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 I | 1 714 |
|---|---|
| Class IIa | 5 756 |
| Class IIb | 337 |
Most frequent device types declared: ATTUNE Articulation Surface, ATTUNE Knee System Cemented FB Tibial Insert, DEPUY MI SYSTEM Reamer, Hip, LPS Hinge Insert Trial, PINNACLE Instrument/Implant Inserter, Hip.
Among these devices, 2 077 are declared sterile, 2 051 implantable, 1 461 reusable.
Devices declared under this manufacturer
- ATTUNE
- ATTUNE KNEE SYSTEM
- BIOLOX DELTA
- DURALOC
- DePuy MI System
- EMPHASYS
- GLOBAL UNITE
- INTUITION FOR HP PARTIAL
- LPS
- P.F.C. SIGMA
- PINNACLE
- SIGMA High Performance
Showing 12 of 7 807 declared devices.
Catalogue references include 1516-20-405, 1581-24-120, 251733814, 2525-10-011, 2545-00-962, 2545-01-035.
European nomenclature codes declared: L091199, P090903020202, L0999, P090803040101, L091102, L0922.
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 |
Device-level evidence
| Devices with a numeric GTIN | 7 807 |
|---|---|
| Found in the U.S. device database | 7 450 |
| Share | 95.4 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | DEPUY IRELAND UC |
What it holds in Canada
| Licences on record | 121 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 57 |
| Class 3 devices | 64 |
| First licensed | 1998-11-03 |
Licence types: Device Family (70), System (43), Single Device (6), Device Group Family (2).
Licensed under: GLOBAL TOTAL SHOULDER SYSTEM, C-STEM MODULAR HIP SYSTEM, S-ROM TOTAL HIP SYSTEM, ELITE MODULAR SYSTEM, PFC SIGMA KNEE SYSTEM, LCS TOTAL KNEE SYSTEM.
North American profile: Both markets. DePuy Ireland UC is registered in both the United States and Canada.
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 |