Skip to content

Veroval® CRP test

by IVT IMUNO, s.r.o. EUDAMED

Active European Union

Ref REF 924140

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number85951597CRPTESTDM Basic UDI-DIDate18 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2025-IVDR/QS-006/A Supplemented

    Quality management system EU IVDR

    Notified body
    3EC International a.s. 2265
    Issued
    14 Sep 2026
    Expires
    16 Sep 2030
    Reason
    Other
  • 2025-IVDR/TD-006/A Supplemented

    Technical documentation EU IVDR

    Notified body
    3EC International a.s. 2265
    Issued
    14 Sep 2026
    Expires
    16 Sep 2030
    Reason
    Other

Specification

EUDAMED

Model / Reference
REF 924140
Primary DI / UDI-DI
08595159701028
Basic UDI-DI
85951597CRPTESTDM
EMDN Code
W01021109 C-reactive protein
Device Class
Class C
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000024304

Properties

  • Animal Tissues
  • Self Testing

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No