{
  "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": 3
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Caviwave Ultrasonic Cleaner (MD-CFE)",
        "InnoWave ECO ULTRASONIC CLEANER (2.6 GAL) (MD-MF)",
        "Renu Klenz (SL-MF, SLDC-RR)",
        "STANDARD BASKET FOR ULTRA (MD-MF)",
        "Klenzyme (SL-CFE)",
        "Prolystica Ultra Concentrate HP Alkaline Detergent (1C17) (SL-MF, SLDC-RR)",
        "Prolystica HP Alkaline Manual Cleaner (1C26) (SL-MF, SLDC-RR)",
        "Multi-Enzymatic Foaming Cleanser RTU",
        "STANDARD BASKET FOR ULTRA+ (MD-MF)",
        "Prolystica 2X Concentrate Neutral Detergent (SL-MF, SLDC-RR)",
        "INSTRUMENT ORGANIZERS FOR InnoWave ULTRA+ (MD-MF)",
        "Prolystica HP Enzymatic Manual Cleaner Dye & Fragance (1C23) (SL-MF, SLDC-RR)",
        "Prolystica 2X Concentrate Enzymatic Presoak and Cleaner (SL-MF, SLDC-RR)",
        "InnoWave Unity 20 Sonic Irrigator (MD-MF)",
        "Valsure Enzymatic Cleaner (SL-MF, SLDC-RR)",
        "RTU Concentrated Z-Sponge",
        "Prolystica HP Alkaline Automated Detergent (1C20) (SL-MF, SLDC-RR)",
        "Valsure Alkaline Detergent (SL-MF, SLDC-RR)",
        "Liqui Jet 2 (SL-CFE)",
        "Non-Foaming Multi-Enzymatic Cleanser",
        "Post Procedure Enzymatic Cleaning Kit",
        "INSTRUMENT ORGANIZERS FOR InnoWave ULTRA (MD-MF)",
        "InnoWave ECO ULTRASONIC CLEANER (5.3 GAL) (MD-MF)",
        "InnoWave ECO 2.6 Gallon Standard Mesh Basket (MD-MF)",
        "INSTRUMENT ORGANIZERS FOR PCF  (MD-CFE)",
        "InnoWave ECO 5.3 Gallon Standard Mesh Basket (MD-MF)",
        "Prolystica Ultra Concentrate Alkaline Detergent (SL-MF, SLDC-RR)",
        "Prolystica Ultra Concentrate HP Neutral Detergent (1C15) (SL-MF, SLDC-RR)",
        "Pre-Klenz Enzymatic Soak Shield Kit 2D66Q5, 2D66J3, 2D66J4, 2D66J6 (SL-MF)",
        "Distal Tip Soakers (MD-CFE)",
        "Valsure Neutral Detergent (SL-MF, SLDC-RR)",
        "Prolystica HP Neutral Manual Cleaner (1C27) (SL-MF, SLDC-RR)",
        "Prolystica 2X Concentrate Alkaline Detergent (SL-MF, SLDC-RR)",
        "Prolystica HP Enzymatic Automated Detergent (1C22) (SL-MF, SLDC-RR)",
        "3E-ZYME Triple Enzyme Cleaning Solution (SL-CFE)",
        "Distal Duck Kit (MD-CFE)",
        "InnoWave ULTRA+ SONIC IRRIGATOR (MD-MF)",
        "InnoWave ULTRA SONIC IRRIGATOR (MD-MF)",
        "Prolystica HP Enzymatic Manual Cleaner (1C24) (SL-MF, SLDC-RR)",
        "InnoWave Unity Sonic Irrigator (MD-MF)",
        "RTU Foaming Z-Sponge",
        "Prolystica HP Neutral Automated Detergent (1C21) (SL-MF, SLDC-RR)",
        "Multi-Enzymatic Cleaner (SL-MF, SLDC-RR)",
        "Prolystica Ultra Concentrate HP Enzymatic Cleaner (1C16) (SL-MF, SLDC-RR)",
        "VERIFY DualAction Ultrasonic Indicator Holder (LCC028)",
        "VERIFY DualAction Ultrasonic Indicator (DUI) (LCC027)"
      ],
      "establishment_type": [
        "Manufacture Medical Device",
        "Complaint File Establishment per 21 CFR 820.198"
      ],
      "registration": {
        "registration_number": "9617134",
        "fei_number": "3000255542",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2027",
        "name": "MEDISAFE UK LTD.",
        "address_line_1": "Unit 7 & 8, Stortford Hall Industrial Park, Dunmow Road",
        "address_line_2": "",
        "city": "Bishops Stortford Hertfordshire",
        "state_code": "",
        "iso_country_code": "GB",
        "zip_code": "",
        "postal_code": "CM23 5GZ",
        "us_agent": {
          "name": "Becky Aldhizer",
          "business_name": "STERIS Corporation",
          "bus_phone_area_code": "440",
          "bus_phone_num": "3927490",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "becky_aldhizer@steris.com",
          "address_line_1": "5960 Heisley Road",
          "address_line_2": "",
          "city": "Mentor",
          "state_code": "OH",
          "iso_country_code": "US",
          "zip_code": "44060",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "STERIS Corporation",
          "owner_operator_number": "10078069",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "5960 Heisley Road",
            "address_2": "",
            "city": "Mentor",
            "state_code": "OH",
            "state_province": "",
            "iso_country_code": "US",
            "postal_code": "44060"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "FLG",
          "created_date": "2020-10-09",
          "owner_operator_number": "10078069",
          "exempt": "",
          "openfda": {
            "device_name": "Cleaner, Ultrasonic, Medical Instrument",
            "medical_specialty_description": "General Hospital",
            "regulation_number": "880.6150",
            "device_class": "1"
          }
        }
      ]
    }
  ]
}