BEUDAMED
    FDA Registration Active 🇨🇳 China

    Ultrasonic Scalpel System, Model: SC100E

    Reg #: 3015540957 · FEI: 3015540957 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD.
    Registration Number
    3015540957
    FEI Number
    3015540957
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.1 Xinxing Yilu Road, Emerging Industrial Cluster Area, Zonghan Subdistrict, Cixi City, Zhejiang
    City
    Cixi Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K212614

    Owner / Operator

    Firm Name
    Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
    Operator Number
    10060870
    Address
    No.1 Xinxing Yilu Road, Emerging Industrial Cluster Area, Zonghan Subdistrict, Cixi City, Zhejiang
    City
    Cixi
    State
    Zhejiang
    Postal Code
    315301
    Country
    CN
    Correspondent
    Guofang Ma

    US Agent

    Business Name
    MID-LINK INTERNATIONAL CO., LTD.
    Contact Name
    Marco Mu
    Address
    2219 Rimlang Drive, Suite 301, Bellingham Barkley Villiage, WA, 98226
    City
    Bakerview
    State
    WA
    ZIP
    98226
    Country
    US
    Email
    [email protected]
    Phone
    702 2095185

    Products

    Device Name Product Code
    Instrument, Ultrasonic Surgical LFL

    Proprietary Names

    Ultrasonic Scalpel System, Model: SC100E ultrasonic mode of Ultrasonic Surgical & Electrosurgical Generator (SC300ES, SC200ES, SC100ES)

    Establishment Types

    Manufacture Medical Device