BEUDAMED
    FDA Registration Active 🇨🇳 China

    UniPearls® Embolic Microspheres

    Reg #: 3033841272 · FEI: 3033841272 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SUZHOU HAOWEI MEDICAL TECHNOLOGY CO., LTD.
    Registration Number
    3033841272
    FEI Number
    3033841272
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Room 304, Building 4, Tianyun Square No.111, Wusongjiang Avenue, Guoxiang Street Wuzhong District, Suzhou
    City
    Suzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K231554

    Owner / Operator

    Firm Name
    Suzhou Haowei Medical Technology Co., Ltd.
    Operator Number
    10091629
    Address
    Room 304, Building 4, Tianyun Square No.111, Wusongjiang Avenue, Guoxiang Street Wuzhong District, Suzhou
    City
    Suzhou
    State
    Jiangsu
    Postal Code
    215124
    Country
    CN
    Correspondent
    Jinyan Shi

    US Agent

    Business Name
    IVASC Technologies, LLC
    Contact Name
    Bo Liu
    Address
    23152 Verdugo Drive, suite A, Laguna Hills, CA 92653
    City
    Laguna Hills
    State
    CA
    ZIP
    92653
    Country
    US
    Email
    [email protected]
    Phone
    949 8705687

    Products

    Device Name Product Code
    Device, Vascular, For Promoting Embolization KRD

    Proprietary Names

    UniPearls® Embolic Microspheres

    Establishment Types

    Manufacture Medical Device