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Interacoustics Affinity Compact

by Interacoustics A/S

Interacoustics Affinity Compact is a Class II device made by Interacoustics A/S, listed in FDA GUDID since 26 Nov 2019 (UDI-DI 05711117198218), 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 Number05711117198218 UDI-DI Date26 Nov 2019ListedStatusListed 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  • Withdrawn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
Interacoustics
Generic name
Audiometric/hearing aid tester
Model / reference
Affinity Compact
Primary DI / UDI-DI
05711117198218
FDA product code
ETW, EWO
GMDN term
Audiometric/hearing aid tester
Device class
Class II
Regulation number
874.3310, 874.1050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Audiometric/hearing aid tester

Similar devices in this category

Other devices filed under Audiometric/hearing aid tester.

Other devices from Interacoustics A/S

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Properties

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