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sueno pro R

by audifon GmbH & Co. KG Germany EUDAMEDGUDID

Ref 025381-9507-312-1720Model Noiser Product code KLWEMDN Y214599

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-025381-9507-312-1720VH Basic UDI-DIDate7 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-025381-9507-312-1720VH UDI-DIDate8 Mar 2019ListedStatusListed

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
sueno pro R EUDAMED
audifon GUDID
Generic Name
Air-conduction hearing aid, behind-the-ear
Model / Ref / Catalog
Noiser, 025381-9507-312-1720, sueno pro R
Primary DI / UDI-DI
D-025381-9507-312-1720VH EUDAMED
EADF025381950731217201 GUDID
Basic UDI-DI
B-025381-9507-312-1720VH
FDA Product Code
KLW
EMDN Code
Y214599 Hearing aids - other
GMDN Term
Air-conduction hearing aid, behind-the-ear
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
874.3400
Market of Registration
Germany
Commercial Distribution
Not in Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Noiser
025381-9507-312-1720
GUDID
sueno pro R
Primary DI / UDI-DIEUDAMED
D-025381-9507-312-1720VH
GUDID
EADF025381950731217201
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000008355

Other devices from audifon GmbH & Co. KG

  • rega XS

    Class IIa

  • Power

    Class IIa

  • rega R

    Class IIa

  • He-S

    Class IIa

  • He-P

    Class IIa

  • offen

    Class IIa

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 ee3a185d-2e55-43ef-a532-d5b56a619811 61 fields · synced 22 Oct 2026
  • FDA UDI 7fdeac92-5a6c-4973-9883-8f324ce406db 35 fields · synced 30 May 2026