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Aireen

by Aireen a.s. Czech Republic EUDAMED

Ref 2.2

EMDN V92

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number859421121AIREEN2HF Basic UDI-DIDate19 Aug 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2023-MDR/QS-006/C Supplemented

    Quality management system EU MDR

    Notified body
    3EC International a.s. 2265
    Issued
    8 Aug 2025
    Expires
    19 May 2028
    Reason
    Other

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
2.2
Primary DI / UDI-DI
08594211210089
Basic UDI-DI
859421121AIREEN2HF
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class IIb
Special Device Type
Software
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000027736

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 220325d2-d36d-46be-82cc-e4ce3c448c59 61 fields · synced 22 Oct 2026