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Hematology Control

by Zybio Inc. China EUDAMED

Ref 0403003Model H5 Check

EMDN W0103010503

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697326286000892K Basic UDI-DIDate18 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Hematology Control
Model / Reference
H5 Check, 0403003
Primary DI / UDI-DI
06941967225898
Basic UDI-DI
697326286000892K
EMDN Code
W0103010503 Multilevel blood controls
Device Class
Class B
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000003349
Authorised representative
QbD RepS BV BE-AR-000000040

Other devices from Zybio Inc.

See all devices from Zybio Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 06941967225898|697326286000892K 61 fields · synced 24 Oct 2026