BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Quantum Diagnostic Module 2

    Reg #: 3006073153 · FEI: 3006073153 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SPECTRUM MEDICAL LTD
    Registration Number
    3006073153
    FEI Number
    3006073153
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Ashville Business Park, Commerce Road
    City
    GLOUCESTER Gloucestershire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K173591

    Owner / Operator

    Firm Name
    SPECTRUM MEDICAL LTD
    Operator Number
    9094087
    Address
    Ashville Business Park, Commerce Road
    City
    Gloucester
    State
    Gloucestershire
    Postal Code
    GL2 9SL
    Country
    GB
    Correspondent
    Asia Lukuc

    US Agent

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

    Products

    Device Name Product Code
    Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass DRY

    Proprietary Names

    Quantum Diagnostic Module 2 Quantum Diagnostic Module 1

    Establishment Types

    Manufacture Medical Device