TEDISEL IBERICA S.L.
ES-MF-000026074 · Spain · Badalona
TEDISEL IBERICA S.L. is registered in the European database on medical devices as a manufacturer, with 32 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 23 |
|---|---|
| Class IIb | 9 |
Most frequent device types declared: UMOS, BASIC-MS, DIAMOND, BASIC-SC, INFUSION STAND.
Among these devices, 9 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 | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 32 |
| 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 |
|---|---|---|
HZ 1000382-1 | issued | 2031-06-18 |