EU → North America Device Access

UTAS Technologies

SK-MF-000022644 · Slovakia · Bratislava

UTAS Technologies is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb7

Among these devices, 6 are declared active.

Devices declared under this manufacturer

Catalogue references include UM 300-10-S, UM 300-15-S, UM 300-20-S, UNT.MON.01, UVENT-M-S, UVENT-T-S.

European nomenclature codes declared: Z1203020201, Z1203010504.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED7
Country of registrationSlovakia

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. UTAS Technologies was not found in either the U.S. or the Canadian register.

Other manufacturers in Slovakia

All Slovakia manufacturers →