OPERON, S.A.
ES-MF-000004790 · Spain · Cuarte de Huerva - Zaragoza
OPERON, S.A. is registered in the European database on medical devices as a manufacturer, with 92 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| other | 92 |
|---|
Most frequent device types declared: 9.231.XXX.YY.ZZZ, 9.134.XXX.YY.ZZZ, 9.024.XXX.YY.ZZZ, 9.050.XXX.YY.ZZZ, 9.065.XXX.YY.ZZZ.
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 | Registered with FDA |
|---|---|
| Matched entry | OPERON, S.A. (ES) · FDA 3007360698 |
| Devices in EUDAMED | 92 |
| Country of registration | Spain |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
IX 1530337-1 | issued | 2030-04-15 |
HX 1530337-1 | supplemented | 2029-12-18 |