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Genesis AI 12 RIC 312

by Starkey Laboratories Inc.

Ref 63346-1Model Receiver-In-Canal (RIC)

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 Number00840388200339 UDI-DI Date26 Jun 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0842318163191V5 Basic UDI-DI 00840388200339UDI-DIDate16 Jan 2024RegisteredStatusActive

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  • Withdrawn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
Genesis AI 12 RIC 312 EUDAMED
Starkey GUDID
Generic Name
Air-conduction hearing aid, receiver-in-canal
Device Name
Genesis AI
Model / Reference
Receiver-In-Canal (RIC) EUDAMED
63346-1 EUDAMED
STARKEY GENESIS AI 12 RIC 312 GUDID
Primary DI / UDI-DI
00840388200339
Basic UDI-DI
0842318163191V5
FDA Product Code
OSM, KLW
EMDN Code
Y2145060102 Behind-the-ear hearing aids with receiver in the canal (ric, rite)
GMDN Term
Air-conduction hearing aid, receiver-in-canal
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
Receiver-In-Canal (RIC)
63346-1
GUDID
STARKEY GENESIS AI 12 RIC 312
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, receiver-in-canal

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