EU → North America Device Access

Remedee Labs SA

FR-MF-000035489 · France · Meylan

Remedee Labs SA is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa7

Most frequent device types declared: Android, Fibromyalgia (F), Osteoarthritis (OA), iOS.

Among these devices, 4 are declared active.

Devices declared under this manufacturer

Catalogue references include REM3AND, REM3CHC-M, REM3IOS, REM3WRB-L-A, REM3WRB-L-F, REM3WRB-S-A.

European nomenclature codes declared: N010199, N010180.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED7
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 GTIN7
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. Remedee Labs SA was not found in either the U.S. or the Canadian register.

Other manufacturers in France

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