{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "ElectroCore, Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/electrocore-inc (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/electrocore-inc",
    "json_url": "https://devicerts.com/manufacturers/electrocore-inc.json",
    "markdown_url": "https://devicerts.com/manufacturers/electrocore-inc.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/"
      },
      {
        "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/electrocore-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": "ElectroCore, Inc.",
    "url": "https://devicerts.com/manufacturers/electrocore-inc",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [
      "ELECTROCORE, LLC"
    ],
    "country": "United States",
    "country_basis": "from SRN",
    "eudamed_status": {
      "status": "active",
      "since_year": null
    },
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "EUDAMED",
      "FDA"
    ],
    "identifiers": [
      {
        "label": "EUDAMED SRN",
        "value": "US-MF-000036987"
      },
      {
        "label": "FDA FEI",
        "value": "3015529603"
      },
      {
        "label": "DUNS",
        "value": "831341628"
      }
    ],
    "summary": "ElectroCore, Inc. is a medical device manufacturer based in the United States, with 122 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II; EU Class IIa and I) as of 15 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 122,
    "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": "FDA GUDID",
        "devices": 86
      },
      {
        "registry": "EUDAMED",
        "devices": 36
      },
      {
        "registry": "FDA 510(k)",
        "devices": 3
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class II",
        "devices": 89
      },
      {
        "class": "EU Class IIa",
        "devices": 30
      },
      {
        "class": "EU Class I",
        "devices": 3
      }
    ],
    "top_emdn_categories": [
      {
        "code": "Z12",
        "name": "Instruments for functional explorations and therapeutic interventions",
        "url": "https://devicerts.com/categories/emdn/Z12",
        "devices": 30
      },
      {
        "code": "V90",
        "name": "Various devices not included in other classes",
        "url": "https://devicerts.com/categories/emdn/V90",
        "devices": 3
      }
    ]
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": [
      {
        "name": "MDSS GmbH",
        "url": "https://devicerts.com/representatives/mdss-gmbh-de-ar-000005430",
        "country": "Germany"
      }
    ]
  },
  "devices": {
    "shown": 50,
    "total": 122,
    "all_devices_url": "https://devicerts.com/manufacturers/electrocore-inc",
    "items": [
      {
        "name": "gammaCore Sapphire SLC Refill Card Kit, 93 days",
        "url": "https://devicerts.com/devices/gammacore-sapphire-slc-refill-card-kit-93-days-12016-02593",
        "model_reference": "12016-02593",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore Sapphire SLC - Evaluation Refill Card Kit",
        "url": "https://devicerts.com/devices/gammacore-sapphire-slc-evaluation-refill-card-kit-12016-02594",
        "model_reference": "12016-02594",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore Sapphire 6-Month Evaluation Device Kit",
        "url": "https://devicerts.com/devices/gammacore-sapphire-6-month-evaluation-device-kit-12016-02003",
        "model_reference": "12016-02003",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore Sapphire 20016-00301-RPL",
        "url": "https://devicerts.com/devices/gammacore-sapphire-20016-00301-rpl",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore Sapphire 20016-00501-RPL",
        "url": "https://devicerts.com/devices/gammacore-sapphire-20016-00501-rpl",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore Sapphire 13016-04501-C",
        "url": "https://devicerts.com/devices/gammacore-sapphire-13016-04501-c",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore Sapphire 13016-04502-C",
        "url": "https://devicerts.com/devices/gammacore-sapphire-13016-04502-c",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore Sapphire 13016-04504-C",
        "url": "https://devicerts.com/devices/gammacore-sapphire-13016-04504-c",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore Sapphire 12016-04999",
        "url": "https://devicerts.com/devices/gammacore-sapphire-12016-04999",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore Sapphire AC Power Adapter 20016-00001-RPL",
        "url": "https://devicerts.com/devices/gammacore-sapphire-ac-power-adapter-20016-00001-rpl",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore 20016-00003-RPL",
        "url": "https://devicerts.com/devices/gammacore-20016-00003-rpl",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore 20016-00006-RPL",
        "url": "https://devicerts.com/devices/gammacore-20016-00006-rpl",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore Emerald 3-Month Device Kit 12116-04003",
        "url": "https://devicerts.com/devices/gammacore-emerald-3-month-device-kit-12116-04003",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore Emerald 12-Month Device Kit 12116-04012",
        "url": "https://devicerts.com/devices/gammacore-emerald-12-month-device-kit-12116-04012",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore Emerald-D Device Kit 12116-04036",
        "url": "https://devicerts.com/devices/gammacore-emerald-d-device-kit-12116-04036",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore Emerald 6-Month Evaluation Device Kit 11116-04006",
        "url": "https://devicerts.com/devices/gammacore-emerald-6-month-evaluation-device-kit-11116-04006",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore 1-Month Refill Kit 12116-04501",
