EU → US Device Access

LENTILLES

FR-MF-000006721 · France · CAEN

LENTILLES is registered in the European database on medical devices as a manufacturer, with 335 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa335

Most frequent device types declared: NON-STERILE RIGID CONTACT LENS, STERILE SOFT CONTACT LENS, NON-STERILE HYBRID CONTACT LENS, NON-STERILE ORTHOKERATOLOGY CONTACT LENS, NON-STERILE SCLERAL CONTACT LENS.

Among these devices, 57 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 EUDAMED335
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
FR26/0000004amended2031-01-13

Other manufacturers in France

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