EU → US Device Access

VIDIA spol. s r.o.

CZ-MF-000036964 · Czechia · Vestec

VIDIA spol. s r.o. is registered in the European database on medical devices as a manufacturer, with 213 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

other213

Most frequent device types declared: ELISA-VIDITEST anti-CMV IgG (CSF), ELISA-VIDITEST anti-VCA EBV IgG (CSF), ELISA-VIDITEST anti-EBNA-1 EBV IgG, ELISA-VIDITEST anti-Borelia recombinant IgG + VIsE (CSF), ELISA-VIDITEST anti-VZV IgG (CSF).

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 EUDAMED213
Country of registrationCzechia
⚠️ 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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