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BEUDAMED

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9,001 results · 34ms · Sources: EU EUDAMED, US FDA

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FDA UDI 7k Certificate 637 Manufacturer 578 FDA Pre-Market Approval 344 FDA registration 57 FDA 510(k) 31 Notified body 25 Basic UDI-DI 16 Device 14 Authorized representative 4 FDA classification 3 Importer 1 + More Filters

Country

United States 8k China 312 Italy 191 Germany 134 Poland 68 Finland 51 Netherlands 49 Switzerland 41 Japan 39 South Korea 39 Belgium 34 Czechia 28 India 25 Türkiye 25 Israel 23 France 21 Austria 17 Canada 16 Slovakia 14 Slovenia 12 + More Countries

Manufacturer

Active Optical Systems Ltd 15 Healthium Medtech Limited 13 Top Engineering Sarl 8 Chetan Meditech Pvt. Ltd. 6 Chirana T.Injecta, A.S. 4 Shenzhen Mindray Bio Medical Electronics Co., Ltd. 4 Cjsc Sp.Arm 3 Euleria Srl Società Benefit 3 Frey Spółka Jawna 3 Gpi S.P.A. 3 Ntc Srl 3 Uv Smart Technologies B.V. 3 Uzumcu Hospital Equipment Metal Processing Industry And Trade Company 3 Aflofarm Farmacja Polska Sp. Z O.O. 2 Ascom Ums Srl 2 B. & B. Dental S.R.L. 2 Bausch & Lomb Gmb H 2 Beckman Coulter Inc. 2 Chiesi Farmaceutici S.P.A. 2 Dear Health Holding Company B.V. 2 + More Manufacturers

Competent Authority

Ministry Of Health Directorate General Of Medical Devices And Pharmaceutical Services 188 Ministry Of Health, Welfare And Sports 180 De/Ca20, Bezirksregierung Düsseldorf Dezernat 24 79 De/Ca05 Behorde Fur Justiz Und Verbraucherschutz 68 The Office For Registration Of Medicinal Products, Medical Devices And Biocidal Products 68 Federal Agency For Medicines And Health Products / / Health Products Division 58 Finnish Medicines Agency, Supervision And Licences, Medical Device Unit 50 Agencia Española De Medicamentos Y Productos Sanitarios 47 De/Ca304 Marktüberwachung Medizinprodukte Bayern 46 Health Products Regulatory Authority, Medical Devices Department 32 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 28 State Institute For Drug Control Medical Device Section 27 The Medicines And Healthcare Products Regulatory Agency 26 Cyprus Medical Devices Authority, Medical And Public Health Services, Ministry Of Health 25 De/Ca22 Bezirksregierung Münster 24 Turkish Medicine And Medical Devices Agency 24 Malta Medicines Authority 21 Austrian National Public Health Institute 16 De/Ca21 Bezirksregierung Köln Dezernat 24 16 Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia: Medical Devices Division / Pharmaceutical Inspection Division – Medical Devices Unit 15 + More Competent Authorities

Kind

Active 10 Professional Testing 4 Reagent 4 Kit 3 Human Tissues 2 Animal Tissues 1 Microbial Substances 1 Single Use 1 + More Kinds

Classification

FDA Class 3 336 FDA Class 2 28 Eu Md Class 1 19 FDA Class 1 12 Eu Md Class 2a 6 Eu Ivd General 3 Eu Ivd Class B 2 + More Classifications

