BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    V-PRO S2 Low Temperature Sterilization System (MY-MF)

    Reg #: 3005899764 · FEI: 3005899764 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    STERIS MEXICO, S. de R.L. de C.V.
    Registration Number
    3005899764
    FEI Number
    3005899764
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    AVENIDA AVANTE 790,, PARQUE INDUSTRIAL GUADALUPE
    City
    GUADALUPE Nuevo Leon
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K222543

    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
    Sterilizer, Chemical MLR
    Washer, Cleaner, Automated, Endoscope NVE
    Sterilizer Automated Loading System PEC
    Sterilizer, Steam FLE

    Proprietary Names

    V-PRO S2 Low Temperature Sterilization System (MY-MF) AMSCO 600 STEAM Sterilizer (MY-MF) V-PRO maX 2 Low Temperature Sterilization System (MY-MF) RAS 12 Rack (FD256) (QB-MF) RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector (QB-MF) RAS 12 Long Rack (FD257) (QB-MF)

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198