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Triangle

by Inventis SRL

Triangle (11689) is a Class II device made by Inventis SRL, listed in FDA GUDID since 6 Mar 2020 (UDI-DI 08054187380778), registry data as of 21 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 21 Oct 2026.

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08054187380778 UDI-DI Date6 Mar 2020ListedStatusListed 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  • Withdrawn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

Generic name
Tone audiometer
Model / Ref / Catalog
TRIANGLE, 11689
Description
AUDIOMETER. Screening audiometer, capable of performing fast and accurate air and bone conduction threshold examination and screening test.
Primary DI / UDI-DI
08054187380778
FDA product code
EWO
GMDN term
Tone audiometer
Device class
Class II
Regulation number
874.1050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Tone audiometer

Similar devices in this category

Other devices filed under Tone audiometer.

Other devices from Inventis SRL

See all devices from Inventis SRL →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (12, all answered No)