{
  "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": 2
    }
  },
  "results": [
    {
      "proprietary_name": [
        "PureRegen Gel Sinus"
      ],
      "establishment_type": [
        "Manufacture Medical Device for Another Party (Contract Manufacturer)",
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "3007327621",
        "fei_number": "3007327621",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "BIOREGEN BIOMEDICAL (CHANGZHOU) CO., LTD",
        "address_line_1": "Building B, No. 117, Xueye Road",
        "address_line_2": "",
        "city": "Changzhou Jiangsu",
        "state_code": "",
        "iso_country_code": "CN",
        "zip_code": "",
        "postal_code": "213125",
        "us_agent": {
          "name": "Charles Mack",
          "business_name": "IRC USA",
          "bus_phone_area_code": "931",
          "bus_phone_num": "6254938",
          "bus_phone_extn": "",
          "fax_area_code": "541",
          "fax_num": "3765063",
          "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": "BioRegen Biomedical (Changzhou) Co., Ltd",
          "owner_operator_number": "10027304",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "Building B, No. 117, Xueye Road",
            "address_2": "",
            "city": "Changzhou",
            "state_code": "CN-JS",
            "state_province": "Jiangsu",
            "iso_country_code": "CN",
            "postal_code": "213125"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "LYA",
          "created_date": "2008-10-23",
          "owner_operator_number": "10027304",
          "exempt": "",
          "openfda": {
            "device_name": "Splint, Intranasal Septal",
            "medical_specialty_description": "Ear, Nose, Throat",
            "regulation_number": "874.4780",
            "device_class": "1"
          }
        }
      ]
    }
  ]
}