Identity
- Trade Name
- MEDILYZER BX WITH ISE EUDAMED
- Device Name
- MEDILYZER BX EUDAMED
- Model / Reference
- 2449-3000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05204309163205 EUDAMED
- Basic UDI-DI
- 5204309000092P9 EUDAMED
- EMDN Code
- W0201010180 CHEMISTRY ANALYSERS - HARDWARE ACCESSORIES 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Medilyzer Bx With Ise 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 | 5204309000092P9 | Class A | Active |
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Manufacturer
- Manufacturer
- Medicon Hellas SA
- EUDAMED SRN
- GR-MF-000013625
Sources (1)
- EUDAMED 2af6eb25-28fc-472c-af43-b159f8ca15ef 61 fields · synced Jul 25, 2026