EU → North America Device Access

Aiforia Technologies Plc

FI-MF-000008986 · Finland · Helsinki

Aiforia Technologies Plc is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Devices declared under this manufacturer

Showing 12 of 17 declared devices.

Catalogue references include Aiforia® Breast Cancer Grading, Aiforia® Clinical AI Model for Breast Cancer - HER2, Aiforia® Clinical AI Model for Breast Cancer; Ki67, Aiforia® Clinical AI Model for Breast Cancer; PR, Aiforia® Clinical Suite Viewer, Aiforia® Gastric Cancer.

European nomenclature codes declared: W0202050392.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED17
Country of registrationFinland

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN17
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. Aiforia Technologies Plc was not found in either the U.S. or the Canadian register.

Other manufacturers in Finland

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