EU → North America Device Access

AJ Medical KB

SE-MF-000004167 · Sweden · LIDINGÖ

AJ Medical KB is registered in the European database on medical devices as a manufacturer, with 46 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa46

Among these devices, 46 are declared active, 45 with a measuring function.

Catalogue references include 1200, AJM-1305-01, AJM-8001-00E, AJM-8005-00ET, AJM-8006-00ET, AJM-8013.

European nomenclature codes declared: Z1203020302, T0306, Z1203020599, V0399.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED46
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 GTIN46
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. AJ Medical KB was not found in either the U.S. or the Canadian register.

Other manufacturers in Sweden

All Sweden manufacturers →