BEUDAMED
    FDA Registration Active 🇨🇳 China

    SUZHOU POWERSITE ELECTRIC CO., LTD.

    Reg #: 3018269927 · FEI: 3018269927 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SUZHOU POWERSITE ELECTRIC CO., LTD.
    Registration Number
    3018269927
    FEI Number
    3018269927
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Floor 1st, 2nd, 4th, Building 5, No.188 Fuchunjiang Road, Suzhou New District, 215151 Suzhou, People's Republic of China
    City
    Suzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K222258

    Owner / Operator

    Firm Name
    Suzhou Powersite Electric Co., Ltd.
    Operator Number
    10080411
    Address
    Building 5, No.188 Fuchunjiang Road, Suzhou New District, 215151 Suzhou, China
    City
    Suzhou
    State
    Jiangsu
    Postal Code
    215000
    Country
    CN
    Correspondent
    Xiaojun Shao

    Products

    Device Name Product Code
    System, X-Ray, Mobile IZL
    Generator, High-Voltage, X-Ray, Diagnostic IZO

    Proprietary Names

    Combined High Frequency X-ray Source Mammographic X-ray High Frequency High Voltage Generator PSG-MG Series Mobile X-ray Radiographic Fluoroscopic High Frequency High Voltage Generator PSG-MF Series Medical X-ray High Frequency High Voltage Generator PSG-HR Series Medical X-ray Computed Tomography High Voltage Generator PSG-CT Series Medical X-ray Radiography Fluoroscopy High Frequency High Voltage Generator PSG-RF Series Mobile Medical X-ray High Frequency High Voltage Generator PSG-M Series

    Establishment Types

    Manufacture Medical Device