EU → North America Device Access

CLINITEX s.r.o.

CZ-MF-000051598 · Czechia · Ostrava

CLINITEX s.r.o. is registered in the European database on medical devices as a manufacturer, with 825 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa825

Devices declared under this manufacturer

Showing 12 of 825 declared devices.

Catalogue references include N14CAAA1NDIHBXX00009, N14CAAA1NDIHBXX00904, N14CAAA1NDIHBXX00908, N15AAAA1NDIHBXX00907, N16CAAA1KDUHAIB00111, N22DAAA1NDIHBXX00010.

European nomenclature codes declared: T0299, T020402, T020401, T020199.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED825
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 GTIN825
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. CLINITEX s.r.o. was not found in either the U.S. or the Canadian register.

Other manufacturers in Czechia

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