BEUDAMED
    FDA Registration Active 🇫🇷 France

    PrisMax System Version 2

    Reg #: 3012149633 · FEI: 3012149633 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    LIDER
    Registration Number
    3012149633
    FEI Number
    3012149633
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    92 Rue des Treize Vents, Zone d'Activite
    City
    MONTREVEL EN BRESSE Auvergne-Rhone-Alpes
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K190910

    Owner / Operator

    Firm Name
    LIDER
    Operator Number
    10078167
    Address
    92 Rue des Treize Vents, Zone d'Activite
    City
    MONTREVEL EN BRESSE
    State
    Auvergne-Rhone-Alpes
    Postal Code
    01340
    Country
    FR
    Correspondent
    Valerie MALGUID

    US Agent

    Business Name
    VANTIVE US HEALTHCARE LLC
    Contact Name
    Jennifer MASEK-LITTLE
    Address
    25212 W. IL Route 120, RLT-08
    City
    Round Lake
    State
    IL
    ZIP
    60073
    Country
    US
    Email
    [email protected]
    Phone
    224 2707027

    Products

    Device Name Product Code
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI

    Proprietary Names

    PrisMax System Version 2

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)