EU → North America Device Access

Wiges AB

SE-MF-000007713 · Sweden · Kinna

Wiges AB is registered in the European database on medical devices as a manufacturer, with 26 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa26

Most frequent device types declared: 5329, 5408, 54087.

Catalogue references include 532902412, 532902413, 532902414, 532903813, 532904414, 540830112.

European nomenclature codes declared: M030405.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED26
Country of registrationSweden

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

Device-level evidence

Devices with a numeric GTIN26
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. Wiges AB was not found in either the U.S. or the Canadian register.

Other manufacturers in Sweden

All Sweden manufacturers →