BEUDAMED
    FDA Registration Active 🇫🇷 France

    INSTITUT GEORGES LOPEZ

    Reg #: 3024820181 · FEI: 3024820181 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    INSTITUT GEORGES LOPEZ
    Registration Number
    3024820181
    FEI Number
    3024820181
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6 ROUTE DE SAINT BONNET
    City
    ST LAURENT DE CHAMOUSSET Rhone
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K221387

    Owner / Operator

    Firm Name
    Institut Georges Lopez
    Operator Number
    10051357
    Address
    Parc tertiaire du Bois Dieu, 1 allee des chevreuils
    City
    Lissieu
    State
    Auvergne-Rhone-Alpes
    Postal Code
    69380
    Country
    FR
    Correspondent
    Matthieu PROUTEAU

    US Agent

    Business Name
    Waters Medical Systems LLC
    Contact Name
    Ashley BANKS
    Address
    2900 37th St Nw Bldg 3
    City
    Rochester
    State
    MN
    ZIP
    55901
    Country
    US
    Email
    [email protected]
    Phone
    507 2523729

    Products

    Device Name Product Code
    Set, Perfusion, Kidney, Disposable KDL
    System, Perfusion, Kidney KDN
    System And Accessories, Isolated Heart, Transport And Preservation MSB

    Proprietary Names

    BEL-GEN Cold Storage Solution Waters IGL Cold Storage Solution PERF-GEN Pulsatile Perfusion Solution Waters IGL Pulsatile Perfusion Solution Celsior Cold Flushing, Storage and Transportation Solution for Hearts

    Establishment Types

    Manufacture Medical Device