BEUDAMED
    FDA Registration Active 🇨🇳 China

    Freedom urine HCG pregnancy test midstream

    Reg #: 3008054239 · FEI: 3008054239 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    21
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CORE TECHNOLOGY CO., LTD.
    Registration Number
    3008054239
    FEI Number
    3008054239
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Room 100, Building C, No.29, Life Park Road, Changping District
    City
    Beijing City
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K150063

    Owner / Operator

    Firm Name
    Core Technology Co., Ltd.
    Operator Number
    10044021
    Address
    Room 100, Building C, No.29, Life Park Road, Changping District
    City
    Beijing City
    State
    CN-BJ
    Postal Code
    102206
    Country
    CN
    Correspondent
    Chen Lizhu

    US Agent

    Business Name
    CorDx, Inc.
    Contact Name
    Vicky Huang
    Address
    9540 Waples St Unit C
    City
    San Diego
    State
    CA
    ZIP
    92121
    Country
    US
    Email
    [email protected]
    Phone
    858 8886916

    Products

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

    Proprietary Names

    Freedom urine HCG pregnancy test midstream Babycheck HCG pregnancy test midstream ACCU NEWS One Step hCG Pregnancy Test Cassette Veltest HCG pregnancy test Freedom HCG pregnancy test Unitest HCG pregnancy test ACCU NEWS Ovulation Test + Pregnancy Test Combo Femometer Ovulation & Pregnancy Test Combo ACCU NEWS One Step hCG Pregnancy Test Strip ACCU NEWS One Step hCG Pregnancy Test Midstream Freedom urine HCG pregnancy test strip ACCU NEWS Pregnancy Test Strip Babycheck HCG pregnancy test strip ACCU NEWS Pregnancy Test Cassette Unitest HCG pregnancy test strip Unitest HCG pregnancy test midstream ACCU NEWS Pregnancy Test Midstream CorDx HCG pregnancy test CorDx Ovulation & Pregnancy Test Combo TyFast HCG pregnancy test SYNTHGENE LH Ovulation Test + HCG Pregnancy Test Combo

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)