BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    3D INSTRUMENTATION SDN BHD

    Reg #: 3014170143 · FEI: 3014170143 · Expires 2026
    View on FDA
    Products
    20
    Proprietary Names
    39
    Establishment Types
    2
    Classifications
    20

    Registration Details

    Registration Name
    3D INSTRUMENTATION SDN BHD
    Registration Number
    3014170143
    FEI Number
    3014170143
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No.95, Lorong IKS Juru 5, Taman Perindustrian Ringan Juru
    City
    Bukit Mertajam Pulau Pinang
    Country
    MY

    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
    Stylet, Surgical, General & Plastic Surgery GAH
    Positioner, Socket KIL
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC
    Nail, Fixation, Bone JDS
    Countersink HWW
    Pin, Fixation, Smooth HTY
    Sacroiliac Joint Fixation OUR
    Bit, Drill HTW
    Neurological Stereotaxic Instrument HAW
    Orthopedic Stereotaxic Instrument OLO
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Orthopedic Manual Surgical Instrument LXH
    Gauge, Depth HTJ
    Rod, Fixation, Intramedullary And Accessories HSB
    Guide, Drill, Ligament LXI
    Powered Microneedle Device QAI
    Orthopedic Tray OJH

    Proprietary Names

    FO Micro Cleaning Stylet POSITIONER, SOCKET Anterior Mid - Shaft Clavicle Plates MDT Plate 1.4mm Drill Top Hat Dorsal Spanning Plate Distal Fibula Plates 1.4mm Mini Fragment Drill Guide Anterior Lateral Clavicle Plates 2mm Lag Screw Drill Guide Proximal Humerus Plate Superior Distal Clav Plates Superior Midshaft Clavicle Plates OIC Small / Mini Fragment Plate System 3.5mm LAG screw Drill Guide FO Countersink (Cannulated) 3.5 Extended Metaphyseal Cannulated hand drill 3.5 Metaphyseal Cannulated Hand drill 0.6 Single-ended Trocar K-wire 70mm FO Micro Screw (Cannulated) SiLO TFX MIS Sacroiliac Joint Fixation System catalog no. 114-303-0124 SiLO TFX Decorticating Reamer 24mm 1.4 FO Micro Drill (Cannulated) 1.1 FO Micro Drill Extended 3.5mm NX Metaphyseal Cannulated Hand Drill 3.5mm NX Metaphyseal Cannulated Hand Drill NX Depth Gauge Lag screw Tissure Protector FO Micro Depth Gauge (Cannulated) Bony Trauma Extremity System (BTES) Screw Range -NX Nail System NX Extremity Nail T10 Cannulated Torx Driver Straight Ball Spike Tibia Drop Tibia Nail Extraction Bolt ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Slotted Mallet FO Micro Screw Kit Tray and Lid

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility