EU → North America Device Access

Eto Garments ApS

DK-MF-000002251 · Denmark · Ejby

Eto Garments ApS is registered in the European database on medical devices as a manufacturer, with 1 454 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa1 454

Catalogue references include 106, 206, 404, 603, 603a, 606.

European nomenclature codes declared: M030499.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED1 454
Country of registrationDenmark

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN1 454
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. Eto Garments ApS was not found in either the U.S. or the Canadian register.

Other manufacturers in Denmark

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