BEUDAMED
    FDA Registration Active 🇨🇳 China

    Smilereader pregnancy test

    Reg #: 3005216656 · FEI: 3005216656 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Equinox Biotech Co., Ltd.
    Registration Number
    3005216656
    FEI Number
    3005216656
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Rongsheng Technological Zone, UNIVERSITY ROAD,
    City
    Shantou Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K053236

    Owner / Operator

    Firm Name
    Equinox Biotech Co., Ltd.
    Operator Number
    9074282
    Address
    No. 12, Gaoxin 2nd Road, Huadu District
    City
    Guangzhou
    State
    Guangdong
    Postal Code
    510800
    Country
    CN

    Products

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

    Proprietary Names

    Smilereader pregnancy test One Step Pregnancy Test

    Establishment Types

    Manufacture Medical Device