BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    APAS Independence

    Reg #: 3023940736 · FEI: 3023940736 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Planet Innovation Blackburn
    Registration Number
    3023940736
    FEI Number
    3023940736
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    31-47 Joseph Street
    City
    Blackburn North Victoria
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K183648

    Owner / Operator

    Firm Name
    Planet Innovation
    Operator Number
    10054268
    Address
    436 Elgar Road
    City
    Box Hill
    State
    Victoria
    Postal Code
    3128
    Country
    AU

    US Agent

    Business Name
    PLANET INNOVATION
    Contact Name
    Krystal Santiago
    Address
    80 Technology Drive
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    310 7075882

    Products

    Device Name Product Code
    Microbial Colony Image Assessment System PPU

    Proprietary Names

    APAS Independence

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)