QKZ - BEUDAMED

BEUDAMED

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4,821 results · 37ms · Sources: EU EUDAMED, US FDA

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FDA UDI 4k FDA registration 367 FDA 510(k) 257 FDA Pre-Market Approval 86 Basic UDI-DI 6 Device 6 FDA classification 3 + More Filters

Country

United States 5k China 80 Canada 7 Germany 7 Poland 6 United Kingdom 6 Hungary 5 Switzerland 5 France 2 Hong Kong 2 Japan 2 Jordan 2 Taiwan 2 Australia 1 Austria 1 Denmark 1 India 1 Ireland 1 Netherlands 1 Singapore 1 + More Countries

Manufacturer

Armedical Spółka Z Ograniczoną Odpowiedzialnością 6 Tobler & Co. Ag 2 Oacp Ie Ltd 1 Rosa Toifl & Co Gmb H 1 Sbo Hearing A/S 1 álvarez Redondo, S.A. 1 + More Manufacturers

Competent Authority

The Office For Registration Of Medicinal Products, Medical Devices And Biocidal Products 6 Office Of Public Health 2 Agencia Española De Medicamentos Y Productos Sanitarios 1 Austrian National Public Health Institute 1 Danish Medicines Agency, Pharmacovigilance & Medical Devices 1 Health Products Regulatory Authority, Medical Devices Department 1 + More Competent Authorities

Kind

Instrument 2 Active 1 Professional Testing 1 + More Kinds

Classification

FDA Class 2 259 FDA Class 3 86 Eu Md Class 1 9 Eu Ivd Class A 2 Eu Md Class 2a 1 FDA Class 1 1 + More Classifications

FDA FEI Number

3000718556 241 1000306617 240 2517506 238 3000210620 237 1832216 235 2246703 234 1050155 232 3001452245 232 1000125596 231 3002806559 231 2432235 230 3000215862 229 1827821 228 3001451797 228 3006198300 228 1036362 226 2050010 226 2050012 226 3002806560 226 1000122204 225 + More FDA FEI Numbers

Regulation

Us FDA 5k Eu Mdr 10 Eu Ivdr 2 + More Regulations

Authorized Representative

Tobler & Co. Gmb H 2 + More Authorized Representatives

FDA Registration Number

1320738 241 2249781 241 2029372 240 2517506 238 2030633 237 1832216 235 2246703 234 1050155 232 2060833 232 2027969 231 2432235 230 9610126 230 2030861 229 1649661 228 1827821 228 3006198300 228 1036362 226 2050010 226 2050012 226 1063851 225 + More FDA Registration Numbers

FDA K Number

Den190037 1 K000400 1 K000460 1 K000606 1 K000768 1 K001225 1 K001397 1 K001417 1 K001421 1 K001560 1 K002266 1 K002447 1 K003809 1 K003865 1 K004034 1 K010177 1 K010564 1 K010645 1 K011499 1 K011609 1 + More FDA K Numbers

Status

On The Market 6 + More Statuses

cobas 8000 cobas ISE MODULE [DOUBLE]

FDA registration

ROCHE DIAGNOSTICS INTERNATIONAL LTD.·78 products·🇨🇭 Switzerland

<1 …238 239 240 241 242 >

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

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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