BEUDAMED
    FDA Registration Active 🇨🇳 China

    PTA High Pressure Balloon Dilatation Catheter

    Reg #: 3027343398 · FEI: 3027343398 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    DK Medical Technology Co., Ltd.
    Registration Number
    3027343398
    FEI Number
    3027343398
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Unit301, 303,305 and 311 bioBAY B1 Building, 218 Xinghu Str., Suzhou Industrial Park, Suzhou, Jiangsu, 215123, #5 Building, Xinhong Industrial Park, #9 Suhong West Rd., Suzhou Industrial Park, Suzhou, Jiangsu, 215000
    City
    Suzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K214009

    Owner / Operator

    Firm Name
    DK Medical Technology Co., Ltd.
    Operator Number
    10087839
    Address
    Unit 301, 303,305 and 311 bioBAY B1 Building, 218 Xinghu Str., Suzhou Industrial Park, Suzhou, Jiangsu, #5 Building, Xinhong Industrial Park, #9 Suhong West Rd., Suzhou Industrial Park, Suzhou, Jiangsu
    City
    Suzhou
    State
    Jiangsu
    Postal Code
    215123
    Country
    CN
    Correspondent
    Quan Shi

    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
    Catheter, Percutaneous DQY
    Catheter, Angioplasty, Peripheral, Transluminal LIT

    Proprietary Names

    PTA High Pressure Balloon Dilatation Catheter

    Establishment Types

    Manufacture Medical Device