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Visionix Prism Bar vertical

by Luneau Technology Operations

Part of a family of 7 devices: see the family page

Ref 8630-1612-53

Visionix Prism Bar vertical is a Class I device made by Luneau Technology Operations, registered in EUDAMED on 7 May 2026 (Basic UDI-DI 13664188000398MN) and listed in FDA GUDID since 8 Jun 2023 (UDI-DI 03664188000466), 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 Number13664188000398MN Basic UDI-DI 03664188000466UDI-DIDate7 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03664188000466 UDI-DI Date8 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 13664188000398MN registered 7 May 2026 Active
  • FDA GUDID UDI-DI 03664188000466 listed 8 Jun 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03664188000466
  2. Registered EUDAMED 13664188000398MN

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  • Withdrawn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
Vertical prism bar (30 dpt) EUDAMED
Visionix GUDID
Generic name
Diagnostic ophthalmic prism
Device name
Prisms for Optometry
Model / reference
8630-1612-53 EUDAMED
Prism Bar vertical GUDID
Primary DI / UDI-DI
03664188000466
Basic UDI-DI
13664188000398MN
FDA product code
HKW
EMDN code
Q0299 Ophthalmic devices - other
GMDN term
Diagnostic ophthalmic prism
Device class
Class I
Regulation number
886.1650
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
Model / referenceEUDAMED
8630-1612-53
GUDID
Prism Bar vertical

Related devices

Category: Diagnostic ophthalmic prism

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)