# Marco

> Active: European Union. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/marco-provue>
- Manufacturer: [View-M Technology](https://devicerts.com/manufacturers/view-m-technology) (South Korea)
- Name in the registry: MARCO
- Device class: Class I (EU MDD / US FDA)
- FDA product code: HOX
- EMDN: Z12120180 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - HARDWARE ACCESSORIES
- GMDN: Visual acuity light box (36380)

## Registrations and authorizations

- **EUDAMED** · CE/MDD · European Union · Basic UDI-DI B-08800074500152 · UDI-DI 08800074500152 · registered 2024-03-08 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 08800074500152 · listed 2020-09-16 · status: Listed (GUDID: in commercial distribution)

## Recalls

No recall on record.

## Identity

- Trade name: MARCO [EUDAMED]; LCD ACUITY DEVICE [FDA GUDID (AccessGUDID)]
- Generic name: Visual acuity light box [FDA GUDID (AccessGUDID)]
- Device name: Visual Chart System [EUDAMED]
- Model / Ref / Catalog: PROVUE [EUDAMED, FDA GUDID (AccessGUDID)]; VLC-1900 [EUDAMED]

## Identifiers

- Primary DI / UDI-DI: 08800074500152 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: B-08800074500152 [EUDAMED]; 88000745VLCYY [EUDAMED]
- FDA product code: HOX [FDA GUDID (AccessGUDID)]
- EMDN code: Z12120180 [EUDAMED]
- GMDN term: Visual acuity light box (36380) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class I [EUDAMED, FDA GUDID (AccessGUDID)]
- Regulation number: 886.1150 [FDA GUDID (AccessGUDID)]
- EU registration type: Legacy device (under a directive) [EUDAMED]; Standard device [EUDAMED]
- EU market of registration: Greece [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Premarket exempt: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Prescription use: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Marco, View-M Technology. deviCERTS medical device catalogue. https://devicerts.com/devices/marco-provue (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/)
- Registry records last synced: 2026-10-25
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/marco-provue.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/marco-provue
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.