BEUDAMED
    FDA Registration Active 🇨🇳 China

    ePA-46B5

    Reg #: 3010288146 · FEI: 3010288146 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Shenzhen BelterHealthMeasurementAndAnalysisTechnologyCo.,Ltd
    Registration Number
    3010288146
    FEI Number
    3010288146
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    702/704,BlockC,Tsinghua Unis Science Park, No.13 Langshan Rd, Hi-Tech Industrial Park(north), Nanshan District
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K134029

    Owner / Operator

    Firm Name
    Shenzhen BelterHealthMeasurementAndAnalysisTechnology CoLtd
    Operator Number
    10043131
    Address
    702/704,BlockC,TsinghuaUnisScience Park, No.13LangshanRd,Hi-TechIndustrialPark(N)
    City
    Nanshan District, Shenzhen
    State
    Guangdong
    Postal Code
    518057
    Country
    CN

    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

    ePA-46B5 Blood Pressure Meter, ePA-46B, PA-46, PA-52, PA-54, IVBPA, T9201,BP2,ePA-13B4, PA-09, ePA-09B4 BLOOD PRESSURE MONITOR, ePA-08B4,EOC-SBPBT-L ePA-10B5

    Establishment Types

    Manufacture Medical Device