EU → US Device Access

SICO Società Italiana Carburo Ossigeno S.p.A.

IT-MF-000028343 · Italy · MILANO (MI)

SICO Società Italiana Carburo Ossigeno S.p.A. is registered in the European database on medical devices as a manufacturer, with 56 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa56

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 EUDAMED56
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
EPT 0477.MDR.22/4851.2reissued2027-06-13
EPT 0477.MDR.22/4850.2reissued2027-06-13
EPT 0477.MDR.22/4849issued2027-06-13

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