BEUDAMED
    FDA Registration Active 🇨🇳 China

    Disposable Endoscopic Linear Cutter Staple and Cartridge

    Reg #: 3013534295 · FEI: 3013534295 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    CHANGZHOU XIN NENG YUAN MEDICAL STAPLER CO., LTD.
    Registration Number
    3013534295
    FEI Number
    3013534295
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.51, Shuishan Road,, Zhonglou Economic Development District
    City
    Changzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K161905

    Owner / Operator

    Firm Name
    Changzhou Xin Neng Yuan Medical Stapler Co., Ltd.
    Operator Number
    10054322
    Address
    No.51, Shuishan Road,, Zhonglou Economic Development District
    City
    Changzhou
    State
    Jiangsu
    Postal Code
    213023
    Country
    CN
    Correspondent
    Hong Zhou

    US Agent

    Business Name
    Mid-link International Inc.
    Contact Name
    Marco Mu
    Address
    2219 Rimland Dr. Suite 301
    City
    Bellingham
    State
    WA
    ZIP
    98226
    Country
    US
    Email
    [email protected]
    Phone
    702 2095185

    Products

    Device Name Product Code
    Staple, Implantable GDW
    Stapler, Surgical GAG

    Proprietary Names

    Disposable Endoscopic Linear Cutter Staple and Cartridge Disposable Circular Stapler Disposable Linear Cutter Stapler and Staple Cartridge Disposable Circular Stapler for Hemorrhoid (PPH) Disposable Linear Stapler

    Establishment Types

    Manufacture Medical Device