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sino S

by audifon GmbH & Co. KG 4 variants

Ref 023164-9036-312-1720Model Hearing aid

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

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-023164-9036-312-1720KB Basic UDI-DI D-023164-9036-312-1720KBUDI-DIDate6 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-023164-9036-312-1720KB UDI-DI Date2 May 2017ListedStatusListed GUDID: 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
sino S EUDAMED
audifon GUDID
Generic Name
Air-conduction hearing aid, behind-the-ear
Model / Ref / Catalog
Hearing aid, 023164-9036-312-1720, sino S
Primary DI / UDI-DI
D-023164-9036-312-1720KB EUDAMED
EADF023164903631217201 GUDID
Basic UDI-DI
B-023164-9036-312-1720KB
510(k) Number
FDA Product Code
KLW, ESD
EMDN Code
Y2145060101 Behind-the-ear hearing aids with receiver in the device (bte)
GMDN Term
Air-conduction hearing aid, behind-the-ear
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
874.3400, 874.3300
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Hearing aid
023164-9036-312-1720
GUDID
sino S
Primary DI / UDI-DIEUDAMED
D-023164-9036-312-1720KB
GUDID
EADF023164903631217201
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000008355

Related devices

Category: Air-conduction hearing aid, behind-the-ear

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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