EU → US Device Access

EKOVUK MEDI, s.r.o.

CZ-MF-000040403 · Czechia · Brno - Dolní Heršpice

EKOVUK MEDI, s.r.o. is registered in the European database on medical devices as a manufacturer, with 15 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa15

Most frequent device types declared: 4000, 7.8.

Among these devices, 15 are declared active, 4 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 EUDAMED15
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.

Notified body certificates

CertificateStatusExpiry
2026-MDR/QS-020issued2031-04-21

Other manufacturers in Czechia

All Czechia manufacturers →