Biolox Forte
by DePuy Ireland UC Ireland EUDAMED
Ref 9111-123Model BIOLOX Forte 12/14 Taper Femoral Heads - Ceramic
EMDN P090804050201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0603295a0027895 | Date30 Jan 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- MDR 776549 Supplemented
Technical documentation EU MDR
- Notified body
- Notified body 2797
- Issued
- 30 Jun 2026
- Expires
- 4 Jun 2029
- Reason
- Change approved
Specification
- Device Name
- 12/14 Taper Femoral Heads - Ceramic
- Model / Reference
- BIOLOX Forte 12/14 Taper Femoral Heads - Ceramic, 9111-123
- Primary DI / UDI-DI
- 10603295359135
- Basic UDI-DI
- 0603295a0027895
- EMDN Code
- P090804050201 Ceramic femoral heads, total hip replacement
- Device Class
- Class III
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- IE-MF-000007377
Other devices from DePuy Ireland UC
Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 10603295359135|0603295A0027895