BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    & Foley Tray (I.C.)

    Reg #: 8040607 · FEI: 3002806591 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BARD SDN. BHD.
    Registration Number
    8040607
    FEI Number
    3002806591
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    LOT 57-C, KULIM INDUSTRIAL ESTATE
    City
    KULIM Kedah
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K910318

    Owner / Operator

    Firm Name
    C. R. Bard, Inc.
    Operator Number
    2212754
    Address
    1 Becton Drive
    City
    Franklin Lakes
    State
    NJ
    Postal Code
    07417
    Country
    US

    Products

    Device Name Product Code
    Catheter, Urological (Antimicrobial) And Accessories MJC

    Proprietary Names

    & Foley Tray (I.C.) Hydrogel/Silver-Coated Foley Cath Bardex I.C. Foley Catheter (offered in strips and trays)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)