BEUDAMED
    FDA Registration Active 🇨🇳 China

    CO2 Laser Therapy System HM-CL200

    Reg #: 3016170453 · FEI: 3016170453 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SHANDONG HUAMEI TECHNOLOGY CO.,LTD.
    Registration Number
    3016170453
    FEI Number
    3016170453
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    588,Changning Street,High-tech District
    City
    Weifang Shandong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K192528

    Owner / Operator

    Firm Name
    Shandong Huamei Technology Co Ltd
    Operator Number
    10061692
    Address
    588,Changning Street,High-tech District
    City
    Weifang
    State
    Shandong
    Postal Code
    261205
    Country
    CN
    Correspondent
    Qinghua Xu

    US Agent

    Business Name
    Believe-Med Technical Service Inc.
    Contact Name
    Wen Xu
    Address
    4611 Maydew Mews Way
    City
    Ellicott
    State
    MD
    ZIP
    21042
    Country
    US
    Email
    [email protected]
    Phone
    443 8968583

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    CO2 Laser Therapy System HM-CL200

    Establishment Types

    Manufacture Medical Device