{
  "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": [
        "FM-200 Doppler Fetal Heart Rate Detector"
      ],
      "establishment_type": [
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "3008457078",
        "fei_number": "3008457078",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2027",
        "name": "Shenzhen Biocare Bio-Medical Equipment Co., Ltd.",
        "address_line_1": "#16-1, Jinhui Road, Jinsha Community",
        "address_line_2": "Kengzi Sub-District, Pingshan New District",
        "city": "Shenzhen Guangdong",
        "state_code": "",
        "iso_country_code": "CN",
        "zip_code": "",
        "postal_code": "518122",
        "us_agent": {
          "name": "Marco Mu",
          "business_name": "MID-LINK INTERNATIONAL CO., LTD",
          "bus_phone_area_code": "360",
          "bus_phone_num": "3257028",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "us.agent@mid-link.net",
          "address_line_1": "2219 Rimlang Drive, Suite 301",
          "address_line_2": "",
          "city": "Bellingham",
          "state_code": "WA",
          "iso_country_code": "US",
          "zip_code": "98226",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "Shenzhen Biocare Bio-Medical Equipment Co., LTD",
          "owner_operator_number": "10036523",
          "official_correspondent": {
            "first_name": "Hongbo",
            "middle_initial": "",
            "last_name": "Zhong",
            "subaccount_company_name": "",
            "phone_number": "86-755-33005899-x"
          },
          "contact_address": {
            "address_1": "#16-1, Jinhui Road, Jinsha Community",
            "address_2": "Kengzi Sub-District, Pingshan New District",
            "city": "Shenzhen",
            "state_code": "CN-GD",
            "state_province": "Guangdong",
            "iso_country_code": "CN",
            "postal_code": "518122"
          }
        }
      },
      "pma_number": "",
      "k_number": "K100626",
      "products": [
        {
          "product_code": "KNG",
          "created_date": "2011-05-13",
          "owner_operator_number": "10036523",
          "exempt": "",
          "openfda": {
            "k_number": [
              "K100626"
            ],
            "device_name": "Monitor, Ultrasonic, Fetal",
            "medical_specialty_description": "Obstetrics/Gynecology",
            "regulation_number": "884.2660",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}