BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    SampLok System

    Reg #: 3003895930 · FEI: 3011649541 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ITL ASIA PACIFIC SDN BHD
    Registration Number
    3003895930
    FEI Number
    3011649541
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Plot 17B, Lorong Bemban 2, Bemban Industrial Estate
    City
    Batu Gajah Perak
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K021941

    Owner / Operator

    Firm Name
    ITL Health Group
    Operator Number
    9033436
    Address
    Level 3, 59 Wentworth Ave
    City
    Kingston
    State
    Australian Capital Territory
    Postal Code
    2604
    Country
    AU
    Correspondent
    Narinder Kanda

    US Agent

    Business Name
    REGULATORY COMPLIANCE EXPERTS, INC.
    Contact Name
    Susan Finneran
    Address
    186 Old Farm Rd.
    City
    Abington
    State
    MA
    ZIP
    02351
    Country
    US
    Email
    [email protected]
    Phone
    781 6640074

    Products

    Device Name Product Code
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Needle, Hypodermic, Single Lumen FMI

    Proprietary Names

    SampLok System SampLok Safety Adapter Cap w/ Luer A100704 A100710 A100645 A100500

    Establishment Types

    Manufacture Medical Device