EU → North America Device Access

FRAMIRAL

FR-MF-000011744 · France · GRASSE

FRAMIRAL is registered in the European database on medical devices as a manufacturer, with 20 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa20

Most frequent device types declared: Acuité Visuelle Dynamique, Barre de Leds Regled, Boule Optocinétique Stimulopt Framiral, EYEXPLOR, FRAMISCOPE.

Among these devices, 18 are declared active.

Devices declared under this manufacturer

Showing 12 of 20 declared devices.

Catalogue references include FRAMI-EYEX, FSCOPE-EU, FSCOPE-EU-EI2, FSCOPE-EU-MFIL, HPOINT.2, MTTBC-PL.

European nomenclature codes declared: Z12140401, Z12140402, Z129013, Z12140480, Z12140403.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED20
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 GTIN20
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. FRAMIRAL was not found in either the U.S. or the Canadian register.

Other manufacturers in France

All France manufacturers →