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Agxo

by SBO Hearing A/S 476 variants

Ref 238170Model HI (BTE)

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number57144640-HI-000014-WQ Basic UDI-DI 05714464115471UDI-DIDate29 Oct 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number05714464115471 UDI-DI Date11 Aug 2022ListedStatusListed GUDID: in commercial distribution

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.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Air-conduction hearing aid, receiver-in-the-ear
Model / reference
HI (BTE), 238170
Primary DI / UDI-DI
05714464115471
Basic UDI-DI
57144640-HI-000014-WQ
FDA product code
OSM
EMDN code
Y2145060102 Behind-the-ear hearing aids with receiver in the canal (ric, rite)
GMDN term
Air-conduction hearing aid, receiver-in-the-ear
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
874.3305
EU registration type
Standard device
EU 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

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Category: Air-conduction hearing aid, receiver-in-canal

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Properties

  • Prescription use
  • Premarket exempt
  • Serial number

Other properties (22)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Lot / batch number: No
  • Expiration date: No
  • Manufacturing date: No