{
  "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": 10
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Transrectal Reusable Needle Guide for EV29L transducer - 18GA",
        "Exact EV5C Transducer",
        "ExactVu High Resolution Micro-Ultrasound System",
        "Exact EV9C Transducer",
        "Transrectal Reusable Needle Guide for EV29L transducer for 16 GA Needle"
      ],
      "establishment_type": [
        "Manufacture Medical Device for Another Party (Contract Manufacturer)"
      ],
      "registration": {
        "registration_number": "3011162972",
        "fei_number": "3011162972",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "SONELE INC.",
        "address_line_1": "2751 John St",
        "address_line_2": "",
        "city": "Markham Ontario",
        "state_code": "",
        "iso_country_code": "CA",
        "zip_code": "",
        "postal_code": "L3R 2Y8",
        "us_agent": {
          "name": "Yong Sun",
          "business_name": "Emergo Global Representation LLC",
          "bus_phone_area_code": "512",
          "bus_phone_num": "3279997",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "USAgent@ul.com",
          "address_line_1": "2500 Bee Cave Rd.",
          "address_line_2": "Bldg. 1, Ste. 300",
          "city": "Austin",
          "state_code": "TX",
          "iso_country_code": "US",
          "zip_code": "78746",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "SONELE Inc.",
          "owner_operator_number": "10051244",
          "official_correspondent": {
            "first_name": "Eric",
            "middle_initial": "",
            "last_name": "Reider",
            "subaccount_company_name": "",
            "phone_number": "1-905-7528886-6014"
          },
          "contact_address": {
            "address_1": "46 Riviera Drive",
            "address_2": "",
            "city": "Markham",
            "state_code": "CA-ON",
            "state_province": "Ontario",
            "iso_country_code": "CA",
            "postal_code": "L3R 5M1"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "OIJ",
          "created_date": "2025-04-23",
          "owner_operator_number": "10051244",
          "exempt": "",
          "openfda": {
            "device_name": "Biopsy Needle Guide Kit",
            "medical_specialty_description": "Radiology",
            "regulation_number": "892.1560",
            "device_class": "2"
          }
        },
        {
          "product_code": "IYO",
          "created_date": "2025-04-23",
          "owner_operator_number": "10051244",
          "exempt": "",
          "openfda": {
            "device_name": "System, Imaging, Pulsed Echo, Ultrasonic",
            "medical_specialty_description": "Radiology",
            "regulation_number": "892.1560",
            "device_class": "2"
          }
        },
        {
          "product_code": "IYN",
          "created_date": "2025-04-23",
          "owner_operator_number": "10051244",
          "exempt": "",
          "openfda": {
            "device_name": "System, Imaging, Pulsed Doppler, Ultrasonic",
            "medical_specialty_description": "Radiology",
            "regulation_number": "892.1550",
            "device_class": "2"
          }
        },
        {
          "product_code": "ITX",
          "created_date": "2025-04-23",
          "owner_operator_number": "10051244",
          "exempt": "",
          "openfda": {
            "device_name": "Transducer, Ultrasonic, Diagnostic",
            "medical_specialty_description": "Radiology",
            "regulation_number": "892.1570",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}