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GL6050

by Zumax Medical CO., LTD.

Ref 475-1810

GL6050 (475-1810) is a Class I device made by Zumax Medical Co., LTD, registered in EUDAMED on 21 Oct 2026 (Basic UDI-DI 69450955illuminatorXY) and listed in FDA GUDID since 21 May 2026 (UDI-DI 06945095543787), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69450955illuminatorXY Basic UDI-DI 06945095543787UDI-DIDate21 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06945095543787 UDI-DI Date21 May 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 69450955illuminatorXY registered 21 Oct 2026 Active
  • FDA GUDID UDI-DI 06945095543787 listed 21 May 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06945095543787
  2. Registered EUDAMED 69450955illuminatorXY

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  • Withdrawn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
GL6050 EUDAMED
zumax GUDID
Generic name
Endoscopic light source unit, battery-powered
Device name
Illuminator
Model / Ref / Catalog
475-1810, GL6050
Primary DI / UDI-DI
06945095543787
Basic UDI-DI
69450955illuminatorXY
FDA product code
HJN
EMDN code
Z12010702 Mobile scialytic lamps
GMDN term
Endoscopic light source unit, battery-powered
Device class
Class I
Regulation number
886.1945
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
Model / referenceEUDAMED
475-1810
GUDID
GL6050

Manufacturer details

EUDAMED SRN
CN-MF-000011126
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

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Properties

  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)