BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    NIPRO CANADA CORPORATION

    Reg #: 8020347 · FEI: 3005612924 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    9
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    NIPRO CANADA CORPORATION
    Registration Number
    8020347
    FEI Number
    3005612924
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    199 ST. DAVID STREET
    City
    LINDSAY Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K080174

    Owner / Operator

    Firm Name
    NIPRO CANADA CORPORATION
    Operator Number
    8020347
    Address
    199 St. David Street, --
    City
    LINDSAY
    State
    Ontario
    Postal Code
    K9V 5K7
    Country
    CA
    Correspondent
    Raphael C DUBE

    US Agent

    Business Name
    Nipro Medical Corporation
    Contact Name
    Jessica Oswald-McLeod
    Address
    3150 Nw 107th Ave
    City
    Doral
    State
    FL
    ZIP
    33172
    Country
    US
    Email
    [email protected]
    Phone
    305 4326699

    Products

    Device Name Product Code
    Set, I.V. Fluid Transfer LHI
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF
    Clamp, Line FKK
    Needle, Hypodermic, Single Lumen FMI
    Accessory Equipment, Cardiopulmonary Bypass KRI
    Stand, Infusion FOX

    Proprietary Names

    TheraSafe Phlebotomy Bag w/needleless Y Adapter & 17GX1 TheraSafe Phlebotomy Bag w/needleless Y Adapter & 18GX1 TheraSafe Phlebotomy Bag with tubing and Y adapter ADULT HEART COOLING JACKET O.R. Perfusion Cannulae CLAMPS Punctur-Guard TUBING ORGANIZER INFUSION STAND

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device