EU → US Device Access

Monath-Electronic

FR-MF-000000834 · France · Rouffach

Monath-Electronic is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa5

Most frequent device types declared: Sonde à main, Stimulation du nerf vague, Module Batterie, Electrodes autocollantes, TENS Cable.

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 EUDAMED5
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
DZ 1379109-1supplemented2029-01-28

Other manufacturers in France

All France manufacturers →