EU → North America 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.

Devices declared under this manufacturer

Catalogue references include H2, P-2, P-3, P2.

European nomenclature codes declared: P900402.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED5
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 GTIN5
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. REGANEMED was not found in either the U.S. or the Canadian register.

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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