EU → North America Device Access

AMIKO SRL

IT-MF-000010697 · Italy · Milano

AMIKO SRL is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa5

Among these devices, 5 are declared active.

Devices declared under this manufacturer

Catalogue references include 08055727430090, 08055727430113, Amiko_on_Aerosol, Amiko_on_Ellipta, Amiko_on_Nexthaler.

European nomenclature codes declared: V9099, V92.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED5
Country of registrationItaly

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

Device-level evidence

Devices with a numeric GTIN5
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. AMIKO SRL was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

All Italy manufacturers →