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Otopront Otolux-LED

by Happersberger Otopront GmbH

Ref 780012Model OTOLUX-LED

Otopront Otolux-LED is a Class I device made by Happersberger Otopront GmbH, registered in EUDAMED on 17 Apr 2026 (Basic UDI-DI 426015454OTLUX2021211033S) and listed in FDA GUDID since 4 Jul 2023 (UDI-DI 04260154546731), active as of 23 Oct 2026.

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

CE MDR

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/MDR EUDAMED Number426015454OTLUX2021211033S Basic UDI-DI 04260154546731UDI-DIDate17 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260154546731 UDI-DI Date4 Jul 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 426015454OTLUX2021211033S registered 17 Apr 2026 Active
  • FDA GUDID UDI-DI 04260154546731 listed 4 Jul 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04260154546731
  2. Registered EUDAMED 426015454OTLUX2021211033S

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Otolux-LED EUDAMED
Otopront GUDID
Generic name
Endoscopic light source unit, battery-powered
Device name
LED Handheld Light Source
Model / reference
OTOLUX-LED, 780012
Primary DI / UDI-DI
04260154546731
Basic UDI-DI
426015454OTLUX2021211033S
FDA product code
KYT
EMDN code
Z12020402 Light sources for endoscopy and minimally invasive surgery
GMDN term
Endoscopic light source unit, battery-powered
Device class
Class I
Regulation number
880.6350
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Endoscopic light source unit, battery-powered

Similar devices in this category

Other devices filed under LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY.

Other devices from Happersberger Otopront GmbH

See all devices from Happersberger Otopront GmbH →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (22, all answered No)