BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    YLite

    Reg #: 3008965332 · FEI: 3008965332 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NORSELD PTY. LTD.
    Registration Number
    3008965332
    FEI Number
    3008965332
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    18 LOWE ST
    City
    ADELAIDE South Australia
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K032397

    Owner / Operator

    Firm Name
    NORSELD PTY. LTD.
    Operator Number
    9029470
    Address
    18 LOWE ST
    City
    ADELAIDE
    State
    South Australia
    Postal Code
    5000
    Country
    AU
    Correspondent
    PETER K SHUTE

    US Agent

    Business Name
    REGULATORY INSIGHT, INC.
    Contact Name
    Kevin Wallis
    Address
    33 Golden Eagle Lane
    City
    Littleton
    State
    CO
    ZIP
    80127
    Country
    US
    Email
    [email protected]
    Phone
    720 9625412

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    YLite Dual Yellow Copper Bromide Laser D10B

    Establishment Types

    Manufacture Medical Device