EU → US Device Access

Cordis Cashel

IE-MF-000018690 · Ireland · Cashel, Co. Tipperary

Cordis Cashel is registered in the European database on medical devices as a manufacturer, with 132 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb126
Class IIa6

Most frequent device types declared: PG3950PPS, PB1560PSS, PG7960PPX, PB1860PSS, PB1240PPX.

Among these devices, 132 are declared sterile, 126 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 EUDAMED132
Country of registrationIreland
⚠️ 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.

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