DePuy Ireland UC
IE-MF-000007377 · Ireland · Ringaskiddy, Co. Cork
DePuy Ireland UC is registered in the European database on medical devices as a manufacturer, with 7 807 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 5 756 |
|---|---|
| Class I | 1 714 |
| Class IIb | 337 |
Most frequent device types declared: SIGMA Insert Trial, SIGMA P.F.C. SIGMA Fixed Bearing Tibial Insert, PINNACLE Liner Trial, P.F.C SIGMA Tibial Insert RP Trial Prosthesis, ATTUNE Knee System Cemented RP Tibial Insert.
Among these devices, 2 077 are declared sterile, 2 051 implantable, 1 461 reusable.
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 | Depuy Ireland UC (IE) · FDA 3015516266 |
| Devices in EUDAMED | 7 807 |
| Country of registration | Ireland |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
MDR 776549 | supplemented | 2029-06-04 |
MDR 776531 | supplemented | 2029-09-11 |
MDR 755949 | supplemented | 2027-10-12 |
MDR 755208 | supplemented | 2029-07-09 |
MDR 743997 | supplemented | 2028-07-17 |