# Eidon Fa, Eidon, Eidon Af, Eidon Uwfl

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

- Canonical page: <https://devicerts.com/devices/eidon-fa-eidon-eidon-af-eidon-uwfl-myc>
- Manufacturer: [Centervue S.P.A.](https://devicerts.com/manufacturers/centervue-s-p-a) (Italy)
- Name in the registry: EIDON FA, EIDON, EIDON AF, EIDON UWFL
- Device class: Class II (US FDA)
- FDA product code: MYC

## Overview

*AI-generated summary, 2026-09-18. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

The Eidon FA, Eidon, Eidon AF, and Eidon UWFL are Scanning Laser Ophthalmoscopes, designed for retinal imaging and diagnostic evaluation of the eye. These devices utilize laser scanning technology to capture high-resolution images of the retina, enabling clinicians to assess retinal health, detect abnormalities, and monitor conditions such as diabetic retinopathy, glaucoma, and age-related macular degeneration (AMD).

These devices are intended for use in ophthalmic clinical settings and are supplied as reusable medical instruments. They are classified under Device Class II and comply with FDA 510(k) clearance, MDD, and MDR regulations. The Eidon series includes multiple models, each tailored for specific diagnostic applications, and must be operated by trained professionals in accordance with manufacturer instructions.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K211328 · decision 2021-08-19 · decision SESE · status: Active
- **EUDAMED** · CE/MDD · European Union · status: Active
- **EUDAMED** · CE/MDR · European Union · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K211328 [FDA 510(k)]
- FDA product code: MYC [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 886.1570 [FDA 510(k)]
- Advisory committee: Ophthalmic [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Eidon Fa, Eidon, Eidon Af, Eidon Uwfl, Centervue S.P.A. deviCERTS medical device catalogue. https://devicerts.com/devices/eidon-fa-eidon-eidon-af-eidon-uwfl-myc (data as of 2026-11-14).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/eidon-fa-eidon-eidon-af-eidon-uwfl-myc.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/eidon-fa-eidon-eidon-af-eidon-uwfl-myc
- 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.