{
  "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": 16
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Isosafe Earloop Procedure Mask(Blue,Yellow)"
      ],
      "establishment_type": [
        "Manufacture Medical Device for Another Party (Contract Manufacturer)"
      ],
      "registration": {
        "registration_number": "3003348807",
        "fei_number": "3003348807",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "ZHENDE MEDICAL CO., LTD.",
        "address_line_1": "GAOBU TOWN",
        "address_line_2": "",
        "city": "SHAOXING Zhejiang",
        "state_code": "",
        "iso_country_code": "CN",
        "zip_code": "",
        "postal_code": "312035",
        "us_agent": {
          "name": "Leeyeo Kee",
          "business_name": "",
          "bus_phone_area_code": "302",
          "bus_phone_num": "6089028",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "regrek.cs@hotmail.com",
          "address_line_1": "19 Holly Cove Ln. Dover, Delaware, 19901, UNITED STATES",
          "address_line_2": "",
          "city": "Dover",
          "state_code": "DE",
          "iso_country_code": "US",
          "zip_code": "19901",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "Zhende Medical Co., Ltd",
          "owner_operator_number": "9050974",
          "official_correspondent": {
            "first_name": "Ming",
            "middle_initial": "",
            "last_name": "Chen",
            "subaccount_company_name": "",
            "phone_number": "86-575-88086666-x"
          },
          "contact_address": {
            "address_1": "GAOBU TOWN",
            "address_2": "--",
            "city": "SHAOXING, ZHEJIANG PROVINCE",
            "state_code": "CN-ZJ",
            "state_province": "",
            "iso_country_code": "CN",
            "postal_code": "312035"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "FXX",
          "created_date": "2020-04-09",
          "owner_operator_number": "9050974",
          "exempt": "",
          "openfda": {
            "device_name": "Mask, Surgical",
            "medical_specialty_description": "General, Plastic Surgery",
            "regulation_number": "878.4040",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}