Identity
- Trade Name
- LDL-Cholesterol EUDAMED
- Device Name
- LDL-Cholesterol EUDAMED
- Model / Reference
- 1418-0227 EUDAMED1417-0227 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05204309087006 EUDAMED05204309136957 EUDAMED
- Basic UDI-DI
- 5204309000035NV EUDAMED
- EMDN Code
- W01010221 LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL EUDAMED
Classification
- Device Class
- Class B 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
LDL-Cholesterol by Medicon Hellas SA — Class B — 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 | 5204309000035NV | Class B | Active |
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Manufacturer
- Manufacturer
- Medicon Hellas SA
- EUDAMED SRN
- GR-MF-000013625
Sources (2)
- EUDAMED 1709bad5-ba7f-4130-8329-0c125bd8a90e 61 fields · synced Jul 12, 2026
- EUDAMED c456c440-62da-46be-8e5b-12dbac5a0e31 61 fields · synced Jul 12, 2026