{
  "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": 1
    }
  },
  "results": [
    {
      "proprietary_name": [
        "APTIMAX Instrument Tray or ULTRA GI Cycle",
        "model:011077-50"
      ],
      "establishment_type": [
        "Manufacture Medical Device for Another Party (Contract Manufacturer)"
      ],
      "registration": {
        "registration_number": "3012892649",
        "fei_number": "3012892649",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "NINGBO INCOTE PRECISION MACHINERY CO., LTD.",
        "address_line_1": "No.1,Wuxiang North Road,",
        "address_line_2": "Wuxiang Industry Zone",
        "city": "Ningbo City Zhejiang",
        "state_code": "",
        "iso_country_code": "CN",
        "zip_code": "",
        "postal_code": "315111",
        "us_agent": {
          "name": "David Lennarz",
          "business_name": "Registrar Corp",
          "bus_phone_area_code": "757",
          "bus_phone_num": "2240177",
          "bus_phone_extn": "",
          "fax_area_code": "757",
          "fax_num": "2240179",
          "email_address": "David.Lennarz@registrarcorp.com",
          "address_line_1": "144 Research Dr",
          "address_line_2": "",
          "city": "Hampton",
          "state_code": "VA",
          "iso_country_code": "US",
          "zip_code": "23666",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "Ningbo Incote Precision Machinery Co., Ltd.",
          "owner_operator_number": "10091589",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "No.1,Wuxiang North Road,",
            "address_2": "Wuxiang Industry Zone",
            "city": "Ningbo City",
            "state_code": "CN-ZJ",
            "state_province": "Zhejiang",
            "iso_country_code": "CN",
            "postal_code": "315111"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "FRG",
          "created_date": "2024-10-17",
          "owner_operator_number": "10091589",
          "exempt": "",
          "openfda": {
            "device_name": "Wrap, Sterilization",
            "medical_specialty_description": "General Hospital",
            "regulation_number": "880.6850",
            "device_class": "2"
          }
        },
        {
          "product_code": "MLR",
          "created_date": "2024-10-17",
          "owner_operator_number": "10091589",
          "exempt": "",
          "openfda": {
            "device_name": "Sterilizer, Chemical",
            "medical_specialty_description": "General Hospital",
            "regulation_number": "880.6860",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}