{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Uc-Care Ltd. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/uc-care-ltd (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/uc-care-ltd",
    "json_url": "https://devicerts.com/manufacturers/uc-care-ltd.json",
    "markdown_url": "https://devicerts.com/manufacturers/uc-care-ltd.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 registration and listing",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm"
      }
    ],
    "eudamed_record_synced": null,
    "fda_recalls_as_of": "2026-11-01",
    "registry_facts_computed": "2026-11-14",
    "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/uc-care-ltd",
    "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": "Uc-Care Ltd",
    "url": "https://devicerts.com/manufacturers/uc-care-ltd",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [],
    "country": null,
    "country_basis": null,
    "eudamed_status": null,
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "FDA"
    ],
    "identifiers": [
      {
        "label": "DUNS",
        "value": "649551124"
      }
    ],
    "summary": "Uc-Care Ltd is a medical device manufacturer, with 39 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) as of 15 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 39,
    "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": 1,
    "sites": 0
  },
  "registry_facts": {
    "covers": "Every device of the manufacturer. A device listed in two registries counts in both.",
    "registries": [
      {
        "registry": "FDA GUDID",
        "devices": 34
      },
      {
        "registry": "FDA 510(k)",
        "devices": 5
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class II",
        "devices": 34
      },
      {
        "class": "FDA Class I",
        "devices": 5
      }
    ],
    "top_emdn_categories": []
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": []
  },
  "devices": {
    "shown": 39,
    "total": 39,
    "all_devices_url": "https://devicerts.com/manufacturers/uc-care-ltd",
    "items": [
      {
        "name": "SmartBx FPRMC00037",
        "url": "https://devicerts.com/devices/smartbx-fprmc00037",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SmartGuide Disposable Needle Guides and Grids FPRPR00013",
        "url": "https://devicerts.com/devices/smartguide-disposable-needle-guides-and-grids-fprpr00013",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Box of 80 SmartBx Disposable Cassettes FPRPR00011",
        "url": "https://devicerts.com/devices/box-of-80-smartbx-disposable-cassettes-fprpr00011",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Sensor Fixator FPRMC00054",
        "url": "https://devicerts.com/devices/sensor-fixator-fprmc00043",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Box of 10 SmartBx Disposable Needle Cribs FPRPR00012",
        "url": "https://devicerts.com/devices/box-of-10-smartbx-disposable-needle-cribs-fprpr00012",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SmartBx Spare parts FPRMC00031",
        "url": "https://devicerts.com/devices/smartbx-spare-parts-fprmc00031",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Navigo™ Workstation FPRMC00039",
        "url": "https://devicerts.com/devices/navigo-workstation-fprmc00039",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SmartBx FPRMC00049",
        "url": "https://devicerts.com/devices/smartbx-fprmc00049",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SmartGuide Disposable Needle Guides and Grids FPRPR00014",
        "url": "https://devicerts.com/devices/smartguide-disposable-needle-guides-and-grids-fprpr00014",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Probe sensor assembly for GE E8CS (square) FPRSA00009",
        "url": "https://devicerts.com/devices/probe-sensor-assembly-for-ge-e8cs-square-fprsa00009",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Navigo™ Workstation FPRMC0016A",
        "url": "https://devicerts.com/devices/navigo-workstation-fprmc0016a",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Probe sensor assembly for Hitachi V53W (square) FPRSA00008",
        "url": "https://devicerts.com/devices/probe-sensor-assembly-for-hitachi-v53w-square-fprsa00008",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Probe sensor assembly for BK 8818 and 8808e (square) FPRSA00007",
        "url": "https://devicerts.com/devices/probe-sensor-assembly-for-bk-8818-and-8808e-square-fprsa00007",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Probe sensor assembly for GE E8CS FPRSA00014",
        "url": "https://devicerts.com/devices/probe-sensor-assembly-for-ge-e8cs-fprsa00014",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Warming System-unit, Cryosurgical FPRMC00034",
        "url": "https://devicerts.com/devices/warming-system-unit-cryosurgical-fprmc00034",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Probe sensor assembly for GE BE9CS FPRSA00019",
