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NuEar Noble AI+ 63441-441

by Starkey Laboratories Inc.

Ref 63441-441Model 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0840388263440XT Basic UDI-DI 00840388215364UDI-DIDate25 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840388215364 UDI-DI Date28 Aug 2026ListedStatusListed 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  • Withdrawn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
NuEar Noble AI+ 20 mRIC R EUDAMED
NuEar Noble AI+ GUDID
Generic Name
Tinnitus masking application software
Device Name
Omega AI+
Model / Reference
63441-441, Receiver-In-Canal (RIC)
Primary DI / UDI-DI
00840388215364
Basic UDI-DI
0840388263440XT
FDA Product Code
OSM, KLW
EMDN Code
Y2145060102 Behind-the-ear hearing aids with receiver in the canal (ric, rite)
GMDN Term
Tinnitus masking application software
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 · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Other devices from Starkey Laboratories Inc.

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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