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egger flex/AB 40 shore, red

by egger Otoplastik + Labortechnik GmbH

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 NumberEGOL207031 UDI-DIDate31 Aug 2022ListedStatusListed 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  • Withdrawn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
egger
Generic Name
Earmould, custom-made
Model / Reference
flex/AB 40 shore, red
Primary DI / UDI-DI
EGOL207031
FDA Product Code
ESD
GMDN Term
Earmould, custom-made
Device Class
Class I
Regulation Number
874.3300
GUDID distribution status
Not in Commercial Distribution

Other devices from egger Otoplastik + Labortechnik GmbH

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

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