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Otodynamics

by Otodynamics Ltd United Kingdom EUDAMED

Ref NOVA-CLN-DPTE +ABR

EMDN Z12140302

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05060396171628 Basic UDI-DIDate23 Mar 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
OtoNova Clinical
Model / Reference
NOVA-CLN-DPTE +ABR
Primary DI / UDI-DI
05060396171628
Basic UDI-DI
B-05060396171628
EMDN Code
Z12140302 Evoked potential audiometry equipments
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
GB-MF-000018964
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Otodynamics

See all devices from Otodynamics →

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (10)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED f6ae37e9-a730-408d-9e39-ea1a70356d41 61 fields · synced 23 Oct 2026