BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    SC+ Hemodialysis Device

    Reg #: 3013536188 · FEI: 3013536188 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    QUANTA DIALYSIS TECHNOLOGIES LTD
    Registration Number
    3013536188
    FEI Number
    3013536188
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    The Woods, Haywood Road
    City
    Warwick Warwickshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K210661

    Owner / Operator

    Firm Name
    Quanta Dialysis Technologies Ltd
    Operator Number
    10080477
    Address
    The Woods, Haywood Road
    City
    Warwick
    State
    Warwickshire
    Postal Code
    CV34 5AH
    Country
    GB
    Correspondent
    Chris Rule

    US Agent

    Business Name
    Quanta Dialysis Technologies Inc
    Contact Name
    Suresh Persaud
    Address
    71 Cherry Hill Drive
    City
    Beverly
    State
    MA
    ZIP
    01915
    Country
    US
    Email
    [email protected]
    Phone
    978 3940763

    Products

    Device Name Product Code
    Set, Tubing, Blood, With And Without Anti-Regurgitation Valve FJK
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI

    Proprietary Names

    SC+ Hemodialysis Device SC+ Dialysate Cartridge SC+ Blood Tube Set Bicarbonate Spare Connectors Set

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility