Identity
- Device Name
- Tristel Rinse Assure EUDAMED
- Model / Reference
- RA Solutions EUDAMEDTSL041901 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060171917250 EUDAMED
- Basic UDI-DI
- 506017191RASOL16E EUDAMED
- EMDN Code
- Z12011385 CLEANING, DISINFECTION AND STERILISATION INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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 Rinse Assure by Tristel Solutions Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506017191RASOL16E | Class I | 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 d695f370-27ee-48e0-9037-eb38f96e1035 61 fields · synced Jun 18, 2026