BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    TRANSMEDIC HEALTHCARE SDN BHD

    Reg #: 3013767421 · FEI: 3013767421 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    TRANSMEDIC HEALTHCARE SDN BHD
    Registration Number
    3013767421
    FEI Number
    3013767421
    Status
    Active
    Expiry Year
    2025
    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
    K201132

    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
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS

    Establishment Types

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