BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Merit PAK

    Reg #: 3012536737 · FEI: 3012536737 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Merit Medical Canada Ltd.
    Registration Number
    3012536737
    FEI Number
    3012536737
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1 Valleywood Drive, units 4&5
    City
    Markham Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K031691

    Owner / Operator

    Firm Name
    Merit Medical Systems, Inc.
    Operator Number
    1721504
    Address
    1600 West Merit Parkway, --
    City
    South Jordan
    State
    UT
    Postal Code
    84095
    Country
    US

    US Agent

    Business Name
    MERIT MEDICAL SYSTEMS, INC.
    Contact Name
    John Knorpp
    Address
    1600 West Merit Parkway, --
    City
    South Jordan
    State
    UT
    ZIP
    84095
    Country
    US
    Email
    [email protected]
    Phone
    801 2084389

    Products

    Device Name Product Code
    Dilator, Vessel, For Percutaneous Catheterization DRE

    Proprietary Names

    Merit PAK Merit S-MAK (Stiffened Mini Access Kit) Merit MAK (Mini Access Kit)

    Establishment Types

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