DESyne® X2 Novolimus Eluting Coronary Stent System
by Elixir Medical Corporation 55 variants
Ref SZR2732
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-SZR27329S D-SZR27329S | Date27 May 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Model / Reference
- SZR2732
- Primary DI / UDI-DI
- D-SZR27329S
- Basic UDI-DI
- B-SZR27329S
- EMDN Code
- P070402010301 Coronary drug eluting stents (des) with polymers
- Device Class
- Class III
- EU market of registration
- Sweden
Manufacturer details
- EUDAMED SRN
- US-MF-000013041
- Authorised representative
- Acorn Regulatory Consultancy Services Ltd IE-AR-000000592
Other devices from Elixir Medical Corporation
Properties
Other properties (8)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No