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BEUDAMED

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501 results · 86ms · Sources: EU EUDAMED, US FDA

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FDA UDI 454 FDA registration 30 FDA 510(k) 12 Authorized representative 3 Importer 1 Manufacturer 1 + More Filters

Country

United States 497 Germany 2 Belgium 1 Malta 1 + More Countries

Manufacturer

Acro Biotech Inc. 2 Igentify Ltd. 2 Lunit Inc. 2 Mf / Sewonmedix Inc. 2 Medi Purpose Pte Ltd 2 Plasmapp Co., Ltd 2 Jade Scientific Inc. Dba American Scientific Products, Chem Pure Chemicals 1 Minaris Medical Co., Ltd. 1 Pointimplant Co., Ltd. 1 Senbitec Co Ltd 1 3 Nt Medical 1 A Mi Global Co., Ltd. 1 A Spine Asia Co., Ltd. 1 Aadhar Medicare Private Limited 1 Ac Cossor And Son (Surgical) Ltd 1 Ace Medical Devices Pvt Ltd 1 Adstec Corporation 1 Aehealth Limited 1 Agd Biomedicals Pvt. Ltd 1 Airs Medical Inc. 1 + More Manufacturers

Competent Authority

Federal Agency For Medicines And Health Products / / Health Products Division 2 De/Ca22 Bezirksregierung Münster 1 De/Ca40 Regierungspräsidium Tübingen Referat 25 Sachgebiet Medizinprodukte 1 Malta Medicines Authority 1 + More Competent Authorities

Classification

FDA Class 2 12 + More Classifications

FDA FEI Number

3013395518 42 2280705 12 3001698565 12 3003231640 12 3007067755 12 3009171501 12 3009881307 12 3015177815 12 1000115322 10 1000126925 10 1000375074 10 1000535235 10 1000657351 10 1210513 10 1222115 10 1421377 10 1450238 10 1611064 10 1811396 10 1831301 10 + More FDA FEI Numbers

Regulation

Us FDA 496 + More Regulations

Authorized Representative

Obelis S.A. 1 + More Authorized Representatives

FDA Registration Number

3013395518 42 1063707 12 2280705 12 3003231640 12 3007067755 12 3009171501 12 3009881307 12 3015177815 12 1000115322 10 1000375074 10 1210513 10 1222115 10 1417367 10 1450238 10 1648579 10 1649690 10 1811396 10 1831301 10 2022474 10 2025292 10 + More FDA Registration Numbers

MedNet EC-REP GmbH

Authorized representative

🇩🇪 Germany·464 Manufacturers·5263 Devices

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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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