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iAudiogram®

by My Medical Assistant France EUDAMED

Ref iAudiogram®

EMDN Z12149092

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR 00127-A Date3 Mar 2025IssuedStatusActive expires 2 Mar 2030

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 00127-A Issued

    Quality management system EU MDR

    Notified body
    KIWA CERMET ITALIA S.P.A. 0476
    Issued
    3 Mar 2025
    Expires
    2 Mar 2030

Specification

EUDAMED · synced 22 Oct 2026

Device Name
AudioPod®
Model / Reference
iAudiogram®
Primary DI / UDI-DI
03770025150000
Basic UDI-DI
3770025150LOGAUDIOPODV7
Direct Marketing DI
03770025150000
EMDN Code
Z12149092 Various ENT instruments - medical device software
Device Class
Class IIa
Special Device Type
Software
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000019847

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 3b63154d-316e-47db-80e8-dfc7083a9903 61 fields · synced 22 Oct 2026