Tristel OPH COMBINATION PACK
by Tristel Solutions Limited 2 variants
Ref TSL024814Model Tristel OPH COMBINATION PACK 1 x (2 x 125ml), 1 x 310
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 | Number506017191OPHCP6C 05060171916512 | 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- Withdrawn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
- Model / Reference
- Tristel OPH COMBINATION PACK 1 x (2 x 125ml), 1 x 310, TSL024814
- Primary DI / UDI-DI
- 05060171916512
- Basic UDI-DI
- 506017191OPHCP6C
- Direct Marketing DI
- 05060171916512
- EMDN Code
- D030302 Sodium chlorite for the disinfection of medical devices
- Device Class
- Class IIa
Manufacturer details
- EUDAMED SRN
- GB-MF-000010046
- Authorised representative
- Tristel NV BE-AR-000006771
Other devices from Tristel Solutions Limited
Properties
Other properties (13)
- Sterile: No
- 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