CARDIVAIS S.A.
ES-MF-000017980 · Spain · Málaga
CARDIVAIS S.A. is registered in the European database on medical devices as a manufacturer, with 138 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 138 |
|---|
Among these devices, 136 are declared sterile.
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 | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 138 |
| Country of registration | Spain |
⚠️ 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.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ES23/00000553 | issued | 2028-05-30 |
2025 PR 0047 | issued | 2030-04-20 |