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Fib

by APIRO Diagnostics Kft. Hungary EUDAMED

Ref 1061EU

EMDN W01030299

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
1061EU
Primary DI / UDI-DI
25999862992198
Basic UDI-DI
59998629921061EU_1V4
Unit of Use DI
15999862992191
EMDN Code
W01030299 Haemostasis reagents - other
Device Class
Class C
Market of Registration
Hungary

Manufacturer details

EUDAMED SRN
HU-MF-000043501

Other devices from APIRO Diagnostics Kft.

  • QC1

    Class C

  • Tpa

    Class C

  • Rvv

    Class C

  • Hi

    Class C

  • In

    Class C

  • Ex

    Class C

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 e67ac4c7-7242-4362-84c2-4b4db3ebd0ae 61 fields · synced 22 Oct 2026