EU → US Device Access

Global D

FR-MF-000024267 · France · BRIGNAIS

Global D is registered in the European database on medical devices as a manufacturer, with 323 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb244
Class IIa79

Among these devices, 43 are declared sterile, 244 implantable, 19 reusable.

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 EUDAMED323
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 00114-Aissued2030-12-02

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