EU → North America 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

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

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

Devices declared under this manufacturer

Showing 12 of 39 declared devices.

Catalogue references include D1PU0005, D1PU0006, D1TA0006, D1TA0008, D1TA0012, P1-AU511.

European nomenclature codes declared: Z12130503, Z12139099.

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; we do not assert it is the same company — why.

Device-level evidence

Devices with a numeric GTIN39
Found in the U.S. device database38
Share97.4 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entrySPINEGUARD S.A.

Notified body certificates

CertificateStatusExpiry
G10 070226 0011issued2029-08-04

Other manufacturers in France

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