BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Loox

    Reg #: 3013785060 · FEI: 3013785060 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    CAMDEN PASSAGE
    Registration Number
    3013785060
    FEI Number
    3013785060
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4 Georgian Court
    City
    Collingwood Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K123431

    Owner / Operator

    Firm Name
    Camden Passage
    Operator Number
    10055878
    Address
    115 First Street, Suite 555
    City
    Collingwood
    State
    Ontario
    Postal Code
    L9Y4W3
    Country
    CA
    Correspondent
    Kyle Rose

    US Agent

    Business Name
    Rook Quality Systems
    Contact Name
    Kyle Rose
    Address
    1155 Mount Vernon Hwy, Suite 800
    City
    Dunwoody
    State
    GA
    ZIP
    30338
    Country
    US
    Email
    [email protected]
    Phone
    404 7179358

    Products

    Device Name Product Code
    Lenses, Soft Contact, Daily Wear LPL

    Proprietary Names

    Loox

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility