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Audika

by SBO Hearing A/S Denmark EUDAMED

Ref 283362Model HI (ITE)

EMDN Y2145060203

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number57144640-HI-00076-RW Basic UDI-DIDate10 Mar 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
HI (ITE), 283362
Primary DI / UDI-DI
05714464169368
Basic UDI-DI
57144640-HI-00076-RW
EMDN Code
Y2145060203 Hearing aids completely-in-the-canal (cic)
Device Class
Class IIa
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000001270

Other devices from Sbo Hearing A/S

See all devices from Sbo Hearing A/S →

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 4e21eeca-5a25-40e6-9b75-796c5e404097 61 fields · synced 22 Oct 2026