K970031 - BEUDAMED

BEUDAMED

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101 results · 45ms · Sources: EU EUDAMED, US FDA

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FDA Pre-Market Approval 69 FDA UDI 17 FDA registration 8 FDA classification 4 FDA 510(k) 3 + More Filters

Country

United States 93 France 3 South Korea 2 Switzerland 2 Mexico 1 + More Countries

Classification

FDA Class 3 69 FDA Class 2 6 + More Classifications

FDA FEI Number

2183744 71 3000206435 71 2025587 69 1713910 68 2011171 68 2015691 68 3001883144 68 3002534070 68 3002806603 68 3002808437 68 3004478276 68 3005334138 68 3005687633 68 3007063218 68 3007113487 68 3010421104 68 3010432890 68 3012179728 68 3014918977 68 3002808269 7 + More FDA FEI Numbers

Regulation

Us FDA 101 + More Regulations

FDA Registration Number

2030624 71 2183744 71 2025587 69 2011171 68 2015691 68 2135147 68 3001883144 68 3002806603 68 3004478276 68 3005687633 68 3007063218 68 3007113487 68 3008500478 68 3010421104 68 3010432890 68 3012179728 68 3014918977 68 9612515 68 9617601 68 8043792 7 + More FDA Registration Numbers

FDA K Number

K000018 1 K000035 1 K000065 1 K000091 1 K000099 1 K000100 1 K000113 1 K000232 1 K000590 1 K000643 1 K000666 1 K000797 1 K000889 1 K000978 1 K001010 1 K001147 1 K001259 1 K001307 1 K001354 1 K001456 1 + More FDA K Numbers

Implant, Endosseous, Root-Form

FDA classification

FDA Class 2 ·Implant, Endosseous, Root-Form

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

BEUDAMED

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BEUDAMED

Rationale
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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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