BEUDAMED
    FDA Registration Active 🇨🇳 China

    Kyphoplasty Balloon Catheter

    Reg #: 3016789487 · FEI: 3016789487 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    JIANGSU CHANGMEI MEDTECH CO.,LTD
    Registration Number
    3016789487
    FEI Number
    3016789487
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.27, Xinke West Road, Luoyang Town, Wujin District
    City
    Changzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K223709

    Owner / Operator

    Firm Name
    Jiangsu Changmei Medtech Co.,Ltd
    Operator Number
    10065161
    Address
    No.27, Xinke West Road, Luoyang Town, Wujin District
    City
    Changzhou
    State
    Jiangsu
    Postal Code
    213104
    Country
    CN
    Correspondent
    Yufang Shen

    US Agent

    Business Name
    MEDRIGHT TECH INC
    Contact Name
    Jessie Yao
    Address
    6302 FORT HAMILTON PARKWAY, 1R
    City
    Brooklyn
    State
    NY
    ZIP
    11219
    Country
    US
    Email
    [email protected]
    Phone
    718 2169957

    Products

    Device Name Product Code
    Arthroscope HRX
    Tamp HXG

    Proprietary Names

    Kyphoplasty Balloon Catheter

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198