EU → US Device Access

REGANEMED

FR-MF-000048872 · France · MARZY

REGANEMED 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 I5

Among these devices, 5 are declared sterile, 5 implantable.

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
2QMS-MDR-0081/07/2026issued2029-07-09
1TD-MDR-0081/07/2026/01issued2029-07-09

Other manufacturers in France

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