BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    Gems Vitrification Set

    Reg #: 3012853704 · FEI: 3012853704 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GENEA BIOMEDX Pty Ltd.
    Registration Number
    3012853704
    FEI Number
    3012853704
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    level2, 321 Kent Street
    City
    Sydney New South Wales
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K162409

    Owner / Operator

    Firm Name
    Genea Biomedx
    Operator Number
    10052443
    Address
    level2, 321 Kent Street
    City
    Sydney
    State
    New South Wales
    Postal Code
    2000
    Country
    AU
    Correspondent
    Regulatory Biomedx

    Products

    Device Name Product Code
    Media, Reproductive MQL

    Proprietary Names

    Gems Vitrification Set Gems Warming Set

    Establishment Types

    Manufacture Medical Device