BEUDAMED
    FDA Registration Active 🇨🇳 China

    Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel

    Reg #: 3014223276 · FEI: 3014223276 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    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
    K241969

    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
    Test, Opiates, Over The Counter NGL

    Proprietary Names

    Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel

    Establishment Types

    Manufacture Medical Device