BEUDAMED
    FDA Registration Active 🇨🇳 China

    Accuryn Monitoring System; Accuryn Sensing Urinary Catheter

    Reg #: 3011707784 · FEI: 3011707784 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    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
    K153655

    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
    Intra-Abdominal Pressure Monitoring Device PHU
    Catheter, Retention Type, Balloon EZL
    Uroflowmeter EXY

    Proprietary Names

    Accuryn Monitoring System; Accuryn Sensing Urinary Catheter

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)