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BEUDAMED

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101 results · 19ms · Sources: EU EUDAMED, US FDA

Filters Classification: FDA Class 2 ×

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FDA 510(k) 94 FDA classification 4 FDA Pre-Market Approval 3 + More Filters

Country

United States 48 United Kingdom 31 Norway 10 Brazil 4 Isle Of Man 2 South Korea 2 Sweden 2 China 1 Türkiye 1 + More Countries

Classification

FDA Class 2 101 + More Classifications

FDA FEI Number

3015550354 31 2915274 27 2026994 25 3012348571 25 1000306617 24 3002807876 24 3004973408 24 1421346 23 3022178699 22 2242436 21 2245285 19 3002800697 19 1181055 18 3003825930 18 3005774014 18 3003268355 17 3007118747 17 3007361513 17 3002806559 16 3015376545 16 + More FDA FEI Numbers

Regulation

Us FDA 101 + More Regulations

FDA Registration Number

3015550354 31 2915274 27 2026994 25 3012348571 25 2029372 24 3004973408 24 9610566 24 1421346 23 3022178699 22 2242436 21 2245285 19 3002800697 19 1181055 18 3003825930 18 9680745 18 3003268355 17 3007118747 17 3007361513 17 3015376545 16 9610126 16 + More FDA Registration Numbers

FDA K Number

K101060 1 K101831 1 K103179 1 K110127 1 K111179 1 K121440 1 K121814 1 K133680 1 K183310 1 K201238 1 K213159 1 K952138 1 + More FDA K Numbers

Droplet Digital Pcr System

FDA classification

FDA Class 2 ·Droplet Digital Pcr System

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

BEUDAMED

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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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