EU → US Device Access

Omega Pharma International NV

BE-MF-000007210 · Belgium · Ghent

Omega Pharma International NV is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb5
Class IIa2

Most frequent device types declared: Protection.

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 EUDAMED7
Country of registrationBelgium
⚠️ 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
20311GB448260506supplemented2027-09-21

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