BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    PENTAX Medical Video Processor (EPK-i8020c)

    Reg #: 3006786907 · FEI: 3006786907 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    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
    K231249

    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
    Endoscope, Accessories, Image Post-Processing For Color Enhancement PEA

    Proprietary Names

    PENTAX Medical Video Processor (EPK-i8020c) PENTAX Medical Keyboard EN (OS-A115)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)