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CK-MB Rapid Test Kit (Fluorescence Immunochromatographic Assay)
EUDAMEDClass IVD General (EU MDR)
Ref 5164C4X025
Identity
- Trade Name
- CK-MB Rapid Test Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Device Name
- CK-MB Rapid Test Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Model / Reference
- 5164C4X025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974464591500 EUDAMED
- Basic UDI-DI
- B-06974464591500 EUDAMED
- EMDN Code
- W0102160701 CREATINE KINASE - MB MASS - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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 Rapid Test Kit (Fluorescence Immunochromatographic Assay) by Guangzhou Decheng Biotechnology 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-06974464591500 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Guangzhou Decheng Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000013536
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 851a526d-99c8-4ea2-bdfd-7c4963bb8074 61 fields · synced Aug 3, 2026