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Otopront Basic Plus

by Happersberger Otopront GmbH 2 variants

Otopront Basic Plus is an ENT examination/treatment system (FDA Class I; FDA product code ETF, Unit, Examining/Treatment, Ent) made by Happersberger Otopront GmbH, listed in FDA GUDID since 4 Jul 2023 (UDI-DI 04260154541026), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04260154541026 UDI-DI Date4 Jul 2023ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Otopront
Generic name
ENT examination/treatment system
Model / reference
BASIC PLUS
Primary DI / UDI-DI
04260154541026
FDA product code
ETF
GMDN term
ENT examination/treatment system
Device class
Class I
Regulation number
874.5300
GUDID distribution status
In Commercial Distribution

Related devices

Category: ENT examination/treatment system

Similar devices in this category

Other devices filed under ENT examination/treatment system.

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Properties

  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (12, all answered No)