Identity
- Trade Name
- CK-MB EUDAMED
- Device Name
- CK-MB EUDAMED
- Model / Reference
- 1418-0297 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05204309128006 EUDAMED
- Basic UDI-DI
- 5204309000015NP EUDAMED
- EMDN Code
- W01010114 CREATINE KINASE - MB ACTIVITY (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
Ck-Mb 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 | 5204309000015NP | Class C | Active |
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Manufacturer
- Manufacturer
- Medicon Hellas SA
- EUDAMED SRN
- GR-MF-000013625
Sources (1)
- EUDAMED 49b6bddf-d48c-443a-b94a-c02219a766d7 61 fields · synced Jun 19, 2026