BEUDAMED
    FDA Registration Active 🇺🇸 United States

    UVAR XTS PHOTOPHERESIS SYSTEM

    Reg #: 3000236920 · FEI: 1000086912 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    MACK MOLDING COMPANY
    Registration Number
    3000236920
    FEI Number
    1000086912
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    608 WARM BROOK RD.
    City
    ARLINGTON
    State
    VT
    ZIP
    05250
    Country
    US

    Regulatory Submissions

    PMA Number
    P860003

    Owner / Operator

    Firm Name
    MACK MOLDING COMPANY
    Operator Number
    9040779
    Address
    608 WARM BROOK RD., --
    City
    Arlington
    State
    VT
    Postal Code
    05250
    Country
    US

    Products

    Device Name Product Code
    System, Photopheresis, Extracorporeal LNR

    Proprietary Names

    UVAR XTS PHOTOPHERESIS SYSTEM Therakos CellEx Photopheresis System

    Establishment Types

    Remanufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)