BEUDAMED
    FDA Registration Active 🇨🇳 China

    DAVID One Step Prescription Pregnancy Test Midstream

    Reg #: 3005216656 · FEI: 3005216656 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    2

    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
    K181551

    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
    Visual, Pregnancy Hcg, Prescription Use JHI

    Proprietary Names

    DAVID One Step Prescription Pregnancy Test Midstream DAVID One Step Home Use Pregnancy Test Strip DAVID One Step Home Use Pregnancy Test Midstream DAVID One Step Prescription Pregnancy Test Cassette 6 Days Ahead Pregnancy Test PREGABLE Pregnancy Test DAVID One Step Prescription Pregnancy Test Strip Early Blush Pregnancy Test DAVID One Step Home Use Pregnancy Test Cassette Smilereader Pregnancy Test DAVID Pregnancy Test DAVID Pregnancy Test Midstream DAVID Pregnancy Test Strip DAVID Ovulation & Pregnancy Test Kit DAVID Ovulation & Pregnancy Test

    Establishment Types

    Manufacture Medical Device