BEUDAMED
    FDA Registration Active 🇨🇳 China

    Bladder Scanner, Model Name: M5, M5 Lite

    Reg #: 3015972810 · FEI: 3015972810 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SUZHOU PEAKSONIC MEDICAL TECHNOLOGY CO., LTD.
    Registration Number
    3015972810
    FEI Number
    3015972810
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2A, West Side of Building G4, Kunshan Hi-Tech Medical Device Industrial Park, Qiandeng Town, Kunshan
    City
    Suzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K213488

    Owner / Operator

    Firm Name
    Suzhou PeakSonic Medical Technology Co., Ltd.
    Operator Number
    10061380
    Address
    2A, West Side of Building G4, Kunshan Hi-Tech Medical Device Industrial Park, Qiandeng Town, Kunshan
    City
    Suzhou
    State
    Jiangsu
    Postal Code
    215341
    Country
    CN
    Correspondent
    Ning Ma

    US Agent

    Business Name
    MEDRIGHT TECH INC
    Contact Name
    Jessie Yao
    Address
    6302 FORT HAMILTON PARKWAY, 1R
    City
    Brooklyn
    State
    NY
    ZIP
    11219
    Country
    US
    Email
    [email protected]
    Phone
    718 2169957

    Products

    Device Name Product Code
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    Bladder Scanner, Model Name: M5, M5 Lite

    Establishment Types

    Manufacture Medical Device