BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    iSR'obot Mona Lisa 2

    Reg #: 3017263724 · FEI: 3017263724 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    SYS-MAC AUTOMATION ENGINEERING PTE LTD
    Registration Number
    3017263724
    FEI Number
    3017263724
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 Woodlands Sector 1, #05-18, Singapore 738068
    City
    Singapore North West
    Country
    SG

    Regulatory Submissions

    510(k) Number
    K213411

    Owner / Operator

    Firm Name
    Sys-Mac Automation Engineering Pte LTd
    Operator Number
    10091178
    Address
    2 Woodlands Sector 1, #05-18, Singapore 738068
    City
    Singapore
    State
    North West
    Postal Code
    738068
    Country
    SG
    Correspondent
    Ali Imamudeen

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX

    Proprietary Names

    iSR'obot Mona Lisa 2

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)