EU → US 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: VIRVINIL GUANTI MONOUSO IN VINILE SENZA POLVERE, VIRNITRILE GUANTI MONOUSO IN NITRILE SENZA POLVERE, LENZUOLINO POLITENATO MT 50 H 60 CM, CUFFIA ELASTICA TONDA IN TNT , SOVRASCARPE IN P.E. BLU CON ELASTICO.

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 registerNot found in the FDA register
Devices in EUDAMED14
Country of registrationItaly
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

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