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CK-MB Rapid Quantitative Test (Fluorescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref HR0201801
Identity
- Device Name
- CK-MB Rapid Quantitative Test (Fluorescence Immunoassay) EUDAMED
- Model / Reference
- HR0201801 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977194141700 EUDAMED
- Basic UDI-DI
- B-06977194141700 EUDAMED
- EMDN Code
- W0102160701 CREATINE KINASE - MB MASS - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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 Rapid Quantitative Test (Fluorescence Immunoassay) by Xiamen BioRay 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-06977194141700 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Xiamen BioRay Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000045502
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 6f9c3534-bee0-42ee-82f4-4185511ef4fb 61 fields · synced Jun 18, 2026