BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Dental Dam

    Reg #: 3005822857 · FEI: 3005822857 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ELASTOMADE ACCESSORIES SDN BHD
    Registration Number
    3005822857
    FEI Number
    3005822857
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Lot 7, Lengkungan Hishamuddin, Kawasan Perusahaan Selat Klang Utara
    City
    Port Klang Selangor
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K942992

    Owner / Operator

    Firm Name
    ELASTOMADE ACCESSORIES SDN BHD
    Operator Number
    9001465
    Address
    Lot 7, Lengkungan Hishamuddin, Kawasan Perusahaan Selat Klang Utara
    City
    Port Klang
    State
    Selangor
    Postal Code
    42000
    Country
    MY
    Correspondent
    Bee Hong Ooi

    US Agent

    Business Name
    FDAIMPORTS LLC
    Contact Name
    FDAIMPORTS.COM LLC
    Address
    2631 Housley Road, #1211
    City
    Annapolis
    State
    MD
    ZIP
    21401
    Country
    US
    Email
    [email protected]
    Phone
    410 2202800

    Products

    Device Name Product Code
    Dam, Rubber EIE

    Proprietary Names

    Dental Dam Royal Shield Latex Free Dental Dam

    Establishment Types

    Manufacture Medical Device