# Visiolite® Access

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

- Canonical page: <https://devicerts.com/devices/visiolite-r-access-ff1167>
- Manufacturer: [FIM Medical](https://devicerts.com/manufacturers/fim-medical) (France)
- Device class: Class I (EU MDR)
- EMDN: Z1212012001 VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 376025345FF1167U2 · UDI-DI 03760253450669 · registered 2026-09-25 · status: Active

## Recalls

No recall on record.

## Identity

- Model / reference: Visiolite Access [EUDAMED]; FF1167 [EUDAMED]

## Identifiers

- Primary DI / UDI-DI: 03760253450669 [EUDAMED]
- Basic UDI-DI: 376025345FF1167U2 [EUDAMED]
- Direct marketing DI: 03760253450669 [EUDAMED]
- EMDN code: Z1212012001 [EUDAMED]

## Classification

- Device class: Class I [EUDAMED]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: France [EUDAMED]

## Properties

- Supplied sterile: No [EUDAMED]
- Sterilise before use: No [EUDAMED]
- Implantable: No [EUDAMED]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED]
- 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]

## Source and citation

- Cite as: Visiolite® Access, FIM Medical. deviCERTS medical device catalogue. https://devicerts.com/devices/visiolite-r-access-ff1167 (data as of 2026-11-14).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-24
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/visiolite-r-access-ff1167.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/visiolite-r-access-ff1167
- 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.