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CK-NAC Kit
EUDAMEDClass IVD General (EU MDR)
Ref B33096Model CK-NAC Kit 200mLRef B29096Model CK-NAC Kit 70mLRef B33097Ref B35096Model CK-NAC Kit 90mLRef B30096Ref B45096Model CK-NAC KitRef B33095Model CK-NAC Kit 420mLRef B30097Ref B45095Model CK-NAC Kit Ref B27098Model CK-NAC Kit 108mLRef B34097Model CK-NAC Kit 61mLRef B35097Model CK-NAC Kit 117mL
Identity
- Trade Name
- CK-NAC Kit EUDAMED
- Device Name
- CK-NAC Kit EUDAMED
- Model / Reference
- CK-NAC Kit 200mL EUDAMEDB33096 EUDAMEDCK-NAC Kit 70mL EUDAMEDB29096 EUDAMEDB33097 EUDAMEDCK-NAC Kit 90mL EUDAMEDB35096 EUDAMEDB30096 EUDAMEDCK-NAC Kit EUDAMEDB45096 EUDAMEDCK-NAC Kit 420mL EUDAMEDB33095 EUDAMEDB30097 EUDAMEDB45095 EUDAMEDCK-NAC Kit 108mL EUDAMEDB27098 EUDAMEDCK-NAC Kit 61mL EUDAMEDB34097 EUDAMEDCK-NAC Kit 117mL EUDAMEDB35097 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683555615718 EUDAMED08683555614926 EUDAMED08683555615725 EUDAMED08683555617200 EUDAMED08683555614148 EUDAMED08683555622327 EUDAMED08683555615701 EUDAMED08683555614155 EUDAMED08683555622310 EUDAMED08683555612601 EUDAMED08683555616548 EUDAMED08683555617217 EUDAMED
- Basic UDI-DI
- B-08683555615718 EUDAMEDB-08683555614926 EUDAMEDB-08683555615725 EUDAMEDB-08683555617200 EUDAMEDB-08683555614148 EUDAMEDB-08683555622327 EUDAMEDB-08683555615701 EUDAMEDB-08683555614155 EUDAMEDB-08683555622310 EUDAMEDB-08683555612601 EUDAMEDB-08683555616548 EUDAMEDB-08683555617217 EUDAMED
- EMDN Code
- W01010113 CREATINE KINASE - TOTAL EUDAMEDW01010114 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-NAC 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-08683555615718 | 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 (12)
- EUDAMED 114993e1-3c31-436f-962e-ccf43bc86625 61 fields · synced Oct 6, 2026
- EUDAMED f4d05796-78ca-4853-aad0-c3c3f259e0bc 61 fields · synced May 16, 2026
- EUDAMED 4d7d38f4-bacc-4b55-ba79-69d703e1d60a 61 fields · synced May 17, 2026
- EUDAMED c97325bc-46f0-4e94-a695-20252f9cf17d 61 fields · synced May 17, 2026
- EUDAMED c90d3b3d-ff0c-4d56-9d42-5bd138a2b8e1 61 fields · synced May 17, 2026
- EUDAMED c7cc0c18-f5a5-4725-813b-bacafbee5b86 61 fields · synced May 18, 2026
- EUDAMED 62874b76-fb91-40da-b8c9-c997c9b8ccb5 61 fields · synced May 18, 2026
- EUDAMED ebfa57d8-3e8c-42e0-90c5-89e69d467732 61 fields · synced May 18, 2026
- EUDAMED 1050e825-9060-4f5d-80fa-758fe29b88e6 61 fields · synced May 18, 2026
- EUDAMED ce466e83-5fbe-4c95-8106-0923c4b0c2b7 61 fields · synced May 18, 2026
- EUDAMED e64a0901-1e15-497a-b7da-f966ac8076a5 61 fields · synced May 19, 2026
- EUDAMED cdb53be9-820a-40c4-a91d-119034c700f4 61 fields · synced May 19, 2026