BEUDAMED
    FDA Registration Active 🇨🇳 China

    Urethral CATHETER, RETENTION TYPE, BALLOON

    Reg #: 3011707784 · FEI: 3011707784 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
    Registration Number
    3011707784
    FEI Number
    3011707784
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Building 2# Hongfeng Road & No.69-71 Hongdou Road, Baimao Industrial Park, Guli Town
    City
    Changshu Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K142635

    Owner / Operator

    Firm Name
    ChangShu Rozer Sterilization Technology Co., Ltd.
    Operator Number
    10049312
    Address
    No.69-71 Hongdou Road, Baimao Industrial Park, Guli Town
    City
    Changshu
    State
    Jiangsu
    Postal Code
    215532
    Country
    CN
    Correspondent
    Gary Zhu

    Products

    Device Name Product Code
    Catheter, Retention Type, Balloon EZL

    Proprietary Names

    Urethral CATHETER, RETENTION TYPE, BALLOON

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)