{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Farapulse Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/farapulse-inc (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/farapulse-inc",
    "json_url": "https://devicerts.com/manufacturers/farapulse-inc.json",
    "markdown_url": "https://devicerts.com/manufacturers/farapulse-inc.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      },
      {
        "registry": "FDA PMA",
        "url": "https://open.fda.gov/apis/device/pma/"
      }
    ],
    "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/farapulse-inc",
    "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": "Farapulse Inc",
    "url": "https://devicerts.com/manufacturers/farapulse-inc",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [],
    "country": "United States",
    "country_basis": "from SRN",
    "eudamed_status": {
      "status": "active",
      "since_year": null
    },
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "EUDAMED"
    ],
    "identifiers": [
      {
        "label": "EUDAMED SRN",
        "value": "US-MF-000017969"
      }
    ],
    "summary": "Farapulse Inc is a medical device manufacturer based in the United States, with 14 devices listed in EUDAMED and FDA PMA (EU Class IIb and III; FDA Class III) as of 14 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 14,
    "devices_note": null,
    "certificates": 0,
    "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": 13
      },
      {
        "registry": "FDA PMA",
        "devices": 1
      }
    ],
    "device_classes": [
      {
        "class": "EU Class IIb",
        "devices": 10
      },
      {
        "class": "EU Class III",
        "devices": 3
      },
      {
        "class": "FDA Class III",
        "devices": 1
      }
    ],
    "top_emdn_categories": [
      {
        "code": "Z12",
        "name": "Instruments for functional explorations and therapeutic interventions",
        "url": "https://devicerts.com/categories/emdn/Z12",
        "devices": 9
      },
      {
        "code": "C02",
        "name": "Arrhythmology devices",
        "url": "https://devicerts.com/categories/emdn/C02",
        "devices": 3
      },
      {
        "code": "C05",
        "name": "Cardiovascular introducer sheaths",
        "url": "https://devicerts.com/categories/emdn/C05",
        "devices": 1
      }
    ]
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": [
      {
        "name": "ICON (LR) Limited",
        "url": "https://devicerts.com/representatives/icon-lr-limited-ie-ar-000006507",
        "country": "Ireland"
      }
    ]
  },
  "devices": {
    "shown": 14,
    "total": 14,
    "all_devices_url": "https://devicerts.com/manufacturers/farapulse-inc",
    "items": [
      {
        "name": "Faradrive™",
        "url": "https://devicerts.com/devices/faradrive-21m402",
        "model_reference": "21M402",
        "device_class": "Class III",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Farastar™",
        "url": "https://devicerts.com/devices/farastar-m004pfce61m400",
        "model_reference": "M004PFCE61M400",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Farastar™",
        "url": "https://devicerts.com/devices/farastar-61m410",
        "model_reference": "61M410",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Farastar™",
        "url": "https://devicerts.com/devices/farastar-61m411",
        "model_reference": "61M411",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Farastar",
        "url": "https://devicerts.com/devices/farastar-61m407",
        "model_reference": "61M407",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Farastar™",
        "url": "https://devicerts.com/devices/farastar-61m409",
        "model_reference": "61M409",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Farastar",
        "url": "https://devicerts.com/devices/farastar-41m404",
        "model_reference": "41M404",
        "device_class": "Class III",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Farastar™",
        "url": "https://devicerts.com/devices/farastar-61m405",
        "model_reference": "61M405",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Farastar",
        "url": "https://devicerts.com/devices/farastar-61m401",
        "model_reference": "61M401",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Farastar™",
        "url": "https://devicerts.com/devices/farastar-61m415",
        "model_reference": "61M415",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Farawave™",
        "url": "https://devicerts.com/devices/farawave-41m401",
        "model_reference": "41M401",
        "device_class": "Class III",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Farastar™",
        "url": "https://devicerts.com/devices/farastar-61m404",
        "model_reference": "61M404",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "FARAPULSE™ Pulsed Field Ablation System (FARAPULSE)",
        "url": "https://devicerts.com/devices/farapulse-pulsed-field-ablation-system-farawave-pulsed-field-p230030",
        "model_reference": "P230030",
        "device_class": "Class III",
        "registries": [
          "PMA"
        ],
        "status": "Active",
        "decision_date": "2024-01-30",
        "open_recall": true
      },
      {
        "name": "Farastar™",
        "url": "https://devicerts.com/devices/farastar-61m417",
        "model_reference": "61M417",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      }
    ]
  },
  "certificates": [],
  "recalls": []
}