EU → North America Device Access

France Développement Electronique

FR-MF-000004028 · France · MONSWILLER

France Développement Electronique is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa7
Class IIb7

Most frequent device types declared: SO-CONNECT, SO-CONNECT PAR, SO-CONNECT+, SO-FILL 100, SO-FILL 20ml.

Among these devices, 6 are declared sterile, 6 active.

Devices declared under this manufacturer

Showing 12 of 14 declared devices.

Catalogue references include SO-CONNECT PAR, SO-CONNECT+, SO-CONNECT+100, SO-EASY+SoFill, SO-FILL 100, SO-FILL 30ml.

European nomenclature codes declared: Z12030301, A020102010201, Z12030380, A020102020102, A0280, A02010299.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED14
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 GTIN11
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. France Développement Electronique was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
ECM25MDR010issued2030-04-29

Other manufacturers in France

All France manufacturers →