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Creatine Kinase-MB (CK-MB)
EUDAMEDClass IVD General (EU MDR)
Ref B21091Model Creatine Kinase-MB 213 mLRef B22090Model Creatine Kinase-MB (CK-MB) 180 mL
Identity
- Trade Name
- Creatine Kinase-MB (CK-MB) EUDAMED
- Device Name
- Creatine Kinase-MB EUDAMEDCreatine Kinase-MB (CK-MB) EUDAMED
- Model / Reference
- Creatine Kinase-MB 213 mL EUDAMEDB21091 EUDAMEDCreatine Kinase-MB (CK-MB) 180 mL EUDAMEDB22090 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683555610287 EUDAMED08683555611970 EUDAMED
- Basic UDI-DI
- B-08683555610287 EUDAMEDB-08683555611970 EUDAMED
- EMDN Code
- W01010114 CREATINE KINASE - MB ACTIVITY (CC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Türkiye 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
Creatine Kinase-MB (CK-MB) by Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇ — 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-08683555610287 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000040334
Sources (2)
- EUDAMED 65afbaaa-f86b-4929-9972-a43e8b7c7d5c 61 fields · synced Jul 22, 2026
- EUDAMED 3c300ded-a14e-4702-bd52-6e1f6de14049 61 fields · synced May 17, 2026