EU → North America 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.

Devices declared under this manufacturer

Showing 12 of 18 declared devices.

Catalogue references include K9350052, K9350053, K9350054, K9350070, K9350071, K9350072.

European nomenclature codes declared: Z11900802.

United States market access

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

Device-level evidence

Devices with a numeric GTIN18
Found in the U.S. device database18
Share100.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: United States only. BARCO S.R.L. is registered in the United States but was not found in the Canadian register.

Other manufacturers in Italy

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