BEUDAMED
    FDA Registration Active 🇨🇳 China

    AUGMENT INTELLIGENT MEDICAL SYSTEM (CHINA) CO., LTD.

    Reg #: 3026309987 · FEI: 3026309987 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    AUGMENT INTELLIGENT MEDICAL SYSTEM (CHINA) CO., LTD.
    Registration Number
    3026309987
    FEI Number
    3026309987
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1801-1812, Floor 18, Block B, Kechuang No.1 Building, No.320 Pubin Road, Jiangpu Sub-District, Pukou District
    City
    Nanjing Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K221499

    Owner / Operator

    Firm Name
    Augment Intelligent Medical System (China) Co., Ltd.
    Operator Number
    10086934
    Address
    1801-1812, Floor 18, Block B, Kechuang No.1 Building, No.320 Pubin Road, Jiangpu Sub-District, Pukou District
    City
    Nanjing
    State
    Jiangsu
    Postal Code
    210000
    Country
    CN

    US Agent

    Business Name
    GRZAN GROUP INC.
    Contact Name
    Andy Smith
    Address
    8825 53 AVE ELMHURST,NY
    City
    Elmhurst
    State
    NY
    ZIP
    11373
    Country
    US
    Email
    [email protected]
    Phone
    332 2015192

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    Minimally Invasive Prostate Surgery Navigation System (AmaKkris SR 1-A-1) Minimally Invasive Prostate Surgery Navigation System (AmaKkris SR 1-A-2)

    Establishment Types

    Manufacture Medical Device