Identity
- Device Name
- Stella System EUDAMED
- Model / Reference
- B EUDAMEDTSL STELLA - B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060171916994 EUDAMED
- Basic UDI-DI
- B-05060171916994 EUDAMED
- EMDN Code
- Z12011301 CLEANING AND DISINFECTION EQUIPMENT 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
Category: Surgical utensil washer/disinfector
Stella System by Tristel Solutions Limited — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-05060171916994 | 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 94855cfb-c932-4574-8089-2df35d6e8bd3 61 fields · synced Jun 18, 2026