EU → US Device Access

LABORATOIRE PRECILENS

FR-MF-000000913 · France · CRETEIL

LABORATOIRE PRECILENS is registered in the European database on medical devices as a manufacturer, with 35 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa35

Most frequent device types declared: Lentilles souples pour amétropie, Lentilles rigides pour amétropie, Lentilles de contact rigides pour cornées irrégulières, Lentilles souples pour controle myopie, Lentille de contact rigide pour controle myopie.

Among these devices, 11 are declared sterile.

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 EUDAMED35
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
40441supplemented2031-04-19

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