BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    BRIGHTWAY BRAND

    Reg #: 9617444 · FEI: 1000153304 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BRIGHTWAY HOLDINGS SDN. BHD.
    Registration Number
    9617444
    FEI Number
    1000153304
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    LOT 1559, JALAN ISTIMEWA,, BATU BELAH
    City
    KLANG, Selangor
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K991940

    Owner / Operator

    Firm Name
    BRIGHTWAY HOLDINGS SDN. BHD.
    Operator Number
    9036471
    Address
    LOT 1559, JALAN ISTIMEWA,, BATU BELAH
    City
    KLANG, SELANGOR
    State
    MY-NOTA
    Postal Code
    42100
    Country
    MY
    Correspondent
    BASKARAN - GOVINDASAMY

    US Agent

    Business Name
    Pragmatic Compliance dba FDAbasics
    Contact Name
    Jerry Doane
    Address
    15815 SW 11th Court Rd
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Surgeon'S Gloves KGO

    Proprietary Names

    BRIGHTWAY BRAND

    Establishment Types

    Manufacture Medical Device