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    FDA Registration Active 🇨🇳 China

    PULNOVO MEDICAL (WUXI) CO., LTD.

    Reg #: 3041086754 · FEI: 3041086754 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

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    Registration Details

    Registration Name
    PULNOVO MEDICAL (WUXI) CO., LTD.
    Registration Number
    3041086754
    FEI Number
    3041086754
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3rd Floor, Building D17, No.1719-17 Huishan Avenue and 3rd Floor, Building D11, No.1719-11 Huishan Avenue Huis
    City
    Wuxi Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K242756

    Owner / Operator

    Firm Name
    Pulnovo Medical (Wuxi) Co., Ltd.
    Operator Number
    10095366
    Address
    3rd Floor, Building D17, No.1719-17 Huishan Avenue and 3rd Floor, Building D11, No.1719-11 Huishan Avenue Huis
    City
    Wuxi
    State
    Jiangsu
    Postal Code
    214000
    Country
    CN
    Correspondent
    Cynthia Chen

    US Agent

    Business Name
    CardioMed Device Consultants LLC
    Contact Name
    Semih Oktay
    Address
    3168 Braverton St
    City
    Edgewater
    State
    MD
    ZIP
    21037
    Country
    US
    Email
    [email protected]
    Phone
    410 2712088

    Products

    Device Name Product Code
    Introducer, Catheter DYB

    Proprietary Names

    PFlexi

    Establishment Types

    Manufacture Medical Device