BEUDAMED
    FDA Registration Active 🇪🇸 Spain

    Large Hydrokit

    Reg #: 3005346382 · FEI: 3005346382 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Transcendencias Comerciales S.L
    Registration Number
    3005346382
    FEI Number
    3005346382
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    C/ Troya Ibilbidea 16, Nave 5A8/5B8
    City
    Ergobia-Astigarraga Guipuzcoa
    Country
    ES

    Regulatory Submissions

    510(k) Number
    K131852

    Owner / Operator

    Firm Name
    Transcendencias Comerciales S.L
    Operator Number
    10021855
    Address
    C/Zubiberri 31- Planta baja local 1
    City
    San Sebastian
    State
    Guipuzcoa
    Postal Code
    20018
    Country
    ES
    Correspondent
    Ramon Echevarria

    US Agent

    Business Name
    Dawa Medical LLC
    Contact Name
    Stephan Toupin
    Address
    7320 NW 12th Street Suite 103
    City
    Miami
    State
    FL
    ZIP
    33126
    Country
    US
    Email
    [email protected]
    Phone
    786 7311159

    Products

    Device Name Product Code
    Colonic Irrigation System KPL

    Proprietary Names

    Large Hydrokit Segmented Hose / Hydrokit with limiter HC-1 Hydrokit with limiter HC-1 Classic Small Hydrokit Segmented Hose / Large Hydrokit

    Establishment Types

    Manufacture Medical Device