EU → North America Device Access

ALE & GIO' GROUP SRL

IT-MF-000048813 · Italy · Matino

ALE & GIO' GROUP SRL is registered in the European database on medical devices as a manufacturer, with 19 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa15
Class IIb4

Most frequent device types declared: AG050, AG051, AG055, BM, NT046.

Catalogue references include AG050, AG055, BM, NT046, NT081, NT092.

European nomenclature codes declared: Z120602, M9099, Y063303, M9099,Z12120116.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED19
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 GTIN19
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. ALE & GIO' GROUP SRL was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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