EU → US Device Access

bioMérieux SA

FR-MF-000004436 · France · Marcy-l'Étoile

bioMérieux SA is registered in the European database on medical devices as a manufacturer, with 433 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

other433

Among these devices, 3 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 EUDAMED433
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
40537issued2031-06-14
40536supplemented2027-04-05

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