BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set

    Reg #: 3004530184 · FEI: 3004530184 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ANDERSEN CALEDONIA LTD
    Registration Number
    3004530184
    FEI Number
    3004530184
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Caledonian House, Phoenix Crescent, Strathclyde Business Park
    City
    Bellshill Scotland
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K222067

    Owner / Operator

    Firm Name
    Andersen Caledonia Ltd
    Operator Number
    10043114
    Address
    Caledonian House, Phoenix Crescent, Strathclyde Business Park
    City
    Bellshill
    State
    Scotland
    Postal Code
    ML4 3NJ
    Country
    GB

    US Agent

    Business Name
    RAF SOLUTIONS USA, INC
    Contact Name
    Edwin Lindsay
    Address
    10124 N.W. 53rd Street, Sunrise
    City
    Fort Lauderdale
    State
    FL
    ZIP
    33351
    Country
    US
    Email
    [email protected]
    Phone
    305 9607262

    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

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)