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QC2

by APIRO Diagnostics Kft. Hungary EUDAMED

Ref 2021EU

EMDN W0103020702

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number2025-IVDR/QS-007/A Date13 Jan 2026IssuedStatusActive expires 7 Oct 2030

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2025-IVDR/QS-007/A Supplemented

    Quality management system EU IVDR

    Notified body
    3EC International a.s. 2265
    Issued
    13 Jan 2026
    Expires
    7 Oct 2030
    Reason
    Add device or group

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
2021EU
Primary DI / UDI-DI
25999862992235
Basic UDI-DI
59998629922021EU_1U3
Unit of Use DI
15999862992238
EMDN Code
W0103020702 Control plasma for haemostasis
Device Class
Class C
Market of Registration
Hungary

Manufacturer details

EUDAMED SRN
HU-MF-000043501

Other devices from APIRO Diagnostics Kft.

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See all devices from APIRO Diagnostics Kft. →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED b7e4c808-bf22-448f-a8e5-3a3327dbcbf2 61 fields · synced 22 Oct 2026