BEUDAMED
    FDA Registration Active 🇫🇷 France

    Celsior Cold Flushing, Storage and Transportation Solution for Hearts

    Reg #: 3024820181 · FEI: 3024820181 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    INSTITUT GEORGES LOPEZ
    Registration Number
    3024820181
    FEI Number
    3024820181
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6 ROUTE DE SAINT BONNET
    City
    ST LAURENT DE CHAMOUSSET Rhone
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K991594

    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
    Contact Name
    Sam Wiegand
    Address
    2900 37th St NW, Building 003
    City
    Rochester
    State
    MN
    ZIP
    55901
    Country
    US
    Email
    [email protected]
    Phone
    507 2523705

    Products

    Device Name Product Code
    System And Accessories, Isolated Heart, Transport And Preservation MSB

    Proprietary Names

    Celsior Cold Flushing, Storage and Transportation Solution for Hearts

    Establishment Types

    Manufacture Medical Device