LuX-Valve Plus
by Jenscare Scientific (Netherlands) B.V. Netherlands EUDAMED
Ref JS/TTVI-30-65Model JS/TTVI-30-70
EMDN P070301030204
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number2293668CE01 | Date7 Jul 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 2293668TD01 Issued
Technical documentation EU MDR
- Notified body
- Notified body 0344
- Issued
- 7 Jul 2026
- Expires
- 1 Jul 2031
- 2293668CE01 Issued
Quality management system EU MDR
- Notified body
- Notified body 0344
- Issued
- 7 Jul 2026
- Expires
- 1 Jul 2030
Specification
- Device Name
- LuX-Valve Plus Transcatheter Tricuspid Valve Implant
- Model / Reference
- JS/TTVI-30-70, JS/TTVI-30-65
- Primary DI / UDI-DI
- 08720876800109
- Basic UDI-DI
- 87208768lux02JL
- EMDN Code
- P070301030204 Stented biological tricuspid valves for percutaneous implant - non-valve tissue of animal origin
- Device Class
- Class III
- Market of Registration
- Denmark
Manufacturer details
- EUDAMED SRN
- NL-MF-000040717
Other devices from Jenscare Scientific (Netherlands) B.V.
Properties & raw data
Show properties, registry sources and raw records
Other properties (10)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 1c1bba90-6607-4322-a843-fa0bdae6934b