SEDECAL, S.A. (SOCIEDAD ESPAÑOLA DE ELECTROMEDICINA Y CALIDAD, S.A.)
ES-MF-000017998 · Spain · Algete
SEDECAL, S.A. (SOCIEDAD ESPAÑOLA DE ELECTROMEDICINA Y CALIDAD, S.A.) is registered in the European database on medical devices as a manufacturer, with 146 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 146 |
|---|
Most frequent device types declared: CTSC, MILLENNIUM, MULTIRAD, NOVA, CHALLENGE X, SALA, PROTEUS XR/f, SEDECAL X, X-RAY GENERATOR SHF, X-RAY GENERATOR SHFR.
Among these devices, 146 are declared active.
Catalogue references include MILL-ELAT-PLUS, MILLENNIUM, MULT-WBS, NET 4000-AT, SHF-1635, SHF-315PSU.
European nomenclature codes declared: Z11039011, Z11039005, Z11039006.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 146 |
| Country of registration | Spain |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 146 |
|---|---|
| Found in the U.S. device database | 116 |
| Share | 79.5 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. SEDECAL, S.A. (SOCIEDAD ESPAÑOLA DE ELECTROMEDICINA Y CALIDAD, S.A.) was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ES23/00000120 | supplemented | 2028-02-06 |