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Unity 4 / Measure DD45 Headphone w. HBA (2000-1)

by Auditdata A/S

Unity 4 / Measure DD45 Headphone w. HBA (2000-1) (100.053) is a Class II device made by Auditdata A/S, listed in FDA GUDID since 21 Aug 2024 (UDI-DI 05711781002835), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05711781002835 UDI-DI Date21 Aug 2024ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Unity 4 / Measure
Generic name
Audiometric/hearing aid tester
Model / Ref / Catalog
DD45 Headphone w. HBA (2000-1), 100.053
Primary DI / UDI-DI
05711781002835
FDA product code
EWO
GMDN term
Audiometric/hearing aid tester
Device class
Class II
Regulation number
874.1050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Audiometric/hearing aid tester

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Properties

  • Premarket exempt
  • Serial number
Other properties (13, all answered No)