EU → US Device Access

EUROSPINE SARL

FR-MF-000001820 · France · L'HAY LES ROSES

EUROSPINE SARL is registered in the European database on medical devices as a manufacturer, with 614 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class I376
Class IIa217
Class IIb21

Among these devices, 153 are declared sterile, 396 implantable, 218 reusable, 13 with a measuring function.

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 EUDAMED614
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
FR25/00000203issued2030-11-04

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