EU → US Device Access

OIARSO, S. COOP

ES-MF-000000866 · Spain · HERNANI

OIARSO, S. COOP is registered in the European database on medical devices as a manufacturer, with 584 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa549
Class IIb35

Most frequent device types declared: 055.12, 131.20, 104.66, 131.12, 057.16.

Among these devices, 577 are declared sterile.

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 EUDAMED584
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
2023 PR 0007issued2028-11-05

Other manufacturers in Spain

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