Identity
- Trade Name
- CYANElite 290 EUDAMEDCYANElite 290 Washing Solution EUDAMED
- Device Name
- CYANElite 290 EUDAMEDCYANElite 290 Washing Solution EUDAMED
- Model / Reference
- CY015 EUDAMEDCY015-WS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404035100295 EUDAMED05404035100417 EUDAMED
- Basic UDI-DI
- 54040351CY0155X EUDAMED54040351CY015-WSXE EUDAMED
- Direct Marketing DI
- 05404035100295 EUDAMED05404035100417 EUDAMED
- EMDN Code
- W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400) EUDAMEDW0201010185 CHEMISTRY ANALYSERS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMEDEUDAMED
New Device
No
EUDAMED
CYANElite 290 by Cypress Diagnostics — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: CYANElite 290 Automated biochemistry analyzer
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 54040351CY0155X | Class A | Active |
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Manufacturer
- Manufacturer
- Cypress Diagnostics
- EUDAMED SRN
- BE-MF-000000033
Sources (2)
- EUDAMED a9354367-b1d8-4c8e-b298-15f0c676273d 61 fields · synced Jul 10, 2026
- EUDAMED 00b6d4c3-4d0a-4a4b-ba43-c235dd2dc5cf 61 fields · synced May 18, 2026