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C-Reactive Protein Kit (Immunoturbidimetric Method)

by Zybio Inc. China EUDAMED

Ref 3011005 EMDN W01021109

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69732628630110*********XH Basic UDI-DIDate20 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
C-Reactive Protein Kit (Immunoturbidimetric Method)
Model / Reference
3011005
Primary DI / UDI-DI
06941967229322
Basic UDI-DI
69732628630110*********XH
EMDN Code
W01021109 C-reactive protein
Device Class
Class C
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
  • Surgical Instrument
Other properties (6)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED 06941967229322|69732628630110*********XH 61 fields · synced 24 Oct 2026