{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "E-Swin. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/e-swin (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/e-swin",
    "json_url": "https://devicerts.com/manufacturers/e-swin.json",
    "markdown_url": "https://devicerts.com/manufacturers/e-swin.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      },
      {
        "registry": "FDA GUDID",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
    ],
    "eudamed_record_synced": "2026-11-07",
    "fda_recalls_as_of": "2026-11-01",
    "registry_facts_computed": "2026-11-14",
    "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/manufacturers/e-swin",
    "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."
  },
  "manufacturer": {
    "name": "E-Swin",
    "url": "https://devicerts.com/manufacturers/e-swin",
    "registered_as": "E-SWIN SAS",
    "abbreviated_name": "E-SWIN",
    "also_registered_as": [],
    "country": "France",
    "country_basis": "from SRN",
    "eudamed_status": {
      "status": "active",
      "since_year": null
    },
    "verified": false,
    "roles": [
      "Manufacturer",
      "Part of a group"
    ],
    "registrations": [
      "EUDAMED"
    ],
    "identifiers": [
      {
        "label": "EUDAMED SRN",
        "value": "FR-MF-000011807"
      },
      {
        "label": "DUNS",
        "value": "267700713"
      }
    ],
    "summary": "E-Swin is a medical device manufacturer based in France, with 8 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU Class IIa; FDA Class I and II) as of 14 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 8,
    "devices_note": null,
    "certificates": 2,
    "fda_recalls_matched_by_name": 0,
    "fda_recalls_ongoing": 0,
    "fda_recalls_ongoing_recent": 0,
    "fda_recalls_ongoing_before": null,
    "fda_establishments": 0,
    "sites": 0
  },
  "registry_facts": {
    "covers": "Every device of the manufacturer. A device listed in two registries counts in both.",
    "registries": [
      {
        "registry": "EUDAMED",
        "devices": 5
      },
      {
        "registry": "FDA GUDID",
        "devices": 2
      },
      {
        "registry": "FDA 510(k)",
        "devices": 1
      }
    ],
    "device_classes": [
      {
        "class": "EU Class IIa",
        "devices": 5
      },
      {
        "class": "FDA Class I",
        "devices": 2
      },
      {
        "class": "FDA Class II",
        "devices": 1
      }
    ],
    "top_emdn_categories": [
      {
        "code": "Z12",
        "name": "Instruments for functional explorations and therapeutic interventions",
        "url": "https://devicerts.com/categories/emdn/Z12",
        "devices": 4
      },
      {
        "code": "X05",
        "name": "High intensity electromagnetic radiation emitting equipment without an intended medical purpose intended for use on the human body for skin resurfacing, tattoo",
        "url": "https://devicerts.com/categories/emdn/X05",
        "devices": 1
      }
    ]
  },
  "related": {
    "site_of": null,
    "part_of": {
      "name": "E-Swin SAS",
      "url": "https://devicerts.com/manufacturers/e-swin-sas"
    },
    "sites": [],
    "authorised_representatives": []
  },
  "devices": {
    "shown": 8,
    "total": 8,
    "all_devices_url": "https://devicerts.com/manufacturers/e-swin",
    "items": [
      {
        "name": "TearCheck T N040US000A08A",
        "url": "https://devicerts.com/devices/tearcheck-t-n040us000a08a",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "TearCheck T V040US000A08A",
        "url": "https://devicerts.com/devices/tearcheck-t-v040us000a08a",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "E>075",
        "url": "https://devicerts.com/devices/e-075-d006af001a12a",
        "model_reference": "D006AF001A12A",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "E>EyeC",
        "url": "https://devicerts.com/devices/e-eyec-onf",
        "model_reference": "K200616",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2020-06-11",
        "open_recall": false
      },
      {
        "name": "E>One Clinic Evolution",
        "url": "https://devicerts.com/devices/e-one-clinic-evolution-d005af001a02a",
        "model_reference": "D005AF001A02A",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "tearcheck",
        "url": "https://devicerts.com/devices/tearcheck-d036af001a08a",
        "model_reference": "D036AF001A08A",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "E-One Clinic RC",
        "url": "https://devicerts.com/devices/e-one-clinic-rc-d002af004bxxx",
        "model_reference": "D002AF004Bxxx",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "We>o",
        "url": "https://devicerts.com/devices/we-o-d029af001b13a",
        "model_reference": "D029AF001B13A",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      }
    ]
  },
  "certificates": [
    {
      "number": "28620240995",
      "type": "Quality management system",
      "legislation": "MDR",
      "notified_body": "Intertek Medical Notified Body AB",
      "issued": "2026-03-24",
      "expires": "2028-05-23",
      "status": "issued",
      "no_longer_listed": false
    },
    {
      "number": "HZ 1024982-1",
      "type": "Quality management system",
      "legislation": "MDR",
      "notified_body": "TÜV Rheinland LGA Products GmbH",
      "issued": "2025-03-02",
      "expires": "2028-05-23",
      "status": "cancelled",
      "no_longer_listed": false
    }
  ],
  "recalls": []
}