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Visionix Nexy

by Luneau Technology Operations

Ref NEXY

Visionix Nexy 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 13664188000381M5) and listed in FDA GUDID since 8 Jun 2023 (UDI-DI 03664188000381), 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 Number13664188000381M5 Basic UDI-DI 03664188000381UDI-DIDate7 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03664188000381 UDI-DI Date8 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 13664188000381M5 registered 7 May 2026 Active
  • FDA GUDID UDI-DI 03664188000381 listed 8 Jun 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03664188000381
  2. Registered EUDAMED 13664188000381M5

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  • Withdrawn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
Nexy EUDAMED
Visionix GUDID
Generic name
Ophthalmic fundus camera
Model / reference
Nexy
Primary DI / UDI-DI
03664188000381
Basic UDI-DI
13664188000381M5
FDA product code
HKI
EMDN code
Q0299 Ophthalmic devices - other
GMDN term
Ophthalmic fundus camera
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
886.1120
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: Ophthalmic fundus camera

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