EU → North America Device Access

Lukáš Balihar

CZ-MF-000047505 · Czechia · Pecka

Lukáš Balihar is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa16

Most frequent device types declared: Křeslo přepravní K 96-150.

Devices declared under this manufacturer

Showing 12 of 16 declared devices.

Catalogue references include K 96 hnědá, K 96 modrá, K 96 smragdová, K 96 žlutá, K 96-150 modrá, K 96-150 smaragdová.

European nomenclature codes declared: V080502.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED16
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 GTIN16
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. Lukáš Balihar was not found in either the U.S. or the Canadian register.

Other manufacturers in Czechia

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