{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "LOCALITE GmbH. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/localite-gmbh (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/localite-gmbh",
    "json_url": "https://devicerts.com/manufacturers/localite-gmbh.json",
    "markdown_url": "https://devicerts.com/manufacturers/localite-gmbh.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/localite-gmbh",
    "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": "LOCALITE GmbH",
    "url": "https://devicerts.com/manufacturers/localite-gmbh",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [],
    "country": "Germany",
    "country_basis": "from SRN",
    "eudamed_status": {
      "status": "active",
      "since_year": null
    },
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "EUDAMED",
      "FDA"
    ],
    "identifiers": [
      {
        "label": "EUDAMED SRN",
        "value": "DE-MF-000005419"
      },
      {
        "label": "FDA FEI",
        "value": "3017603615"
      },
      {
        "label": "DUNS",
        "value": "315271657"
      }
    ],
    "summary": "LOCALITE GmbH is a medical device manufacturer based in Germany, with 73 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU Class I and IIa; FDA Class II) as of 15 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 73,
    "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": 53
      },
      {
        "registry": "FDA GUDID",
        "devices": 37
      },
      {
        "registry": "FDA 510(k)",
        "devices": 1
      }
    ],
    "device_classes": [
      {
        "class": "EU Class I",
        "devices": 40
      },
      {
        "class": "FDA Class II",
        "devices": 21
      },
      {
        "class": "EU Class IIa",
        "devices": 12
      }
    ],
    "top_emdn_categories": [
      {
        "code": "V90",
        "name": "Various devices not included in other classes",
        "url": "https://devicerts.com/categories/emdn/V90",
        "devices": 40
      },
      {
        "code": "V92",
        "name": "Medical device software - not included in other classes",
        "url": "https://devicerts.com/categories/emdn/V92",
        "devices": 12
      }
    ]
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": []
  },
  "devices": {
    "shown": 50,
    "total": 73,
    "all_devices_url": "https://devicerts.com/manufacturers/localite-gmbh",
    "items": [
      {
        "name": "Localite TMS Navigator TS Adapterbox",
        "url": "https://devicerts.com/devices/localite-tms-navigator-ts-adapterbox-900687",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Localite TMS Navigator TS System Cart",
        "url": "https://devicerts.com/devices/localite-tms-navigator-ts-system-cart-900588",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Localite TMS Navigator TS Adhesive Pads, square-cut (90 Pcs.)",
        "url": "https://devicerts.com/devices/localite-tms-navigator-ts-12355",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Localite TMS Navigator TS Camera Cart for Vicra/Lyra",
        "url": "https://devicerts.com/devices/localite-tms-navigator-ts-camera-cart-for-vicr",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Localite TMS Navigator TS",
        "url": "https://devicerts.com/devices/localite-tms-navigator-ts-10232-39ab24d5",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Localite TMS Navigator TS",
        "url": "https://devicerts.com/devices/localite-tms-navigator-ts-10235-d5a80457",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Localite TMS Navigator TS Functional Data (Software Module)",
        "url": "https://devicerts.com/devices/localite-tms-navigator-ts-10233-eb4cc5c3",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Localite TMS Navigator TS Functional Data (Software Module)",
        "url": "https://devicerts.com/devices/localite-tms-navigator-ts-10233",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Localite TMS Navigator TS Calibration Pins, 25/10",
        "url": "https://devicerts.com/devices/localite-tms-navigator-ts-002097",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Localite TMS Navigator TS MR-Based (Image Data Component)",
        "url": "https://devicerts.com/devices/localite-tms-navigator-ts-10226-24acaa3e",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Localite TMS Navigator TS TMS Navigator SW MR-Based",
        "url": "https://devicerts.com/devices/localite-tms-navigator-ts-10205-0f1eb09b",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Localite TMS Navigator TS",
        "url": "https://devicerts.com/devices/localite-tms-navigator-ts-10235",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Localite TMS Navigator TS TMS Navigator SW MR-Less",
        "url": "https://devicerts.com/devices/localite-tms-navigator-ts-10206-8a5a2a44",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Localite TMS Navigator TS System Cart",
        "url": "https://devicerts.com/devices/localite-tms-navigator-ts-900587",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Localite TMS Navigator TS MR-Based (Image Data Component)",
        "url": "https://devicerts.com/devices/localite-tms-navigator-ts-10226",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Localite TMS Navigator TS",
        "url": "https://devicerts.com/devices/localite-tms-navigator-ts-10232",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Localite TMS Navigator TS TMS Navigator SW MR-Less",
        "url": "https://devicerts.com/devices/localite-tms-navigator-ts-10206",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Localite TMS Navigator TS Adhesive Pads, round (250 pcs.)",
        "url": "https://devicerts.com/devices/localite-tms-navigator-ts-12354",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Localite TMS Navigator TS MR-Less (Image Data Component)",
        "url": "https://devicerts.com/devices/localite-tms-navigator-ts-10225-7246d009",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Localite TMS Navigator TS MR-Less (Image Data Component)",
        "url": "https://devicerts.com/devices/localite-tms-navigator-ts-10225",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Trackerring, 29 mm",
        "url": "https://devicerts.com/devices/trackerring-29-mm-014222",
