EU → North America Device Access

Etac Immedia A/S

DK-MF-000019241 · Denmark · Gedved

Etac Immedia A/S is registered in the European database on medical devices as a manufacturer, with 352 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa352

Most frequent device types declared: Care, Positioning Cushions, Positioning Horizontal, Positioning Sitting, Special Solutions.

Devices declared under this manufacturer

Showing 12 of 352 declared devices.

Catalogue references include IM00100, IM10506, IM15108, IM15112, IM15113, IM4115S.

European nomenclature codes declared: Y122799, V080399, Y1299, V9099, Y1899.

United States market access

FDA establishment registerRegistered with FDA
Matched entryETAC IMMEDIA A/S (DK) · FDA 3007615630
Devices in EUDAMED352
Country of registrationDenmark

Device-level evidence

Devices with a numeric GTIN352
Found in the U.S. device database73
Share20.7 %

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: United States only. Etac Immedia A/S is registered in the United States but was not found in the Canadian register.

Other manufacturers in Denmark

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