Rocket Pleural Vent Ambulatory Pneumothorax Device with Safety Needle Mounted 8Fg Catheter protected flutter valve, vent and self adhesive fixation device
Ref R54565
Active
CE MDR
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/MDR | Number50552709PP08AFB 05055270975430 | Date27 Oct 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- TF_R008 PP Pleural Vent
- Model / Reference
- R54565
- Primary DI / UDI-DI
- 05055270975430
- Basic UDI-DI
- 50552709PP08AFB
- EMDN Code
- A060203 Pleural drainages with valve and kits
- Device Class
- Class IIa
- Medical Purpose
- The procedure pack is intended to combine devices which have their own individual intended purposes.
Manufacturer details
- EUDAMED SRN
- GB-PR-000030677