Unic®
by Evolutis France EUDAMED
Ref E27 515Model UNIC® Reverse Shoulder
EMDN P09018001
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number376025538P090103ROPG4 | Date23 Nov 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 017-00-00-MDR Issued
Technical documentation EU MDR
- Notified body
- ITALCERT SRL 0426
- Issued
- 6 Apr 2023
- Expires
- 5 Apr 2028
Specification
- Device Name
- UNIC® Reverse Shoulder
- Model / Reference
- UNIC® Reverse Shoulder, E27 515
- Primary DI / UDI-DI
- 03760255385235
- Basic UDI-DI
- 376025538P090103ROPG4
- EMDN Code
- P09018001 Shoulder prostheses fixing screws
- Device Class
- Class III
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- FR-MF-000000492
Other devices from Evolutis
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 b0a9aacf-9472-4d8a-aecc-47f2fb6bd414