EU → US Device Access

CeraRoot SL

ES-MF-000000251 · Spain · Les Franqueses del Vallès

CeraRoot SL is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa7

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 registerSimilar name found — unverified
Matched entryCERAROOT S.L. (ES) · FDA 3008808095
Devices in EUDAMED7
Country of registrationSpain
⚠️ A similar name exists in the FDA register. We do not assert that it is the same company — the two registers share no common identifier, and a name alone is not proof. This entry needs a human check.

Other manufacturers in Spain

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