{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Sunnex, Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/sunnex-inc (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/sunnex-inc",
    "json_url": "https://devicerts.com/manufacturers/sunnex-inc.json",
    "markdown_url": "https://devicerts.com/manufacturers/sunnex-inc.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA GUDID",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "eudamed_record_synced": null,
    "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/sunnex-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": "Sunnex, Inc.",
    "url": "https://devicerts.com/manufacturers/sunnex-inc",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [
      "Sunnex"
    ],
    "country": "United States",
    "country_basis": "FDA applicant, unverified",
    "eudamed_status": null,
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [],
    "identifiers": [],
    "summary": "Sunnex, Inc. is a medical device manufacturer, with 65 devices listed in FDA GUDID and FDA 510(k) (FDA Class I and II) and 2 FDA recalls as of 14 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 65,
    "devices_note": null,
    "certificates": 0,
    "fda_recalls_matched_by_name": 2,
    "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": 63
      },
      {
        "registry": "FDA 510(k)",
        "devices": 2
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class I",
        "devices": 54
      },
      {
        "class": "FDA Class II",
        "devices": 11
      }
    ],
    "top_emdn_categories": []
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": []
  },
  "devices": {
    "shown": 50,
    "total": 65,
    "all_devices_url": "https://devicerts.com/manufacturers/sunnex-inc",
    "items": [
      {
        "name": "Celestial Star CS2050D-MRI",
        "url": "https://devicerts.com/devices/celestial-star-cs2050d-mri",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Leo Minor LMI-550",
        "url": "https://devicerts.com/devices/leo-minor-lmi-550",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pf PF2006-32-Uk",
        "url": "https://devicerts.com/devices/pf-pf2006-32-uk",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Leo Minor LMI-400",
        "url": "https://devicerts.com/devices/leo-minor-lmi-400",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Tri Star TSLED-M",
        "url": "https://devicerts.com/devices/tri-star-tsled-m",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pf PF2015-44",
        "url": "https://devicerts.com/devices/pf-pf2015-44",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Celestial Star CSLED-D",
        "url": "https://devicerts.com/devices/celestial-star-csled-d",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Leo Minor LMI-400-AU",
        "url": "https://devicerts.com/devices/leo-minor-lmi-400-au",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Leo Minor LMI-400-UK",
        "url": "https://devicerts.com/devices/leo-minor-lmi-400-uk",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pf PF28010",
        "url": "https://devicerts.com/devices/pf-pf28010-9fffea26",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Tri Star TS2015M",
        "url": "https://devicerts.com/devices/tri-star-ts2015m",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Leo Minor LMI-300",
        "url": "https://devicerts.com/devices/leo-minor-lmi-300",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Tri Star TS2035W-E",
        "url": "https://devicerts.com/devices/tri-star-ts2035w-e",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Celestial Star CS2050C-MRI",
        "url": "https://devicerts.com/devices/celestial-star-cs2050c-mri",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Celestial Star CS2050M-UK",
        "url": "https://devicerts.com/devices/celestial-star-cs2050m-uk",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Celestial Star CSLED-C-HW",
        "url": "https://devicerts.com/devices/celestial-star-csled-c-hw",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Tri Star TS2015M-AU",
        "url": "https://devicerts.com/devices/tri-star-ts2015m-au",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Tri Star TS2035M-E",
        "url": "https://devicerts.com/devices/tri-star-ts2035m-e",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Celestial Star CSLED-CLA29",
        "url": "https://devicerts.com/devices/celestial-star-csled-cla29",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pf PF28016-M-Uk",
        "url": "https://devicerts.com/devices/pf-pf28016-m-uk",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Tri Star TS2035M",
        "url": "https://devicerts.com/devices/tri-star-ts2035m",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Celestial Star CSLED-DLA29",
        "url": "https://devicerts.com/devices/celestial-star-csled-dla29",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Celestial Star CS2050D",
        "url": "https://devicerts.com/devices/celestial-star-cs2050d",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Leo Minor LMI-700",
        "url": "https://devicerts.com/devices/leo-minor-lmi-700",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Tri Star TSLED-W",
        "url": "https://devicerts.com/devices/tri-star-tsled-w",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pf PF2017-44PI-Au",
        "url": "https://devicerts.com/devices/pf-pf2017-44pi-au",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pf Pf-2015-44PI-Uk",
        "url": "https://devicerts.com/devices/pf-pf-2015-44pi-uk",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Tri Star TS2015W",
        "url": "https://devicerts.com/devices/tri-star-ts2015w",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Tri Star TS2035W-AU",
        "url": "https://devicerts.com/devices/tri-star-ts2035w-au",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Celestial Star CS2050C-MRI-UK",
        "url": "https://devicerts.com/devices/celestial-star-cs2050c-mri-uk",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Celestial Star CSLED-D-HW",
        "url": "https://devicerts.com/devices/celestial-star-csled-d-hw",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pf PF2006-32-Eu",
        "url": "https://devicerts.com/devices/pf-pf2006-32-eu",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pf PF2017-44-Uk",
        "url": "https://devicerts.com/devices/pf-pf2017-44-uk",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Leo Minor LMI-550-AU",
        "url": "https://devicerts.com/devices/leo-minor-lmi-550-au",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Celestial Star CS2050W-E",
        "url": "https://devicerts.com/devices/celestial-star-cs2050w-e",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Celestial Star CSLED-W",
        "url": "https://devicerts.com/devices/celestial-star-csled-w",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Tri Star TS2035M-AU",
        "url": "https://devicerts.com/devices/tri-star-ts2035m-au",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pf PF28016-M",
        "url": "https://devicerts.com/devices/pf-pf28016-m",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Celestial Star CS2050C-39",
        "url": "https://devicerts.com/devices/celestial-star-cs2050c-39",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Tri Star TS2015W-AU",
        "url": "https://devicerts.com/devices/tri-star-ts2015w-au",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Celestial Star CS2050C",
        "url": "https://devicerts.com/devices/celestial-star-cs2050c",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Celestial Star CS2050D-29LA",
        "url": "https://devicerts.com/devices/celestial-star-cs2050d-29la",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Tri Star TS2015W-E",
        "url": "https://devicerts.com/devices/tri-star-ts2015w-e",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Tri Star TS2035W",
        "url": "https://devicerts.com/devices/tri-star-ts2035w",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Celestial Star CS2050W-UK",
        "url": "https://devicerts.com/devices/celestial-star-cs2050w-uk",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pf PF2006-32",
        "url": "https://devicerts.com/devices/pf-pf2006-32",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Celestial Star CSLED-W-AU",
        "url": "https://devicerts.com/devices/celestial-star-csled-w-au",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Celestial Star CS2050M-MRI-UK",
        "url": "https://devicerts.com/devices/celestial-star-cs2050m-mri-uk",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Celestial Star CS2050M",
        "url": "https://devicerts.com/devices/celestial-star-cs2050m",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Leo Minor LMI-700-AU",
        "url": "https://devicerts.com/devices/leo-minor-lmi-700-au",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      }
    ]
  },
  "certificates": [],
  "recalls": [
    {
      "number": "Z-1100-2007",
      "classification": "Unclassified (pre-2012)",
      "status": "Terminated",
      "initiated": "2007-02-13",
      "product_code": "FTA",
      "reason": "Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder."
    },
    {
      "number": "Z-1101-2007",
      "classification": "Unclassified (pre-2012)",
      "status": "Terminated",
      "initiated": "2007-02-13",
      "product_code": "FTA",
      "reason": "Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder."
    }
  ]
}