BEUDAMED
    FDA Registration Active 🇨🇳 China

    BP11G

    Reg #: 3009155917 · FEI: 3009155917 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
    Registration Number
    3009155917
    FEI Number
    3009155917
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 5, the Second Industrial Zone, Zhukeng Community, Longtian Street, Pingshan District
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K163648

    Owner / Operator

    Firm Name
    Grandway Technology (Shenzhen) Limited
    Operator Number
    10036359
    Address
    No. 5, the Second Industrial Zone, Zhukeng Community, Longtian Street, Pingshan District
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518118
    Country
    CN
    Correspondent
    Patrick Chow

    US Agent

    Business Name
    IRC USA
    Contact Name
    Charles Mack
    Address
    2950 E Lindrick Dr.
    City
    Chandler
    State
    AZ
    ZIP
    85249
    Country
    US
    Email
    [email protected]
    Phone
    931 6254938

    Products

    Device Name Product Code
    System, Measurement, Blood-Pressure, Non-Invasive DXN

    Proprietary Names

    BP11G BM54 MD5451 MD47A1 AFIB-4/0148 MD41A0 MD6300

    Establishment Types

    Manufacture Medical Device