EU → North America Device Access

MZ Liberec, a.s.

CZ-MF-000006120 · Czechia · Rudník

MZ Liberec, a.s. is registered in the European database on medical devices as a manufacturer, with 171 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb145
Class IIa26

Among these devices, 154 are declared active.

Devices declared under this manufacturer

Showing 12 of 171 declared devices.

Catalogue references include OK07-05, OK07-55, OK24-16, OK24-28, OK24-57, SPR11-1W.

European nomenclature codes declared: Z120309, Z12019080.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED171
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 GTIN171
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. MZ Liberec, a.s. was not found in either the U.S. or the Canadian register.

Other manufacturers in Czechia

All Czechia manufacturers →