BEUDAMED
    FDA Registration Active 🇨🇳 China

    GUANGDONG XINYU ELECTRONIC AND TECHNOLOGY CO., LTD

    Reg #: 3013510081 · FEI: 3013510081 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    2

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    Registration Details

    Registration Name
    GUANGDONG XINYU ELECTRONIC AND TECHNOLOGY CO., LTD
    Registration Number
    3013510081
    FEI Number
    3013510081
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    NUMBER 42, CUICHENG ROAD, CUIHENG NEW DISTRICT
    City
    ZHONGSHAN Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K241590

    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
    Analyzer, Body Composition, Exempt PUH
    System, Measurement, Blood-Pressure, Non-Invasive DXN

    Proprietary Names

    XY-6711 XY-6010 XY-6705 XY-6701 XY-6702 XY-6706 BF180, BF179, ES-32MD XY-6168 XY-6169,XY-6169-BO XY-6061-BO,XY-6025 XY-6027 XY-6029 XY-6030 XY-6031 XY-6032 XY-6033 XY-6035 XY-6010 XY-6012 XY-6013 XY-6015A XY-6015B XY-6016 XY-6026 XY-6028 XY-6039 XY-6051 XY-6052 XY-6055 XY-6058 XY-M01B, XY-6110, XY-6112, XY-6103, XY-6101, XY-6008, XY-6009, XY-6107, XY-6109 XY-6079 XY-6080 XY-6081 XY-6082 XY-6085 XY-6086 XY-6088 XY-6089 XY-6090 XY-6091 XY-6092 XY-6093 XY-6095 XY-6061 XY-6063 XY-6065 XY-6066 XY-6068 XY-6069 XY-6069N XY-6070 XY-6071 XY-6073 XY-6075 XY-6076 XY-6078 Arm Blood Pressure Monitor, XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09 Wrist Blood Pressure Monitor, XY-W01A, XY-W01B

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device