Optomed Oy - BEUDAMED

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1,441 results · 65ms · Sources: EU EUDAMED, US FDA

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FDA UDI 1k Basic UDI-DI 18 Device 18 FDA 510(k) 12 FDA registration 10 Certificate 4 FDA classification 2 Manufacturer 2 + More Filters

Country

United States 1k Finland 54 Israel 2 France 1 Thailand 1 + More Countries

Manufacturer

Optomed Oyj 40 + More Manufacturers

Competent Authority

Finnish Medicines Agency, Supervision And Licences, Medical Device Unit 42 + More Competent Authorities

Kind

Active 15 Single Use 1 + More Kinds

Classification

Eu Md Class 1 20 Eu Md Class 2a 16 FDA Class 2 13 FDA Class 1 1 + More Classifications

Notified Body

Sgs Fimko Oy 22 + More Notified Bodies

FDA FEI Number

3007710608 12 3006546174 7 1000114111 6 1000122772 6 1000159913 6 1000175127 6 1000181430 6 1000292048 6 1000391004 6 1000582291 6 1316463 6 1419226 6 1926681 6 2020550 6 2027009 6 2080939 6 2242863 6 2521877 6 2918630 6 2936921 6 + More FDA FEI Numbers

Regulation

Us FDA 1k Eu Mdd 24 Eu Mdr 12 + More Regulations

FDA Registration Number

3007710608 12 3006546174 7 1000181430 6 1000391004 6 1054713 6 1316463 6 1319721 6 1419226 6 1528142 6 1926681 6 2020550 6 2027009 6 2080939 6 2242863 6 2320749 6 2521877 6 2918630 6 2936921 6 3002439654 6 3002807715 6 + More FDA Registration Numbers

FDA K Number

Den190040 1 K200755 1 K201992 1 K223347 1 K242807 1 K243065 1 K932867 1 K944667 1 + More FDA K Numbers

Certificate Type

Mdd Annex Ii (Excluding Section 4) 20 Mdr Qms 2 + More Certificate Types

Status

On The Market 16 No Longer On The Market 2 + More Statuses

Cpr Aid Device Without Feedback

FDA classification

FDA Class 1 ·Cpr Aid Device Without Feedback

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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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