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Novidan 99-0011-01

by Novidan, 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850049194471 UDI-DI Date25 Nov 2024ListedStatusListed 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  • Withdrawn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
Novidan
Generic Name
Air-conduction hearing aid, receiver-in-canal
Model / Reference
99-0011-01
Primary DI / UDI-DI
00850049194471
FDA Product Code
QUG
GMDN Term
Air-conduction hearing aid, receiver-in-canal
Device Class
Class II
Regulation Number
874.3305
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Category: Air-conduction hearing aid, receiver-in-canal

Other devices from Novidan, Inc.

See all devices from Novidan, Inc. →

Properties

  • Over-the-Counter
  • Premarket Exempt

Other properties (12)

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