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Light sources with LED

by Richard Wolf GmbH 5 variants

Ref 5166001Model 10000201092

Light sources with LED (5166001) is a device classified as Class I in the EU and Class II in the US made by Richard Wolf GmbH, registered in EUDAMED on 4 Dec 2025 (Basic UDI-DI 405520727052019-0017664PT) and listed in FDA GUDID since 21 Jul 2017 (UDI-DI 04055207055229), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number405520727052019-0017664PT Basic UDI-DI 04055207055229UDI-DIDate4 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04055207055229 UDI-DI Date21 Jul 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 405520727052019-0017664PT registered 4 Dec 2025 Active
  • FDA GUDID UDI-DI 04055207055229 listed 21 Jul 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04055207055229
  2. Registered EUDAMED 405520727052019-0017664PT

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  • Withdrawn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
Endolight
Generic name
Endoscopic light source unit, line-powered
Device name
Light sources with LED
Model / Ref / Catalog
10000201092, 5166001
Description
LIGHT SOURCE FLEX LED 42W LED, low operating noise level, LED, buttons, WOLF light cable connection, 6500K, U: 100-240VAC, 50/60Hz, Dim (wxhxd) 150x55x220mm
Primary DI / UDI-DI
04055207055229
Basic UDI-DI
405520727052019-0017664PT
Direct marketing DI
04055207055229
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

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.

Manufacturer details

EUDAMED SRN
DE-MF-000007048

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 Richard Wolf GmbH

See all devices from Richard Wolf GmbH →

Properties

  • Serial number
  • Manufacturing date
Other properties (23, all answered No)