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rega R

by audifon GmbH & Co. KG Germany EUDAMEDGUDID

Ref 023175-9047-312-1720Model Hearing aid Product code KLWEMDN Y2145060102

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-023175-9047-312-1720QB Basic UDI-DIDate23 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-023175-9047-312-1720QB UDI-DIDate2 May 2017ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDD Expiring
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
rega R EUDAMED
audifon GUDID
Generic Name
Air-conduction hearing aid, receiver-in-canal
Model / Ref / Catalog
Hearing aid, 023175-9047-312-1720, rega R
Primary DI / UDI-DI
D-023175-9047-312-1720QB EUDAMED
EADF023175904731217201 GUDID
Basic UDI-DI
B-023175-9047-312-1720QB
510(k) Number
FDA Product Code
KLW, ESD
EMDN Code
Y2145060102 Behind-the-ear hearing aids with receiver in the canal (ric, rite)
GMDN Term
Air-conduction hearing aid, receiver-in-canal
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
874.3400, 874.3300
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Hearing aid
023175-9047-312-1720
GUDID
rega R
Primary DI / UDI-DIEUDAMED
D-023175-9047-312-1720QB
GUDID
EADF023175904731217201
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000008355

Related devices

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

Other devices from audifon GmbH & Co. KG

See all devices from audifon GmbH & Co. KG →

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Serial Number
  • Manufacturing Date
Other properties (19)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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

Sources (2)

  • EUDAMED 2e0c7108-8e51-4040-b3cb-e7ffb7251869 61 fields · synced 22 Oct 2026
  • FDA UDI f05ce6a1-2ce7-4be9-8f75-0c4b17920a81 35 fields · synced 30 May 2026