CARDIACASSIST, INC. - BEUDAMED

BEUDAMED

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101 results · 75ms · Sources: EU EUDAMED, US FDA

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FDA UDI 66 FDA 510(k) 24 FDA registration 9 Authorized representative 1 Manufacturer 1 + More Filters

Country

United States 100 Italy 1 + More Countries

Manufacturer

Cardiac Assist, Inc. Dba Tandem Life 1 + More Manufacturers

Competent Authority

Ministry Of Health Directorate General Of Medical Devices And Pharmaceutical Services 2 + More Competent Authorities

Classification

FDA Class 2 23 FDA Class 1 1 + More Classifications

FDA FEI Number

3002534070 20 1928237 19 1000138054 18 3010163695 18 3019807891 18 1000116158 17 1000306431 17 2528981 17 3003306248 17 3005426550 17 2011171 16 1220648 15 2916596 15 3002807111 15 3009649876 15 3011554160 15 3014990448 15 1000123180 14 3000204839 14 3002807095 14 + More FDA FEI Numbers

Regulation

Us FDA 99 + More Regulations

Authorized Representative

Sorin Group Italia S.R.L. 1 + More Authorized Representatives

FDA Registration Number

9617601 20 1928237 19 1319639 18 3010163695 18 3019807891 18 2029275 17 2184009 17 2528981 17 3003306248 17 9680841 17 2011171 16 1220648 15 2916596 15 3005941719 15 3011554160 15 3014990448 15 8010762 15 1123137 14 1124841 14 3002807090 14 + More FDA Registration Numbers

Sorin Group Italia S.r.L.

Authorized representative

🇮🇹 Italy·1 Manufacturer

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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