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Starkey Evolv Ai 1600 Iic Nw

by Starkey Laboratories Inc.

Ref 63329-SHTModel 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0842318163311UP Basic UDI-DI 00842318187161UDI-DIDate25 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842318187161 UDI-DI Date30 Jun 2023ListedStatusListed 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  • Withdrawn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
Starkey Evolv Ai 1600 Iic Nw EUDAMED
Starkey GUDID
Generic Name
Tinnitus masking application software
Device Name
Evolv AI
Model / Reference
Custom EUDAMED
63329-SHT EUDAMED
STARKEY EVOLV AI 1600 IIC NW GUDID
Primary DI / UDI-DI
00842318187161
Basic UDI-DI
0842318163311UP
FDA Product Code
ESD, KLW
EMDN Code
Y2145060204 Hearing aids invisible-in-the-canal (iic)
GMDN Term
Tinnitus masking application software
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
874.3300, 874.3400
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
Custom
63329-SHT
GUDID
STARKEY EVOLV AI 1600 IIC NW
Device ClassEUDAMED
Class IIa
GUDID
Class I

Related devices

Category: Air-conduction hearing aid, canalTinnitus masking application software

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