EU → North America Device Access

Zlatarna Celje d.o.o.

SI-MF-000021928 · Slovenia · Celje

Zlatarna Celje d.o.o. is registered in the European database on medical devices as a manufacturer, with 19 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa19

Most frequent device types declared: 60111001.

Among these devices, 19 are declared implantable.

Devices declared under this manufacturer

Showing 12 of 19 declared devices.

Catalogue references include 60111001, 60111008, 60111011, 60111025, 60111050, 60111057.

European nomenclature codes declared: Q010601.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED19
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 GTIN19
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. Zlatarna Celje d.o.o. was not found in either the U.S. or the Canadian register.

Other manufacturers in Slovenia

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