Identity
- Trade Name
- Creatine Kinase MB EUDAMED
- Device Name
- Creatine Kinase MB EUDAMED
- Model / Reference
- HBEL05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404035101537 EUDAMED
- Basic UDI-DI
- B-05404035101537 EUDAMED
- EMDN Code
- W01010114 CREATINE KINASE - MB ACTIVITY (CC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
Creatine Kinase MB by Cypress Diagnostics — 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-05404035101537 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Cypress Diagnostics
- EUDAMED SRN
- BE-MF-000000033
Sources (1)
- EUDAMED 9614e0d1-2bcf-4815-81eb-d8f2c3bb19e3 61 fields · synced Jul 8, 2026