EU → North America Device Access

SAN.KO.M. d.o.o.

SI-MF-000003862 · Slovenia · Ljubljana

SAN.KO.M. d.o.o. is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa10

Devices declared under this manufacturer

Catalogue references include (50/ 55/ 51/ 56/ 52/ 57/ 53/ 58/ 54/ 59/ 80/ 86/ 82 XXX XXX) / (55/ 58, 700/ 701/ 702 XXX XXX, 724 XXX XXX, 735 XXX XXX, 737 XXX XXX, 740 XXX XXX.

European nomenclature codes declared: S0199, S010301, S010302, S01020201.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED10
Country of registrationSlovenia

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

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. SAN.KO.M. d.o.o. was not found in either the U.S. or the Canadian register.

Other manufacturers in Slovenia

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