BEUDAMED
    FDA Registration Active 🇫🇷 France

    INSTITUT GEORGES LOPEZ

    Reg #: 3010765841 · FEI: 3010765841 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    13
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    INSTITUT GEORGES LOPEZ
    Registration Number
    3010765841
    FEI Number
    3010765841
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Parc tertiaire du Bois Dieu, 1 allee des chevreuils
    City
    Lissieu Auvergne-Rhone-Alpes
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K221386

    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 And Accessories, Isolated Heart, Transport And Preservation MSB
    System, Perfusion, Kidney KDN
    Clamp, Line FKK

    Proprietary Names

    PERF-GEN Pulsatile Perfusion Solution Waters IGL Pulsatile Perfusion Solution Celsior Cold Flushing, Storage and Transportation Solution for Hearts PCAN RM4 PCL P2PC PEL Perfusion Clamp DCX Disposable Cassette Perfusion Coupler BEL-GEN Cold Storage Solution Waters IGL Cold Storage Solution

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility