BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    PRIMED MEDICAL PRODUCTS INC.

    Reg #: 9615270 · FEI: 3002750002 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    14

    Registration Details

    Registration Name
    PRIMED MEDICAL PRODUCTS INC.
    Registration Number
    9615270
    FEI Number
    3002750002
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    200, 2003 - 91 Street SW
    City
    Edmonton Alberta
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K213427

    Owner / Operator

    Firm Name
    PRIMED Medical Products Inc.
    Operator Number
    9030179
    Address
    200, 2003 - 91 Street SW
    City
    EDMONTON
    State
    Alberta
    Postal Code
    T6X 0W8
    Country
    CA
    Correspondent
    Kam Ching

    US Agent

    Business Name
    Medical Device Post-Production Services Inc.
    Contact Name
    Robert Duffy
    Address
    16405 Summer Sage Road
    City
    Poway
    State
    CA
    ZIP
    92064
    Country
    US
    Email
    [email protected]
    Phone
    858 2318858

    Products

    Device Name Product Code
    Pediatric/Child Facemask OXZ
    Cap, Surgical FYF
    Gown, Examination FME
    Mask, Surgical FXX
    Polymer Patient Examination Glove LZA
    Shield, Protective, Personnel KPY
    Wrap, Sterilization FRG
    Non-Surgical Gown OEA
    Accessory, Surgical Apparel LYU
    Tray, Surgical LRP
    Gown, Isolation, Surgical FYC
    Instrument, Manual, Surgical, General Use MDM
    Cover, Shoe, Operating-Room FXP
    Dress, Surgical FYE

    Proprietary Names

    PRIMED Surgical Masks and PRIMED Procedure Masks PRIMED Sterilization Wrap PRIMAGARD PRIMASOFT PRIMED Surgical Masks PRIMED Procedure Masks

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device