{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-09-07",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 11
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Disposable Closed Suction Catheter",
        "Long-acting Type: 6Fr,8Fr,10Fr,12Fr,14Fr,16Fr",
        "Child Type: 6Fr,8Fr",
        "Standard Type: 6Fr,8Fr,10Fr,12Fr,14Fr,16Fr",
        "Disposable Suction Catheter,Model:iSKX06 6Fr;iSKX08 8Fr;iSKX10 10Fr;iSKX12 12Fr;iSKX14 14Fr;iSKX16 16Fr"
      ],
      "establishment_type": [
        "Manufacture Medical Device for Another Party (Contract Manufacturer)",
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "3013528571",
        "fei_number": "3013528571",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "SHENZHEN INSIGHTERS MEDICAL TECHNOLOGY CO., LTD.",
        "address_line_1": "Floor 13th, HTM Building, Ganli Road",
        "address_line_2": "Longgang District",
        "city": "Shenzhen Guangdong",
        "state_code": "",
        "iso_country_code": "CN",
        "zip_code": "",
        "postal_code": "518000",
        "us_agent": {
          "name": "Charles Mack",
          "business_name": "IRC USA",
          "bus_phone_area_code": "931",
          "bus_phone_num": "6254938",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "ircfda@gmail.com",
          "address_line_1": "2950 E Lindrick Dr",
          "address_line_2": "",
          "city": "Chandler",
          "state_code": "AZ",
          "iso_country_code": "US",
          "zip_code": "85249",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "Shenzhen Insighters Medical Technology Co., Ltd.",
          "owner_operator_number": "10053495",
          "official_correspondent": {
            "first_name": "Baohong",
            "middle_initial": "",
            "last_name": "Fang",
            "subaccount_company_name": "",
            "phone_number": "86-755-89313133-x"
          },
          "contact_address": {
            "address_1": "The 13th floor of Hengtemei Building,Ganli Road No. 3",
            "address_2": "",
            "city": "Shenzhen",
            "state_code": "CN-GD",
            "state_province": "Guangdong",
            "iso_country_code": "CN",
            "postal_code": "518000"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "BSY",
          "created_date": "2021-12-21",
          "owner_operator_number": "10053495",
          "exempt": "",
          "openfda": {
            "device_name": "Catheters, Suction, Tracheobronchial",
            "medical_specialty_description": "Anesthesiology",
            "regulation_number": "868.6810",
            "device_class": "1"
          }
        }
      ]
    }
  ]
}