BEUDAMED
    FDA Registration Active 🇨🇳 China

    Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe

    Reg #: 3017448139 · FEI: 3017448139 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    ZHEJIANG CURAWAY MEDICAL TECHNOLOGY CO., LTD
    Registration Number
    3017448139
    FEI Number
    3017448139
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Room 106, Building 1, No.600, 21st Avenue, Baiyang Sub-district, Qiantang New District
    City
    Hangzhou Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K222001

    Owner / Operator

    Firm Name
    Zhejiang CuraWay Medical Technology Co., Ltd.
    Operator Number
    10076584
    Address
    Room 106, Building 1, No.600, 21st Avenue, Baiyang Sub-district, Qiantang New District
    City
    Hangzhou City
    State
    Zhejiang
    Postal Code
    310018
    Country
    CN
    Correspondent
    Yao Zhang

    US Agent

    Business Name
    Performance International Inc.
    Contact Name
    Dennis Xu
    Address
    4004 Pepperton Dr.
    City
    Raleigh
    State
    NC
    ZIP
    27606
    Country
    US
    Email
    [email protected]
    Phone
    919 8590478

    Products

    Device Name Product Code
    Low Energy Direct Current Thermal Ablation System OAB

    Proprietary Names

    Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device Foreign Private Label Distributor