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ILU4CIC-Hp

by GN Hearing A/S EUDAMEDGUDID

Active European Union

Ref ILU4CIC-HPModel ITC

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number57082960000613F Basic UDI-DIDate14 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05708296383061 UDI-DIDate10 Feb 2026ListedStatusListed 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  • Withdrawn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 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Beltone
Generic Name
Air-conduction hearing aid, canal
Model / Reference
ITC, ILU4CIC-HP
Primary DI / UDI-DI
05708296383061
Basic UDI-DI
57082960000613F
FDA Product Code
ESD
EMDN Code
Y2145060203 Hearing aids completely-in-the-canal (cic)
GMDN Term
Air-conduction hearing aid, canal
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
874.3300
Market of Registration
Germany
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 I

Manufacturer details

EUDAMED SRN
DK-MF-000009536

Other devices from Gn Hearing A/S

See all devices from Gn Hearing A/S →

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