EU → US Device Access

PENTAFERTE ITALIA SRL

IT-MF-000040982 · Italy · Campli

PENTAFERTE ITALIA SRL is registered in the European database on medical devices as a manufacturer, with 232 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa228
Class IIb4

Among these devices, 230 are declared sterile, 65 with a measuring function.

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 registerSimilar name found — unverified
Matched entryPENTAFERTE ITALIA S.R.L. (IT) · FDA 3004756837
Devices in EUDAMED232
Country of registrationItaly
⚠️ A similar name exists in the FDA register. We do not assert that it is the same company — the two registers share no common identifier, and a name alone is not proof. This entry needs a human check.

Other manufacturers in Italy

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