BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    CarbonAid

    Reg #: 3009988302 · FEI: 3009988302 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    STERIPACK ASIA SDN BHD
    Registration Number
    3009988302
    FEI Number
    3009988302
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Lot 119992, Jalan Canang Emas 8,, Telok Gong
    City
    Klang Selangor
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K112975

    Owner / Operator

    Firm Name
    SteriPack Asia Sdn Bhd
    Operator Number
    10043162
    Address
    Lot 119992, Jalan Canang Emas 8,, Telok Gong
    City
    Klang
    State
    Selangor
    Postal Code
    42000
    Country
    MY
    Correspondent
    Wai Woon Khoo

    US Agent

    Business Name
    SteriPack USA (Limited) LLC
    Contact Name
    Marinela Cebic
    Address
    4255 S Pipkin Rd
    City
    Lakeland
    State
    FL
    ZIP
    33811
    Country
    US
    Email
    [email protected]
    Phone
    863 6482333

    Products

    Device Name Product Code
    Insufflator, Laparoscopic HIF

    Proprietary Names

    CarbonAid CarbonMini

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)