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Sonic

by SBO Hearing A/S EUDAMEDGUDID 335 variants

Withdrawn No longer placed on the EU market

Ref 274914Model OneApp

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number57144640-ONEAPP-00090-K8 Basic UDI-DIDate7 May 2025RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID Number05714464146055 UDI-DIDate20 Jan 2025ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Withdrawn
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Generic Name
Hearing aid/implant system remote control
Model / Reference
OneApp, 274914
Primary DI / UDI-DI
05714464146055
Basic UDI-DI
57144640-ONEAPP-00090-K8
FDA Product Code
OSM, KLW
EMDN Code
Y214599 Hearing aids - other
GMDN Term
Hearing aid/implant system remote control
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
874.3305, 874.3400
Special Device Type
Software
Market of Registration
Denmark
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
DK-MF-000001270

Other devices from Sbo Hearing A/S

See all devices from Sbo Hearing A/S →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (21)

  • Sterile: No
  • Single Use: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No