EU → US Device Access

Ing. Carlo Alberto Issoglio & C. srl

IT-MF-000035570 · Italy · Omegna

Ing. Carlo Alberto Issoglio & C. srl is registered in the European database on medical devices as a manufacturer, with 2 700 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb1 639
Class IIa1 061

Among these devices, 895 are declared sterile, 1 639 implantable, 1 061 reusable.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED2 700
Country of registrationItaly
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Notified body certificates

CertificateStatusExpiry
0425-MDR-030149-01issued2030-09-10

Other manufacturers in Italy

All Italy manufacturers →