17 results
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122ms
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Sources: EU EUDAMED, US FDA
IDx-DR
FDA registration
Digital Diagnostics Inc.·1 product·🇺🇸 United States
LumineticsCore
FDA registration
Digital Diagnostics Inc.·1 product·🇺🇸 United States
LumineticsCore
FDA registration
Digital Diagnostics Inc.·1 product·🇺🇸 United States
IDx-DR
FDA UDI
Digital Diagnostics Inc.·00860005195619·
IDx-DR
FDA UDI
Digital Diagnostics Inc.·00860005195626·
IDx-DR
FDA 510(k)
FDA Class 2
·Ophthalmic
IDx-DR v2.3
FDA 510(k)
FDA Class 2
·Ophthalmic
HOROS MD
FDA UDI
ICAT SOLUTIONS LTD·05070002336808·The Horos MD™ is an interactive image display a...
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
Advena Limited
Authorized representative
🇲🇹 Malta·467 Manufacturers·13717 Devices
Obelis s.a.
Authorized representative
🇧🇪 Belgium·546 Manufacturers·18515 Devices
MedNet EC-REP GmbH
Authorized representative
🇩🇪 Germany·464 Manufacturers·5263 Devices
Lotus NL B.V.
Authorized representative
🇳🇱 Netherlands·584 Manufacturers·21427 Devices
Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·4Kscore Test
SUNGO Europe B.V.
Authorized representative
🇳🇱 Netherlands·1571 Manufacturers·20390 Devices
MedPath GmbH
Authorized representative
🇩🇪 Germany·537 Manufacturers·13464 Devices
Caretechion GmbH
Authorized representative
🇩🇪 Germany·158 Manufacturers·1463 Devices