{
  "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": "2026-10-26",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 4
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Surearly Digital Ovulation Test",
        "Surearly Ovulation Test Strip",
        "Surearly SMART",
        "Surearly SMART Ovulation Test",
        "Surearly SMART Ovulation Test Starter Kit"
      ],
      "establishment_type": [
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "3010879605",
        "fei_number": "3010879605",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "SUGENTECH, INC.",
        "address_line_1": "721-26, Jeongjungyeonje-ro, Osong-eup, Heungdeok-gu",
        "address_line_2": "",
        "city": "Cheongju-si Chungbuk",
        "state_code": "",
        "iso_country_code": "KR",
        "zip_code": "",
        "postal_code": "28161",
        "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": "Sugentech, Inc.",
          "owner_operator_number": "10046776",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "721-26, Jeongjungyeonje-ro, Osong-eup, Heungdeok-gu",
            "address_2": "",
            "city": "Cheongju-si",
            "state_code": "KR-43",
            "state_province": "Chungbuk",
            "iso_country_code": "KR",
            "postal_code": "28161"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "NGE",
          "created_date": "2014-05-11",
          "owner_operator_number": "10046776",
          "exempt": "",
          "openfda": {
            "device_name": "Test, Luteinizing Hormone (Lh), Over The Counter",
            "medical_specialty_description": "Clinical Chemistry",
            "regulation_number": "862.1485",
            "device_class": "1"
          }
        }
      ]
    }
  ]
}