Notified Body

Tüv Rheinland Lga Products Gmb H 436 Sgs Belgium Nv 129 Tuv Rheinland Italia Srl 80 3 Ec International A.S. 70 Kiwa Dare B.V. 62 Italcert Srl 59 Udem Adriatic D.O.O. 53 Tuv Nord Polska Sp. Z O.O 48 Sgs Fimko Oy 47 Istituto Superiore Di Sanita' 39 Slovenian Institute Of Quality And Metrology Siq 37 Eurofins Electric & Electronics Finland Oy 29 Bureau Veritas Italia S.P.A. 25 Dqs Medizinprodukte Gmb H 24 Polskie Centrum Badan I Certyfikacji S.A. 23 Intertek Medical Notified Body Ab 16 Institut Pro Testováni A Certifikaci, A. S. (Institute For Testing And Certification) Merged With Ex Nb 1390 14 Icim S.P.A. 12 Mdc Medical Device Certification Gmbh 9 Tüv Süd Product Service Gmb H 9 + More Notified Bodies

FDA FEI Number

1920664 259 2936921 259 3001362763 259 3002483854 259 3002807715 259 3003288808 259 3003691824 259 3006695864 259 3012236936 259 1028232 58 2017865 58 3000203466 58 3002806500 58 3006705815 58 3008377825 58 3013288201 58 2124215 57 2182208 57 2938836 57 3002807576 57 + More FDA FEI Numbers

Regulation

Us FDA 8k Eu Mdr 17 Eu Mdd 8 Eu Ivdd 3 Eu Ivdr 2 + More Regulations

Authorized Representative

Shanghai International Holding Corp. Gmb H(europe) 63 Lotus Nl B.V. 41 Emergo Europe B.V. 28 Wellkang Ltd 26 Med Path Gmb H 24 Qs Medical Device Registration Ltd 24 Advena Limited 21 Sungo Europe B.V. 21 Med Net Ec Rep Gmb H 20 Cmc Medical Devices & Drugs Sl 19 Caretechion Gmb H 17 Obelis S.A. 16 Mdss Gmb H 14 Riomavix Ltd 14 Meddevices Lifesciences B.V. 13 Share Info Gmb H 12 Medical Technology Promedt Consulting Gmb H 10 Prolinx Gmb H 10 Eunitor Gmb H 8 Lepu Medical (Europe) Cooperatief U.A. 8 + More Authorized Representatives

FDA Registration Number

1920664 259 2936921 259 3002807715 259 3003288808 259 3006695864 259 3007606649 259 3012236936 259 8030392 259 9615030 259 9710340 259 1028232 58 2017865 58 2133641 58 3006705815 58 3008494315 58 3013288201 58 9610139 58 2032521 57 2124215 57 2182208 57 + More FDA Registration Numbers

FDA K Number

Den230008 1 K801050 1 K853261 1 K930118 1 K935146 1 K955881 1 K973189 1 + More FDA K Numbers

Certificate Type

Mdr Qms 1k Ivdr Qms 72 Mdd Annex Ii (Excluding Section 4) 64 Mdd Annex V 42 Mdr Technical Documentation 41 Mdd Annex Ii Section 4 23 Mdr Qa 17 Ivdd Annex Iv (Excluding Sections 4, 6) 9 Ivdd Annex Iii Section 6 6 Mdd Annex Iii 6 Mdd Annex Iv 6 Ivdd Annex Iv Section 4 5 Ivdr Technical Documentation 5 Mdd Annex Vi 5 Mdr Type Examination 4 Aimdd Annex Ii (Excluding Section 4) 1 Mdr Product Verification 1 + More Certificate Types

Status

On The Market 14 + More Statuses

DEKRA Certification B.V.

🇳🇱 Netherlands·216 Manufacturers·7327 Basic UDI-DIs

<1 …447 448 449 450 451 >

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

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EU MDR

EU MDR Medical Devices EU MDR Active Medical Devices EU MDR Class I Medical Devices EU MDR Class I Software Devices EU MDR Class IIa Medical Devices EU MDR Class IIa Software Devices EU MDR Class IIb Medical Devices EU MDR Class IIb Software Devices EU MDR Class III Medical Devices EU MDR Class III Software Devices EU MDR Implantable Medical Devices EU MDR Measuring Function Medical Devices EU MDR Software Medical Devices

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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