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BEUDAMED

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5,341 results · 39ms · Sources: EU EUDAMED, US FDA

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FDA UDI 4k FDA registration 795 FDA 510(k) 412 Device 209 Basic UDI-DI 114 FDA classification 53 Manufacturer 6 FDA Pre-Market Approval 4 Authorized representative 3 Importer 3 Certificate 2 + More Filters

Country

United States 5k Ireland 225 Türkiye 63 China 58 United Kingdom 39 Germany 36 France 16 Canada 15 Pakistan 13 Taiwan 13 Mexico 12 Italy 11 Vietnam 9 Hong Kong 8 Switzerland 8 Costa Rica 7 Malaysia 7 South Korea 7 India 6 Japan 5 + More Countries

Manufacturer

Cf Pharma Ireland Ltd 174 Kaf Grup Sağlik Hi̇zmetleri̇ İnşaat Sanayi̇ Ve Ti̇caret Li̇mi̇ted şi̇rketi̇ 37 Gale Med Corporation 5 Eurosilicone Sas 4 Tcoag Ireland Ltd 4 Ortimplant Ortopedi Ve Tıbbi Aletleri Sanayi Ticaret Limited şirketi 3 Aero Medi̇kal Sağlik Turi̇zmi̇ Tibbi̇ ürünler Ve İth. İhr. San. Ti̇c. Ltd. şti̇. 2 Ast Vision Care Inc. 2 Anetic Aid Ltd 2 Anhui Anyu Latex Products Co., Ltd 2 Artis Cf 2 Asel Tibbi Aletler A.S. 2 Bonegraft Biomaterials Co. 2 Diamond Diagnostics Inc 2 Etablissements Franco Et Fils 2 Galt Medical Corp. 2 Kci Usa Inc. 2 Mediphacos Industrias Médicas S/A 2 Sbo Hearing A/S 2 3 M Company 1 + More Manufacturers

Competent Authority

Health Products Regulatory Authority, Medical Devices Department 184 Turkish Medicine And Medical Devices Agency 61 Ministry Of Health, Welfare And Sports 17 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 12 De/Ca05 Behorde Fur Justiz Und Verbraucherschutz 5 De/Ca09 Staatliches Gewerbeaufsichtsamt Hannover 5 Ministry Of Health Directorate General Of Medical Devices And Pharmaceutical Services 5 Agencia Española De Medicamentos Y Productos Sanitarios 4 Federal Agency For Medicines And Health Products / / Health Products Division 4 Nemzeti Népegészségügyi és Gyógyszerészeti Központ 4 De/Ca29 Regierungspräsidium Darmstadt Abteilung Arbeitsschutz Und Umwelt 3 De/Ca39, Regierungspräsidium Freiburg Referat 25 3 Danish Medicines Agency, Pharmacovigilance & Medical Devices 3 Austrian National Public Health Institute 2 De/Ca22 Bezirksregierung Münster 2 Finnish Medicines Agency, Supervision And Licences, Medical Device Unit 2 Infarmed – National Authority Of Medicines And Health Products, I.P 2 State Health Care Accreditation Agency Under The Ministry Of Health Of The Republic Of Lithuania 2 Swedish Medical Products Agency 2 The Medicines And Healthcare Products Regulatory Agency 2 + More Competent Authorities

Kind

Single Use 77 Sterile 27 Sterilization 23 Implantable 6 Professional Testing 5 Instrument 2 Kit 2 Latex 2 Reagent 2 Reprocessed 2 Administering Medicine 1 Cmr Substance 1 Endocrine Disruptor 1 Medicinal Product 1 Microbial Substances 1 New Device 1 Reusable 1 + More Kinds

Classification

FDA Class 2 262 FDA Class 1 202 Eu Md Class 2a 197 Eu Md Class 1 80 Eu Md Class 2b 20 Eu Md Class 3 11 Eu Ivd Class A 9 Eu Ivd General 6 FDA Class 3 4 FDA Unclassified 1 + More Classifications

Notified Body

Italcert Srl 174 Bsi Group The Netherlands B.V. 7 Udem Uluslararasi Belgelendirme Denetim Egitim Merkezi San. Ve Tic. A.ş. 6 Ht Cert (Health Technology Certification Ltd) 4 Polskie Centrum Badan I Certyfikacji S.A. 4 Tüv Süd Product Service Gmb H 4 Dnv Product Assurance As 2 Kiwa Belgelendirme Hizmetleri A.ş. 2 Turkish Standards Institution (Tse) 2 3 Ec International A.S. 1 Dekra Certification Gmb H 1 Dnv Medcert Gmb H 1 Sgs Fimko Oy 1 Szutest Uygunluk Değerlendirme A.ş. 1 + More Notified Bodies

FDA FEI Number

1832216 187 1000306617 140 3003750284 121 3006224287 120 3014150341 113 3003952975 106 1000122536 85 3015550354 85 3013557562 78 3005670738 76 1318354 74 1000186023 72 1000520007 71 1181055 67 3024463179 67 3012494290 64 3016630443 63 3002792284 59 3003917514 59 2024674 54 + More FDA FEI Numbers

Regulation

Us FDA 5k Eu Mdd 215 Eu Mdr 93 Eu Ivdr 9 Eu Ivdd 6 + More Regulations

Authorized Representative

Emergo Europe B.V. 9 Obelis S.A. 7 Mdss Gmb H 4 Med Net Ec Rep Gmb H 4 Shanghai International Holding Corp. Gmb H(europe) 4 Cmc Medical Devices & Drugs Sl 3 Kci Manufacturing Unlimited Company 3 Lotus Nl B.V. 3 Diamond Diagnostics Inc. Hungary Branch Office 2 Eu Uk Authorised Representative Ltd 2 Ktr Europe Gmb H 2 Medical Technology Promedt Consulting Gmb H 2 Mediphacos Technologies, Unipessoal Lda. 2 Nic Gmb H 2 Narcmed Kft. 2 Spine Save Gmb H 2 Mps Medical Product Service Gmb H 1 3 M Deutschland Gmb H (Medical) 1 Antex Medi Solution 1 Ar Experts B.V. 1 + More Authorized Representatives

FDA Registration Number

1832216 187 2029372 140 3003750284 121 8010096 120 3014150341 113 2032682 106 1528450 85 3015550354 85 3013557562 78 3005360469 76 1318354 74 9615056 72 2030538 71 1181055 67 3024463179 67 3012494290 64 3016630443 63 3002792284 59 3003917514 59 2024674 54 + More FDA Registration Numbers

FDA K Number

Den050004 1 K003204 1 K020706 1 K020707 1 K020717 1 K021172 1 K021687 1 K021789 1 K022133 1 K022713 1 K022845 1 K023779 1 K032166 1 K033525 1 K041445 1 K042643 1 K051191 1 K051435 1 K052092 1 K053553 1 + More FDA K Numbers

Certificate Type

Mdd Annex V 179 Mdd Annex Ii (Excluding Section 4) 26 Mdd Annex Ii Section 4 9 + More Certificate Types

Status

On The Market 207 No Longer On The Market 2 + More Statuses

cobas 8000 cobas ISE MODULE [DOUBLE]

FDA registration

ROCHE DIAGNOSTICS INTERNATIONAL LTD.·78 products·🇨🇭 Switzerland

<1 …264 265 266 267 268 >

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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