BEUDAMED
    FDA Registration Active 🇨🇳 China

    Synxess Neurovascular Guidewire

    Reg #: 3034543750 · FEI: 3034543750 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ENLIGHT MEDICAL TECHNOLOGIES (SHENZHEN) CO., LTD.
    Registration Number
    3034543750
    FEI Number
    3034543750
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5-6/F, Building A, Xinghui Technology Industrial Park, 52 Huaning Road, Xinshi Community, Dalang Street, Longhua District
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K240871

    Owner / Operator

    Firm Name
    Enlight Medical Technologies (Shenzhen) Co., Ltd.
    Operator Number
    10091943
    Address
    5-6/F, Building A, Xinghui Technology Industrial Park, 52 Huaning Road, Xinshi Community, Dalang Street, Longhua District, Shenzhen, P.R. China
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518109
    Country
    CN

    Products

    Device Name Product Code
    Guide, Wire, Catheter, Neurovasculature MOF

    Proprietary Names

    Synxess Neurovascular Guidewire Synxess WaveSelect Neurovascular Guidewire

    Establishment Types

    Manufacture Medical Device