EU → North America Device Access

Grundium Oy

FI-MF-000005144 · Finland · Tampere

Grundium Oy is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Most frequent device types declared: MGU-00001, MGU-00005, Ocus M 20 MGU-30009, Ocus M 40 MGU-30008.

Devices declared under this manufacturer

Catalogue references include MGU-00001, MGU-00003, MGU-00005, MGU-30008, MGU-30009.

European nomenclature codes declared: W0202050304.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED5
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 GTIN5
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. Grundium Oy was not found in either the U.S. or the Canadian register.

Other manufacturers in Finland

All Finland manufacturers →