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Widex A/S

DK-MF-000025153 · Denmark · Lynge

Widex A/S is registered in the European database on medical devices as a manufacturer, with 2 913 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa2 913

Most frequent device types declared: BTE, CUSTOM, PROGRAMMING, RIC.

Among these devices, 2 913 are declared active.

Devices declared under this manufacturer

Showing 12 of 2 913 declared devices.

Catalogue references include 10972970, 10973608, 10973715, 10987939, 10989647, 10994985.

European nomenclature codes declared: Y2145060102, Y2145060101, Y2145060201, Y2145060202, Z121401.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED2 913
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 GTIN2 913
Found in the U.S. device database2 072
Share71.1 %
⚠ 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. Widex A/S was not found in either the U.S. or the Canadian register.

Other manufacturers in Denmark

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