EU → North America Device Access

MEdisain Oy

FI-MF-000012422 · Finland · Piikkiö

MEdisain 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

Class IIa5

Most frequent device types declared: ME01, ME03, ME04, ME05.

Devices declared under this manufacturer

Catalogue references include ME01, ME02, ME03, ME04, ME05.

European nomenclature codes declared: M9001, M030501.

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. MEdisain Oy was not found in either the U.S. or the Canadian register.

Other manufacturers in Finland

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