{
  "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": 3
    }
  },
  "results": [
    {
      "proprietary_name": [
        "LELTEK Ultrasound Imaging System"
      ],
      "establishment_type": [
        "Manufacture Medical Device for Another Party (Contract Manufacturer)"
      ],
      "registration": {
        "registration_number": "3016842138",
        "fei_number": "3016842138",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "HUKUI BIOTECHNOLOGY CO., LTD.",
        "address_line_1": "8F-1 & 2, No.1",
        "address_line_2": "Huanke 1st Rd.",
        "city": "Zhubei City Hsinchu",
        "state_code": "",
        "iso_country_code": "TW",
        "zip_code": "",
        "postal_code": "302047",
        "us_agent": {
          "name": "Michael Kuo",
          "business_name": "",
          "bus_phone_area_code": "310",
          "bus_phone_num": "6916682",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "michael@hukuibio.com",
          "address_line_1": "2055 Junction Ave, Suite 100",
          "address_line_2": "",
          "city": "San Jose",
          "state_code": "CA",
          "iso_country_code": "US",
          "zip_code": "95131",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "Hukui Biotechnology Co., Ltd.",
          "owner_operator_number": "10090863",
          "official_correspondent": {
            "first_name": "Amy",
            "middle_initial": "",
            "last_name": "Tsai",
            "subaccount_company_name": "",
            "phone_number": "886-2-25796538-x"
          },
          "contact_address": {
            "address_1": "11F-1, No. 2, Sec. 3, Bade Rd.",
            "address_2": "",
            "city": "Taipei City",
            "state_code": "TW-TPE",
            "state_province": "",
            "iso_country_code": "TW",
            "postal_code": "105608"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "IYO",
          "created_date": "2026-01-04",
          "owner_operator_number": "10090863",
          "exempt": "",
          "openfda": {
            "device_name": "System, Imaging, Pulsed Echo, Ultrasonic",
            "medical_specialty_description": "Radiology",
            "regulation_number": "892.1560",
            "device_class": "2"
          }
        },
        {
          "product_code": "IYN",
          "created_date": "2026-01-04",
          "owner_operator_number": "10090863",
          "exempt": "",
          "openfda": {
            "device_name": "System, Imaging, Pulsed Doppler, Ultrasonic",
            "medical_specialty_description": "Radiology",
            "regulation_number": "892.1550",
            "device_class": "2"
          }
        },
        {
          "product_code": "ITX",
          "created_date": "2026-01-04",
          "owner_operator_number": "10090863",
          "exempt": "",
          "openfda": {
            "device_name": "Transducer, Ultrasonic, Diagnostic",
            "medical_specialty_description": "Radiology",
            "regulation_number": "892.1570",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}