EU → North America Device Access

Fimet Oy

FI-MF-000006831 · Finland · Askola

Fimet Oy is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa16

Most frequent device types declared: F1, F1 Arcus, NEO, NEO CART, NEO CEILING.

Among these devices, 16 are declared active.

Devices declared under this manufacturer

Showing 12 of 16 declared devices.

Catalogue references include 0140, 0200, 0202, 06429810585066, 06429810585097, F1.

European nomenclature codes declared: Z12110101, Z12110180.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED16
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 GTIN16
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. Fimet Oy was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
FI24/00000041supplemented2029-05-23

Other manufacturers in Finland

All Finland manufacturers →