Skip to content

Evertone

by Evertone Pty. Limited Australia EUDAMED

Ref auris otoscopeModel Auris

EMDN Z12021009

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0930900DIGOTO01Q7 Basic UDI-DIDate27 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Digital Otoscope
Model / Reference
Auris, auris otoscope
Primary DI / UDI-DI
09309000591015
Basic UDI-DI
0930900DIGOTO01Q7
Direct Marketing DI
09309000591015
EMDN Code
Z12021009 Direct outpatient video-otoscopes
Device Class
Class I
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
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 9fba27d0-8e14-4133-8493-115729517e45 61 fields · synced 23 Oct 2026