EU → North America Device Access

Nordic activity AB

SE-MF-000002371 · Sweden · HÖGANÄS

Nordic activity AB is registered in the European database on medical devices as a manufacturer, with 81 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa81

Most frequent device types declared: 1-1111, 1-1220, 1-1226, 1-2246-HR, 1-2255-RA.

Among these devices, 5 are declared active.

Devices declared under this manufacturer

Showing 12 of 81 declared devices.

Catalogue references include 1-1111, 1-1220, 1-1226, 1-2246-HR, 1-2255-RA, 1-2311.

European nomenclature codes declared: Y093303, Y120612, Y091299, Y181899, Y1803, Y1899.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED81
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 GTIN81
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. Nordic activity AB was not found in either the U.S. or the Canadian register.

Other manufacturers in Sweden

All Sweden manufacturers →