Identity
- Trade Name
- CK-MB Test Kit FIA EUDAMED
- Device Name
- CK-MB Test Kit FIA EUDAMED
- Model / Reference
- CK-MB-D06a EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CK-MB-D06aL4 EUDAMED
- Basic UDI-DI
- B-CK-MB-D06aL4 EUDAMED
- EMDN Code
- W0102160701 CREATINE KINASE - MB MASS - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
CK-MB Test Kit FIA by Hangzhou Aichek Medical Technology Co., Ltd. — 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-CK-MB-D06aL4 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED fb6202ca-b675-4727-b8e7-90ec880b3eb6 61 fields · synced Aug 3, 2026