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Visionix VX22-NP

by Luneau Technology Operations

Ref VX22-NPModel VX22

Visionix VX22-NP is a Class I device made by Luneau Technology Operations, registered in EUDAMED on 7 May 2026 (Basic UDI-DI 13664188000152LL) and listed in FDA GUDID since 8 Jun 2023 (UDI-DI 03664188000237), 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 Number13664188000152LL Basic UDI-DI 03664188000237UDI-DIDate7 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03664188000237 UDI-DI Date8 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 13664188000152LL registered 7 May 2026 Active
  • FDA GUDID UDI-DI 03664188000237 listed 8 Jun 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03664188000237
  2. Registered EUDAMED 13664188000152LL

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  • Withdrawn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
VX22-Np EUDAMED
Visionix GUDID
Generic name
Visual acuity light box
Device name
VX22
Model / reference
VX22-NP, VX22
Primary DI / UDI-DI
03664188000237
Basic UDI-DI
13664188000152LL
Direct marketing DI
03664188000237
FDA product code
HOX
EMDN code
Q0299 Ophthalmic devices - other
GMDN term
Visual acuity light box
Device class
Class I
Regulation number
886.1150
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Related devices

Category: Visual acuity light box

Similar devices in this category

Other devices filed under OPHTHALMIC DEVICES - OTHER.

Other devices from Luneau Technology Operations

See all devices from Luneau Technology Operations →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)