Skip to content

Starkey Evolv Ai 1000 Itc R

by Starkey Laboratories Inc. EUDAMEDGUDID

Active European Union

Ref 63310-SHTModel Custom

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0842318163311UP Basic UDI-DIDate25 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842318185877 UDI-DIDate30 Jun 2023ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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 on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Starkey Evolv Ai 1000 Itc R EUDAMED
Starkey GUDID
Generic Name
Tinnitus masking application software
Device Name
Evolv AI
Model / Reference
Custom EUDAMED
63310-SHT EUDAMED
STARKEY EVOLV AI 1000 ITC R GUDID
Primary DI / UDI-DI
00842318185877
Basic UDI-DI
0842318163311UP
FDA Product Code
OSM, KLW
EMDN Code
Y2145060202 Hearing aids in-the-canal (itc)
GMDN Term
Tinnitus masking application software
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
874.3305, 874.3400
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
63310-SHT
GUDID
STARKEY EVOLV AI 1000 ITC R
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