EU → US Device Access

FABRICACIONES ORTOPEDICAS ALBACETE, S.L.

ES-MF-000004660 · Spain · ALBACETE

FABRICACIONES ORTOPEDICAS ALBACETE, S.L. is registered in the European database on medical devices as a manufacturer, with 1 799 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa1 799

Most frequent device types declared: ROLLATOR KARIBU.

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 EUDAMED1 799
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.

Other manufacturers in Spain

All Spain manufacturers →