EU → North America Device Access

Medicon Hellas SA

GR-MF-000013625 · Greece · Gerakas

Medicon Hellas SA is registered in the European database on medical devices as a manufacturer, with 415 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Devices declared under this manufacturer

Showing 12 of 415 declared devices.

Catalogue references include 1415-0070, 1417-0127, 1417-0847, 1418-0097, 1418-0167, 1419-0022.

European nomenclature codes declared: W0101050302, W0103010105, W01010230, W0102152003, W01010207, W0102152203.

United States market access

FDA establishment registerRegistered with FDA
Matched entryMEDICON HELLAS SA (GR) · FDA 3006716639
Devices in EUDAMED415
Country of registrationGreece

Device-level evidence

Devices with a numeric GTIN415
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: United States only. Medicon Hellas SA is registered in the United States but was not found in the Canadian register.

Other manufacturers in Greece

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