        "url": "https://devicerts.com/devices/gammacore-1-month-refill-kit-12116-04501",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore 3-Month Refill Kit 12116-04503",
        "url": "https://devicerts.com/devices/gammacore-3-month-refill-kit-12116-04503",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore 6-Month Evaluation Refill Kit 11116-04506",
        "url": "https://devicerts.com/devices/gammacore-6-month-evaluation-refill-kit-11116-04506",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore 12-Month Refill Kit 12116-04512",
        "url": "https://devicerts.com/devices/gammacore-12-month-refill-kit-12116-04512",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore Emerald 1-Month Licensed Device Kit 13116-04001",
        "url": "https://devicerts.com/devices/gammacore-emerald-1-month-licensed-device-kit-13116-04001",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore Emerald 3-Month Licensed Device Kit 13116-04003",
        "url": "https://devicerts.com/devices/gammacore-emerald-3-month-licensed-device-kit-13116-04003",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore Emerald 36-Month Licensed Device Kit 13116-04036",
        "url": "https://devicerts.com/devices/gammacore-emerald-36-month-licensed-device-kit-13116-04036",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore Emerald 12-Month Licensed Device Kit 13116-04012",
        "url": "https://devicerts.com/devices/gammacore-emerald-12-month-licensed-device-kit-13116-04012",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore 1-Month Card 12116-04501-C",
        "url": "https://devicerts.com/devices/gammacore-1-month-card-12116-04501-c",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore 12-Month Card 12116-04512-C",
        "url": "https://devicerts.com/devices/gammacore-12-month-card-12116-04512-c",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore 3-Month Card 12116-04503-C",
        "url": "https://devicerts.com/devices/gammacore-3-month-card-12116-04503-c",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore Emerald Handset - Replacement 12116-04901-RPL",
        "url": "https://devicerts.com/devices/gammacore-emerald-handset-replacement-12116-04901-rpl",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore Emerald Replacement Charging Pad 12116-04902-RPL",
        "url": "https://devicerts.com/devices/gammacore-emerald-replacement-charging-pad-12116-04902-rpl",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore Emerald Replacement USB Cable 12116-04903-RPL",
        "url": "https://devicerts.com/devices/gammacore-emerald-replacement-usb-cable-12116-04903-rpl",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore Emerald Replacement Power Block 12116-04904-RPL",
        "url": "https://devicerts.com/devices/gammacore-emerald-replacement-power-block-12116-04904-rpl",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore Sapphire 20016-00502-RPL",
        "url": "https://devicerts.com/devices/gammacore-sapphire-20016-00502-rpl",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore Emerald 20116-00001-RPL",
        "url": "https://devicerts.com/devices/gammacore-emerald-20116-00001-rpl",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore Emerald 20116-10301-RPL",
        "url": "https://devicerts.com/devices/gammacore-emerald-20116-10301-rpl",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore Emerald 50022-00004-RPL",
        "url": "https://devicerts.com/devices/gammacore-emerald-50022-00004-rpl",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore Emerald 50022-00078-RPL",
        "url": "https://devicerts.com/devices/gammacore-emerald-50022-00078-rpl",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gmmaCore - Refill Card 12116-00501-C",
        "url": "https://devicerts.com/devices/gmmacore-refill-card-12116-00501-c",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore Refill Card 12116-00503-C",
        "url": "https://devicerts.com/devices/gammacore-refill-card-12116-00503-c",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore Refill Card 12116-00512-C",
        "url": "https://devicerts.com/devices/gammacore-refill-card-12116-00512-c",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore Sapphire SLC Handset - Replacement",
        "url": "https://devicerts.com/devices/gammacore-sapphire-slc-handset-replacement-20016-10301-rpl",
        "model_reference": "20016-10301-RPL",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore Sapphire 93-Day Device Kit (For Trial Use)",
        "url": "https://devicerts.com/devices/gammacore-sapphire-93-day-device-kit-for-trial-use-12016-02002-v",
        "model_reference": "12016-02002 v",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore Sapphire 31-Day Starter Kit",
        "url": "https://devicerts.com/devices/gammacore-sapphire-31-day-starter-kit-12016-02001",
        "model_reference": "12016-02001",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore Sapphire 93-DayStarter Kit",
        "url": "https://devicerts.com/devices/gammacore-sapphire-93-daystarter-kit-12016-02002",
        "model_reference": "12016-02002",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "gammaCore Sapphire Charging Station / Case - Replacement",
        "url": "https://devicerts.com/devices/gammacore-sapphire-charging-station-case-replacement-20016-10501-rpl",
        "model_reference": "20016-10501-RPL",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Replacement AC Power Adapter Blade Kit",
        "url": "https://devicerts.com/devices/replacement-ac-power-adapter-blade-kit-20016-00002-rpl",
        "model_reference": "20016-00002-RPL",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
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  "certificates": [],
  "recalls": []
}