EU → North America Device Access

Etac A/S

DK-MF-000017724 · Denmark · Gedved

Etac A/S is registered in the European database on medical devices as a manufacturer, with 455 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa455

Most frequent device types declared: Ceiling Hoist, Mobile Hoist, Sit-to-Stand Aid, Sit-to-Stand Hoist, Sling.

Devices declared under this manufacturer

Showing 12 of 455 declared devices.

Catalogue references include 1109001-2.3M, 1109003-1.4MOD1, 1109003-1.4MOD2, 1109003-6M-MOD1, 1109008-2M, 1721020.

European nomenclature codes declared: Y1299, V9099, Y122799.

United States market access

FDA establishment registerRegistered with FDA
Matched entryEtac A/S (DK) · FDA 3004137175
Devices in EUDAMED455
Country of registrationDenmark

Device-level evidence

Devices with a numeric GTIN455
Found in the U.S. device database152
Share33.4 %

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

Other manufacturers in Denmark

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