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05-0760led

by SCHÖLLY FIBEROPTIC GmbH

Ref 05-0760ledModel White Light Sources

05-0760led is a device classified as Class I in the EU and Class II in the US made by SCHÖLLY FIBEROPTIC GmbH, registered in EUDAMED on 2 Jun 2026 (Basic UDI-DI 42504801WLLIGHTSOURCESLK) and listed in FDA GUDID since 20 Mar 2019 (UDI-DI 04250480107645), 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 Number42504801WLLIGHTSOURCESLK Basic UDI-DI 04250480107645UDI-DIDate2 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250480107645 UDI-DI Date20 Mar 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 42504801WLLIGHTSOURCESLK registered 2 Jun 2026 Active
  • FDA GUDID UDI-DI 04250480107645 listed 20 Mar 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250480107645
  2. Registered EUDAMED 42504801WLLIGHTSOURCESLK

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  • Withdrawn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

Generic name
Endoscopic light source unit, line-powered
Model / reference
05-0760led, White Light Sources
Primary DI / UDI-DI
04250480107645
Basic UDI-DI
42504801WLLIGHTSOURCESLK
Direct marketing DI
04250480107645
FDA product code
NTN
EMDN code
Z12020402 Light sources for endoscopy and minimally invasive surgery
GMDN term
Endoscopic light source unit, line-powered
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

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

Related devices

Category: Endoscopic light source unit, line-powered

Similar devices in this category

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

Other devices from SCHÖLLY FIBEROPTIC GmbH

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  • 11-0441-A

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See all devices from SCHÖLLY FIBEROPTIC GmbH →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)