BEUDAMED
    FDA Registration Active 🇨🇳 China

    Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)

    Reg #: 3017019647 · FEI: 3017019647 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SHENZHEN YHLO BIOTECH CO., LTD.
    Registration Number
    3017019647
    FEI Number
    3017019647
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Building 1, YHLO Biopark, Baolong 2nd Road, Baolong Subdistrict, Longgang District
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K223690

    Owner / Operator

    Firm Name
    SHENZHEN YHLO BIOTECH CO., LTD.
    Operator Number
    10082247
    Address
    Building 1, YHLO Biopark, Baolong 2nd Road, Baolong Subdistrict, Longgang District
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518116
    Country
    CN
    Correspondent
    Dan Wang

    US Agent

    Business Name
    LSI International Inc
    Contact Name
    Joe Shia
    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
    System, Test, Human Chorionic Gonadotropin DHA
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE

    Proprietary Names

    Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) iFlash-HCG

    Establishment Types

    Manufacture Medical Device