{
  "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": [
        "ReBOSSIS QDS",
        "ReBOSSIS"
      ],
      "establishment_type": [
        "Manufacture Medical Device for Another Party (Contract Manufacturer)"
      ],
      "registration": {
        "registration_number": "3013497559",
        "fei_number": "3013497559",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "Kaigen Pharma Co., Ltd. Tenjin Factory",
        "address_line_1": "2-5-3 Tenjin",
        "address_line_2": "",
        "city": "Otaru-shi Hokkaid?",
        "state_code": "",
        "iso_country_code": "JP",
        "zip_code": "",
        "postal_code": "047-0011",
        "us_agent": {
          "name": "Floyd Larson",
          "business_name": "PAXMED INTERNATIONAL, LLC",
          "bus_phone_area_code": "858",
          "bus_phone_num": "7921235",
          "bus_phone_extn": "",
          "fax_area_code": "858",
          "fax_num": "7921236",
          "email_address": "flarson@paxmed.com",
          "address_line_1": "1925 Palomar Oaks Way Ste 210",
          "address_line_2": "",
          "city": "Carlsbad",
          "state_code": "CA",
          "iso_country_code": "US",
          "zip_code": "92008",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "Kaigen Pharma Co.,Ltd.",
          "owner_operator_number": "10052192",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "2-5-3 Tenjin",
            "address_2": "",
            "city": "Otaru-shi",
            "state_code": "JP-01",
            "state_province": "Hokkaid?",
            "iso_country_code": "JP",
            "postal_code": "047-0011"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "MQV",
          "created_date": "2017-12-18",
          "owner_operator_number": "10052192",
          "exempt": "",
          "openfda": {
            "device_name": "Filler, Bone Void, Calcium Compound",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3045",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}