EU → North America Device Access

ITALRES SRL

IT-MF-000029584 · Italy · Sesto Fiorentino

ITALRES SRL is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa7

Most frequent device types declared: 10DM.

Among these devices, 7 are declared active.

Devices declared under this manufacturer

Catalogue references include 10DM, 20DM, 30DM.

European nomenclature codes declared: Z12062899.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED7
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 GTIN7
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. ITALRES SRL was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
IT340023issued2030-02-26

Other manufacturers in Italy

All Italy manufacturers →