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.
Devices declared under this manufacturer
- Angio-Pack
- Angiography pack
- Angiologie pack
- Coro-Pack HUG (Genève)
- EPU/Pacemaker pack
- Laser-set
- PICC pack
- PICC-Pack
- Phlebo pack, Biel
- Radiologie Set Kantonsspital Frauenfeld
- Radiologie-pack
- Spinal surgery set
Showing 12 of 138 declared devices.
Catalogue references include 2LC020013, 2LC020048, 411015/05, 414044/02, 416011/04, 425037/01.
European nomenclature codes declared: T0202, A03020102, T020199, T030102, C0104010280, T0203.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 138 |
| 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 | 138 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
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. CARDIVAIS S.A. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ES23/00000553 | issued | 2028-05-30 |
2025 PR 0047 | issued | 2030-04-20 |