        "url": "https://devicerts.com/devices/probe-sensor-assembly-for-ge-be9cs-fprsa00019",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Probe sensor assembly for Hitachi V53W FPRSA00012",
        "url": "https://devicerts.com/devices/probe-sensor-assembly-for-hitachi-v53w-fprsa00012",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Probe sensor assembly for Hitachi EUP-U533 FPRSA00018",
        "url": "https://devicerts.com/devices/probe-sensor-assembly-for-hitachi-eup-u533-fprsa00018",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Probe sensor assembly for MindRay FPRSA00013",
        "url": "https://devicerts.com/devices/probe-sensor-assembly-for-mindray-fprsa00013",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Probe sensor assembly for BK 8667 (square) FPRSA00011",
        "url": "https://devicerts.com/devices/probe-sensor-assembly-for-bk-8667-square-fprsa00011",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Probe sensor assembly for EndoCare FPRSA00015",
        "url": "https://devicerts.com/devices/probe-sensor-assembly-for-endocare-fprsa00015",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Warming System-catheter FPRMC00035",
        "url": "https://devicerts.com/devices/warming-system-catheter-fprmc00035",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Civco classic stepper sensor fixator FPRSA00022",
        "url": "https://devicerts.com/devices/civco-classic-stepper-sensor-fixator-fprsa00022",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Probe sensor assembly for Philips BP10-5es FPRSA00020",
        "url": "https://devicerts.com/devices/probe-sensor-assembly-for-philips-bp10-5es-fprsa00020",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ascension transmitter Cubic Assembly ASMCH00034",
        "url": "https://devicerts.com/devices/ascension-transmitter-cubic-assembly-asmch00034",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Computer (Industrial) FPRCO00011",
        "url": "https://devicerts.com/devices/computer-industrial-fprco00011",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Probe sensor assembly for Civco 8848 FPRSA00017",
        "url": "https://devicerts.com/devices/probe-sensor-assembly-for-civco-8848-fprsa00017",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Roll Stand + Arm HRDGN00023",
        "url": "https://devicerts.com/devices/roll-stand-arm-hrdgn00023",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Positioning System FPRMC00036",
        "url": "https://devicerts.com/devices/positioning-system-fprmc00036",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Endocar Tamplate Fixator FPRSA00023",
        "url": "https://devicerts.com/devices/endocar-tamplate-fixator-fprsa00023",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Probe sensor FPRSA00024",
        "url": "https://devicerts.com/devices/probe-sensor-fprsa00024",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Probe sensor assembly for D&K 8848 FPRSA00016",
        "url": "https://devicerts.com/devices/probe-sensor-assembly-for-dandk-8848-fprsa00016",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "D&K Stepper template fixator FPRSA00021",
        "url": "https://devicerts.com/devices/dandk-stepper-template-fixator-fprsa00021",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Probe sensor assembly for BK 8808 (square) FPRSA00006",
        "url": "https://devicerts.com/devices/probe-sensor-assembly-for-bk-8808-square-fprsa00006",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Uc-Care Navigo Sytem",
        "url": "https://devicerts.com/devices/uc-care-navigo-sytem-llz",
        "model_reference": "K100784",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2011-11-01",
        "open_recall": false
      },
      {
        "name": "Navigo Workstation Version 2.0",
        "url": "https://devicerts.com/devices/navigo-workstation-version-2-0-llz",
        "model_reference": "K173054",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2018-01-16",
        "open_recall": false
      },
      {
        "name": "UC-CARE NaviGo Workstation",
        "url": "https://devicerts.com/devices/uc-care-navigo-workstation-llz",
        "model_reference": "K160934",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2017-02-06",
        "open_recall": false
      },
      {
        "name": "Uc-Care Warming System",
        "url": "https://devicerts.com/devices/uc-care-warming-system-geh",
        "model_reference": "K090978",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2009-08-10",
        "open_recall": false
      },
      {
        "name": "Navigo Workstation 2.3 (FPRMC00039)",
        "url": "https://devicerts.com/devices/navigo-workstation-2-3-fprmc00039-llz",
        "model_reference": "K250664",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2025-08-07",
        "open_recall": false
      }
    ]
  },
  "certificates": [],
  "recalls": []
}