DynamX Sirolimus Eluting Coronary Bioadaptor System
by Elixir Medical Corporation United States EUDAMED
Ref VIR2532Model VIR2014 EMDN P07040199
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number081750801DynamXVIR4F | Date13 Nov 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 2025-MDR/QS-051 Issued
Quality management system EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 10 Nov 2025
- Expires
- 8 Nov 2029
- 2025-MDR/TD-051 Issued
Technical documentation EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 10 Nov 2025
- Expires
- 8 Nov 2029
Specification
- Model / Reference
- VIR2014, VIR2532
- Primary DI / UDI-DI
- 00817508012899
- Basic UDI-DI
- 081750801DynamXVIR4F
- EMDN Code
- P07040199 Vascular endoprostheses - other
- Device Class
- Class III
- 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 & raw data
Show properties, registry sources and raw records
Other properties (9)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
Sources (1)
- EUDAMED 55644a5e-24df-41fa-8894-43b44cc75543