EU → North America Device Access

SEPTONA ΑΝΩΝΥΜΟΣ ΒΙΟΜΗΧΑΝΙΚΗ ΚΑΙ ΕΜΠΟΡΙΚΗ ΕΤΑΙΡΕΙΑ ΠΑΡΑΦΑΡΜΑΚΕΥΤΙΚΩΝ ΠΡΟΙΟΝΤΩΝ (διακριτικός τίτλος SEPTONA AE)

GR-MF-000018243 · Greece · Inofita, Viotia

SEPTONA ΑΝΩΝΥΜΟΣ ΒΙΟΜΗΧΑΝΙΚΗ ΚΑΙ ΕΜΠΟΡΙΚΗ ΕΤΑΙΡΕΙΑ ΠΑΡΑΦΑΡΜΑΚΕΥΤΙΚΩΝ ΠΡΟΙΟΝΤΩΝ (διακριτικός τίτλος SEPTONA AE) is registered in the European database on medical devices as a manufacturer, with 62 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa62

Devices declared under this manufacturer

Showing 12 of 62 declared devices.

Catalogue references include 12, 3106, 3125, 3308, 3337, 3339.

European nomenclature codes declared: M010101, T04010299, T04010102, T04010103.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED62
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 GTIN62
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. SEPTONA ΑΝΩΝΥΜΟΣ ΒΙΟΜΗΧΑΝΙΚΗ ΚΑΙ ΕΜΠΟΡΙΚΗ ΕΤΑΙΡΕΙΑ ΠΑΡΑΦΑΡΜΑΚΕΥΤΙΚΩΝ ΠΡΟΙΟΝΤΩΝ (διακριτικός τίτλος SEPTONA AE) was not found in either the U.S. or the Canadian register.

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