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Legion

by Alcon Laboratories, Inc.

Ref 8065753089

Legion (8065753089) is a Class I device made by Alcon Laboratories, Inc., registered in EUDAMED on 2 Sep 2026 (Basic UDI-DI 038065GMN000287HT) and listed in FDA GUDID since 22 Jul 2026 (UDI-DI 00380657530892), 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 Number038065GMN000287HT Basic UDI-DI 00380657530892UDI-DIDate2 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380657530892 UDI-DI Date22 Jul 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038065GMN000287HT registered 2 Sep 2026 Active
  • FDA GUDID UDI-DI 00380657530892 listed 22 Jul 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380657530892
  2. Registered EUDAMED 038065GMN000287HT

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  • Withdrawn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
Medical device integration rack
Model / reference
8065753089
Primary DI / UDI-DI
00380657530892
Basic UDI-DI
038065GMN000287HT
FDA product code
HMF
EMDN code
Z12129001 Ophthalmological instrument stands
GMDN term
Medical device integration rack
Device class
Class I
Regulation number
886.1860
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000016248
Authorised representative
Alcon Laboratories Belgium BE-AR-000014721

Similar devices in this category

Other devices filed under OPHTHALMOLOGICAL INSTRUMENT STANDS.

Other devices from Alcon Laboratories, Inc.

See all devices from Alcon Laboratories, Inc. →

Properties

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