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Maico ERO SCAN

by MAICO Diagnostics GmbH 2 variants

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04262406074207 UDI-DI Date29 Sep 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  • Withdrawn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
Maico
Generic Name
Otoacoustic emission system, battery-powered
Model / Reference
ERO SCAN
Primary DI / UDI-DI
04262406074207
FDA Product Code
EWO
GMDN Term
Otoacoustic emission system, battery-powered
Device Class
Class II
Regulation Number
874.1050
GUDID distribution status
In Commercial Distribution

Other devices from Maico Diagnostic GmbH

See all devices from Maico Diagnostic GmbH →

Properties

  • Serial Number
  • Manufacturing Date

Other properties (12)

  • 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
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No