BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    651115T-PM Fluido Blood and Fluid Warmer FAS (110-120V)- SYK

    Reg #: 3021073836 · FEI: 3021073836 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TSC Life
    Registration Number
    3021073836
    FEI Number
    3021073836
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Bedrijvenpark Twente Noord 48, --
    City
    Almelo Overijssel
    Country
    NL

    Regulatory Submissions

    510(k) Number
    BK050058

    Owner / Operator

    Firm Name
    THE SURGICAL COMPANY INTERNATIONAL BV
    Operator Number
    9101201
    Address
    Paalbergweg 3, --
    City
    Amsterdam
    State
    Noord-Holland
    Postal Code
    1105 AG
    Country
    NL
    Correspondent
    Federica Federici

    US Agent

    Business Name
    TSC Life US Inc.
    Contact Name
    Chris Duffie
    Address
    6400 S Fiddlers Green Cir Ste 305
    City
    Greenwood Village
    State
    CO
    ZIP
    80111
    Country
    US
    Email
    [email protected]
    Phone
    773 5204980

    Products

    Device Name Product Code
    Device, Warming. Blood And Plasma KZL

    Proprietary Names

    651115T-PM Fluido Blood and Fluid Warmer FAS (110-120V)- SYK 671500-PM Fluido Trauma set, sterile - SYK 651115-PM Fluido Blood and Fluido Warmer SA (110-120V) - SYK 671200-PM Fluido Standard set, sterile - SYK

    Establishment Types

    Manufacture Medical Device