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Creatine Kinase MB Isoenzyme Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref CK-MB6011Y, CK-MB6012Y, CK-MB6013Y, CK-MB6014Y, CK-MB6015Y, CK-MB6011N, CK-MB6012N, CK-MB6013N, CK-MB6014N, CK-MB6015N
Identity
- Trade Name
- Creatine Kinase MB Isoenzyme Reagent Kit EUDAMED
- Device Name
- Creatine Kinase MB Isoenzyme Reagent Kit EUDAMED
- Model / Reference
- CK-MB6011Y, CK-MB6012Y, CK-MB6013Y, CK-MB6014Y, CK-MB6015Y, CK-MB6011N, CK-MB6012N, CK-MB6013N, CK-MB6014N, CK-MB6015N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CK-MB60175 EUDAMED
- Basic UDI-DI
- B-CK-MB60175 EUDAMED
- EMDN Code
- W01010114 CREATINE KINASE - MB ACTIVITY (CC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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 Isoenzyme Reagent Kit by Hangzhou Aichek Medical Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-CK-MB60175 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED ef3d715e-b6d0-4a67-b849-34815240b4f6 61 fields · synced Jun 18, 2026
- EUDAMED ef3d715e-b6d0-4a67-b849-34815240b4f6-1 61 fields · synced Jun 10, 2026