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Siemens UNITY 3 INSERTS (REFURBISHED)

by WS Audiology USA, Inc.

Listed FDA GUDID listing, not in commercial distribution

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 Number05711781000053 UDI-DI Date8 May 2016ListedStatusListed GUDID: not 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  • Withdrawn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
Siemens
Generic Name
Audiometric/hearing aid tester
Model / Ref / Catalog
UNITY 3 INSERTS (REFURBISHED), 10933231
Primary DI / UDI-DI
05711781000053
FDA Product Code
EWO
GMDN Term
Audiometric/hearing aid tester
Device Class
Class II
Regulation Number
874.1050
GUDID distribution status
Not in Commercial Distribution

Other devices from WS Audiology USA, Inc.

See all devices from WS Audiology USA, Inc. →

Properties

  • Prescription Use
  • Premarket Exempt
  • Manufacturing Date

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
  • Serial Number: No
  • Expiration Date: No