{
  "format": "devicerts.device.v1",
  "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).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/eidon-fa-eidon-eidon-af-eidon-uwfl-myc",
    "json_url": "https://devicerts.com/devices/eidon-fa-eidon-eidon-af-eidon-uwfl-myc.json",
    "markdown_url": "https://devicerts.com/devices/eidon-fa-eidon-eidon-af-eidon-uwfl-myc.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      }
    ],
    "registry_records_last_synced": "2026-10-22",
    "status_as_of": "2026-11-14",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "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",
    "disclaimer": "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."
  },
  "device": {
    "name": "Eidon Fa, Eidon, Eidon Af, Eidon Uwfl",
    "registry_name": "EIDON FA, EIDON, EIDON AF, EIDON UWFL",
    "url": "https://devicerts.com/devices/eidon-fa-eidon-eidon-af-eidon-uwfl-myc",
    "manufacturer": {
      "name": "Centervue S.P.A.",
      "url": "https://devicerts.com/manufacturers/centervue-s-p-a",
      "country": "Italy",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "European Union and United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K211328",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "MYC"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "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).\n\nThese 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.",
      "ai_generated": true,
      "generated_on": "2026-09-18",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K211328",
      "number_label": null,
      "device_udi_di": null,
      "date": "2021-08-19",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    },
    {
      "registry": "EUDAMED",
      "region": "European Union",
      "type": "CE/MDD",
      "number": null,
      "number_label": null,
      "device_udi_di": null,
      "date": null,
      "date_kind": null,
      "decision_code": null,
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      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    },
    {
      "registry": "EUDAMED",
      "region": "European Union",
      "type": "CE/MDR",
      "number": null,
      "number_label": null,
      "device_udi_di": null,
      "date": null,
      "date_kind": null,
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K211328",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "MYC",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class II",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 886.1570",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Ophthalmic",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA decision",
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            {
              "value": "SESE",
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                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    }
  ]
}