EU → North America Device Access

BOURNAS MEDICALS

GR-MF-000023099 · Greece · Athens

BOURNAS MEDICALS is registered in the European database on medical devices as a manufacturer, with 687 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa670

Most frequent device types declared: BEDPAN, DENTAL BIBS, GENTLE PRODUCTS, GLOVE SERIES, Hygiene Series.

Devices declared under this manufacturer

Showing 12 of 687 declared devices.

Catalogue references include 108.015.SGB, 108.017.SAM100, 108.025.SE.P50, 108.033.SAM150, 110.201.L, 121.007.M.BL.

European nomenclature codes declared: T030502, T0306, T01020204, T0299, S010299, T01020201.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED687
Country of registrationGreece

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

Device-level evidence

Devices with a numeric GTIN687
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. BOURNAS MEDICALS was not found in either the U.S. or the Canadian register.

Other manufacturers in Greece

All Greece manufacturers →