LINK Embrace Shoulder System
by Waldemar Link GmbH & Co. KG Germany EUDAMED
Ref 645-060/58Model Glenoid insert, uncemented, UHMWPE, anatomic
EMDN P09010302
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number4026575-1-OEX-300003-W8 | Date10 Aug 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 057-00-02-MDR Supplemented
Technical documentation EU MDR
- Notified body
- ITALCERT SRL 0426
- Issued
- 13 May 2025
- Expires
- 12 Sep 2029
- Reason
- Other
Specification
- Device Name
- LINK Embrace Shoulder System
- Model / Reference
- Glenoid insert, uncemented, UHMWPE, anatomic, 645-060/58
- Primary DI / UDI-DI
- 04026575240401
- Basic UDI-DI
- 4026575-1-OEX-300003-W8
- EMDN Code
- P09010302 Anatomical shoulder prosthesis inserts
- Device Class
- Class III
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000005215
Other devices from Waldemar Link GmbH & Co. KG
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 04026575240401|4026575-1-OEX-300003-W8