EU → North America 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-03 Clase I Bandas PE ACRIS 453, TF-04 Clase I Tiras FOAM ACRIS 453, TF-09 Clase I Tapes NW SPT5.

Devices declared under this manufacturer

Showing 12 of 67 declared devices.

Catalogue references include 309683, 310686, 510002771, 510004727, 51030047, 51030109.

European nomenclature codes declared: M04010199, V9099, M0599, M04010102, M04010101, M04040301.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED67
Country of registrationSpain

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN67
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. Orkla Cederroth, SAU was not found in either the U.S. or the Canadian register.

Other manufacturers in Spain

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