EU → North America Device Access

Eonex d.o.o.

HR-MF-000025730 · Croatia · Trnovec Bartolovečki

Eonex d.o.o. is registered in the European database on medical devices as a manufacturer, with 66 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa62
Class IIb4

Among these devices, 4 are declared implantable, 37 reusable, 3 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 66 declared devices.

Catalogue references include ZHI 032, ZHI 041, ZHI 102, ZHI 220, ZHI 326, ZHT 715.

European nomenclature codes declared: L091099, L091001, P091399, P09120503, P09120699, P09120603.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED66
Country of registrationCroatia

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

Device-level evidence

Devices with a numeric GTIN66
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. Eonex d.o.o. was not found in either the U.S. or the Canadian register.

Other manufacturers in Croatia

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