{
  "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": 1
    }
  },
  "results": [
    {
      "proprietary_name": [
        "PyloPlus"
      ],
      "establishment_type": [
        "Manufacture Medical Device",
        "Complaint File Establishment per 21 CFR 820.198"
      ],
      "registration": {
        "registration_number": "3010837197",
        "fei_number": "3010837197",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "FISCHER ANALYSEN INSTRUMENTE GMBH",
        "address_line_1": "Brahestr. 25-27",
        "address_line_2": "",
        "city": "Leipzig Saxony",
        "state_code": "",
        "iso_country_code": "DE",
        "zip_code": "",
        "postal_code": "04347",
        "us_agent": {
          "name": "Philip Ross",
          "business_name": "Gulf Coast Scientific, Inc. / ARJ Medical, Inc.",
          "bus_phone_area_code": "813",
          "bus_phone_num": "8551557",
          "bus_phone_extn": "7912",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "PRoss@gulfcoastscientific.com",
          "address_line_1": "13812 Wright Cir",
          "address_line_2": "",
          "city": "Tampa",
          "state_code": "FL",
          "iso_country_code": "US",
          "zip_code": "33626",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "Fischer ANalysen Instrumente GmbH",
          "owner_operator_number": "10062455",
          "official_correspondent": {
            "first_name": "Martin",
            "middle_initial": "",
            "last_name": "Schaich",
            "subaccount_company_name": "",
            "phone_number": "49-0341-24450-0"
          },
          "contact_address": {
            "address_1": "Brahestr. 25-27",
            "address_2": "",
            "city": "Leipzig",
            "state_code": "DE-SN",
            "state_province": "Saxony",
            "iso_country_code": "DE",
            "postal_code": "04347"
          }
        }
      },
      "pma_number": "P170022",
      "k_number": "",
      "products": [
        {
          "product_code": "OZA",
          "created_date": "2020-03-05",
          "owner_operator_number": "10062455",
          "exempt": "",
          "openfda": {
            "device_name": "Test, Urea Adult And Pediatric (Breath),",
            "medical_specialty_description": "Microbiology",
            "regulation_number": "866.3110",
            "device_class": "3",
            "pma_number": [
              "P170022"
            ]
          }
        }
      ]
    }
  ]
}