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Ck-Mb
EUDAMEDClass C (EU MDR)
Ref 1419-0299Ref 1578-0295Ref 1417-0290Ref 1419-0292
Identity
- Trade Name
- CK-MB EUDAMEDCK-MB CONTROL EUDAMED
- Device Name
- CK-MB EUDAMED
- Model / Reference
- 1419-0299 EUDAMED1578-0295 EUDAMED1417-0290 EUDAMED1419-0292 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05204309147496 EUDAMED05204309131990 EUDAMED05204309137046 EUDAMED05204309087266 EUDAMED
- Basic UDI-DI
- 5204309000015NP EUDAMED
- EMDN Code
- W01010114 CREATINE KINASE - MB ACTIVITY (CC) EUDAMEDW0101050201 ENZYME CONTROLS 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 (4)
- EUDAMED 60765325-24f9-440c-af44-1656604ee934 61 fields · synced Jul 30, 2026
- EUDAMED 14e94372-786d-42e4-8756-537ac9f2d71b 61 fields · synced May 17, 2026
- EUDAMED 2664a632-cd18-4a34-826a-af7fe90e1a20 61 fields · synced May 17, 2026
- EUDAMED 93640fbe-a2d5-4734-b6f1-5e63e87a802d 61 fields · synced May 18, 2026