Identity
- Trade Name
- HBDH EUDAMED
- Device Name
- HBDH EUDAMED
- Model / Reference
- 1417-0812 EUDAMED1415-0812 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05204309153664 EUDAMED05204309168279 EUDAMED
- Basic UDI-DI
- 5204309000082P6 EUDAMED
- EMDN Code
- W01010118 HYDROXYBUTYRATE DEHYDROGENASE 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
Hbdh 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 | 5204309000082P6 | Class B | 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 2689352b-3a0d-451d-8ef9-5613f244acdf 61 fields · synced Jul 19, 2026
- EUDAMED 96f02766-5646-4738-a431-d6039381de75 61 fields · synced May 16, 2026