BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Superior Distal Clav Plates

    Reg #: 3014170143 · FEI: 3014170143 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    3D INSTRUMENTATION SDN BHD
    Registration Number
    3014170143
    FEI Number
    3014170143
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.95, Lorong IKS Juru 5, Taman Perindustrian Ringan Juru
    City
    Bukit Mertajam Pulau Pinang
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K242995

    Owner / Operator

    Firm Name
    3D Instrumentation Sdn Bhd
    Operator Number
    10056829
    Address
    No 95, Lorong IKS Juru 5, Taman Perindustrian Ringan Juru,, Bukit Mertajam
    City
    Penang
    State
    Pulau Pinang
    Postal Code
    14000
    Country
    MY

    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
    Plate, Fixation, Bone HRS

    Proprietary Names

    Superior Distal Clav Plates Dorsal Spanning Plate Distal Fibula Plates OIC Small / Mini Fragment Plate System Anterior Lateral Clavicle Plates 3.5mm LAG screw Drill Guide Anterior Mid - Shaft Clavicle Plates Superior Midshaft Clavicle Plates Proximal Humerus Plate MDT Plate

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)