{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "icometrix NV. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/icometrix-nv (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/icometrix-nv",
    "json_url": "https://devicerts.com/manufacturers/icometrix-nv.json",
    "markdown_url": "https://devicerts.com/manufacturers/icometrix-nv.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": "2026-11-15",
    "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/icometrix-nv",
    "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": "icometrix NV",
    "url": "https://devicerts.com/manufacturers/icometrix-nv",
    "registered_as": "icometrix",
    "abbreviated_name": null,
    "also_registered_as": [],
    "country": "Belgium",
    "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": "BE-MF-000006329"
      },
      {
        "label": "DUNS",
        "value": "400793486"
      }
    ],
    "summary": "icometrix NV is a medical device manufacturer based in Belgium, with 27 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II and I; EU Class IIa) as of 15 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 27,
    "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": 0,
    "sites": 0
  },
  "registry_facts": {
    "covers": "Every device of the manufacturer. A device listed in two registries counts in both.",
    "registries": [
      {
        "registry": "FDA GUDID",
        "devices": 17
      },
      {
        "registry": "EUDAMED",
        "devices": 7
      },
      {
        "registry": "FDA 510(k)",
        "devices": 3
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class II",
        "devices": 17
      },
      {
        "class": "EU Class IIa",
        "devices": 7
      },
      {
        "class": "FDA Class I",
        "devices": 3
      }
    ],
    "top_emdn_categories": [
      {
        "code": "V92",
        "name": "Medical device software - not included in other classes",
        "url": "https://devicerts.com/categories/emdn/V92",
        "devices": 7
      }
    ]
  },
  "related": {
    "site_of": null,
    "part_of": {
      "name": "icometrix",
      "url": "https://devicerts.com/manufacturers/icometrix"
    },
    "sites": [],
    "authorised_representatives": []
  },
  "devices": {
    "shown": 27,
    "total": 27,
    "all_devices_url": "https://devicerts.com/manufacturers/icometrix-nv",
    "items": [
      {
        "name": "icobrain ctp 1.7",
        "url": "https://devicerts.com/devices/icobrain-ctp-1-7",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "icobrain aria 1.2",
        "url": "https://devicerts.com/devices/icobrain-aria-1-2",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "icompanion 1",
        "url": "https://devicerts.com/devices/icompanion-1",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "icobrain ct 6.4",
        "url": "https://devicerts.com/devices/icobrain-ct-6-4",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "icobrain 6",
        "url": "https://devicerts.com/devices/icobrain-6",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "icobrain mr 5.17",
        "url": "https://devicerts.com/devices/icobrain-mr-5-17",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "icobrain 4.0",
        "url": "https://devicerts.com/devices/icobrain-4-0",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "icobrain mr 5.14",
        "url": "https://devicerts.com/devices/icobrain-mr-5-14",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "icobrain ctp 1",
        "url": "https://devicerts.com/devices/icobrain-ctp-1",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "icompanion 2.2",
        "url": "https://devicerts.com/devices/icompanion-2-2",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "icobrain mr 5.15",
        "url": "https://devicerts.com/devices/icobrain-mr-5-15",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "icobrain 3",
        "url": "https://devicerts.com/devices/icobrain-3",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "icompanion 2.1",
        "url": "https://devicerts.com/devices/icompanion-2-1",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "icobrain aria 1.1",
        "url": "https://devicerts.com/devices/icobrain-aria-1-1",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "icobrain 5",
        "url": "https://devicerts.com/devices/icobrain-5",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "icobrain 2",
        "url": "https://devicerts.com/devices/icobrain-2",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "icobrain mr 5.16",
        "url": "https://devicerts.com/devices/icobrain-mr-5-16",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "icobrain mr",
        "url": "https://devicerts.com/devices/icobrain-mr-5-16-z",
        "model_reference": "5.16.z",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "icobrain aria",
        "url": "https://devicerts.com/devices/icobrain-aria-qbs",
        "model_reference": "K240712",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2024-11-07",
        "open_recall": false
      },
      {
        "name": "Icobrain",
        "url": "https://devicerts.com/devices/icobrain-llz-k192130",
        "model_reference": "K192130",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2019-12-13",
        "open_recall": false
      },
      {
        "name": "icobrain",
        "url": "https://devicerts.com/devices/icobrain-llz",
        "model_reference": "K181939",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2018-11-06",
        "open_recall": false
      },
      {
        "name": "icobrain mr",
        "url": "https://devicerts.com/devices/icobrain-mr-5-15-z",
        "model_reference": "5.15.z",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "icobrain ct",
        "url": "https://devicerts.com/devices/icobrain-ct-6-4-z",
        "model_reference": "6.4.z",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "icompanion",
        "url": "https://devicerts.com/devices/icompanion-2-2-z",
        "model_reference": "2.2.z",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "icobrain mr",
        "url": "https://devicerts.com/devices/icobrain-mr-6-16-z",
        "model_reference": "6.16.z",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "icobrain ctp",
        "url": "https://devicerts.com/devices/icobrain-ctp-1-7-z",
        "model_reference": "1.7.z",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "icobrain mr",
        "url": "https://devicerts.com/devices/icobrain-mr-5-17-z",
        "model_reference": "5.17.z",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      }
    ]
  },
  "certificates": [
    {
      "number": "BE23/00000345",
      "type": "Quality management system",
      "legislation": "MDR",
      "notified_body": "SGS Belgium NV",
      "issued": "2023-12-11",
      "expires": "2028-12-11",
      "status": "supplemented",
      "no_longer_listed": false
    }
  ],
  "recalls": []
}