{
  "format": "devicerts.device.v1",
  "cite_as": "Disposable NIBP Cuff, Shenzhen Changke Connect Electronics Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/disposable-nibp-cuff-dxq (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/disposable-nibp-cuff-dxq",
    "json_url": "https://devicerts.com/devices/disposable-nibp-cuff-dxq.json",
    "markdown_url": "https://devicerts.com/devices/disposable-nibp-cuff-dxq.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      }
    ],
    "registry_records_last_synced": "2026-10-22",
    "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/devices/disposable-nibp-cuff-dxq",
    "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."
  },
  "device": {
    "name": "Disposable NIBP Cuff",
    "registry_name": "Disposable NIBP Cuff",
    "url": "https://devicerts.com/devices/disposable-nibp-cuff-dxq",
    "manufacturer": {
      "name": "Shenzhen Changke Connect Electronics Co., Ltd.",
      "url": "https://devicerts.com/manufacturers/fda-fei-3017619536",
      "country": "China",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "European Union and United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K193629",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "DXQ"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The Disposable Non-Invasive Blood Pressure Cuff is a single-use medical device designed for measuring blood pressure without invasive procedures. Classified under the nomenclature for blood pressure measurement devices, it utilises a cuff-based oscillometric method to estimate systolic and diastolic pressure via arterial pulsations.\n\nSupplied in single-use packaging, this cuff is intended for one-time clinical or veterinary use and must be discarded after use. Authorised under FDA 510(k) clearance (K193629) and MDR compliance, it is available in multiple sizes, including adult (25–35 cm) and veterinary variants. Non-woven material construction ensures sterility and hygiene, with no MRI safety restrictions specified.",
      "ai_generated": true,
      "generated_on": "2026-09-18",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K193629",
      "number_label": null,
      "device_udi_di": null,
      "date": "2020-03-25",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    },
    {
      "registry": "EUDAMED",
      "region": "European Union",
      "type": "CE/MDR",
      "number": null,
      "number_label": null,
      "device_udi_di": null,
      "date": null,
      "date_kind": null,
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K193629",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "DXQ",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class II",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 870.1120",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Cardiovascular",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA decision",
          "values": [
            {
              "value": "SESE",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    }
  ]
}