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GoCheck Audiometric Headphone Assembly Sennheiser HD280 Pro for i15

by Gobiquity, Inc.

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB43061000100 UDI-DI Date2 Jun 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
GoCheck Audiometric Headphone Assembly
Generic Name
Tone audiometer
Model / Reference
Sennheiser HD280 Pro for i15
Primary DI / UDI-DI
B43061000100
FDA Product Code
ETT
GMDN Term
Tone audiometer
Device Class
Class I
Regulation Number
874.1100
GUDID distribution status
In Commercial Distribution

Other devices from Gobiquity, Inc.

Properties

  • Prescription Use
  • Premarket Exempt

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No