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Audibel Aris AI 20 ITC R

by Starkey Laboratories Inc. EUDAMEDGUDID

Active European Union

Ref 72148-ABLModel Custom

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0842318172153UZ Basic UDI-DIDate6 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840388211120 UDI-DIDate27 Aug 2025ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • 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 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Audibel Aris AI 20 ITC R EUDAMED
Audibel GUDID
Generic Name
Tinnitus masking application software
Device Name
Omega AI
Model / Reference
Custom EUDAMED
72148-ABL EUDAMED
Audibel Aris AI 20 ITC R GUDID
Primary DI / UDI-DI
00840388211120
Basic UDI-DI
0842318172153UZ
FDA Product Code
KLW, OSM
EMDN Code
Y2145060202 Hearing aids in-the-canal (itc)
GMDN Term
Tinnitus masking application software
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
874.3400, 874.3305
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Custom
72148-ABL
GUDID
Audibel Aris AI 20 ITC R
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000014382
Authorised representative
Starkey Laboratories (Germany) GmbH DE-AR-000010831

Other devices from Starkey Laboratories Inc.

See all devices from Starkey Laboratories Inc. →

Properties

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