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SoundLens Synergy i IIC

by Starkey Laboratories Inc.

Ref 1SYVK1IModel SoundLens Custom

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

CE MDR

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number084231811SYVN1NET Basic UDI-DI 00842318114914UDI-DIDate26 Jun 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00842318114914 UDI-DI Date23 Sep 2016ListedStatusListed 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.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
SoundLens Synergy i IIC EUDAMED
Starkey GUDID
Generic Name
Tinnitus masking application software
Air-conduction hearing aid, canal
Device Name
SoundLens Custom
Model / Ref / Catalog
SoundLens Custom, 1SYVK1I, SOUNDLENS SYNERGY I2400 IIC, VK1I
Primary DI / UDI-DI
00842318114914, 00842318100108
Basic UDI-DI
084231811SYVN1NET
Direct Marketing DI
00842318114914
FDA Product Code
KLW, OSM
EMDN Code
Y2145060204 Hearing aids invisible-in-the-canal (iic)
GMDN Term
Tinnitus masking application software
Air-conduction hearing aid, canal
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
874.3400, 874.3305
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
SoundLens Custom
1SYVK1I
GUDID
SOUNDLENS SYNERGY I2400 IIC
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000014382
Authorised representative
Starkey Laboratories (Germany) GmbH DE-AR-000010831

Other devices from Starkey Laboratories Inc.

See all devices from Starkey Laboratories Inc. →

Properties

  • Prescription Use
  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No