EU → US Device Access

BIONEN SRL

IT-MF-000018461 · Italy · Firenze

BIONEN SRL is registered in the European database on medical devices as a manufacturer, with 430 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa430

Among these devices, 86 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 registerRegistered with FDA
Matched entryBIONEN SRL (IT) · FDA 3008617703
Devices in EUDAMED430
Country of registrationItaly

Other manufacturers in Italy

All Italy manufacturers →