BEUDAMED
    FDA Registration Active 🇨🇳 China

    COMPAI HEALTHCARE (SUZHOU) CO.,LTD

    Reg #: 3017889703 · FEI: 3017889703 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    COMPAI HEALTHCARE (SUZHOU) CO.,LTD
    Registration Number
    3017889703
    FEI Number
    3017889703
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Room 3A05, Building 2, No.8 Changting Road,High-tech Zone, Suzhou, Jiangsu, P.R. China
    City
    Suzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K230136

    Owner / Operator

    Firm Name
    CompAI Healthcare (Suzhou) Co.,ltd
    Operator Number
    10086645
    Address
    Room 3A05, Building 2, No.8 Changting Road,High-tech Zone, Suzhou, Jiangsu, P.R. China
    City
    Suzhou
    State
    Jiangsu
    Postal Code
    215151
    Country
    CN
    Correspondent
    Sheng Peng

    Products

    Device Name Product Code
    Cabinet, X-Ray System MWP
    Container, Specimen, Non-Sterile NNI

    Proprietary Names

    TrueView 200 Pro-US TureView 100 Pro QuadraView 100 TrueView Core 100Pro-US

    Establishment Types

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