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1066 OTOsuite 8-49-88000

by Natus Medical Denmark ApS

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 Number05713315000751 UDI-DI Date22 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  • Withdrawn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
1066 OTOsuite
Generic Name
Speech audiometer
Model / Ref / Catalog
8-49-88000
Primary DI / UDI-DI
05713315000751
FDA Product Code
EWO
GMDN Term
Speech audiometer
Device Class
Class II
Regulation Number
874.1050
GUDID distribution status
In Commercial Distribution

Other devices from Natus Medical Denmark ApS

See all devices from Natus Medical Denmark ApS →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

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