EU → North America Device Access

GIALDI S.R.L.

IT-MF-000048723 · Italy · Reggiolo (RE)

GIALDI S.R.L. is registered in the European database on medical devices as a manufacturer, with 125 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa125

Among these devices, 3 are declared active.

Devices declared under this manufacturer

Showing 12 of 125 declared devices.

Catalogue references include 100045, 110455, 110459.HD, 140410, 140420, 140431.

European nomenclature codes declared: Y122103, Y122106, Y091203, Y120606, Y122109, Y121806.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED125
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 GTIN125
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. GIALDI S.R.L. was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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