← Back to catalogue
CK-MB Kit
EUDAMEDClass IVD General (EU MDR)
Ref B34091Model CK-MB Kit 92mLRef B24090Model CK-MB Kit 340mL Ref B29095Model CK-MB Kit 200mLRef B33091Ref B24091Model CK-MB Kit 100mLRef B30091Ref B35091Model CK-MB Kit 90mLRef B28092Model CK-MB Kit 78mLRef B30090Model CK-MB Kit 420 mL
Identity
- Trade Name
- CK-MB Kit EUDAMED
- Device Name
- CK-MB Kit EUDAMED
- Model / Reference
- CK-MB Kit 92mL EUDAMEDB34091 EUDAMEDCK-MB Kit 340mL EUDAMEDB24090 EUDAMEDCK-MB Kit 200mL EUDAMEDB29095 EUDAMEDB33091 EUDAMEDCK-MB Kit 100mL EUDAMEDB24091 EUDAMEDB30091 EUDAMEDCK-MB Kit 90mL EUDAMEDB35091 EUDAMEDCK-MB Kit 78mL EUDAMEDB28092 EUDAMEDCK-MB Kit 420 mL EUDAMEDB30090 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683555616517 EUDAMED08683555613424 EUDAMED08683555614919 EUDAMED08683555615695 EUDAMED08683555613431 EUDAMED08683555614117 EUDAMED08683555617187 EUDAMED08683555618696 EUDAMED08683555614100 EUDAMED
- Basic UDI-DI
- B-08683555616517 EUDAMEDB-08683555613424 EUDAMEDB-08683555614919 EUDAMEDB-08683555615695 EUDAMEDB-08683555613431 EUDAMEDB-08683555614117 EUDAMEDB-08683555617187 EUDAMEDB-08683555618696 EUDAMEDB-08683555614100 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
CK-MB Kit 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-08683555616517 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000040334
Sources (9)
- EUDAMED a6912605-ac36-44aa-9242-f03f02fa04d8 61 fields · synced Jul 30, 2026
- EUDAMED 8c770086-2b7e-4bef-87ef-266e125a98da 61 fields · synced May 17, 2026
- EUDAMED 2649fe0f-497e-4d3a-9d9c-270e1e165d19 61 fields · synced May 17, 2026
- EUDAMED e81cc805-3a09-4b31-92e6-672bee02a5fc 61 fields · synced May 18, 2026
- EUDAMED 8fe68e62-5ac7-4959-b5ce-913737eccf1f 61 fields · synced May 18, 2026
- EUDAMED 801a7852-1ee5-4bb4-a597-b0fc6c68af16 61 fields · synced May 18, 2026
- EUDAMED cbf83853-7adc-4787-94aa-d37894841548 61 fields · synced May 18, 2026
- EUDAMED d8ababcb-4d9e-417e-a6fc-1945989d02d5 61 fields · synced May 18, 2026
- EUDAMED 5a7080c1-a1fa-4434-8a1c-2dc9b1dbca18 61 fields · synced May 18, 2026