BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Biotrue ONEday for Presbyopia (30 pack)

    Reg #: 3017069344 · FEI: 3017069344 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    KITS EYECARE LTD
    Registration Number
    3017069344
    FEI Number
    3017069344
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2955 HEBB AVENUE
    City
    VANCOUVER British Columbia
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K132715

    Owner / Operator

    Firm Name
    KITS EYECARE LTD.
    Operator Number
    10050286
    Address
    510 SEYMOUR ST. SUITE 1020
    City
    Vancouver
    State
    British Columbia
    Postal Code
    V6B 3J5
    Country
    CA
    Correspondent
    Stefan Bohdanowicz

    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
    Lenses, Soft Contact, Daily Wear LPL
    Lens, Contact, (Disposable) MVN

    Proprietary Names

    Biotrue ONEday for Presbyopia (30 pack) Biotrue ONEday for Presbyopia (90 pack)

    Establishment Types

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