LithiX Hertz Contact Intravascular Lithotripsy Catheter
by Elixir Medical Corporation EUDAMED
Active
Ref DAR3014Model DAR1514
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number2024-MDR/QS-061/A | Date22 Apr 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 2024-MDR/QS-061/A Supplemented
Quality management system EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 22 Apr 2026
- Expires
- 8 Nov 2029
- Reason
- Change approved
- 2024-MDR/TD-061/A Supplemented
Technical documentation EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 22 Apr 2026
- Expires
- 8 Nov 2029
- Reason
- Add device or group
Specification
- Model / Reference
- DAR1514, DAR3014
- Primary DI / UDI-DI
- 00817508015029
- Basic UDI-DI
- 081750801LithiXY7
- EMDN Code
- C0104010206 Coronary vascular lithotripsy catheters
- Device Class
- Class III
- Market of Registration
- Austria
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 (12)
- Implantable: No
- 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