmb H 4 Szutest Uygunluk Değerlendirme A.ş. 1 + More Notified Bodies

FDA FEI Number

1417592 92 3001236905 84 3018094310 81 1928237 78 2020550 78 3007475226 78 3013247477 74 1526534 73 3002807798 73 3002807072 72 3002902735 70 3006943846 67 3026408938 66 3005012805 65 1216677 63 3005747797 63 1643817 62 3013298431 62 3000215273 61 1820334 60 + More FDA FEI Numbers

Regulation

Us FDA 2k Eu Ivdd 107 Eu Mdr 46 Eu Ivdr 30 Eu Mdd 2 + More Regulations

Authorized Representative

Lotus Nl B.V. 86 Komas Medical Technology Gmb H 66 Y. Sung Handelsvertretung 64 Advena Limited 6 Cmc Medical Devices & Drugs Sl 4 Humiss International B.V. 4 Kowa Europe Gmb H 4 Kowa Medical Care Europe Gmb H 4 Shanghai International Holding Corp. Gmb H(europe) 4 Share Info Consultant Service Llc 4 Align Technology B.V. 3 Diamond Diagnostics Inc. Hungary Branch Office 3 Emergo Europe B.V. 3 Koo Europe 2 Med Net Ec Rep Gmb H 2 Kowa Pharmaceutical Europe Gmb H 1 + More Authorized Representatives

FDA Registration Number

1417592 92 1423537 84 3018094310 81 1928237 78 2020550 78 3010202439 78 3013247477 74 1526534 73 9610773 73 9612074 72 9616088 70 3006943846 67 3026408938 66 3005012805 65 1216677 63 3011137372 63 1643817 62 3013298431 62 1423662 61 1820334 60 + More FDA Registration Numbers

FDA K Number

Den020003 1 Den060002 1 Den120019 1 Den140022 1 Den160062 1 Den170044 1 Den180062 1 Den190039 1 Den190042 1 Den210006 1 Den210022 1 Den210049 1 Den230012 1 Den240062 1 K000299 1 K001162 1 K003113 1 K003195 1 K003325 1 K003710 1 + More FDA K Numbers

Certificate Type

Mdd Annex V 4 Mdd Annex Ii (Excluding Section 4) 1 + More Certificate Types

Status

On The Market 105 + More Statuses

SUNGO Europe B.V.

Authorized representative

🇳🇱 Netherlands·1571 Manufacturers·20390 Devices

<1 …126 127 128 129 130 >

Data last updated 04 / 2026. Visit the official EUDAMED website for up-to-date data.

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EU MDR

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EU IVDR

EU IVDR In Vitro Diagnostic Devices EU IVDR Class A In Vitro Diagnostic Devices EU IVDR Class A Software Devices EU IVDR Class B In Vitro Diagnostic Devices EU IVDR Class B Software Devices EU IVDR Class C In Vitro Diagnostic Devices EU IVDR Class C Software Devices EU IVDR Class D In Vitro Diagnostic Devices EU IVDR Class D Software Devices EU IVDR Instrument Devices EU IVDR Kit Devices EU IVDR Reagent Devices EU IVDR Software Devices

FDA

FDA Medical Devices FDA Class I Medical Devices FDA Class II Medical Devices FDA Class III Medical Devices

By Country

EU IVDR Medical Devices from China EU IVDR Medical Devices from France EU IVDR Medical Devices from Germany EU IVDR Medical Devices from Romania EU IVDR Medical Devices from United States EU MDR Medical Devices from China EU MDR Medical Devices from Egypt EU MDR Medical Devices from Finland EU MDR Medical Devices from France EU MDR Medical Devices from Germany EU MDR Medical Devices from Italy EU MDR Medical Devices from Pakistan EU MDR Medical Devices from Poland EU MDR Medical Devices from Spain EU MDR Medical Devices from Türkiye EU MDR Medical Devices from United Kingdom EU MDR Medical Devices from United States

Notified Bodies

BSI Group The Netherlands B.V. DEKRA Certification B.V. DNV Product Assurance AS POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. SGS Belgium NV TÜV Rheinland LGA Products GmbH TÜV SÜD Product Service GmbH UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.

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