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Tumor Marker Control
EUDAMEDClass C (EU MDR)
Ref BYZKH0101Model Analyzer (automatic and non-automatic)Ref BYZKH0203Ref BYZKH0103
Identity
- Trade Name
- Tumor Marker Control EUDAMED
- Model / Reference
- Analyzer (automatic and non-automatic) EUDAMEDBYZKH0101 EUDAMEDBYZKH0203 EUDAMEDBYZKH0103 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974925050768 EUDAMED06974925050829 EUDAMED06974925050782 EUDAMED
- Basic UDI-DI
- 697492505000005TC EUDAMED
- EMDN Code
- W0102152005 TUMOUR 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
Tumor Marker 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 | 697492505000005TC | 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 (3)
- EUDAMED 7f33fb99-4fb7-4816-a899-218ce109b2a4 61 fields · synced Oct 6, 2026
- EUDAMED 500d7c01-b04c-49aa-aa28-d15e02688fc2 61 fields · synced May 19, 2026
- EUDAMED 272d0b74-2bb5-48b3-a553-2b6d16b0dc9a 61 fields · synced May 19, 2026