BEUDAMED
    FDA Registration Active 🇭🇺 Hungary

    XBody Hungary Zrt.

    Reg #: 3011792111 · FEI: 3011792111 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

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    Registration Details

    Registration Name
    XBody Hungary Zrt.
    Registration Number
    3011792111
    FEI Number
    3011792111
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Torok Ignac u. 66
    City
    Gyor
    Country
    HU

    Regulatory Submissions

    510(k) Number
    K242926

    Owner / Operator

    Firm Name
    XBody Hungary Zrt.
    Operator Number
    10060736
    Address
    Gyorgy Aladar u. 35-39.
    City
    Budapest
    State
    HU-BU
    Postal Code
    1125
    Country
    HU

    US Agent

    Business Name
    Medical Device Academy Incorporated
    Contact Name
    Robert Packard
    Address
    345 Lincoln Hill Rd
    City
    Cuttingsville
    State
    VT
    ZIP
    05738
    Country
    US
    Email
    [email protected]
    Phone
    802 2581881

    Products

    Device Name Product Code
    Stimulator, Muscle, Powered, For Muscle Conditioning NGX

    Proprietary Names

    XBody Go USA, XBody Pro USA, XBody DrySuit, XBody DryWear XBody Newave USA XBody Go USA, XBody Pro USA

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device