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Tristel Fuse for Medical Surfaces
EUDAMEDClass IIa (EU MDR)
Ref TSL011201Model 40 sachets
Identity
- Device Name
- Tristel Fuse for Medical Surfaces EUDAMED
- Model / Reference
- 40 sachets EUDAMEDTSL011201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060171918196 EUDAMED
- Basic UDI-DI
- B-05060171918196 EUDAMED
- EMDN Code
- D030302 SODIUM CHLORITE FOR THE DISINFECTION OF MEDICAL DEVICES EUDAMED
Classification
- Device Class
- Class IIa 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 Fuse for Medical Surfaces by Tristel Solutions Limited — Class IIa — 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-05060171918196 | 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 (1)
- EUDAMED 841ac984-179c-44e1-8f29-bc445aa90e95 61 fields · synced Jul 9, 2026