BEUDAMED
    FDA Registration Active 🇮🇳 India

    HOT RIDER

    Reg #: 9613932 · FEI: 3001687671 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Suretex Prophylactics (India) Private Limited
    Registration Number
    9613932
    FEI Number
    3001687671
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Plot No. 74-91 KIADB Industrial Estate, Jigani II Phase, Anekal Taluk
    City
    BANGALORE Karnataka
    Country
    IN

    Regulatory Submissions

    510(k) Number
    K010371

    Owner / Operator

    Firm Name
    Suretex Prophylactics (India) Private Limited
    Operator Number
    9029871
    Address
    Plot No. 74-91 KIADB Industrial Estate, Jigani-2nd Phase, Anekal Taluk
    City
    Bangalore
    State
    Karnataka
    Postal Code
    560 105
    Country
    IN
    Correspondent
    Prabhakar - KL

    US Agent

    Business Name
    SXWELL USA LLC
    Contact Name
    ALEXANDRA KIRKLAND
    Address
    66 Hudson Blvd E Fl 24
    City
    New York
    State
    NY
    ZIP
    10001
    Country
    US
    Email
    [email protected]
    Phone
    848 2293224

    Products

    Device Name Product Code
    Condom HIS
    Condom With Nonoxynol-9 LTZ

    Proprietary Names

    HOT RIDER Lifestyles, contempo - Glycerine

    Establishment Types

    Manufacture Medical Device