EU → US 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, 84356572500UK, 84356572530UU, 84356572540UX, 84356572510UN.

Among these devices, 78 are declared reusable.

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 EUDAMED733
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.

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