BEUDAMED
    FDA Registration Active 🇨🇳 China

    Zemits LumaGenix

    Reg #: 3016170453 · FEI: 3016170453 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    2

    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
    K200751

    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 Light Based Non-Laser Surgical Instrument With Thermal Effect ONF
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    Zemits LumaGenix Photodynamic Therapy (PDT) Equipment HM-PDT 100 Photodynamic Therapy (PDT) Equipment HM-PDT 500 Photodynamic Therapy (PDT) Equipment HM-PDT 200 Photodynamic Therapy (PDT) Equipment HM-PDT 900

    Establishment Types

    Manufacture Medical Device