EU → North America Device Access

WSAUD A/S

DK-MF-000015974 · Denmark · Lynge

WSAUD A/S is registered in the European database on medical devices as a manufacturer, with 8 641 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa8 641

Most frequent device types declared: BTE, CHARGER, CUSTOM, INSTANT FIT, PROGRAMMING.

Among these devices, 8 641 are declared active.

Devices declared under this manufacturer

Showing 12 of 8 641 declared devices.

Catalogue references include 21003746, 21004434, 21007507, 21026747, 21030802, 21031008.

European nomenclature codes declared: Y2145060102, Y2145060101, Y2145060201, Y214580, Y214599, Y2145060202.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED8 641
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 GTIN8 641
Found in the U.S. device database4 091
Share47.3 %
⚠ The two levels disagree here. This company’s name was not found in the FDA establishment register, yet some of its devices are in the U.S. device database. The likeliest reading is that the name match failed.

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. WSAUD A/S was not found in either the U.S. or the Canadian register.

Other manufacturers in Denmark

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