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Cholesterol
EUDAMEDClass B (EU MDR)
Ref 1418-0042Ref 1418-0047Ref 1415-0047Ref 1417-0047
Identity
- Trade Name
- CHOLESTEROL EUDAMED
- Device Name
- CHOLESTEROL EUDAMED
- Model / Reference
- 1418-0042 EUDAMED1418-0047 EUDAMED1415-0047 EUDAMED1417-0047 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05204309175031 EUDAMED05204309039807 EUDAMED05204309167807 EUDAMED05204309136667 EUDAMED
- Basic UDI-DI
- 5204309000013NK EUDAMED
- Direct Marketing DI
- 05204309039807 EUDAMED05204309167807 EUDAMED05204309136667 EUDAMED
- EMDN Code
- W01010205 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
Category: Total cholesterol lipid IVD, reagent
Cholesterol by Medicon Hellas SA — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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- DIRUI — DIRUI INDUSTRIAL CO., LTD · IVD General
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- Liquick Cor-CHOL 30 — PZ CORMAY Spółka Akcyjna · IVD General
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 | 5204309000013NK | Class B | Active |
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Manufacturer
- Manufacturer
- Medicon Hellas SA
- EUDAMED SRN
- GR-MF-000013625
Sources (4)
- EUDAMED baf21309-fe3b-4d42-99d2-1b52dbbc45c5 61 fields · synced Jul 31, 2026
- EUDAMED 72f85398-fd34-4fb7-a462-97abbed747a7 61 fields · synced May 18, 2026
- EUDAMED 50aea1d8-542f-42fb-886f-93ffae80298b 61 fields · synced May 18, 2026
- EUDAMED de7bc5e7-8298-47ea-89ef-8206dcc93046 61 fields · synced May 18, 2026