{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Brightheart. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/brightheart (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/brightheart",
    "json_url": "https://devicerts.com/manufacturers/brightheart.json",
    "markdown_url": "https://devicerts.com/manufacturers/brightheart.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      },
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "FDA GUDID",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA registration and listing",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm"
      }
    ],
    "eudamed_record_synced": "2026-11-07",
    "fda_recalls_as_of": "2026-11-01",
    "registry_facts_computed": "2026-11-15",
    "status_as_of": "2026-11-15",
    "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/brightheart",
    "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": "Brightheart",
    "url": "https://devicerts.com/manufacturers/brightheart",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [],
    "country": "France",
    "country_basis": "from SRN",
    "eudamed_status": {
      "status": "active",
      "since_year": null
    },
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "EUDAMED",
      "FDA"
    ],
    "identifiers": [
      {
        "label": "EUDAMED SRN",
        "value": "FR-MF-000044855"
      },
      {
        "label": "DUNS",
        "value": "279036039"
      }
    ],
    "summary": "Brightheart is a medical device manufacturer based in France, with 10 devices listed in FDA 510(k), EUDAMED and FDA GUDID (FDA Class II; EU Class IIa) as of 15 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 10,
    "devices_note": null,
    "certificates": 1,
    "fda_recalls_matched_by_name": 0,
    "fda_recalls_ongoing": 0,
    "fda_recalls_ongoing_recent": 0,
    "fda_recalls_ongoing_before": null,
    "fda_establishments": 1,
    "sites": 0
  },
  "registry_facts": {
    "covers": "Every device of the manufacturer. A device listed in two registries counts in both.",
    "registries": [
      {
        "registry": "FDA 510(k)",
        "devices": 5
      },
      {
        "registry": "EUDAMED",
        "devices": 3
      },
      {
        "registry": "FDA GUDID",
        "devices": 3
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class II",
        "devices": 8
      },
      {
        "class": "EU Class IIa",
        "devices": 2
      }
    ],
    "top_emdn_categories": [
      {
        "code": "Z12",
        "name": "Instruments for functional explorations and therapeutic interventions",
        "url": "https://devicerts.com/categories/emdn/Z12",
        "devices": 2
      }
    ]
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": []
  },
  "devices": {
    "shown": 10,
    "total": 10,
    "all_devices_url": "https://devicerts.com/manufacturers/brightheart",
    "items": [
      {
        "name": "B-Right Screen Fetal Heart",
        "url": "https://devicerts.com/devices/b-right-screen-fetal-heart-fesmd01",
        "model_reference": "FESMD01",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "B-Right Views Fetal Heart V1.x",
        "url": "https://devicerts.com/devices/b-right-views-fetal-heart-v1-x",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "B-Right Screen Fetal Heart V1.1.x",
        "url": "https://devicerts.com/devices/b-right-screen-fetal-heart-v1-1-x",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "B-Right Views",
        "url": "https://devicerts.com/devices/b-right-views-bvcmd02",
        "model_reference": "BVCMD02",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "B-Right Screen Fetal Heart V1.0.0",
        "url": "https://devicerts.com/devices/b-right-screen-fetal-heart-v1-0-0",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Fetal EchoScan (v1.1)",
        "url": "https://devicerts.com/devices/fetal-echoscan-v1-1-pok",
        "model_reference": "K251071",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2025-05-02",
        "open_recall": false
      },
      {
        "name": "Fetal EchoScan (v1.2)",
        "url": "https://devicerts.com/devices/fetal-echoscan-v1-2-pok",
        "model_reference": "K252294",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2025-12-08",
        "open_recall": false
      },
      {
        "name": "BrightHeart View Classifier",
        "url": "https://devicerts.com/devices/brightheart-view-classifier-qih-k243684",
        "model_reference": "K243684",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2025-05-07",
        "open_recall": false
      },
      {
        "name": "Fetal EchoScan",
        "url": "https://devicerts.com/devices/fetal-echoscan-pok",
        "model_reference": "K242342",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2024-11-14",
        "open_recall": false
      },
      {
        "name": "BrightHeart View Classifier",
        "url": "https://devicerts.com/devices/brightheart-view-classifier-qih",
        "model_reference": "K251456",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2025-06-05",
        "open_recall": false
      }
    ]
  },
  "certificates": [
    {
      "number": "SCAR-21.2.1.1",
      "type": "Quality management system",
      "legislation": "MDR",
      "notified_body": "Scarlet NB B.V.",
      "issued": "2026-08-11",
      "expires": "2031-06-01",
      "status": "supplemented",
      "no_longer_listed": false
    }
  ],
  "recalls": []
}