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Primus By Auditdata 2000 Primus HIT Unit

by Auditdata A/S

Primus By Auditdata 2000 Primus HIT Unit is a Class II device made by Auditdata A/S, listed in FDA GUDID since 22 Sep 2016 (UDI-DI 05711781000022), 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 Number05711781000022 UDI-DI Date22 Sep 2016ListedStatusListed 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  • Withdrawn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
Primus By Auditdata
Generic name
Hearing aid tester, electrical
Model / reference
2000 Primus HIT Unit
Primary DI / UDI-DI
05711781000022
FDA product code
ETW
GMDN term
Hearing aid tester, electrical
Device class
Class II
Regulation number
874.3310
GUDID distribution status
In Commercial Distribution

Related devices

Category: Hearing aid tester, electrical

Similar devices

Other devices filed under FDA product code ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems).

Other devices from Auditdata A/S

See all devices from Auditdata A/S →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)