EU → North America 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 HYBRID CONTACT LENS, NON-STERILE ORTHOKERATOLOGY CONTACT LENS, NON-STERILE RIGID CONTACT LENS, NON-STERILE SCLERAL CONTACT LENS, STERILE SOFT CONTACT LENS.

Among these devices, 57 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 335 declared devices.

Catalogue references include AS DT, CK, D+, KL, MANY, S/M.

European nomenclature codes declared: Q02100402, Q0210040102.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED335
Country of registrationFrance

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN335
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. LENTILLES was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
FR26/0000004amended2031-01-13

Other manufacturers in France

All France manufacturers →