EU → North America Device Access

Intercapital SRL

RO-MF-000024139 · Romania · Sibiu

Intercapital SRL is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa7

Devices declared under this manufacturer

Catalogue references include AEAMedical3Adulti, AEAMedical3Copii, AEAMedical3CopiiA, AEAMedical4Adulti, AEAMedical4AdultiN, AKESO10B.

European nomenclature codes declared: T020604, T020603.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED7
Country of registrationRomania

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

Device-level evidence

Devices with a numeric GTIN7
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. Intercapital SRL was not found in either the U.S. or the Canadian register.

Other manufacturers in Romania

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