Elekta Ltd - BEUDAMED

BEUDAMED

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21 results · 64ms · Sources: EU EUDAMED, US FDA

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FDA 510(k) 14 FDA UDI 3 Manufacturer 2 Authorized representative 1 FDA registration 1 + More Filters

Country

United States 8 United Kingdom 6 Canada 4 China 1 Sweden 1 Türkiye 1 + More Countries

Manufacturer

Elekta Inc. 1 Elekta Limited 1 Elekta Ltd. 1 + More Manufacturers

Competent Authority

Swedish Medical Products Agency 2 Turkish Medicine And Medical Devices Agency 1 + More Competent Authorities

Classification

FDA Class 2 14 + More Classifications

FDA FEI Number

1000113153 14 1000115748 14 1000123143 14 1000143606 14 1000160359 14 1000162206 14 1000208827 14 1000227792 14 1000306139 14 1000518731 14 1000521490 14 1000523114 14 1038814 14 1047843 14 1219183 14 1220477 14 1450662 14 1526854 14 1720929 14 1721113 14 + More FDA FEI Numbers

Regulation

Us FDA 18 + More Regulations

Authorized Representative

Elekta Solutions Ab 1 + More Authorized Representatives

FDA Registration Number

1000162206 14 1000523114 14 1038814 14 1047843 14 1055485 14 1123169 14 1219183 14 1220477 14 1450662 14 1526854 14 1530561 14 1647149 14 1651102 14 1720929 14 1721113 14 1722661 14 1932738 14 2030598 14 2134494 14 2155 14 + More FDA Registration Numbers

METSİS MEDİKAL TEKNİK SİSTEMLER ELEKT OTO İNS TUR VE SAN TİC LTD STİ

🇹🇷 Türkiye

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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