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Fin-ceramica faenza spa

IT-MF-000023496 · Italy · Faenza

Fin-ceramica faenza spa is registered in the European database on medical devices as a manufacturer, with 110 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class I110

Most frequent device types declared: MaioRegen, RegenOss, PFS015005-40-00, PFS015005-50-00, 01600406.

Among these devices, 110 are declared sterile, 110 implantable.

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 registerRegistered with FDA
Matched entryFIN-CERAMICA FAENZA SPA (IT) · FDA 3006130229
Devices in EUDAMED110
Country of registrationItaly

Notified body certificates

CertificateStatusExpiry
CVD0005230226issued2028-03-12
CVD000423issued2028-03-12
CSQ0008230326issued2028-03-12
C787129issued2031-03-10

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