EU → North America Device Access

Aktiebolaget Elektronik-Konstruktion Innovation

SE-MF-000008551 · Sweden · LULEÅ

Aktiebolaget Elektronik-Konstruktion Innovation is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa7

Among these devices, 7 are declared active.

Devices declared under this manufacturer

Catalogue references include L905035000, L905140300, L905140400, L905140705, L905150000, L905155000.

European nomenclature codes declared: B0180.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED7
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 GTIN7
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. Aktiebolaget Elektronik-Konstruktion Innovation was not found in either the U.S. or the Canadian register.

Other manufacturers in Sweden

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