EU → North America Device Access

Lasi-Kostamo Oy

FI-MF-000014801 · Finland · Turku

Lasi-Kostamo Oy is registered in the European database on medical devices as a manufacturer, with 38 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa38

Most frequent device types declared: LaKo/imk.

Devices declared under this manufacturer

Showing 12 of 38 declared devices.

Catalogue references include LaKo/imk 1,5/11, LaKo/imk 1,5/6, LaKo/imk 1,5/9, LaKo/imk 2/9, LaKo/imk 3,5/11, LaKo/imk 4/11.

European nomenclature codes declared: A0680.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED38
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 GTIN38
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. Lasi-Kostamo Oy was not found in either the U.S. or the Canadian register.

Other manufacturers in Finland

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