BIOMERIEUX SA - BEUDAMED

BEUDAMED

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

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FDA registration 512 FDA UDI 325 FDA 510(k) 19 Manufacturer 3 Authorized representative 1 Importer 1 + More Filters

Country

United States 692 France 156 Spain 7 Italy 5 Canada 1 + More Countries

Manufacturer

Luméd Inc. 2 Specific Diagnostics 2 Aalto Scientific, Ltd. 1 Astute Medical, Inc. 1 Bio Fire Diagnostics, Llc 1 Itl Asia Pacific Sdn. Bhd. 1 Microbiologics, Inc. 1 + More Manufacturers

Competent Authority

Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 5 + More Competent Authorities

Classification

FDA Class 2 18 FDA Class 1 1 + More Classifications

FDA FEI Number

1950204 189 3031977134 121 3008237827 91 1000611339 39 3002773840 26 3002769706 14 3007808629 14 1111096 13 1119779 12 1924669 12 2919016 12 3010770794 12 1000515493 11 3001236277 11 3002806332 11 3012389632 11 3013661582 11 3003261083 7 3009307598 7 3006198300 4 + More FDA FEI Numbers

Regulation

Us FDA 856 + More Regulations

Authorized Representative

Bio Mérieux Sa 2 C Epartner4 U 1 Qb D Rep S Bv 1 + More Authorized Representatives

FDA Registration Number

1950204 189 3031977134 121 9615754 91 8020790 39 3002773840 26 3002769706 14 9615755 14 1111096 13 1119779 12 1924669 12 2919016 12 3010770794 12 1530126 11 1649518 11 3012389632 11 3013661582 11 8021914 11 3009307598 7 9615037 5 3006198300 4 + More FDA Registration Numbers

ETEST Plazomicin (PLZ) (0.016-256 µg/mL)

FDA Class 2 ·Microbiology

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

BEUDAMED

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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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