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Cardiac Markers Control

by Zhengzhou Bioyuan Biotech Co. Ltd. 13 variants

Ref BYZKC0402Model Analyzer (automatic and non-automatic)

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697492505000003T8 Basic UDI-DI 06974925050409UDI-DIDate13 Aug 2024RegisteredStatusActive EUDAMED: not on the EU market

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
Analyzer (automatic and non-automatic), BYZKC0402
Primary DI / UDI-DI
06974925050409
Basic UDI-DI
697492505000003T8
EMDN Code
W0102152004 Cardiac marker controls
Device Class
Class C

Manufacturer details

EUDAMED SRN
CN-MF-000021426
Authorised representative
QbD RepS BV BE-AR-000000040

Other devices from Zhengzhou Bioyuan Biotech Co. Ltd.

See all devices from Zhengzhou Bioyuan Biotech Co. Ltd. →

Properties

  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No