EU → North America 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

Devices declared under this manufacturer

Catalogue references include 006.011, 006.012, 006.016, 006.017, 006.021, 006.034.

European nomenclature codes declared: P01020180.

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; we do not assert it is the same company — why.

Device-level evidence

Devices with a numeric GTIN7
Found in the U.S. device database7
Share100.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryCERAROOT SL.

What it holds in Canada

Licences on record2
Currently active0
Class 2 devices1
Class 3 devices1
First licensed2011-11-04

Licence types: Device Family (1), Device Group (1).

Licensed under: CERAROOT ZIRCONIUM OXIDE DENTAL IMPLANT, CERAROOT GUIDED SURGERY SYSTEM.

Other manufacturers in Spain

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