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Cardiac Markers Control
EUDAMEDClass C (EU MDR)
Ref BYZKC0301Model Analyzer (automatic and non-automatic)Ref BYZKC0101
Identity
- Trade Name
- Cardiac Markers Control EUDAMED
- Model / Reference
- Analyzer (automatic and non-automatic) EUDAMEDBYZKC0301 EUDAMEDBYZKC0101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974925050355 EUDAMED06974925050270 EUDAMED
- Basic UDI-DI
- 697492505000003T8 EUDAMED
- EMDN Code
- W0102152004 CARDIAC MARKER CONTROLS EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
New Device
No
EUDAMED
Cardiac Markers Control by Zhengzhou Bioyuan Biotech Co. Ltd. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697492505000003T8 | Class C | Active |
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Manufacturer
- Manufacturer
- Zhengzhou Bioyuan Biotech Co. Ltd.
- EUDAMED SRN
- CN-MF-000021426
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED eb311208-2883-4439-bd8d-09a2f584400a 61 fields · synced Jul 30, 2026
- EUDAMED ccc2dbbf-d66e-4a7f-81a1-c826bb63cf9f 61 fields · synced May 19, 2026