Skip to content

05-0094l-nir

by SCHÖLLY FIBEROPTIC GmbH 2 variants

Part of a family of 19 devices: see the family page

Ref 05-0094l-nirModel Fiberoptic Light Guides

05-0094l-nir is a Class I device made by SCHÖLLY FIBEROPTIC GmbH, registered in EUDAMED on 25 Feb 2026 (Basic UDI-DI 42504801FOLIGHTGUIDESHV) and listed in FDA GUDID since 17 Jan 2025 (UDI-DI 04250480112564), 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 Number42504801FOLIGHTGUIDESHV Basic UDI-DI 04250480112564UDI-DIDate25 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250480112564 UDI-DI Date17 Jan 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 42504801FOLIGHTGUIDESHV registered 25 Feb 2026 Active
  • FDA GUDID UDI-DI 04250480112564 listed 17 Jan 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250480112564
  2. Registered EUDAMED 42504801FOLIGHTGUIDESHV

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  • Withdrawn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
Fibreoptic light cable, reusable
Model / reference
05-0094l-nir, Fiberoptic Light Guides
Primary DI / UDI-DI
04250480112564
Basic UDI-DI
42504801FOLIGHTGUIDESHV
Direct marketing DI
04250480112564
FDA product code
EQH
EMDN code
Z12020480 Instruments for the acquisition and management of endoscopic and minimally invasive surgery images - hardware accessories
GMDN term
Fibreoptic light cable, reusable
Device class
Class I
Regulation number
874.4350
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Unsafe
Size
Length — 3000 Millimeter

Related devices

Category: Fibreoptic light cable

Similar devices in this category

Other devices filed under INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES - HARDWARE ACCESSORIES.

Other devices from SCHÖLLY FIBEROPTIC GmbH

  • PE591A

    Class IIa

  • SmartVue®

    Class I

  • 41.0600d

    Class I

  • 11-0441-A

    Class IIa

See all devices from SCHÖLLY FIBEROPTIC GmbH →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)