BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    BIOTRACE VERISURE and SEALSURE Indicators and Readers

    Reg #: 3015392401 · FEI: 3015392401 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ASP Global Manufacturing GmbH
    Registration Number
    3015392401
    FEI Number
    3015392401
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Im Majorenacker 10
    City
    SCHAFFHAUSEN
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K191021

    Owner / Operator

    Firm Name
    Advanced Sterilization Products
    Operator Number
    9068155
    Address
    33 Technology Drive, --
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Brent Lewis

    US Agent

    Business Name
    ADVANCED STERILIZATION PRODUCTS
    Contact Name
    Brent Lewis
    Address
    33 Technology Drive, --
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    425 2177539

    Products

    Device Name Product Code
    Indicator, Physical/Chemical Sterilization Process JOJ
    Indicator, Biological Sterilization Process FRC

    Proprietary Names

    BIOTRACE VERISURE and SEALSURE Indicators and Readers

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device