{
  "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": 9
    }
  },
  "results": [
    {
      "proprietary_name": [
        "DiaSpect Tm Cuvettes",
        "DiaSpect Tm"
      ],
      "establishment_type": [
        "Develop Specifications But Do Not Manufacture At This Facility",
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "3004838836",
        "fei_number": "3004838836",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "EKF DIAGNOSTIC GMBH",
        "address_line_1": "EBENDORFER CHAUSEE 3",
        "address_line_2": "",
        "city": "BARLEBEN/MADGEBURG Saxony-Anhalt",
        "state_code": "",
        "iso_country_code": "DE",
        "zip_code": "",
        "postal_code": "D-39179",
        "us_agent": {
          "name": "Stephen Gorski",
          "business_name": "Imagenix, Inc.",
          "bus_phone_area_code": "414",
          "bus_phone_num": "7374596",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "stephengorski@me.com",
          "address_line_1": "S65w35739 Piper Rd",
          "address_line_2": "",
          "city": "Eagle",
          "state_code": "WI",
          "iso_country_code": "US",
          "zip_code": "53119",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "EKF DIAGNOSTIC GMBH",
          "owner_operator_number": "9057009",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "EBENDORFER CHAUSEE 3",
            "address_2": "BARLEBEN/MADGEBURG",
            "city": "SAXONY-ANHALT",
            "state_code": "DE-NOTA",
            "state_province": "",
            "iso_country_code": "DE",
            "postal_code": "D-39179"
          }
        }
      },
      "pma_number": "",
      "k_number": "BK200520",
      "products": [
        {
          "product_code": "GKR",
          "created_date": "2021-03-09",
          "owner_operator_number": "9057009",
          "exempt": "",
          "openfda": {
            "device_name": "System, Hemoglobin, Automated",
            "medical_specialty_description": "Hematology",
            "regulation_number": "864.5620",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}