BEUDAMED
    FDA Registration Active 🇨🇳 China

    POLY Go

    Reg #: 3008393409 · FEI: 3008393409 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    XUZHOU KERNEL MEDICAL EQUIPMENT CO LTD
    Registration Number
    3008393409
    FEI Number
    3008393409
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Kernel Mansion, Economic Development District
    City
    Xuzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K180900

    Owner / Operator

    Firm Name
    XUZHOU KERNEL MEDICAL EQUIPMENT CO LTD
    Operator Number
    10046889
    Address
    Kernel Mansion, Economic Development District
    City
    Xuzhou
    State
    Jiangsu
    Postal Code
    221004
    Country
    CN
    Correspondent
    Wei Zhao

    US Agent

    Business Name
    Mid-link International Inc
    Contact Name
    Marco Mu
    Address
    2219 Rimlang Drive, Suite 301
    City
    Bellingham
    State
    WA
    ZIP
    98226
    Country
    US
    Email
    [email protected]
    Phone
    702 2095185

    Products

    Device Name Product Code
    Over-The-Counter Powered Light Based Laser For Acne OLP

    Proprietary Names

    POLY Go

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)