BEUDAMED
    FDA Registration Active 🇫🇷 France

    RM4 KIDNEY PERFUSION SYSTEM

    Reg #: 3031600052 · FEI: 3031600052 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    OEM DEVELOPMENT
    Registration Number
    3031600052
    FEI Number
    3031600052
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    39 BVD de la romanerie
    City
    SAINT BARTHELEMY D ANJOU Maine-et-Loire
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K211224

    Owner / Operator

    Firm Name
    OEM Developement
    Operator Number
    10091097
    Address
    39 Boulevard de la romanerie
    City
    Saint Barthélémy d'anjou
    State
    Maine-et-Loire
    Postal Code
    49124
    Country
    FR
    Correspondent
    Guylaine FOUCHE

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Dr
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    System, Perfusion, Kidney KDN

    Proprietary Names

    RM4 KIDNEY PERFUSION SYSTEM

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)