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HDL-Cholesterol
EUDAMEDClass B (EU MDR)
Ref 1419-0240Ref 1419-0242Ref 1418-0240Ref 1417-0242
Identity
- Trade Name
- HDL-Cholesterol EUDAMEDHDL CHOLESTEROL EUDAMED
- Device Name
- HDL-Cholesterol EUDAMED
- Model / Reference
- 1419-0240 EUDAMED1419-0242 EUDAMED1418-0240 EUDAMED1417-0242 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05204309122981 EUDAMED05204309093274 EUDAMED05204309171422 EUDAMED05204309175116 EUDAMED
- Basic UDI-DI
- 5204309000027NW EUDAMED
- EMDN Code
- W01010215 HIGH DENSITY LIPOPROTEIN CHOLESTEROL 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
HDL-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 | 5204309000027NW | Class B | Active |
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Manufacturer
- Manufacturer
- Medicon Hellas SA
- EUDAMED SRN
- GR-MF-000013625
Sources (4)
- EUDAMED aa6a9231-a958-4106-807c-beb9e8051b9d 61 fields · synced Jul 28, 2026
- EUDAMED 88973e49-a100-4e74-a948-3b6c2337206e 61 fields · synced May 16, 2026
- EUDAMED 2a464c59-7483-42a0-a85e-91fb717de81c 61 fields · synced May 17, 2026
- EUDAMED a96cc54e-c2de-4128-b0d6-12c0f54ea9b2 61 fields · synced Jul 11, 2026