EU → North America Device Access

Aprikos Medical AS

NO-MF-000044411 · Norway · Oslo

Aprikos Medical AS is registered in the European database on medical devices as a manufacturer, with 4 333 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa4 333

Among these devices, 4 251 are declared reusable, 35 active.

Devices declared under this manufacturer

Showing 12 of 4 333 declared devices.

Catalogue references include AM02-154-18, AM03-238-18, AM04-125-38, AM13-165-11, AM16-105-18, AM22-195-01.

European nomenclature codes declared: L031399, L03140199, L010499, L0205, L031306, L0901.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED4 333
Country of registrationNorway

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

Device-level evidence

Devices with a numeric GTIN4 333
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. Aprikos Medical AS was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
HU25/00000077issued2030-08-07

Other manufacturers in Norway

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