EU → North America Device Access

FCOM srl

IT-MF-000033695 · Italy · bassano del grappa

FCOM srl is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa16

Most frequent device types declared: BENDA SALVAPELLE, SPORT TAPE.

Devices declared under this manufacturer

Showing 12 of 16 declared devices.

Catalogue references include 12TAPE2,5, 12TAPE3,8, 1SALVWHITE7.0, 6EXTREMETAPE5, 6SALVWHITE7.0, 6TAPE1.

European nomenclature codes declared: M030403, M03030202.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED16
Country of registrationItaly

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN16
Found in the U.S. device database0
Share0.0 %

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: Neither register. FCOM srl was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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