BEUDAMED
    FDA Registration Active 🇨🇳 China

    SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)

    Reg #: 3029929134 · FEI: 3029929134 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MACROLUX MEDICAL TECHNOLOGY CO., LTD.
    Registration Number
    3029929134
    FEI Number
    3029929134
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    301, Building 3, NamTai Inno Park In Guang Ming Avenue, Guangming
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K240978

    Owner / Operator

    Firm Name
    MacroLux Medical Technology Co., Ltd.
    Operator Number
    10089857
    Address
    301, Building 3, NamTai Inno Park In Guang Ming Avenue, Guangming
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518107
    Country
    CN
    Correspondent
    Linbin Ye

    US Agent

    Business Name
    ICAS Biologics Co., Ltd.
    Contact Name
    Sarah Galemmo
    Address
    20 Via Lucca D310
    City
    Irvine
    State
    CA
    ZIP
    92612
    Country
    US
    Email
    [email protected]
    Phone
    661 8033155

    Products

    Device Name Product Code
    Hysteroscope (And Accessories) HIH

    Proprietary Names

    SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)

    Establishment Types

    Manufacture Medical Device