Identity
- Trade Name
- ETHANOL CALIBRATOR EUDAMED
- Device Name
- ETHANOL CALIBRATOR EUDAMED
- Model / Reference
- 1478-1120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05204309077885 EUDAMED
- Basic UDI-DI
- B-05204309077885 EUDAMED
- EMDN Code
- W0102152201 TDM/DRUG STANDARDS AND CALIBRATORS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
No
EUDAMED
Ethanol Calibrator 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-05204309077885 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medicon Hellas SA
- EUDAMED SRN
- GR-MF-000013625
Sources (1)
- EUDAMED 5ad8bc25-0e09-4aaa-984c-7ed1c02c1187 61 fields · synced Jul 24, 2026