        "model_reference": "014222",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Trackeraufsatz, Geo. 4",
        "url": "https://devicerts.com/devices/trackeraufsatz-geo-4-003224",
        "model_reference": "003224",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Stirnband",
        "url": "https://devicerts.com/devices/stirnband-001207",
        "model_reference": "001207",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Trackeraufsatz MR, Geo. 4",
        "url": "https://devicerts.com/devices/trackeraufsatz-mr-geo-4-003228",
        "model_reference": "003228",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Kopftracker für Stirnband",
        "url": "https://devicerts.com/devices/kopftracker-fur-stirnband-000206",
        "model_reference": "000206",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Trackeraufsatz MR, Geo. 2",
        "url": "https://devicerts.com/devices/trackeraufsatz-mr-geo-2-003226",
        "model_reference": "003226",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Universaltracker, Geo. 3",
        "url": "https://devicerts.com/devices/universaltracker-geo-3-001223",
        "model_reference": "001223",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Universaltracker, Geo. 4",
        "url": "https://devicerts.com/devices/universaltracker-geo-4-001224",
        "model_reference": "001224",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "TMS Navigator Software",
        "url": "https://devicerts.com/devices/tms-navigator-software-010233",
        "model_reference": "010233",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Localite TMS Navigator TS",
        "url": "https://devicerts.com/devices/localite-tms-navigator-ts-haw",
        "model_reference": "K223577",
        "device_class": "Class II",
        "registries": [
          "510(k)",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": "2023-04-17",
        "open_recall": false
      },
      {
        "name": "Universaltracker, Geo. 1",
        "url": "https://devicerts.com/devices/universaltracker-geo-1-001221",
        "model_reference": "001221",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pointer Ti",
        "url": "https://devicerts.com/devices/pointer-ti-021112",
        "model_reference": "021112",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Klebbare Basis für Tracker",
        "url": "https://devicerts.com/devices/klebbare-basis-fur-tracker-014227",
        "model_reference": "014227",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Kamerarollwagen für Spectra/Vega",
        "url": "https://devicerts.com/devices/kamerarollwagen-fur-spectra-vega-001212",
        "model_reference": "001212",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Kalibrierhilfe MV Cool D-B80 A/P",
        "url": "https://devicerts.com/devices/kalibrierhilfe-mv-cool-d-b80-a-p-002008",
        "model_reference": "002008",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Kopftrackeraufsatz MR",
        "url": "https://devicerts.com/devices/kopftrackeraufsatz-mr-014229",
        "model_reference": "014229",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Schwenkarm für Kamerarollwagen/Wandhalterung (kurz)",
        "url": "https://devicerts.com/devices/schwenkarm-fur-kamerarollwagen-wandhalterung-kurz-200002",
        "model_reference": "200002",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "TMS Navigator Software",
        "url": "https://devicerts.com/devices/tms-navigator-software-010232",
        "model_reference": "010232",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Trackeraufsatz, Geo. 2",
        "url": "https://devicerts.com/devices/trackeraufsatz-geo-2-003222",
        "model_reference": "003222",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Verlängerung für Trackerhalterung, 50 mm",
        "url": "https://devicerts.com/devices/verlangerung-fur-trackerhalterung-50-mm-003229",
        "model_reference": "003229",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Trackeraufsatz, Geo. 1",
        "url": "https://devicerts.com/devices/trackeraufsatz-geo-1-003221",
        "model_reference": "003221",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Wandhalterung für Premium Trackingkamera",
        "url": "https://devicerts.com/devices/wandhalterung-fur-premium-trackingkamera-001211",
        "model_reference": "001211",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Fußschalter-Splitter",
        "url": "https://devicerts.com/devices/fussschalter-splitter-001166",
        "model_reference": "001166",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Trackeraufsatz, Geo. 3",
        "url": "https://devicerts.com/devices/trackeraufsatz-geo-3-003223",
        "model_reference": "003223",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "TMS Navigator SW MR-Less",
        "url": "https://devicerts.com/devices/tms-navigator-sw-mr-less-010206",
        "model_reference": "010206",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Klebepads, rund (250 St.)",
        "url": "https://devicerts.com/devices/klebepads-rund-250-st-012354",
        "model_reference": "012354",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Trackeraufsatz MR, Geo. 3",
        "url": "https://devicerts.com/devices/trackeraufsatz-mr-geo-3-003227",
        "model_reference": "003227",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Schwenkarm für Kamerarollwagen/Wandhalterung",
        "url": "https://devicerts.com/devices/schwenkarm-fur-kamerarollwagen-wandhalterung-200001",
        "model_reference": "200001",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "TMS Navigator SW MR-Based for Axilum Robotics TMS-Robot",
        "url": "https://devicerts.com/devices/tms-navigator-sw-mr-based-for-axilum-robotics-tms-robot-010207",
        "model_reference": "010207",
        "device_class": "Class IIa",
        "registries": [
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        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Trackerring, 25 mm",
        "url": "https://devicerts.com/devices/trackerring-25-mm-014221",
        "model_reference": "014221",
        "device_class": "Class I",
        "registries": [
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          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      }
    ]
  },
  "certificates": [],
  "recalls": []
}