Identity
- Trade Name
- Lyse for CYANHemato 380 EUDAMED
- Device Name
- Lyse for CYANHemato 380 EUDAMED
- Model / Reference
- CY017-R02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404035100493 EUDAMED
- Basic UDI-DI
- B-05404035100493 EUDAMED
- EMDN Code
- W0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Lyse for CYANHemato 380 by Cypress Diagnostics — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: How to use the CYANHemato 380
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-05404035100493 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Cypress Diagnostics
- EUDAMED SRN
- BE-MF-000000033
Sources (1)
- EUDAMED 5c8b4cd3-c31a-42d6-ba42-9b2b44afe1c0 61 fields · synced Jul 9, 2026