BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Haemotec, a division of Fresenius Medical Care Canada Inc.

    Reg #: 3005578748 · FEI: 3005578748 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    Haemotec, a division of Fresenius Medical Care Canada Inc.
    Registration Number
    3005578748
    FEI Number
    3005578748
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    383 JOSEPH-CARRIER
    City
    VAUDREUIL-DORION Quebec
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K212620

    Owner / Operator

    Firm Name
    Fresenius Medical Care Renal Therapies Group, LLC
    Operator Number
    9030510
    Address
    920 WINTER STREET, --
    City
    Waltham
    State
    MA
    Postal Code
    02451
    Country
    US
    Correspondent
    Rachel Lloyd

    US Agent

    Business Name
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Contact Name
    DENISE OPPERMANN
    Address
    920 WINTER ST.
    City
    Waltham
    State
    MA
    ZIP
    02451
    Country
    US
    Email
    [email protected]
    Phone
    781 9969103

    Products

    Device Name Product Code
    Dialysate Concentrate For Hemodialysis (Liquid Or Powder) KPO
    Set, Tubing, Blood, With And Without Anti-Regurgitation Valve FJK
    Subsystem, Water Purification FIP
    Accessories, Blood Circuit, Hemodialysis KOC
    Disinfectant, Dialysate Delivery System NII
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI

    Proprietary Names

    NaturaLyte Liquid Acid Concentrate Citrasate Liquid Acid Concentrate 5008X CAREsystem

    Establishment Types

    Manufacture Medical Device