BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    BERGAMOT SDN BHD

    Reg #: 3014743234 · FEI: 3014743234 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BERGAMOT SDN BHD
    Registration Number
    3014743234
    FEI Number
    3014743234
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    NO. 7 & 8, JALAN SINARAN 6, KAWASAN PERINDUSTRIAN SINARAN
    City
    KAJANG Selangor
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K001619

    Owner / Operator

    Firm Name
    BERGAMOT SDN BHD
    Operator Number
    10079487
    Address
    NO. 7 & 8, JALAN SINARAN 6, KAWASAN PERINDUSTRIAN SINARAN
    City
    KAJANG
    State
    Selangor
    Postal Code
    43000
    Country
    MY
    Correspondent
    SITI KARTIKA HAMDAN

    Products

    Device Name Product Code
    Polymer Patient Examination Glove LZA

    Establishment Types

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