EU → North America Device Access

Fysioline Oy

FI-MF-000001173 · Finland · Tampere

Fysioline Oy is registered in the European database on medical devices as a manufacturer, with 60 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa60

Most frequent device types declared: 134_060, 134_120, 167_206, 800_276, 800_547.

Among these devices, 3 are declared active.

Devices declared under this manufacturer

Showing 12 of 60 declared devices.

Catalogue references include 135_070; 135_067, 135_120; 135_121, 165_300, 167_200; 167_201; 167_203; 167_204; 167_205, 611_0002, 800_370.

European nomenclature codes declared: V9099, D0701.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED60
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 GTIN47
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. Fysioline Oy was not found in either the U.S. or the Canadian register.

Other manufacturers in Finland

All Finland manufacturers →