Identity
- Trade Name
- ETHANOL EUDAMEDETHANOL CONTROL EUDAMED
- Device Name
- ETHANOL EUDAMEDETHANOL CONTROL EUDAMED
- Model / Reference
- 1418-1120 EUDAMED1478-1125 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05204309061747 EUDAMED05204309085392 EUDAMED
- Basic UDI-DI
- B-05204309061747 EUDAMEDB-05204309085392 EUDAMED
- EMDN Code
- W0102090207 ETHANOL (ALCOHOL) EUDAMEDW0102152001 TDM/DRUG CONTROLS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Ethanol by Medicon Hellas SA — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-05204309061747 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Medicon Hellas SA
- EUDAMED SRN
- GR-MF-000013625
Sources (2)
- EUDAMED c8dead95-579e-41d6-8fb9-61390e64e62a 61 fields · synced Aug 1, 2026
- EUDAMED c99724c7-5fab-4251-89f2-df70a8a7009f 61 fields · synced May 19, 2026