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AMH Control
EUDAMEDClass B (EU MDR)
Ref BYZKA0301Model Analyzer (automatic and non-automatic)
Identity
- Trade Name
- AMH Control EUDAMED
- Model / Reference
- Analyzer (automatic and non-automatic) EUDAMEDBYZKA0301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974925050089 EUDAMED
- Basic UDI-DI
- 697492505000001T4 EUDAMED
- EMDN Code
- W0102152002 HORMONE CONTROLS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
New Device
No
EUDAMED
AMH Control by Zhengzhou Bioyuan Biotech Co. Ltd. — Class B — 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 | 697492505000001T4 | Class B | 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 (1)
- EUDAMED 446783e3-5e31-4c5d-a775-f8e31fbd836a 61 fields · synced Jun 18, 2026