EU → US Device Access

SURGIVAL CO., S.A.U.

ES-MF-000028629 · Spain · Paterna

SURGIVAL CO., S.A.U. is registered in the European database on medical devices as a manufacturer, with 249 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb146
Class I103

Most frequent device types declared: AGUJA KIRSCHNER, CABEZA FEMORAL ENDOCEFÁLICA, TORNILLO CANULADO PIE SURGIFEET, CLAVO STEINMANN, PRÓTESIS PARCIAL DE THOMPSON.

Among these devices, 109 are declared sterile, 249 implantable.

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 EUDAMED249
Country of registrationSpain
⚠️ 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
2026 DR 0091issued2029-02-05
2026 DR 0087issued2029-02-05
2026 DR 0073issued2029-02-05
2025 DR 0054issued2029-02-05
2025 DR 0053issued2029-02-05
2024 CR 0015supplemented2029-02-05

Other manufacturers in Spain

All Spain manufacturers →