EU → US Device Access

Orkla Cederroth, SAU

ES-MF-000003606 · Spain · Bigues i Riells, Barcelona

Orkla Cederroth, SAU is registered in the European database on medical devices as a manufacturer, with 67 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa67

Most frequent device types declared: TF-01 Clase I Tiras Infantil PE ACRIS 453, TF-02 Clase I Tiras PE ACRIS 453, TF-05 Clase I Tiras MPPE ACRIS 453, TF-04 Clase I Tiras FOAM ACRIS 453, TF-10 Clase I Tiras PU.

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 EUDAMED67
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 →