BEUDAMED
    FDA Registration Active 🇨🇳 China

    LumenCross Imaging Catheter (F2)

    Reg #: 3013351723 · FEI: 3013351723 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SHENZHEN VIVOLIGHT MEDICAL DEVICE&TECHNOLOGY CO., LTD.
    Registration Number
    3013351723
    FEI Number
    3013351723
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Room 511-A, 5th Floor, Block B, Building R2, High-tech Industrial Park, No. 020, South Seventh Road, Gaoxin Community, Yuehai Street, Nanshan District
    City
    shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K242098

    Owner / Operator

    Firm Name
    Shenzhen Vivolight Medical Device&Technology Co., Ltd.
    Operator Number
    10054042
    Address
    Room 511-A, 5th Floor, Block B, Building R2, High-tech Industrial Park, No. 020, South Seventh Road, Gaoxin Community, Yuehai Street, Nanshan District
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518063
    Country
    CN
    Correspondent
    Pengyang Gao

    US Agent

    Business Name
    Hlongmed International Ltd.
    Contact Name
    Anny zhao
    Address
    1312 17th Street#692 Denver, CO 80202
    City
    Denver
    State
    CO
    ZIP
    80202
    Country
    US
    Email
    [email protected]
    Phone
    503 3344880

    Products

    Device Name Product Code
    Catheter, Intravascular, Diagnostic DQO
    System, Imaging, Optical Coherence Tomography (Oct) NQQ

    Proprietary Names

    LumenCross Imaging Catheter (F2) Cornaris Intravascular Imaging System (Mobile-E) Cornaris Intravascular Imaging System (P80-E)

    Establishment Types

    Manufacture Medical Device