BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    QUANTUM PUREFLOW CARDIOPLEGIA HEAT EXCHANGER

    Reg #: 3016746283 · FEI: 3016746283 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SPECTRUM MEDICAL SRL
    Registration Number
    3016746283
    FEI Number
    3016746283
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Via di Mezzo, 23
    City
    Mirandola Modena
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K212688

    Owner / Operator

    Firm Name
    Spectrum Medical SRL
    Operator Number
    10069754
    Address
    Via di Mezzo, 23
    City
    Mirandola
    State
    Modena
    Postal Code
    41037
    Country
    IT
    Correspondent
    Raffaella Tommasini

    US Agent

    Business Name
    Spectrum Medical Inc.
    Contact Name
    Cameron Schmitt
    Address
    481 Munn Road, Suite 180
    City
    Fort Mill
    State
    SC
    ZIP
    29715
    Country
    US
    Email
    [email protected]
    Phone
    803 8333964

    Products

    Device Name Product Code
    Heat-Exchanger, Cardiopulmonary Bypass DTR

    Proprietary Names

    QUANTUM PUREFLOW CARDIOPLEGIA HEAT EXCHANGER QUANTUM PUREFLOW STANDARD HEAT EXCHANGER

    Establishment Types

    Manufacture Medical Device