BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Medtronic Exacta External Drainage and Monitoring System (Exacta EDMS)

    Reg #: 3004593495 · FEI: 3004593495 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Plexus Manufacturing Sdn. Bhd.
    Registration Number
    3004593495
    FEI Number
    3004593495
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Bayan Lepas Free Industrial Zone, Phase II
    City
    Bayan Lepas Pulau Pinang
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K201118

    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
    Catheter, Ventricular HCA
    Device, Monitoring, Intracranial Pressure GWM

    Proprietary Names

    Medtronic Exacta External Drainage and Monitoring System (Exacta EDMS)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)