EU → North America Device Access

VAKUFORM s.r.o.

CZ-MF-000044602 · Czechia · Zlín

VAKUFORM s.r.o. is registered in the European database on medical devices as a manufacturer, with 39 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa39

Most frequent device types declared: VAKUOVÉ DLAHY A MATRACE.

Devices declared under this manufacturer

Showing 12 of 39 declared devices.

Catalogue references include VM-104/2, VM-176/2, VM-180/1, VM-194/2, VS-103/2, VS-202.

European nomenclature codes declared: M03050299, V08050103.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED39
Country of registrationCzechia

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

Device-level evidence

Devices with a numeric GTIN39
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. VAKUFORM s.r.o. was not found in either the U.S. or the Canadian register.

Other manufacturers in Czechia

All Czechia manufacturers →