Identity
- Trade Name
- MEDICLEAN EUDAMEDMEDICLEAN 5P 5L EUDAMED
- Device Name
- MEDICLEAN EUDAMED
- Model / Reference
- 1412-1073 EUDAMED1412-1077 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05204309018154 EUDAMED05204309048342 EUDAMED
- Basic UDI-DI
- 5204309000060NU EUDAMED
- EMDN Code
- W0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Greece 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
New Device
No
EUDAMED
Mediclean by Medicon Hellas SA — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 5204309000060NU | Class A | Active |
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Manufacturer
- Manufacturer
- Medicon Hellas SA
- EUDAMED SRN
- GR-MF-000013625
Sources (2)
- EUDAMED 1e6a0aae-d25c-4788-812c-8eabfaa180dd 61 fields · synced Jul 29, 2026
- EUDAMED afd306da-9a21-465d-83a2-97aff5fea155 61 fields · synced May 18, 2026