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sueno pro R

by audifon GmbH & Co. KG 9 variants

Ref 025381-9507-3120-1720Model Noiser

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-025381-9507-3120-1720XP Basic UDI-DI D-025381-9507-3120-1720XPUDI-DIDate8 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-025381-9507-3120-1720XP UDI-DI Date8 Mar 2019ListedStatusListed GUDID: not in commercial distribution

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.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
sueno pro R EUDAMED
audifon GUDID
Generic Name
Air-conduction hearing aid, behind-the-ear
Model / Ref / Catalog
Noiser, 025381-9507-3120-1720, sueno pro R
Primary DI / UDI-DI
D-025381-9507-3120-1720XP EUDAMED
EADF0253819507312017201 GUDID
Basic UDI-DI
B-025381-9507-3120-1720XP
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
EU market of registration
Germany
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Noiser
025381-9507-3120-1720
GUDID
sueno pro R
Primary DI / UDI-DIEUDAMED
D-025381-9507-3120-1720XP
GUDID
EADF0253819507312017201
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000008355

Other devices from audifon GmbH & Co. KG

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    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

  • 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