EU → US Device Access

CONCEPTION ET FABRICATION DE PRODUITS MEDICAUX ET PARAMEDICAUX

FR-MF-000010345 · France · Tremblay-en-France

CONCEPTION ET FABRICATION DE PRODUITS MEDICAUX ET PARAMEDICAUX is registered in the European database on medical devices as a manufacturer, with 448 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa448

Most frequent device types declared: Instruments endodontiques manuels, Sterile Niti Engine Files.

Among these devices, 194 are declared sterile, 1 reusable.

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 EUDAMED448
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
0425-MDR-030134-01issued2030-06-29

Other manufacturers in France

All France manufacturers →