{
  "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": 4
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Hemato Check Module"
      ],
      "establishment_type": [
        "Develop Specifications But Do Not Manufacture At This Facility",
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "8010061",
        "fei_number": "3002807736",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "NIHON SEIMITSU SOKKI CO., LTD.",
        "address_line_1": "2508-13 NAKAGO",
        "address_line_2": "",
        "city": "SHIBUKAWA Gunma",
        "state_code": "",
        "iso_country_code": "JP",
        "zip_code": "",
        "postal_code": "377-0293",
        "us_agent": {
          "name": "FLORENCE ROSTAMI",
          "business_name": "FLORENCE ROSTAMI LAW, LLC",
          "bus_phone_area_code": "212",
          "bus_phone_num": "2093962",
          "bus_phone_extn": "",
          "fax_area_code": "917",
          "fax_num": "6773697",
          "email_address": "frostami@rostamilaw.com",
          "address_line_1": "420 Lexington Ave Rm 1402",
          "address_line_2": "",
          "city": "New York",
          "state_code": "NY",
          "iso_country_code": "US",
          "zip_code": "10170",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "NIHON SEIMITSU SOKKI CO., LTD.",
          "owner_operator_number": "8010061",
          "official_correspondent": {
            "first_name": "HIDEKI",
            "middle_initial": "",
            "last_name": "SATO",
            "subaccount_company_name": "",
            "phone_number": "81-279-202311-x"
          },
          "contact_address": {
            "address_1": "2508-13 NAKAGO",
            "address_2": "",
            "city": "SHIBUKAWA, GUNMA",
            "state_code": "JP-NOTA",
            "state_province": "",
            "iso_country_code": "JP",
            "postal_code": "377-0293"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "CDM",
          "created_date": "2023-07-30",
          "owner_operator_number": "8010061",
          "exempt": "",
          "openfda": {
            "device_name": "Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)",
            "medical_specialty_description": "Clinical Chemistry",
            "regulation_number": "862.1785",
            "device_class": "1"
          }
        }
      ]
    }
  ]
}