BEUDAMED
    FDA Registration Active 🇮🇳 India

    SKYN ELITE KING SIZE CONDOM

    Reg #: 9613932 · FEI: 3001687671 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    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
    K171172

    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, Synthetic MOL

    Proprietary Names

    SKYN ELITE KING SIZE CONDOM SKYN ORIGINAL SKYN EXTRA STUDDED SKYN ELITE EXTRA LUBE SKYN LARGE LIFESTYLES NON LATEX CONDOM LIFESTYLES NON LATEX CONDOMS SKYN ELITE KING CONDOM SKYN ELITE LARGE LIFESTYLES NATURAL LATEX FREE SKYN ELITE LARGE CONDOM SKYN ELITE

    Establishment Types

    Manufacture Medical Device