BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Solyx SIS Delivery device, Solyx Blue SIS Delivery Device

    Reg #: 3010609699 · FEI: 3010609699 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    FIRST ENGINEERING PLASTICS (M) SDN. BHD.
    Registration Number
    3010609699
    FEI Number
    3010609699
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.23, Jalan Persiaran Teknologi, Taman Teknologi Johor
    City
    Senai Johor
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K172565

    Owner / Operator

    Firm Name
    First Engineering Plastics (M) Sdn. Bhd.
    Operator Number
    10084526
    Address
    No.23, Jalan Persiaran Teknologi, Taman Teknologi Johor
    City
    Senai
    State
    Johor
    Postal Code
    814000
    Country
    MY

    US Agent

    Business Name
    Sunningdale Tech Inc.
    Contact Name
    Vincent Rajah Paskaran
    Address
    100 West Big Beaver, Suite 200,
    City
    Troy
    State
    MI
    ZIP
    48084
    Country
    US
    Email
    [email protected]
    Phone
    248 5260517

    Products

    Device Name Product Code
    Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence PWJ

    Proprietary Names

    Solyx SIS Delivery device, Solyx Blue SIS Delivery Device Obtryx Delivery Device (Curved & Halo)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)