EU → US Device Access

Unimed Pharma spol. s r.o.

SK-MF-000003111 · Slovakia · Bratislava - Ružinov

Unimed Pharma spol. s r.o. is registered in the European database on medical devices as a manufacturer, with 81 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb81

Most frequent device types declared: 1x10 ml, 1x10 ml, 2x10 ml, 1x10 mL, 1×0,5 ml.

Among these devices, 81 are declared sterile.

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 EUDAMED81
Country of registrationSlovakia
⚠️ 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 Slovakia

All Slovakia manufacturers →