BEUDAMED
    FDA Registration Active 🇨🇳 China

    EvenSpheres, EqualSpheres

    Reg #: 3031240343 · FEI: 3031240343 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SUZHOU HENGRUI HONGYUAN MEDICAL CO., LTD.
    Registration Number
    3031240343
    FEI Number
    3031240343
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 100, Tangjiabang Road, Suzhou Industrial Park
    City
    Suzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K210562

    Owner / Operator

    Firm Name
    Suzhou Hengrui Hongyuan Medical Co., Ltd.
    Operator Number
    10090677
    Address
    No. 100, Tangjiabang Road, Suzhou Industrial Park
    City
    Suzhou
    State
    Jiangsu
    Postal Code
    215123
    Country
    CN
    Correspondent
    Angela Wang

    US Agent

    Business Name
    PUREVISION AI, INC.
    Contact Name
    DJ Fang
    Address
    111 Town Square Place, Suite 1203
    City
    Jersey City
    State
    NJ
    ZIP
    07310
    Country
    US
    Email
    [email protected]
    Phone
    201 5035758

    Products

    Device Name Product Code
    Agents, Embolic, For Treatment Of Uterine Fibroids NAJ
    Device, Vascular, For Promoting Embolization KRD

    Proprietary Names

    EvenSpheres, EqualSpheres

    Establishment Types

    Manufacture Medical Device