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Tristel Duo For Rigid Optics
EUDAMEDClass IIb (EU MDR)
Ref TSL022507Model 6 x (2 x 125ml)
Identity
- Device Name
- Tristel Duo For Rigid Optics EUDAMED
- Model / Reference
- 6 x (2 x 125ml) EUDAMEDTSL022507 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060171911807 EUDAMED
- Basic UDI-DI
- B-05060171911807 EUDAMED
- EMDN Code
- D030302 SODIUM CHLORITE FOR THE DISINFECTION OF MEDICAL DEVICES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Tristel Duo For Rigid Optics by Tristel Solutions Limited — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05060171911807 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Tristel Solutions Limited
- EUDAMED SRN
- GB-MF-000010046
- Authorised Representative
- Tristel NV BE-AR-000006771
Sources (1)
- EUDAMED fdea696a-2eb3-4930-9d5b-5eef71d2b9e4 61 fields · synced Jun 18, 2026