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SIGNIA Pure C&G MaX 2

by WS Audiology USA, 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 Number05714880298222 UDI-DI Date5 Aug 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  • Withdrawn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
Signia
Generic Name
Air-conduction hearing aid, receiver-in-canal
Model / Ref / Catalog
Pure C&G MaX 2, 21053726
Primary DI / UDI-DI
05714880298222
FDA Product Code
OSM, KLW
GMDN Term
Air-conduction hearing aid, receiver-in-canal
Device Class
Class II
Regulation Number
874.3305, 874.3400
GUDID distribution status
In Commercial Distribution

Other devices from WS Audiology USA, Inc.

See all devices from WS Audiology USA, Inc. →

Properties

  • Prescription Use
  • Premarket Exempt
  • Serial Number

Other properties (11)

  • 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
  • Expiration Date: No
  • Manufacturing Date: No