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Starkey Evolv Ai 2000 Bte 13 Pwrpls

by Starkey Laboratories Inc.

Ref 63245, 63264-1Model Evolv AI, Behind-the-Ear (BTE)

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
United StatesGUDID listing GUDID Number00842318187390 UDI-DI Date30 Jun 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0842318163241UT Basic UDI-DI Date14 Mar 2022RegisteredStatusActive

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  • Withdrawn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 2000 Bte 13 Pwrpls EUDAMED
Starkey Evolv Ai 2000 Bte 13 EUDAMED
Starkey GUDID
Generic Name
Air-conduction hearing aid, behind-the-ear
Device Name
BTE Air Conduction Hearing Aid
Evolv AI
Model / Reference
Evolv AI EUDAMED
63245 EUDAMED
Behind-the-Ear (BTE) EUDAMED
63264-1 EUDAMED
STARKEY EVOLV AI 2000 BTE 13 GUDID
STARKEY EVOLV AI 2000 POWER PLUS BTE 13 GUDID
Primary DI / UDI-DI
00842318187390, 00842318184252
Basic UDI-DI
0842318163241UT
FDA Product Code
OSM, KLW
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
874.3305, 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
Evolv AI
63245
Behind-the-Ear (BTE)
63264-1
GUDID
STARKEY EVOLV AI 2000 BTE 13
STARKEY EVOLV AI 2000 POWER PLUS BTE 13
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

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

Related devices

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

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