EU → US Device Access

GARDHEN BILANCE

IT-MF-000013019 · Italy · POMIGLIANO D'ARCO

GARDHEN BILANCE is registered in the European database on medical devices as a manufacturer, with 41 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa41

Most frequent device types declared: Poltrone Hospital, POLTRONE MEDICALI ELETTRICHE CON SISTEMA DI PESATURA, LETTI MEDICI ELETTRICI CON SISTEMA DI PESATURA, LETTI MEDICI PER TRATTAMENTO, DIAGNOSI E MONITORAGGIO, POLTRONE OPERATORIE.

Among these devices, 41 are declared active, 18 with a measuring function.

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 EUDAMED41
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.

Other manufacturers in Italy

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