BEUDAMED
    FDA Registration Active 🇨🇳 China

    One Step hCG Test Strip, One Step hCG Test Cassette, One Step hCG Test Midstream

    Reg #: 3014171027 · FEI: 3014171027 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    WEIHAI KANGZHOU BIOTECHNOLOGY ENGINEERING CO., LTD.
    Registration Number
    3014171027
    FEI Number
    3014171027
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    (Room 401-402, Building B, Innovation Base) No. 213-3, Huoju Road,
    City
    Weihai Shandong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K183097

    Owner / Operator

    Firm Name
    Weihai Kangzhou Biotechnology Engineering Co., Ltd.
    Operator Number
    10056397
    Address
    (Room 401-402, Building B, Innovation Base) No. 213-3, Huoju Road,
    City
    Weihai
    State
    Shandong
    Postal Code
    264205
    Country
    CN
    Correspondent
    Yong Qi

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.,
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

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

    Proprietary Names

    One Step hCG Test Strip, One Step hCG Test Cassette, One Step hCG Test Midstream Walgreens Ovulation Test + Pregnancy Test combo ,Walgreens One Step Ovulation Test

    Establishment Types

    Manufacture Medical Device