{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Uvision360, Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/uvision360-inc (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/uvision360-inc",
    "json_url": "https://devicerts.com/manufacturers/uvision360-inc.json",
    "markdown_url": "https://devicerts.com/manufacturers/uvision360-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/"
      }
    ],
    "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/uvision360-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": "Uvision360, Inc.",
    "url": "https://devicerts.com/manufacturers/uvision360-inc",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [],
    "country": "United States",
    "country_basis": "FDA applicant, unverified",
    "eudamed_status": null,
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [],
    "identifiers": [],
    "summary": "Uvision360, Inc. is a medical device manufacturer, with 14 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) 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": "FDA GUDID",
        "devices": 10
      },
      {
        "registry": "FDA 510(k)",
        "devices": 4
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class II",
        "devices": 13
      },
      {
        "class": "FDA Class I",
        "devices": 1
      }
    ],
    "top_emdn_categories": []
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": []
  },
  "devices": {
    "shown": 14,
    "total": 14,
    "all_devices_url": "https://devicerts.com/manufacturers/uvision360-inc",
    "items": [
      {
        "name": "Uvision Hysteroscope Cable 20050",
        "url": "https://devicerts.com/devices/uvision-hysteroscope-cable-20050",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LUMINELLE DTx 360 Rotatable Disposable Sheaths LUMDTx-360",
        "url": "https://devicerts.com/devices/luminelle-dtx-360-rotatable-disposable-sheaths-20020",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) LUMBx-360 DOWN",
        "url": "https://devicerts.com/devices/luminelle-bx-360deg-rotatable-disposable-sheath-biopsy-20085",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LUMINELLE Aspirator LUM-A",
        "url": "https://devicerts.com/devices/luminelle-aspirator-20081",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LUMINELLE DTx Hysteroscopy System LumDTX-A",
        "url": "https://devicerts.com/devices/luminelle-dtx-hysteroscopy-system-20030",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) LUMBx-360 UP",
        "url": "https://devicerts.com/devices/luminelle-bx-360deg-rotatable-disposable-sheath-biopsy-20080",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Uvision Hysteroscope LUMDTx-A1",
        "url": "https://devicerts.com/devices/uvision-hysteroscope-20010",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LUMINELLE Dx 360o Rotatable Disposable Sheath (Diagnostic) LUMDx-360",
        "url": "https://devicerts.com/devices/luminelle-dx-360o-rotatable-disposable-sheath-diagnostic-20070",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LUMINELLE DTx 360 Rigid Rotatable Disposable Sheath LUMDTx-360R",
        "url": "https://devicerts.com/devices/luminelle-dtx-360-rigid-rotatable-disposable-sheath-20060",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Luminelle DTx Control Hub 20012",
        "url": "https://devicerts.com/devices/luminelle-dtx-control-hub-20012",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Luminelle DTx Hysteroscopy System",
        "url": "https://devicerts.com/devices/luminelle-dtx-hysteroscopy-system-faj",
        "model_reference": "K181909",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2018-08-16",
        "open_recall": false
      },
      {
        "name": "LUMINELLE DTx System",
        "url": "https://devicerts.com/devices/luminelle-dtx-system-faj",
        "model_reference": "K210512",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2021-06-30",
        "open_recall": false
      },
      {
        "name": "Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid",
        "url": "https://devicerts.com/devices/luminelle-dtx-hysteroscopy-system-luminelle-360-rotatable-st-hih",
        "model_reference": "K190827",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2019-06-06",
        "open_recall": false
      },
      {
        "name": "Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)",
        "url": "https://devicerts.com/devices/luminelle-dtx-hysteroscopy-system-luminelle-dx-360-rotatable-hih",
        "model_reference": "K192278",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2019-11-01",
        "open_recall": false
      }
    ]
  },
  "certificates": [],
  "recalls": []
}