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LuxOR 00380657525607

by Alcon Laboratories, Inc.

LuxOR 00380657525607 is an ophthalmic surgical microscope (FDA Class I; FDA product code HRM, Microscope, Operating & Accessories, Ac-Powered, Ophthalmic) made by Alcon Laboratories, Inc., registered in EUDAMED and listed in FDA GUDID since 28 Sep 2022 (UDI-DI 00380657525607), 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
United StatesGUDID listing GUDID Number00380657525607 UDI-DI Date28 Sep 2022ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Active
  • FDA GUDID UDI-DI 00380657525607 listed 28 Sep 2022 Listed

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  • Withdrawn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
LuxOR
Generic name
Ophthalmic surgical microscope
Model / reference
00380657525607
Primary DI / UDI-DI
00380657525607
FDA product code
HRM
GMDN term
Ophthalmic surgical microscope
Device class
Class I
Regulation number
878.4700
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ophthalmic surgical microscope

Similar devices in this category

Other devices filed under Ophthalmic surgical microscope.

Other devices from Alcon Laboratories, Inc.

See all devices from Alcon Laboratories, Inc. →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)