Skip to content

Nuance Audio

by Luxottica Group S.p.A 13 variants

Ref REB0080A0Model AAW0002EL

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

CE MDR

Valid until

Not listed

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
United StatesGUDID listing GUDID Number08056262487013 UDI-DI Date13 May 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number8056597000000Y214580TE0H2 Basic UDI-DI 08056262487013UDI-DIDate18 Dec 2024RegisteredStatusActive

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  • Withdrawn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
Hearing aid/implant system remote control
Device Name
Nuance Audio Remote Control
Model / Reference
AAW0002EL, REB0080A0
Primary DI / UDI-DI
08056262487013
Basic UDI-DI
8056597000000Y214580TE0H2
Direct Marketing DI
08056262487013
FDA Product Code
QUG
EMDN Code
Y214580 Hearing aids or hearing devices - accessories
GMDN Term
Hearing aid/implant system remote control
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
874.3305
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
IT-MF-000041132

Other devices from Luxottica Group S.P.A.

See all devices from Luxottica Group S.P.A. →

Properties

  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No