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Livio Ai Itc R

by Starkey Laboratories Inc. EUDAMEDGUDID

Active European Union

Ref 63235Model Custom

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0842318163231UQ Basic UDI-DIDate26 Jun 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00842318181237 UDI-DIDate11 Mar 2020ListedStatusListed 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  • Withdrawn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 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Livio Ai Itc R EUDAMED
Starkey GUDID
Generic Name
Air-conduction hearing aid, canal
Device Name
Livio
Model / Ref / Catalog
Custom EUDAMED
63235 EUDAMED
STARKEY LIVIO AI 1000 ITC R GUDID
63235-SHT GUDID
Primary DI / UDI-DI
00842318181237
Basic UDI-DI
0842318163231UQ
Direct Marketing DI
00842318181237
FDA Product Code
KLW, OSM
EMDN Code
Y2145060202 Hearing aids in-the-canal (itc)
GMDN Term
Air-conduction hearing aid, canal
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
63235
GUDID
STARKEY LIVIO AI 1000 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