EU → US Device Access

BARCO S.R.L.

IT-MF-000026408 · Italy · Saronno

BARCO S.R.L. is registered in the European database on medical devices as a manufacturer, with 18 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa18

Most frequent device types declared: Clinical Review Display, surgical monitor.

Among these devices, 18 are declared active.

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 entryBARCO S.R.L. (IT) · FDA 1000181154
Devices in EUDAMED18
Country of registrationItaly

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