BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    PRUDENCE CLASSIC

    Reg #: 3012909279 · FEI: 3012909279 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    DKT DE MEXICO S.A. de C.V.
    Registration Number
    3012909279
    FEI Number
    3012909279
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Avenida Anillo de Circunvalacion 127 Tercer Piso, Colonia Atlantida
    City
    Ciudad de Mexico
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K002393

    Owner / Operator

    Firm Name
    DKT de Mexico S.A. de C.V.
    Operator Number
    10055943
    Address
    Avenida Anillo de Circunvalacion 127 Tercer Piso, Colonia Atlantida
    City
    Ciudad de Mexico
    State
    MX-NOTA
    Postal Code
    04370
    Country
    MX

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Condom HIS

    Proprietary Names

    PRUDENCE CLASSIC Condom

    Establishment Types

    Repack or Relabel Medical Device Export Device to the United States But Perform No Other Operation on Device