EU → US 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-FILL R50-T, SO-FILL 30ml, SO-FILL 100, SO-CONNECT PAR.

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

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 registerNot found in the FDA register
Devices in EUDAMED14
Country of registrationFrance
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Notified body certificates

CertificateStatusExpiry
ECM25MDR010issued2030-04-29

Other manufacturers in France

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