EU → US Device Access

ΣΤΡΩΜΑΤΟΠΟΙΙΑ ΑΘΗΝΩΝ ΕΠΕ

EL-MF-000043080 · Greece · MANDRA ATTIKIS

ΣΤΡΩΜΑΤΟΠΟΙΙΑ ΑΘΗΝΩΝ ΕΠΕ is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It has a company name that cannot be normalised for comparison.

What this manufacturer declares

Class IIa7

Most frequent device types declared: SOFLEX MED D.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerName not comparable
Devices in EUDAMED7
Country of registrationGreece

Other manufacturers in Greece

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