BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    SYSTEM 1 endo Quick Connects (HP-MF, CM-SD)

    Reg #: 9680353 · FEI: 3004097451 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    STERIS Canada ULC
    Registration Number
    9680353
    FEI Number
    3004097451
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    490 Boulevard Armand-Paris
    City
    QUEBEC
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K210737

    Owner / Operator

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

    US Agent

    Business Name
    STERIS Corporation
    Contact Name
    Becky Aldhizer
    Address
    5960 Heisley Rd
    City
    Mentor
    State
    OH
    ZIP
    44060
    Country
    US
    Email
    [email protected]
    Phone
    440 3927490

    Products

    Device Name Product Code
    Sterilant, Medical Devices MED

    Proprietary Names

    SYSTEM 1 endo Quick Connects (HP-MF, CM-SD) SYSTEM 1E Trays and Containers (QB-MF, CM-SD) SYSTEM 1 endo Trays and Containers (QB-MF, CM-SD) S40 Sterilant Concentrate (MM-MF, CM-SD) SYSTEM 1E Quick Connects (HP-MF, CM-SD) SYSTEM 1E Liquid Chemical Sterilant Processing System (QB-MF, CM-SD) SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) (QB-MF, CM-SD) SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800) (QB-CFE)

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198