BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    ARTRON LABORATORIES INC.

    Reg #: 3005445066 · FEI: 3005445066 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    ARTRON LABORATORIES INC.
    Registration Number
    3005445066
    FEI Number
    3005445066
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3938 North Fraser Way
    City
    Burnaby British Columbia
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K060019

    Owner / Operator

    Firm Name
    Artron Laboratories Inc.
    Operator Number
    10045485
    Address
    3938 North Fraser Way
    City
    Burnaby
    State
    British Columbia
    Postal Code
    V5J 5H6
    Country
    CA
    Correspondent
    Helen Ke

    US Agent

    Business Name
    Keva Inc.
    Contact Name
    Pierce Liu
    Address
    2794 Peace Portal Dr Unit 130
    City
    Blaine
    State
    WA
    ZIP
    98230
    Country
    US
    Email
    [email protected]
    Phone
    360 6841217

    Products

    Device Name Product Code
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Visual, Pregnancy Hcg, Prescription Use JHI
    Test, Luteinizing Hormone (Lh), Over The Counter NGE

    Establishment Types

    Manufacture Medical Device