{
  "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": "2026-10-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Sirius Pintuition Test Kit",
        "Sirius Pintuition Seed 7cm",
        "Sirius Pintuition Base Unit",
        "Sirius Pintuition Seed 12cm",
        "Sirius Pintuition Probe",
        "Sirius Pintuition Slim Probe",
        "Sirius Pintuition Slim Test Kit"
      ],
      "establishment_type": [
        "Develop Specifications But Do Not Manufacture At This Facility",
        "Complaint File Establishment per 21 CFR 820.198"
      ],
      "registration": {
        "registration_number": "3020733550",
        "fei_number": "3020733550",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "SIRIUS MEDICAL SYSTEMS B.V.",
        "address_line_1": "High Tech Campus 41",
        "address_line_2": "",
        "city": "Eindhoven Noord-Brabant",
        "state_code": "",
        "iso_country_code": "NL",
        "zip_code": "",
        "postal_code": "5656AE",
        "us_agent": {
          "name": "Dana Troup",
          "business_name": "",
          "bus_phone_area_code": "317",
          "bus_phone_num": "5015238",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "dana.troup@sirius-medical.com",
          "address_line_1": "13898 N Rim Trl",
          "address_line_2": "",
          "city": "Marana",
          "state_code": "AZ",
          "iso_country_code": "US",
          "zip_code": "85658",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "Sirius Medical Systems B.V.",
          "owner_operator_number": "10082996",
          "official_correspondent": {
            "first_name": "Bram",
            "middle_initial": "",
            "last_name": "Schermers",
            "subaccount_company_name": "",
            "phone_number": "31-620-116299-x"
          },
          "contact_address": {
            "address_1": "High Tech Campus 41",
            "address_2": "",
            "city": "Eindhoven",
            "state_code": "NL-NB",
            "state_province": "Noord-Brabant",
            "iso_country_code": "NL",
            "postal_code": "5656AE"
          }
        }
      },
      "pma_number": "",
      "k_number": "K223682",
      "products": [
        {
          "product_code": "PBY",
          "created_date": "2023-11-15",
          "owner_operator_number": "10082996",
          "exempt": "",
          "openfda": {
            "k_number": [
              "K223682"
            ],
            "device_name": "Temporary Tissue Marker",
            "medical_specialty_description": "General, Plastic Surgery",
            "regulation_number": "878.4300",
            "device_class": "2"
          }
        },
        {
          "product_code": "NEU",
          "created_date": "2023-11-15",
          "owner_operator_number": "10082996",
          "exempt": "",
          "openfda": {
            "device_name": "Marker, Radiographic, Implantable",
            "medical_specialty_description": "General, Plastic Surgery",
            "regulation_number": "878.4300",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}