Dragonfly™ Transcatheter Mitral Valve Repair System
by Hangzhou Valgen Medtech Co., Ltd China EUDAMED
Ref SN0409 EMDN P07038004
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69715077500018T | Date21 Jul 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 2283633CE01 Issued
Quality management system EU MDR
- Notified body
- Notified body 0344
- Issued
- 7 Apr 2025
- Expires
- 1 Apr 2030
- 2283633TD01 Issued
Technical documentation EU MDR
- Notified body
- Notified body 0344
- Issued
- 7 Apr 2025
- Expires
- 1 Apr 2030
Specification
- Model / Reference
- SN0409
- Primary DI / UDI-DI
- 06971507751181
- Basic UDI-DI
- 69715077500018T
- EMDN Code
- P07038004 Heart valve reconstruction implants
- Device Class
- Class III
- Market of Registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- CN-MF-000037140
- Authorised representative
- MedNet EC-REP C III GmbH DE-AR-000011196
Other devices from Hangzhou Valgen Medtech Co., Ltd
Properties & raw data
Show properties, registry sources and raw records
Other properties (10)
- 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
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 06971507751181|69715077500018T