Fujirebio Europe - BEUDAMED

BEUDAMED

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21 results · 70ms · Sources: EU EUDAMED, US FDA

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FDA Pre-Market Approval 6 FDA registration 5 FDA UDI 4 Manufacturer 4 Authorized representative 1 Importer 1 + More Filters

Country

United States 12 Belgium 8 Japan 1 + More Countries

Manufacturer

Atila Biosystems Inc. 2 Fujirebio Diagnostics, Inc. 2 Fujirebio Inc. 2 Bee Robotics 1 Bio Molecular Systems Pty Ltd 1 Eone Biotech Co., Ltd. 1 Sol Gent Co., Ltd. 1 + More Manufacturers

Competent Authority

Federal Agency For Medicines And Health Products / / Health Products Division 5 Ministry Of Health, Welfare And Sports 1 + More Competent Authorities

Classification

FDA Class 2 6 + More Classifications

FDA FEI Number

3002608770 11 3005248192 6 3005670738 6 3011561946 6 3017013438 6 + More FDA FEI Numbers

Regulation

Us FDA 15 + More Regulations

Authorized Representative

Fujirebio Europe N.V. 3 Sungo Europe B.V. 1 + More Authorized Representatives

FDA Registration Number

9615837 11 3005248192 6 3005360469 6 3011561946 6 3017013438 6 + More FDA Registration Numbers

Fujirebio Europe N.V.

Authorized representative

🇧🇪 Belgium·3 Manufacturers

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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