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Aurality

by Ahead of Health AS Norway EUDAMED

Ref HT1

EMDN Z12140392

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number709006563HT1HG Basic UDI-DIDate10 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
HT1
Primary DI / UDI-DI
07090065630000
Basic UDI-DI
709006563HT1HG
EMDN Code
Z12140392 Evoked potential audiometry instruments - medical device software
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Norway

Manufacturer details

EUDAMED SRN
NO-MF-000044410

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 fd54898d-4426-49ac-94c8-dc22720e9aad 61 fields · synced 22 Oct 2026