BEUDAMED
    FDA Registration Active 🇨🇳 China

    SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO.,LTD

    Reg #: 3010610113 · FEI: 3010610113 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO.,LTD
    Registration Number
    3010610113
    FEI Number
    3010610113
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No.23 Jinxiu East Road, Pingshan District
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K232587

    Owner / Operator

    Firm Name
    Shenzhen New Industries Biomedical Engineering Co.,Ltd
    Operator Number
    10049797
    Address
    No. 23, Jinxiu East Road, Pingshan District
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518122
    Country
    CN
    Correspondent
    Xiaoli Wang

    US Agent

    Business Name
    LSI International
    Contact Name
    Joe Xia
    Address
    504 E Diamond Ave Ste I
    City
    Gaithersburg
    State
    MD
    ZIP
    20877
    Country
    US
    Email
    [email protected]
    Phone
    240 5057880

    Products

    Device Name Product Code
    Reagent, Coronavirus Serological QKO
    System, Test, Vitamin D MRG
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE

    Proprietary Names

    MAGLUMI 2019-nCoV IgM MAGLUMI 2019-nCoV IgG MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer MAGLUMI 25-OH Vitamin D

    Establishment Types

    Manufacture Medical Device