EU → US Device Access

groupe lépine

FR-MF-000001182 · France · Genay Cedex

groupe lépine is registered in the European database on medical devices as a manufacturer, with 1 805 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa1 805

Most frequent device types declared: Orthopaedic prostheses positioners, reusable, Class Ir Instrument, Class I Instrument, Orthopaedic implant reamers, single use, Orthopaedic rasps and files, reusable.

Among these devices, 86 are declared sterile, 66 implantable, 1 739 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 EUDAMED1 805
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.

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