Identity
- Trade Name
- G-6-PDH EUDAMEDG-6-PDH CALIBRATOR EUDAMED
- Device Name
- G-6-PDH EUDAMED
- Model / Reference
- 1415-0910 EUDAMED1578-0912 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05204309167500 EUDAMED05204309174300 EUDAMED
- Basic UDI-DI
- 5204309000023NN EUDAMED
- EMDN Code
- W0103019001 CELLULAR ENZYME DETERMINATION REAGENTS (G-6-PDH, PYRUVATE KINASE) EUDAMEDW0101050302 CALIBRATORS SINGLE COMPONENT (CC) EUDAMED
Classification
- Device Class
- Class C 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
G-6-Pdh by Medicon Hellas SA — Class C — 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 | 5204309000023NN | Class C | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medicon Hellas SA
- EUDAMED SRN
- GR-MF-000013625
Sources (2)
- EUDAMED d04f186d-56c4-4280-bb3b-809e12c09c8e 61 fields · synced Aug 3, 2026
- EUDAMED 498aaec1-2690-4793-b109-359df32400f1 61 fields · synced May 17, 2026