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Visionix VX65

by Luneau Technology Operations

Ref VX65

Visionix VX65 is a Class I device made by Luneau Technology Operations, registered in EUDAMED on 7 May 2026 (Basic UDI-DI 13664188000077LX) and listed in FDA GUDID since 2 Jan 2025 (UDI-DI 03664188000077), 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 Number13664188000077LX Basic UDI-DI 03664188000077UDI-DIDate7 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03664188000077 UDI-DI Date2 Jan 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 13664188000077LX registered 7 May 2026 Active
  • FDA GUDID UDI-DI 03664188000077 listed 2 Jan 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03664188000077
  2. Registered EUDAMED 13664188000077LX

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  • Withdrawn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
VX65 EUDAMED
Visionix GUDID
Generic name
Phoropter, electric
Model / reference
VX65
Primary DI / UDI-DI
03664188000077
Basic UDI-DI
13664188000077LX
Direct marketing DI
03664188000077
FDA product code
HKN
EMDN code
Q0299 Ophthalmic devices - other
GMDN term
Phoropter, electric
Device class
Class I
Regulation number
886.1770
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Related devices

Category: Phoropter, electric

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

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