EU → US Device Access

SpineGuard.S.A

FR-MF-000004720 · France · Vincennes

SpineGuard.S.A is registered in the European database on medical devices as a manufacturer, with 39 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa38
other1

Most frequent device types declared: D1TAXXXX, P1-AUXXX, D1PUXXXX, D1STXXXX, P2ND2201.

Among these devices, 23 are declared sterile, 16 reusable, 14 active.

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 registerSimilar name found — unverified
Matched entrySPINEGUARD, SA (FR) · FDA 3008102049
Devices in EUDAMED39
Country of registrationFrance
⚠️ A similar name exists in the FDA register. We do not assert that it is the same company — the two registers share no common identifier, and a name alone is not proof. This entry needs a human check.

Notified body certificates

CertificateStatusExpiry
G10 070226 0011issued2029-08-04

Other manufacturers in France

All France manufacturers →