Tracflex Plus S Tracheostomy Tube Set
by Teleflex Medical 48 variants
Ref 858164-000080
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 | Number08019020000000000000176KW 14026704941428 | Date21 Jul 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- Withdrawn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
- RÜSCH Tracflex Plus S
- Model / Reference
- 858164-000080
- Primary DI / UDI-DI
- 14026704941428
- Basic UDI-DI
- 08019020000000000000176KW
- Direct Marketing DI
- 44026704941429
- EMDN Code
- R0105020201 Tracheostomic cannulas, cuffed, reinforced, with fixed flange, and kits
- Device Class
- Class IIb
- EU market of registration
- Ireland
Manufacturer details
- EUDAMED SRN
- IE-MF-000015868
Other devices from Teleflex Medical
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