BEUDAMED
    FDA Registration Active 🇨🇳 China

    HIGHTOP Pregnancy Rapid Test Cassette

    Reg #: 3014223276 · FEI: 3014223276 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    QINGDAO HIGHTOP BIOTECH CO., LTD.
    Registration Number
    3014223276
    FEI Number
    3014223276
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.369 Hedong Road, Hi-tech Industrial Development Zone
    City
    Qingdao Shandong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K192123

    Owner / Operator

    Firm Name
    Qingdao HIGHTOP Biotech Co., Ltd.
    Operator Number
    10061479
    Address
    No.369 Hedong Road, Hi-tech Industrial Development Zone
    City
    Qingdao
    State
    Shandong
    Postal Code
    266112
    Country
    CN

    US Agent

    Business Name
    LSI
    Contact Name
    Joe Xia
    Address
    504E Diamond Ave., Suite J
    City
    Gaithersburg
    State
    MD
    ZIP
    20877
    Country
    US
    Email
    [email protected]
    Phone
    240 5057880

    Products

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

    Proprietary Names

    HIGHTOP Pregnancy Rapid Test Cassette HIGHTOP Pregnancy Rapid Test Midstream HIGHTOP Pregnancy Rapid Test Strip

    Establishment Types

    Manufacture Medical Device