← Back to catalogue

AMH Control

EUDAMED

Class B (EU MDR)

Ref BYZKA0201Model Analyzer (automatic and non-automatic)Ref BYZKA0101Ref BYZKA0302Ref BYZKA0102Ref BYZKA0202

by Zhengzhou Bioyuan Biotech Co. Ltd.

Identity

Trade Name
AMH Control EUDAMED
Model / Reference
Analyzer (automatic and non-automatic) EUDAMED
BYZKA0201 EUDAMED
BYZKA0101 EUDAMED
BYZKA0302 EUDAMED
BYZKA0102 EUDAMED
BYZKA0202 EUDAMED

Identifiers

Primary DI / UDI-DI
06974925050041 EUDAMED
06974925050003 EUDAMED
06974925050096 EUDAMED
06974925050010 EUDAMED
06974925050058 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Zhengzhou Bioyuan Biotech Co. Ltd.
EUDAMED SRN
CN-MF-000021426
Authorised Representative
QbD RepS BV BE-AR-000000040

Sources (5)

  • EUDAMED c7977633-0300-487b-b119-e560769d83d6 61 fields · synced Jul 23, 2026
  • EUDAMED 21ea3195-f5c4-4bdc-8fc4-13cdf20082c6 61 fields · synced May 18, 2026
  • EUDAMED 627f9746-418f-48d6-8bfd-c46f0d54dd66 61 fields · synced May 18, 2026
  • EUDAMED c5852d64-3ec0-49d9-a46c-440a19207676 61 fields · synced May 18, 2026
  • EUDAMED 57f4f23a-a409-4d27-8912-b0374c02cb14 61 fields · synced May 18, 2026