K000011 - BEUDAMED

BEUDAMED

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61 results · 39ms · Sources: EU EUDAMED, US FDA

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FDA UDI 25 FDA registration 18 FDA Pre-Market Approval 10 FDA classification 4 FDA 510(k) 3 Basic UDI-DI 1 + More Filters

Country

United States 52 Canada 2 Netherlands 2 United Kingdom 2 Australia 1 Denmark 1 Mexico 1 + More Countries

Manufacturer

Sbo Hearing A/S 1 + More Manufacturers

Competent Authority

Danish Medicines Agency, Pharmacovigilance & Medical Devices 1 + More Competent Authorities

Kind

Active 1 Software 1 + More Kinds

Classification

FDA Class 3 11 FDA Class 2 6 Eu Md Class 2a 1 + More Classifications

FDA FEI Number

1000121056 15 1820334 15 2124215 15 3002806565 15 3002807314 15 3010273872 15 1000306431 13 3004091615 13 1028232 12 2011171 12 2024024 12 2024168 12 3001451463 12 3001452571 12 3002095335 12 3002807111 12 3002808050 12 3004635528 12 3007738736 12 3009380063 12 + More FDA FEI Numbers

Regulation

Us FDA 60 Eu Mdr 1 + More Regulations

FDA Registration Number

1000121056 15 1820334 15 2124215 15 3002807314 15 3010273872 15 9681260 15 1028232 13 1225687 13 3004091615 13 2011171 12 2024024 12 2024168 12 2029275 12 2134265 12 2939561 12 2953200 12 3005941719 12 3007738736 12 3009380063 12 8043892 12 + More FDA Registration Numbers

FDA K Number

K000001 1 K000011 1 K000012 1 K001033 1 K001198 1 K001251 1 K001257 1 K001454 1 K001736 1 K002206 1 K002212 1 K002289 1 K002346 1 K002707 1 K002907 1 K002962 1 K003084 1 K003100 1 K003394 1 K003398 1 + More FDA K Numbers

Stent, Coronary

FDA classification

FDA Class 3 ·Stent, Coronary

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

BEUDAMED

A better medical device search engine by OpenRegulatory.

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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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