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Marco

by View-M Technology

Part of a family of 16 devices: see the family page

Ref PROVUEModel VLC-1900

Marco (PROVUE) is a visual acuity light box (EU MDD Class I; FDA Class I; FDA product code HOX, Chart, Visual Acuity) made by View-M Technology, registered in EUDAMED on 8 Mar 2024 (Basic UDI-DI B-08800074500152) and listed in FDA GUDID since 16 Sep 2020 (UDI-DI 08800074500152), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800074500152 Basic UDI-DI 08800074500152UDI-DIDate8 Mar 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08800074500152 UDI-DI Date16 Sep 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08800074500152 registered 8 Mar 2024 Active
  • FDA GUDID UDI-DI 08800074500152 listed 16 Sep 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800074500152
  2. Registered EUDAMED B-08800074500152

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  • Withdrawn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
Marco EUDAMED
LCD Acuity Device GUDID
Generic name
Visual acuity light box
Device name
Visual Chart System
Model / Ref / Catalog
PROVUE, VLC-1900
Primary DI / UDI-DI
08800074500152
Basic UDI-DI
B-08800074500152, 88000745VLCYY
FDA product code
HOX
EMDN code
Z12120180 Ophtalmology assessments and diagnosis instruments - hardware accessories
GMDN term
Visual acuity light box
Device class
Class I
Regulation number
886.1150
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
Greece
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
KR-MF-000010996
Authorised representative
Obelis s.a. BE-AR-000000106

Similar devices in this category

Other devices filed under OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from View-M Technology

See all devices from View-M Technology →

Properties

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