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 has a similarly named entry in the FDA register that we have not verified.
What this manufacturer declares
| Class IIb | 146 |
|---|
Most frequent device types declared: X-RAY GENERATOR SHF, X-RAY GENERATOR SHFR, MILLENNIUM, MULTIRAD, NOVA, CHALLENGE X, SALA, PROTEUS XR/f, SEDECAL X, CTSC.
Among these devices, 146 are declared active.
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 register | Similar name found — unverified |
|---|---|
| Matched entry | SEDECAL S.A. (ES) · FDA 9617251 |
| Devices in EUDAMED | 146 |
| Country of registration | Spain |
⚠️ 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.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ES23/00000120 | supplemented | 2028-02-06 |