BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Aixplorer®& Aixplorer® Ultimate

    Reg #: 3006786907 · FEI: 3006786907 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Plexus Manufacturing Sdn .Bhd.
    Registration Number
    3006786907
    FEI Number
    3006786907
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Plot 87, 88 & 89 Lebuhraya Kampung Jawa,
    City
    Bayan Lepas Pulau Pinang
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K173021

    Owner / Operator

    Firm Name
    PLEXUS CORP.
    Operator Number
    3019588
    Address
    ONE PLEXUS WAY, --
    City
    Neenah
    State
    WI
    Postal Code
    54956
    Country
    US

    Products

    Device Name Product Code
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    Aixplorer®& Aixplorer® Ultimate

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)