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AIRAscore

by AIRAmed GmbH Germany EUDAMED

EMDN Z11069082

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberZ-25-052-S-IX-E Date17 Sep 2025IssuedStatusActive expires 16 Sep 2030

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • Z-25-052-S-IX-E Issued

    Quality management system EU MDR

    Notified body
    Notified body 0633
    Issued
    17 Sep 2025
    Expires
    16 Sep 2030

Specification

EUDAMED · synced 22 Oct 2026

Primary DI / UDI-DI
04260723680071
Basic UDI-DI
426072368AIRAscore2E
Direct Marketing DI
04260723680071
EMDN Code
Z11069082 Various digital bioimaging management instruments - software accessories
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000006413

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 83738204-7908-4421-82fa-237901df866b 61 fields · synced 22 Oct 2026