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Tristel DUO OPH
EUDAMEDClass IIa (EU MDR)
Ref TSL023901Model 1 x (2 x 125ml)Model 2 x (2 x 125ml)
Identity
- Trade Name
- Tristel DUO OPH EUDAMED
- Device Name
- DUO OPH EUDAMEDTristel Duo OPH EUDAMED
- Model / Reference
- 1 x (2 x 125ml) EUDAMEDTSL023901 EUDAMED2 x (2 x 125ml) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060171919889 EUDAMED
- Basic UDI-DI
- 506017191DOOPH14F EUDAMEDB-05060171919889 EUDAMED
- Direct Marketing DI
- 05060171919889 EUDAMED
- EMDN Code
- D030302 SODIUM CHLORITE FOR THE DISINFECTION OF MEDICAL DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMEDNorthern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Tristel DUO OPH by Tristel Solutions Limited — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 506017191DOOPH14F | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 506017191DOOPH14F | Class IIa | Active |
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Manufacturer
- Manufacturer
- Tristel Solutions Limited
- EUDAMED SRN
- GB-MF-000010046
- Authorised Representative
- Tristel NV BE-AR-000006771
Sources (2)
- EUDAMED 7fc0892c-d7c3-4373-bdcd-c4ce0c22ea2e 61 fields · synced Jul 17, 2026
- EUDAMED 86e253f8-57c2-460b-9c54-16418013751d 61 fields · synced May 19, 2026