EU → North America Device Access

VIRCOL SPA

IT-MF-000031137 · Italy · SESTO CALENDE

VIRCOL SPA is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa14

Most frequent device types declared: BAVAGLIE MONOUSO, CUFFIA ELASTICA TONDA IN TNT, LENZUOLINO POLITENATO MT 100 H 60 CM, LENZUOLINO POLITENATO MT 50 H 60 CM, SOVRASCARPE IN P.E. BLU CON ELASTICO.

Devices declared under this manufacturer

Showing 12 of 14 declared devices.

Catalogue references include CAN151M, CAN248M, CAN248XL, CAN251S, CAN251XL, CCA160.

European nomenclature codes declared: T01020201, T01020204, Y0999, T030502, T0205, T01010202.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED14
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 GTIN14
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. VIRCOL SPA was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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