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BEUDAMED

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61 results · 64ms · Sources: EU EUDAMED, US FDA

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FDA UDI 32 FDA 510(k) 15 FDA registration 12 Authorized representative 1 Manufacturer 1 + More Filters

Country

United States 34 Israel 26 Belgium 1 + More Countries

Manufacturer

Jade Scientific Inc. Dba American Scientific Products, Chem Pure Chemicals 1 Minaris Medical Co., Ltd. 1 3 Nt Medical 1 A Mi Global Co., Ltd. 1 A Spine Asia Co., Ltd. 1 Agd Biomedicals Pvt. Ltd 1 Ami Inc. 1 Aneuvo 1 Anjir Talaee 1 Asep Healthcare Ltd 1 Aspivix Sa 1 Austar Hearing Science & Technology (Xiamen) Co., Ltd. 1 Axg Industries Sdn Bhd 1 Azure Vault Ltd 1 Aadi Med Private Limited (Formerly Known As Shiva Products) 1 Abdos Labtech Private Limited 1 Acro Biotech Inc. 1 Admetec Solutions Ltd 1 Advance Dx, Inc. 1 Advanced Med Tech Solutions Private Limited 1 + More Manufacturers

Competent Authority

Federal Agency For Medicines And Health Products / / Health Products Division 2 + More Competent Authorities

Classification

FDA Class 2 15 + More Classifications

FDA FEI Number

3008753275 27 3013917867 15 3027645761 15 3007048256 14 3008085016 14 3010761224 14 3011070163 14 3011307265 14 3014254831 14 3001236277 11 3001431138 11 3005028741 11 3005154439 11 3006515340 11 3008108972 11 3008770252 11 3008915316 11 3008929787 11 3010402752 11 3023528661 11 + More FDA FEI Numbers

Regulation

Us FDA 59 + More Regulations

Authorized Representative

Obelis S.A. 1 + More Authorized Representatives

FDA Registration Number

3008753275 27 3013917867 15 3027645761 15 3007048256 14 3008085016 14 3010761224 14 3011070163 14 3011307265 14 3014254831 14 1649518 11 3001431138 11 3004940677 11 3005028741 11 3006515340 11 3008770252 11 3008915316 11 3008929787 11 3010402752 11 3023528661 11 3035374386 11 + More FDA Registration Numbers

Obelis s.a.

Authorized representative

🇧🇪 Belgium·546 Manufacturers·18515 Devices

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

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BEUDAMED

Rationale
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Tools

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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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