BEUDAMED
    FDA Registration Active 🇨🇳 China

    Wrist Blood Pressure Monitor, XY-W01A, XY-W01B

    Reg #: 3013510081 · FEI: 3013510081 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GUANGDONG XINYU ELECTRONIC AND TECHNOLOGY CO., LTD
    Registration Number
    3013510081
    FEI Number
    3013510081
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    NUMBER 42, CUICHENG ROAD, CUIHENG NEW DISTRICT
    City
    ZHONGSHAN Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K241634

    Owner / Operator

    Firm Name
    GUANGDONG XINYU ELECTRONIC AND TECHNOLOGY CO., LTD
    Operator Number
    10054235
    Address
    NUMBER 42, CUICHENG ROAD, CUIHENG NEW, DISTRICT
    City
    ZHONGSHAN
    State
    Guangdong
    Postal Code
    528400
    Country
    CN
    Correspondent
    Rita Long

    US Agent

    Business Name
    TJ Chai Investment LLC
    Contact Name
    Terry Chai
    Address
    1 Queenberry Way
    City
    Basking Ridge
    State
    NJ
    ZIP
    07920
    Country
    US
    Email
    [email protected]
    Phone
    908 6361278

    Products

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

    Proprietary Names

    Wrist Blood Pressure Monitor, XY-W01A, XY-W01B

    Establishment Types

    Manufacture Medical Device