EU → US Device Access

Spinreact S.A.U.

ES-MF-000011023 · Spain · Sant Esteve de Bas

Spinreact S.A.U. is registered in the European database on medical devices as a manufacturer, with 638 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

other638

Most frequent device types declared: No, NO.

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 EUDAMED638
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
HX 1552211-1supplemented2030-02-04

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