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KOVAL PROIZVODNJA IN TRGOVINA, D.O.O.

SI-MF-000003206 · Slovenia · Loka pri Žusmu

KOVAL PROIZVODNJA IN TRGOVINA, D.O.O. is registered in the European database on medical devices as a manufacturer, with 135 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa135

Among these devices, 122 are declared active.

Devices declared under this manufacturer

Showing 12 of 135 declared devices.

Catalogue references include 10022011, 10068933, 10068962, 11004020, 11992002, 74330550.

European nomenclature codes declared: Y093312, Y120612, V08060101, V080603, V08050399, Y091203.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED135
Country of registrationSlovenia

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

Device-level evidence

Devices with a numeric GTIN135
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. KOVAL PROIZVODNJA IN TRGOVINA, D.O.O. was not found in either the U.S. or the Canadian register.

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