Skip to content

Evertone

by Evertone Pty. Limited Australia EUDAMED

Ref AUDIOMETER MODEL AUIRISModel Auris

EMDN Z121401

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number9309000591009Y Basic UDI-DIDate5 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Audiometer
Model / Reference
Auris, AUDIOMETER MODEL AUIRIS
Primary DI / UDI-DI
09309000591008
Basic UDI-DI
9309000591009Y
Direct Marketing DI
09309000591008
EMDN Code
Z121401 Audiometers
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
AU-MF-000028109
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Evertone Pty. Limited

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 ac3de6bc-cd12-4c8d-9394-3b6d06a35159 61 fields · synced 24 Oct 2026