EU → North America Device Access

AP GROUP SRL

IT-MF-000048451 · Italy · Bari

AP GROUP SRL is registered in the European database on medical devices as a manufacturer, with 23 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa23

Most frequent device types declared: Guanciale serie Fisiopharm 500x800x120.

Devices declared under this manufacturer

Showing 12 of 23 declared devices.

Catalogue references include 08055598960030, 08055598960054, 08055598960061, 08055598960085, 08055598960122, 08055598960160.

European nomenclature codes declared: V080702, V08030102.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED23
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 GTIN23
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. AP GROUP SRL was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

All Italy manufacturers →