EU → North America Device Access

DELEO S.A.S.

FR-MF-000000215 · France · frejus

DELEO S.A.S. is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa4
Class IIb1

Among these devices, 1 are declared active, 1 with a measuring function.

Devices declared under this manufacturer

Catalogue references include GP-CONT-L1, GP-PRO-L1, GP-PRO-S1, REV-01, SUB-01-220.

European nomenclature codes declared: M9001, Z12040201, U0780.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED5
Country of registrationFrance

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

Device-level evidence

Devices with a numeric GTIN4
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. DELEO S.A.S. was not found in either the U.S. or the Canadian register.

Other manufacturers in France

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