BEUDAMED
    FDA Registration Active 🇨🇳 China

    AMSure® Sterile Water, and Sterile Normal Saline for Wound Flush

    Reg #: 3009848807 · FEI: 3009848807 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    LUCKY STAR LRRADIATION SCIENCE CO.,LTD SHANGHAI
    Registration Number
    3009848807
    FEI Number
    3009848807
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.758Tianying Road,Qingpu Industrial Zone
    City
    Shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K181423

    Owner / Operator

    Firm Name
    Lucky Star lrradiation Science Co.,Ltd Shanghai
    Operator Number
    10085638
    Address
    No.758Tianying Road,Qingpu Industrial Zone
    City
    Shanghai
    State
    CN-SH
    Postal Code
    201700
    Country
    CN
    Correspondent
    Tony Ye

    US Agent

    Business Name
    RGLM Consulting LLC
    Contact Name
    Roy Zhang
    Address
    6113 Swift Current Way
    City
    Clarksville
    State
    MD
    ZIP
    21029
    Country
    US
    Email
    [email protected]
    Phone
    425 2364274

    Products

    Device Name Product Code
    Dressing, Wound, Drug FRO

    Proprietary Names

    AMSure® Sterile Water, and Sterile Normal Saline for Wound Flush

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)