BEUDAMED
    FDA Registration Active 🇨🇳 China

    1 BY ONE Bluetooth Blood Pressure Monitor Model:703NA-0005; TMB-1585-BT

    Reg #: 3011420269 · FEI: 3011420269 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO.,LTD
    Registration Number
    3011420269
    FEI Number
    3011420269
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Zone A, No.105, Dongli Road, Torch Development District
    City
    Zhongshan Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K131395

    Owner / Operator

    Firm Name
    Guangdong Transtek Medical Electronics Co.,Ltd
    Operator Number
    10048437
    Address
    Zone A, No.105 ,Dongli Road,, Torch Development District
    City
    Zhongshan
    State
    Guangdong
    Postal Code
    528437
    Country
    CN
    Correspondent
    Vince Zeng

    US Agent

    Business Name
    SHARE INFO INC.
    Contact Name
    Clare Ho
    Address
    3557 158th St Flushing
    City
    Auburndale
    State
    NY
    ZIP
    11358
    Country
    US
    Email
    [email protected]
    Phone
    929 14102 ext. 964

    Products

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

    Proprietary Names

    1 BY ONE Bluetooth Blood Pressure Monitor Model:703NA-0005; TMB-1585-BT Dario Smart Blood Pressure Monitor Gen 2, Model :1217-05 Blood Pressure Monitor,model: ABP-2088-T VILIBRUN Blood Pressure Monitor, Model :BM1585 Renpho Smart Blood Pressure Monitor , Model:RP-BPM001S Renpho Smart Blood Pressure Monitor , Model:TMB-1872-B Etekcity Smart Blood Pressure Monitor, Model :TMB-1583-BS EZFAST Blood Pressure Monitor,Model : TMB-2080-K Blood Pressure Monitor,Model : TMB-2080-K,TMB-2088, TMB-2083; Blood Pressure Monitor,Model :51-1490 Meraw Blood Pressure Monitor Irregular Heartbeat Monitoring, Dual Users, Model Number: TMB-2088-C Easy@Home Blood Pressure Monitor,Model: EBP-08B

    Establishment Types

    Manufacture Medical Device