BEUDAMED
    FDA Registration Active 🇺🇸 United States

    STERIS CORPORATION

    Reg #: 1937531 · FEI: 1937531 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    56
    Establishment Types
    4
    Classifications
    4

    Registration Details

    Registration Name
    STERIS CORPORATION
    Registration Number
    1937531
    FEI Number
    1937531
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    7501 Page Ave
    City
    Saint Louis
    State
    MO
    ZIP
    63133
    Country
    US

    Regulatory Submissions

    510(k) Number
    K232918

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    10078069
    Address
    5960 Heisley Road
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Cleaner, Ultrasonic, Medical Instrument FLG
    Accessories, Germicide, Cleaning, For Endoscopes NZA
    Basin For Endoscope Reprocessing PHT
    Sterilant, Medical Devices MED
    SHM

    Proprietary Names

    Prolystica Multi-Enzymatic Cleaner (1C38) Prolystica 100 PID Prion Inactivating Detergent 8E-Zyme Cleaner RevitalOx PAA HLD Solution Part B (SL-MF, SLDC-RR) enspire 300 Series Connectors (HP-MF) enspire 300 Series Automated Endoscope Reprocessor (QB-MF) RevitalOx PAA HLD Solution Part A (MM-MF) Revital-Ox Rigid Container System (2D93Q0) (SL-CFE, SLDC-RR) Revital-Ox Flexible Container - Round (2D94Q0) (SL-CFE, SLDC-RR) Revital-Ox Resert High Level Disinfectant (SL-MF, SLDC-RR) Prolystica Pass-Thru Disinfectant Wipes (1C061D) (SL-SD, SLDC-RR) STANDARD BASKET FOR ULTRA+ (MD-MF) Prolystica HP Enzymatic Automated Detergent (1C22) (SL-MF, SLDC-RR) Liqui Jet 2 (SL-CFE) Prolystica Ultra Concentrate Alkaline Detergent (SL-MF, SLDC-RR) Valsure Alkaline Detergent (SL-MF, SLDC-RR) Prolystica 2X Concentrate Neutral Detergent (SL-MF, SLDC-RR) Prolystica 2X Concentrate Alkaline Detergent (SL-MF, SLDC-RR) Prolystica 2X Concentrate Enzymatic Presoak and Cleaner (SL-MF, SLDC-RR) RTU Concentrated Z-Sponge RTU Foaming Z-Sponge Distal Duck Kit (MD-CFE) Prolystica HP Neutral Manual Cleaner (1C27) (SL-MF, SLDC-RR) Prolystica HP Enzymatic Manual Cleaner (1C24) (SL-MF, SLDC-RR) Prolystica HP Alkaline Automated Detergent (1C20) (SL-MF, SLDC-RR) InnoWave ECO ULTRASONIC CLEANER (5.3 GAL) (MD-MF) Valsure Enzymatic Cleaner (SL-MF, SLDC-RR) STANDARD BASKET FOR ULTRA (MD-MF) Valsure Neutral Detergent (SL-MF, SLDC-RR) InnoWave ECO 2.6 Gallon Standard Mesh Basket (MD-MF) 3E-ZYME Triple Enzyme Cleaning Solution (SL-CFE) Multi-Enzymatic Foaming Cleanser RTU InnoWave ULTRA SONIC IRRIGATOR (MD-MF) INSTRUMENT ORGANIZERS FOR PCF (MD-CFE) VERIFY DualAction Ultrasonic Indicator (DUI) (LCC027) Prolystica Ultra Concentrate HP Enzymatic Cleaner (1C16) (SL-MF, SLDC-RR) InnoWave Unity Sonic Irrigator (MD-MF) Renu Klenz (SL-MF, SLDC-RR) Multi-Enzymatic Cleaner (SL-MF, SLDC-RR) INSTRUMENT ORGANIZERS FOR InnoWave ULTRA (MD-MF) Prolystica HP Alkaline Manual Cleaner (1C26) (SL-MF, SLDC-RR) Prolystica Ultra Concentrate HP Alkaline Detergent (1C17) (SL-MF, SLDC-RR) Prolystica HP Enzymatic Manual Cleaner Dye & Fragance (1C23) (SL-MF, SLDC-RR) InnoWave Unity 20 Sonic Irrigator (MD-MF) Klenzyme (SL-CFE) InnoWave ECO ULTRASONIC CLEANER (2.6 GAL) (MD-MF) Post Procedure Enzymatic Cleaning Kit InnoWave ULTRA+ SONIC IRRIGATOR (MD-MF) Prolystica HP Neutral Automated Detergent (1C21) (SL-MF, SLDC-RR) INSTRUMENT ORGANIZERS FOR InnoWave ULTRA+ (MD-MF) Prolystica Ultra Concentrate HP Neutral Detergent (1C15) (SL-MF, SLDC-RR) InnoWave ECO 5.3 Gallon Standard Mesh Basket (MD-MF) Non-Foaming Multi-Enzymatic Cleanser VERIFY DualAction Ultrasonic Indicator Holder (LCC028) Distal Tip Soakers (MD-CFE) Pre-Klenz Enzymatic Soak Shield Kit 2D66Q5, 2D66J3, 2D66J4, 2D66J6 (SL-MF)

    Establishment Types

    Manufacture Device in the United States for Export Only Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility