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Otopront Smart

by Happersberger Otopront GmbH

Ref 220000Model SMART

Otopront Smart is an ENT examination/treatment system (EU MDD Class IIa; FDA Class I; FDA product code ETF, Unit, Examining/Treatment, Ent) made by Happersberger Otopront GmbH, registered in EUDAMED on 16 Apr 2026 (Basic UDI-DI B-04260154540012) and listed in FDA GUDID since 4 Jul 2023 (UDI-DI 04260154540012), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04260154540012 Basic UDI-DI 04260154540012UDI-DIDate16 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260154540012 UDI-DI Date4 Jul 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04260154540012 registered 16 Apr 2026 Active
  • FDA GUDID UDI-DI 04260154540012 listed 4 Jul 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04260154540012
  2. Registered EUDAMED B-04260154540012

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Smart EUDAMED
Otopront GUDID
Generic name
ENT examination/treatment system
Device name
ENT Treatment Unit
Model / reference
SMART, 220000
Primary DI / UDI-DI
04260154540012
Basic UDI-DI
B-04260154540012
FDA product code
ETF
EMDN code
Z121402 ENT treatment units
GMDN term
ENT examination/treatment system
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
874.5300
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: ENT examination/treatment system

Similar devices in this category

Other devices filed under ENT INSTRUMENTS.

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Properties

  • Administering medicine
  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (19, all answered No)