{
  "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": {
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        "NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B",
        "CoralWell, NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B,",
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      ],
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        "fei_number": "3029929134",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "MACROLUX MEDICAL TECHNOLOGY CO., LTD.",
        "address_line_1": "301, Building 3, NamTai Inno Park In Guang Ming Avenue, Guangming",
        "address_line_2": "",
        "city": "Shenzhen Guangdong",
        "state_code": "",
        "iso_country_code": "CN",
        "zip_code": "",
        "postal_code": "518107",
        "us_agent": {
          "name": "Sarah Galemmo",
          "business_name": "ICAS Biologics Co., Ltd.",
          "bus_phone_area_code": "661",
          "bus_phone_num": "8033155",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "US.agent@icas.org.cn",
          "address_line_1": "20 Via Lucca D310",
          "address_line_2": "",
          "city": "Irvine",
          "state_code": "CA",
          "iso_country_code": "US",
          "zip_code": "92612",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "MacroLux Medical Technology Co., Ltd.",
          "owner_operator_number": "10089857",
          "official_correspondent": {
            "first_name": "Linbin",
            "middle_initial": "",
            "last_name": "Ye",
            "subaccount_company_name": "",
            "phone_number": "86-755-88656680-815"
          },
          "contact_address": {
            "address_1": "301, Building 3, NamTai Inno Park In Guang Ming Avenue, Guangming",
            "address_2": "",
            "city": "Shenzhen",
            "state_code": "CN-GD",
            "state_province": "Guangdong",
            "iso_country_code": "CN",
            "postal_code": "518107"
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        }
      },
      "pma_number": "",
      "k_number": "K250452",
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        {
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            "device_name": "Endoscopic Access Overtube, Gastroenterology-Urology",
            "medical_specialty_description": "Gastroenterology, Urology",
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}