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Rx 34 Sterling 80 (Destro 124/65 Bluetooth)

by PERSONUS Srl Italy EUDAMED

Ref 3480124DBTModel Hearing Aid EMDN Y2145060202

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number80522754580PS Basic UDI-DIDate8 Mar 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Sterling 80
Model / Reference
Hearing Aid, 3480124DBT
Primary DI / UDI-DI
08052275450099
Basic UDI-DI
80522754580PS
EMDN Code
Y2145060202 Hearing aids in-the-canal (itc)
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000032051

Other devices from PERSONUS Srl

See all devices from PERSONUS Srl →

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 a270855f-2e53-4c62-8ef5-f1bf07871f1d 61 fields · synced 22 Oct 2026