BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    DOMREX Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant

    Reg #: 3007501254 · FEI: 3007501254 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    DOMREX PHARMA INC.
    Registration Number
    3007501254
    FEI Number
    3007501254
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    269 rue Robinson
    City
    Saint-Eustache Quebec
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K222058

    Owner / Operator

    Firm Name
    DOMREX PHARMA INC.
    Operator Number
    10078102
    Address
    269 rue Robinson
    City
    Saint-Eustache
    State
    Quebec
    Postal Code
    J7R 5V7
    Country
    CA

    US Agent

    Business Name
    Regulatory Insight, Inc.
    Contact Name
    Kevin Walls
    Address
    33 Golden Eagle Lane
    City
    Littleton
    State
    CO
    ZIP
    80127
    Country
    US
    Email
    [email protected]
    Phone
    720 9625412

    Products

    Device Name Product Code
    Surgeon'S Gloves KGO
    Medical Glove, Specialty LZC

    Proprietary Names

    DOMREX Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant

    Establishment Types

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