EU → North America Device Access

IRISBOND CROWDBONDING, S.L.

ES-MF-000004335 · Spain · DONOSTIA

IRISBOND CROWDBONDING, S.L. is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa8

Most frequent device types declared: Eye-Tracking Based Solution, Standalone Eye-Tracker.

Among these devices, 8 are declared active.

Devices declared under this manufacturer

Catalogue references include 01.03HIRU, 01.03HIRU.HIRUAPP, 01.03HIRU.HIRUSYSTRAY, 01.04LAU, 02.PP00.LEGACY, 02.PP01.

European nomenclature codes declared: Y214212, Y210906.

United States market access

FDA establishment registerRegistered with FDA
Matched entryIRISBOND CROWDBONDING, S.L. (ES) · FDA 3017237915
Devices in EUDAMED8
Country of registrationSpain

Device-level evidence

Devices with a numeric GTIN8
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: United States only. IRISBOND CROWDBONDING, S.L. is registered in the United States but was not found in the Canadian register.

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