BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    TRANSMEDIC HEALTHCARE SDN BHD

    Reg #: 3013767421 · FEI: 3013767421 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    13

    Registration Details

    Registration Name
    TRANSMEDIC HEALTHCARE SDN BHD
    Registration Number
    3013767421
    FEI Number
    3013767421
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    B4-1-1, Solaris Dutamas, No 1, Jalan Dutamas 1
    City
    Kuala Lumpur Kuala Lumpur
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K171296

    Owner / Operator

    Firm Name
    TRANSMEDIC HEALTHCARE SDN BHD
    Operator Number
    10091473
    Address
    B4-1-1, Solaris Dutamas, No 1, Jalan Dutamas 1
    City
    Kuala Lumpur
    State
    Kuala Lumpur
    Postal Code
    50480
    Country
    MY

    US Agent

    Business Name
    Arthrex Inc.
    Contact Name
    David Rogers
    Address
    1370 Creekside Blvd
    City
    Naples
    State
    FL
    ZIP
    34108
    Country
    US
    Email
    [email protected]
    Phone
    800 9337001

    Products

    Device Name Product Code
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Washer, Bolt Nut HTN
    Laparoscope, General & Plastic Surgery GCJ
    System, X-Ray, Angiographic IZI
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Instrument, Manual, Surgical, General Use MDM
    Balance, Analytical JQO
    Table And Attachments, Operating-Room BWN
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS
    Controller, Foot, Handpiece And Cord EBW

    Proprietary Names

    CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE INSTRUMENT, MANUAL, SURGICAL, GENERAL USE balance, analytical Table and attachments, operating-room INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device