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Hp NU320-02

by Nuheara Limited

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850000562004 UDI-DI Date20 Mar 2023ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Hp
Generic Name
Air-conduction hearing aid, in-the-ear
Model / Reference
NU320-02
Primary DI / UDI-DI
00850000562004
510(k) Number
FDA Product Code
QUH
GMDN Term
Air-conduction hearing aid, in-the-ear
Device Class
Class II
Regulation Number
874.3325
GUDID distribution status
In Commercial Distribution

Related devices

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

Other devices from Nuheara Limited

Properties

  • Over-the-Counter
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No