BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    NovoSorb MTX

    Reg #: 3007886187 · FEI: 3007886187 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    POLYNOVO BIOMATERIALS PTY LTD
    Registration Number
    3007886187
    FEI Number
    3007886187
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2/320 lorimer Street
    City
    Port Melbourne Victoria
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K221686

    Owner / Operator

    Firm Name
    PolyNovo Biomaterials Pty Ltd
    Operator Number
    10046720
    Address
    2/320 Lorimer Street
    City
    Port Melbourne
    State
    Victoria
    Postal Code
    3207
    Country
    AU
    Correspondent
    Shruti Dave

    US Agent

    Business Name
    PolyNovo
    Contact Name
    JOSEPH DEPAOLO
    Address
    2121 Palomar Airport Rd, Suite 350
    City
    Carlsbad
    State
    CA
    ZIP
    92011
    Country
    US
    Email
    [email protected]
    Phone
    760 4485515

    Products

    Device Name Product Code
    Absorbable Synthetic Wound Dressing QSZ

    Proprietary Names

    NovoSorb MTX

    Establishment Types

    Manufacture Medical Device