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BEUDAMED

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2,541 results · 38ms · Sources: EU EUDAMED, US FDA

Filter by

FDA registration 1k FDA UDI 999 FDA 510(k) 153 Basic UDI-DI 21 Device 21 FDA Pre-Market Approval 14 FDA classification 3 Importer 2 Manufacturer 2 + More Filters

Country

United States 1k China 1k Iceland 29 Spain 20 Taiwan 14 Canada 12 Malaysia 9 Germany 8 Israel 8 United Kingdom 5 Japan 4 France 3 Ireland 3 Australia 2 Denmark 2 Hungary 2 Pakistan 2 Switzerland 2 Argentina 1 Greece 1 + More Countries

Manufacturer

Blackhills Diagnostic Resources S.L.U. 20 Besmed Health Business Corp. 10 Innomed, Inc. 7 Dr. Hinz Dental Vertriebsgesellschaft Mb H & Co. Kg 2 Funke Medical Gmb H 1 Heartfelt Technologies Ltd 1 Longly Biotechnology (Wuhan) Co.,Ltd. 1 + More Manufacturers

Competent Authority

Agencia Española De Medicamentos Y Productos Sanitarios 20 Ministry Of Health, Welfare And Sports 10 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 7 De/Ca18 Bezirksregierung Arnsberg 2 Icelandic Medicines Agency 2 De/Ca22 Bezirksregierung Münster 1 De/Ca304 Marktüberwachung Medizinprodukte Bayern 1 De/Ca32 Landesamt Für Soziales, Jugend Und Versorgung 1 Health Products Regulatory Authority, Medical Devices Department 1 Swedish Medical Products Agency 1 + More Competent Authorities

Kind

Kit 8 Microbial Substances 8 Professional Testing 8 Reagent 8 Sterilization 6 Active 1 + More Kinds

Classification

FDA Class 2 155 Eu Ivd General 12 Eu Md Class 1 11 Eu Md Class 2a 11 FDA Class 3 10 Eu Ivd Class C 8 FDA Class 1 5 + More Classifications

Notified Body

Bsi Group The Netherlands B.V. 12 Dekra Certification B.V. 10 + More Notified Bodies

FDA FEI Number

2432235 115 2517506 115 3006198300 115 1000122044 114 1000135102 114 1000136573 114 1000206808 114 1000305840 114 1181121 114 1220972 114 1616487 114 1827821 114 2050010 114 2050012 114 2250051 114 2939693 114 3000148879 114 3000215862 114 3000308930 114 3002642396 114 + More FDA FEI Numbers

Regulation

Us FDA 2k Eu Ivdd 12 Eu Mdr 12 Eu Mdd 10 Eu Ivdr 8 + More Regulations

Authorized Representative

Casus Europe B.V. 10 Mdi Europa Gmb H 10 Medi Mark Europe Sarl. 7 Heartfelt Technologies Europe Ltd 1 Med Path Gmb H 1 + More Authorized Representatives

FDA Registration Number

2432235 115 2517506 115 3006198300 115 1064608 114 1181121 114 1220972 114 1319681 114 1319809 114 1616487 114 1827821 114 2030861 114 2050010 114 2050012 114 2085064 114 2247288 114 2250051 114 2939693 114 3000148879 114 3000308930 114 3002642396 114 + More FDA Registration Numbers

FDA K Number

K051108 1 K091544 1 K131975 1 K760345 1 K760410 1 K760411 1 K760412 1 K760476 1 K761343 1 K770267 1 K770313 1 K770613 1 K770818 1 K771465 1 K771836 1 K772028 1 K780041 1 K780101 1 K780563 1 K781128 1 + More FDA K Numbers

Certificate Type

Ivdd Annex Iv (Excluding Sections 4, 6) 12 Mdd Annex Ii (Excluding Section 4) 10 + More Certificate Types

Status

On The Market 21 + More Statuses

cobas 8000 cobas ISE MODULE [DOUBLE]

FDA registration

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

<1 …124 125 126 127 128 >

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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