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Visionix VX118

by Luneau Technology Operations

Ref VX118

Visionix VX118 is a device classified as Class IIa in the EU and Class II in the US made by Luneau Technology Operations, registered in EUDAMED on 7 May 2026 (Basic UDI-DI 13664188001180LY) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 03664188001180), 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 Number13664188001180LY Basic UDI-DI 03664188001180UDI-DIDate7 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03664188001180 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 13664188001180LY registered 7 May 2026 Active
  • FDA GUDID UDI-DI 03664188001180 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03664188001180
  2. Registered EUDAMED 13664188001180LY

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  • Withdrawn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
VX118 EUDAMED
Visionix GUDID
Generic name
Optical pachymeter
Model / reference
VX118
Primary DI / UDI-DI
03664188001180
Basic UDI-DI
13664188001180LY
FDA product code
HKX, HKO
EMDN code
Q0299 Ophthalmic devices - other
GMDN term
Optical pachymeter
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
886.1930, 886.1760
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Automated ophthalmic refractometerOptical pachymeter

Similar devices

Also classified as Optical pachymeter.

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

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