EU → North America Device Access

Radiante SAS

FR-MF-000000485 · France · Châtellerault

Radiante SAS is registered in the European database on medical devices as a manufacturer, with 2 643 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa2 643

Devices declared under this manufacturer

Showing 12 of 2 643 declared devices.

Catalogue references include 73755-00077-00, 73757-00010-00, 73814-00000-00, 74144-00002-00, 74315-00003-00, 74367-00023-00.

European nomenclature codes declared: M030405.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED2 643
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 GTIN2 643
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. Radiante SAS was not found in either the U.S. or the Canadian register.

Other manufacturers in France

All France manufacturers →