BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    AssureTouch Ultra

    Reg #: 9611959 · FEI: 3002677549 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    AMD Medicom Inc.
    Registration Number
    9611959
    FEI Number
    3002677549
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2555 Chemin de l'Aviation
    City
    Pointe-Claire, Montreal Quebec
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K221165

    Owner / Operator

    Firm Name
    AMD Medicom Inc.
    Operator Number
    8020405
    Address
    2555 Chemin de l'Aviation, --
    City
    Pointe-Claire (Montreal)
    State
    Quebec
    Postal Code
    H9P 2Z2
    Country
    CA

    US Agent

    Business Name
    United Medical Enterprise
    Contact Name
    Brent Geiger
    Address
    3301 Stagecoach, Rd NE Thomson
    City
    Thomson
    State
    GA
    ZIP
    30824
    Country
    US
    Email
    [email protected]
    Phone
    763 2189292

    Products

    Device Name Product Code
    Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs OPJ
    Medical Glove, Specialty LZC
    Polymer Patient Examination Glove LZA
    Fentanyl And Other Opioid Protection Glove QDO

    Proprietary Names

    AssureTouch Ultra

    Establishment Types

    Foreign Private Label Distributor Complaint File Establishment per 21 CFR 820.198