EU → North America Device Access

IBODONTIT S.L.

ES-MF-000002315 · Spain · Zaragoza

IBODONTIT S.L. is registered in the European database on medical devices as a manufacturer, with 733 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa530
Class IIb203

Most frequent device types declared: 01, 21, 84356572500UK, 84356572510UN, 84356572530UU.

Among these devices, 78 are declared reusable.

Catalogue references include HE-41710, HE-41914, HEZ-50010, IBO 1601 702, IBO 1802 702, IBO 2903 702.

European nomenclature codes declared: Q010280, Q010207.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED733
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 GTIN733
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. IBODONTIT S.L. was not found in either the U.S. or the Canadian register.

Other manufacturers in Spain

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