EU → North America Device Access

MATERASSO Slovakia, s.r.o.

SK-MF-000044986 · Slovakia · Oravské Veselé

MATERASSO Slovakia, s.r.o. is registered in the European database on medical devices as a manufacturer, with 509 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa509

Most frequent device types declared: HR matrac, Penový matrac, Pružinový matrac.

Devices declared under this manufacturer

Showing 12 of 509 declared devices.

Catalogue references include 8586020354269, 8586025254441, 8586025256308, 8586025256667, 8586025257879, 8586025259026.

European nomenclature codes declared: V080702.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED509
Country of registrationSlovakia

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

Device-level evidence

Devices with a numeric GTIN509
Found in the U.S. device database0
Share0.0 %

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. MATERASSO Slovakia, s.r.o. was not found in either the U.S. or the Canadian register.

Other manufacturers in Slovakia

All Slovakia manufacturers →