{
  "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": "2026-10-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 5
    }
  },
  "results": [
    {
      "proprietary_name": [
        "NovaLine SP-C35 Transducer Protector"
      ],
      "establishment_type": [
        "Manufacture Medical Device",
        "Export Device to the United States But Perform No Other Operation on Device"
      ],
      "registration": {
        "registration_number": "3013217742",
        "fei_number": "3013217742",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "BAIN MEDICAL EQUIPMENT(GUANGZHOU) CO., LTD.",
        "address_line_1": "No.10 Juncheng Road, Eastern Zone of Guangzhou Economic & Technological Development District",
        "address_line_2": "",
        "city": "Guangzhou Guangdong",
        "state_code": "",
        "iso_country_code": "CN",
        "zip_code": "",
        "postal_code": "510760",
        "us_agent": {
          "name": "David Lennarz",
          "business_name": "Registrar Corp",
          "bus_phone_area_code": "757",
          "bus_phone_num": "2240177",
          "bus_phone_extn": "",
          "fax_area_code": "757",
          "fax_num": "2240179",
          "email_address": "david.lennarz@registrarcorp.com",
          "address_line_1": "144 Research Dr",
          "address_line_2": "",
          "city": "Hampton",
          "state_code": "VA",
          "iso_country_code": "US",
          "zip_code": "23666",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "Bain Medical Equipment(Guangzhou) Co., Ltd.",
          "owner_operator_number": "10059567",
          "official_correspondent": {
            "first_name": "Zoe",
            "middle_initial": "",
            "last_name": "Zeng",
            "subaccount_company_name": "",
            "phone_number": "86-20-66856868-290"
          },
          "contact_address": {
            "address_1": "No.10 Juncheng Road, Eastern Zone of Guangzhou Economic & Technological Development District",
            "address_2": "",
            "city": "Guangzhou",
            "state_code": "CN-GD",
            "state_province": "Guangdong",
            "iso_country_code": "CN",
            "postal_code": "510760"
          }
        }
      },
      "pma_number": "",
      "k_number": "K240164",
      "products": [
        {
          "product_code": "FIB",
          "created_date": "2024-07-28",
          "owner_operator_number": "10059567",
          "exempt": "",
          "openfda": {
            "k_number": [
              "K240164"
            ],
            "device_name": "Protector, Transducer, Dialysis",
            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.5820",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}