BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Healstone hCG One Step Pregnancy Test

    Reg #: 3014301129 · FEI: 3014301129 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    HEALSTONE BIOTECH INC.
    Registration Number
    3014301129
    FEI Number
    3014301129
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Unit #650 - 655 West Kent Avenue North
    City
    Vancouver British Columbia
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K212418

    Owner / Operator

    Firm Name
    Healstone Biotech Inc.
    Operator Number
    10056764
    Address
    Unit 650, 655 West Kent Ave. N.
    City
    Vancouver
    State
    British Columbia
    Postal Code
    V6P6T7
    Country
    CA
    Correspondent
    Chichi Liu

    Products

    Device Name Product Code
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX

    Proprietary Names

    Healstone hCG One Step Pregnancy Test

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198