EU → North America Device Access

MOLITAN a.s.

CZ-MF-000054572 · Czechia · Břeclav

MOLITAN a.s. is registered in the European database on medical devices as a manufacturer, with 23 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa23

Most frequent device types declared: EffectaCare / PrimaCare.

Devices declared under this manufacturer

Showing 12 of 23 declared devices.

Catalogue references include 4PCA21100AS, 4PCAC1100AS, 4PCB51100AS, 4PCBC1100AS, 4PCBD1100AS, 4PCDC1100AS.

European nomenclature codes declared: V080702.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED23
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 GTIN23
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. MOLITAN a.s. was not found in either the U.S. or the Canadian register.

Other manufacturers in Czechia

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