← Back to catalogue
Creatine Kinase
EUDAMEDClass IVD General (EU MDR)
Ref CK 321Model Diaglobal Photometer
Identity
- Trade Name
- Creatine Kinase EUDAMED
- Device Name
- DP 350 / DP 550 EUDAMED
- Model / Reference
- Diaglobal Photometer EUDAMEDCK 321 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-4260152490074SM EUDAMED
- Basic UDI-DI
- B-4260152490074SM EUDAMED
- EMDN Code
- W01010113 CREATINE KINASE - TOTAL EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Creatine Kinase by Diaglobal GmbH — 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-4260152490074SM | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Diaglobal GmbH
- EUDAMED SRN
- DE-MF-000032608
Sources (1)
- EUDAMED e25b0d5a-cb38-40c2-819c-d2fe36374505 61 fields · synced Jun 18, 2026