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Unity 4 INSITU Package

by Auditdata A/S

Unity 4 INSITU Package (21031181) is a Class II device made by Auditdata A/S, listed in FDA GUDID since 21 Aug 2024 (UDI-DI 00571178100316), not in commercial distribution (GUDID) as of 23 Oct 2026.

Listed FDA GUDID listing, not in commercial distribution

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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00571178100316 UDI-DI Date21 Aug 2024ListedStatusListed GUDID: not 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  • Withdrawn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
Generic name
Audiometric/hearing aid tester
Model / Ref / Catalog
Unity 4 INSITU Package, 21031181
Primary DI / UDI-DI
00571178100316
FDA product code
EWO
GMDN term
Audiometric/hearing aid tester
Device class
Class II
Regulation number
874.1050
GUDID distribution status
Not in Commercial Distribution

Similar devices

Other devices filed under FDA product code EWO (Audiometer).

Other devices from Auditdata A/S

See all devices from Auditdata A/S →

Properties

  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)