EU → US Device Access

C.O.C. FARMACEUTICI S.R.L.

IT-MF-000019321 · Italy · SANT'AGATA BOLOGNESE

C.O.C. FARMACEUTICI S.R.L. is registered in the European database on medical devices as a manufacturer, with 206 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb203
Class IIa3

Most frequent device types declared: DT/01/DT/003, DT/01/DT/007, DT/01/DT/010, DT/01/DT/001, DT/01/DT/002.

Among these devices, 205 are declared sterile.

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 EUDAMED206
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
091/MDRsupplemented2028-03-19

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