EU → US Device Access

Medline International France SAS

FR-MF-000000676 · France · Châteaubriant

Medline International France SAS is registered in the European database on medical devices as a manufacturer, with 2 750 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa2 750

Among these devices, 927 are declared sterile.

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 EUDAMED2 750
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
MDR 768587supplemented2028-05-09

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