BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    SPECTRUM MEDICAL SRL

    Reg #: 3016746283 · FEI: 3016746283 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    39
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    SPECTRUM MEDICAL SRL
    Registration Number
    3016746283
    FEI Number
    3016746283
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Via di Mezzo, 23
    City
    Mirandola Modena
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K241206

    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
    Reservoir, Blood, Cardiopulmonary Bypass DTN
    Oxygenator, Cardiopulmonary Bypass DTZ
    Heat-Exchanger, Cardiopulmonary Bypass DTR
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF
    Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type KFM
    Accessory Equipment, Cardiopulmonary Bypass KRI

    Proprietary Names

    QUANTUM PERFUSION HYBRID SYSTEM QUANTUM PERFUSION BLOOD OXYGENATOR VT200-E3 QUANTUM PERFUSION BLOOD OXYGENATOR VT75-E3 QUANTUM PERFUSION BLOOD OXYGENATOR VT160-E3 QUANTUM PUREFLOW STANDARD HEAT EXCHANGER QUANTUM PERFUSION DUAL LUMEN CANNULA QUANTUM PERFUSION CENTRIFUGAL BLOOD PUMP CP20 WITH INTEGRATED SENSORS QUANTUM PERFUSION CENTRIFUGAL BLOOD PUMP CP20 Quantum PureFlow Standard Heat Exchanger Quantum PureFlow Cardioplegia Heat Exchanger QUANTUM SUPERPAC CARDIOPLEGIA Quantum Perfusion Arterial Cannula Graft KIT CPC QUANTUM PERFUSION CAPNOMETER LINE SET QUANTUM SUPERPAC TUBING SET QUANTUM SUPERPAC CARDIOPLEGIA SET KIT QUANTUM SUPERPAC TUBING SET QUANTUM SUPERPAC ADAPTER TUBING SET QUANTUM PERFUSION CENTRIFUGAL BLOOD PUMP CP37 WITH INTEGRATED SENSORS Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors QUANTUM PERFUSION CENTRIFUGAL BLOOD PUMP CP22NG WITH INTEGRATED SENSORS QUANTUM PERFUSION DUAL LUMEN CANNULA 31F-V1 Quantum Perfusion Blood Oxygenator QUANTUM SUPERPAC CPB QUANTUM PERFUSION BLOOD OXYGENATOR VT75-E1 QUANTUM PERFUSION BLOOD OXYGENATOR VT75-E2 QUANTUM PERFUSION BLOOD OXYGENATOR WITH INTEGRATED AF AND SENSOR QUANTUM PERFUSION BLOOD OXYGENATOR WITH INTEGRATED AF QUANTUM PUREFLOW CARDIOPLEGIA HEAT EXCHANGER Quantum Perfusion Centrifugal Blood Pump Quantum PureFlow Centrifugal Blood Pump QUANTUM PERFUSION CENTRIFUGAL BLOOD PUMP CP20NG WITH INTEGRATED SENSORS QUANTUM PERFUSION BLOOD OXYGENATOR with INTEGRATED AF QUANTUM PERFUSION BLOOD OXYGENATOR with INTEGRATED AF AND SENSOR Quantum Perfusion Dual Lumen Cannula 24F Quantum Perfusion Single Lumen Cannula 22F Quantum Perfusion Dual Lumen Cannula 31F Quantum Perfusion Dual Lumen Cannula 27F QUANTUM PUREFLOW STANDARD HEAT EXCHANGER MEDIUM FLOW 1/4 W

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device