← Back to catalogue
Creatine Kinase (CK)
EUDAMEDClass IVD General (EU MDR)
Ref 238 004Ref 238 001Ref 238 002
Identity
- Trade Name
- Creatine Kinase (CK) EUDAMED
- Device Name
- Creatine Kinase (CK) EUDAMED
- Model / Reference
- 238 004 EUDAMED238 001 EUDAMED238 002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230041017488 EUDAMED62230041017242 EUDAMED62230041017310 EUDAMED
- Basic UDI-DI
- B-62230041017488 EUDAMEDB-62230041017242 EUDAMEDB-62230041017310 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
Yes
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 (CK) by Egyptian Company For Biotechnology-Spectrum 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-62230041017488 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- EG-MF-000032599
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED 333e5cb4-c8e1-4c4f-9b32-6029f52e0b83 61 fields · synced Oct 6, 2026
- EUDAMED db436617-f321-42d5-a40f-e08a78caa3c6 61 fields · synced May 17, 2026
- EUDAMED e4eb4fad-b3f4-4f97-9c0d-dd71c36ff622 61 fields · synced May 18, 2026