BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    DX PRODUCTS LIMITED

    Reg #: 3010386378 · FEI: 3010386378 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    12
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    DX PRODUCTS LIMITED
    Registration Number
    3010386378
    FEI Number
    3010386378
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Unit 1 Horbury Junction Industrial Estate, Calder Vale Rd
    City
    Horbury Wakefield
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K160211

    Owner / Operator

    Firm Name
    DX Products Limited
    Operator Number
    10044627
    Address
    Unit 1 Horbury Junction Industrial Estat, Calder Vale Rd
    City
    Horbury
    State
    Wakefield
    Postal Code
    WF4 5ER
    Country
    GB
    Correspondent
    Joe Mosalski

    US Agent

    Business Name
    Heyer Regulatory Solutions, LLC
    Contact Name
    Sheila Hemeon-Heyer
    Address
    125 CHERRY LN
    City
    AMHERST
    State
    MA
    ZIP
    01002
    Country
    US
    Email
    [email protected]
    Phone
    413 3308578

    Products

    Device Name Product Code
    Device, External Penile Rigidity LKY
    Lubricant, Personal NUC

    Proprietary Names

    Bathmate Hydromax X20, X20 Xtreme, X30, X30 Xtreme, X40, X40 Xtreme, X50 Xtreme (and accessories) Bathmate Hercules (and accessories) VaxAid V5 Deluxe, VaxAid V6 Deluxe,, VaxAid V7 Deluxe, VaxAid V8 Deluxe, VaxAid V9 Deluxe (and accessories) Xersizer 5, Xersizer Pro 6, Xersizer 7, Xersizer Pro 5, Xersizer Pro 7, Xersizer Pro 8, Xersizer Pro 9 (and accessories) Bathmate HydroXtreme3, HydroXtreme5, HydroXtreme7, HydroXtreme7 Wide Boy, HydroXtreme 8, HydroXtreme9, HydroXtreme11 Bathmate Hydro7 (and accessories) Xersizer Pro 5X, Xersizer Pro 7X, Xersizer Pro 9X (and accessories) Bathmate Hydromax3, Hydromax5, Hydromax6, Hydromax7, Hydromax7 Wide Boy, Hydromax 8, Hydromax9 (and accessories) HydroXtreme 6, HydroXtreme 8 Bathmate Spartan, Barbarian, Gladiator Power Rings, Maximus Power Rings VaxAid V7 Trainer and VaxAid V30 Bathmate Pleasure Lube

    Establishment Types

    Manufacture Medical Device Foreign Private Label Distributor Export Device to the United States But Perform No Other Operation on Device