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Visionix VX90

by Luneau Technology Operations

Ref VX90

Visionix VX90 is a Class I device made by Luneau Technology Operations, registered in EUDAMED on 7 May 2026 (Basic UDI-DI B-03664188000169) and listed in FDA GUDID since 2 Jan 2025 (UDI-DI 03664188000169), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

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/MDD EUDAMED NumberB-03664188000169 Basic UDI-DI 03664188000169UDI-DIDate7 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03664188000169 UDI-DI Date2 Jan 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-03664188000169 registered 7 May 2026 Active
  • FDA GUDID UDI-DI 03664188000169 listed 2 Jan 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03664188000169
  2. Registered EUDAMED B-03664188000169

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
VX90 EUDAMED
Visionix GUDID
Generic name
Automated ophthalmic refractometer
Model / reference
VX90
Primary DI / UDI-DI
03664188000169
Basic UDI-DI
B-03664188000169
FDA product code
HKO
EMDN code
Q0299 Ophthalmic devices - other
GMDN term
Automated ophthalmic refractometer
Device class
Class I
Regulation number
886.1760
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Related devices

Category: Automated ophthalmic refractometer

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
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (18, all answered No)