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DOMEL, d.o.o.

SI-MF-000030074 · Slovenia · ŽELEZNIKI

DOMEL, d.o.o. is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Most frequent device types declared: Laboratory centrifuge.

Devices declared under this manufacturer

Catalogue references include 1230.3.500/IVD (120V), 1232.3.005/IVD (120V), 1232.3.010/IVD (120V), 1472.3.000/IVD (120V), 230.3.000/IVD (230V), 232.3.005/IVD (230V).

European nomenclature codes declared: W02069003, W02069005.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED12
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 GTIN12
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. DOMEL, d.o.o. was not found in either the U.S. or the Canadian register.

Other manufacturers in Slovenia

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