BEUDAMED
    FDA Registration Active 🇨🇳 China

    AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER

    Reg #: 3005515211 · FEI: 3005515211 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    AMSINO MEDICAL (SHANGHAI) CO., LTD.
    Registration Number
    3005515211
    FEI Number
    3005515211
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Building No. 1-3, 16, Lane 355, Huazhe Road, Songjiang Export Processing Zone
    City
    SHANGHAI
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K101824

    Owner / Operator

    Firm Name
    AMSINO MEDICAL (SHANGHAI) CO., LTD.
    Operator Number
    9080886
    Address
    SONGJIANG EXPORT PROCESSING, ZONE PHASE V, LOT # 1-3
    City
    SHANGHAI
    State
    CN-NOTA
    Postal Code
    201613
    Country
    CN
    Correspondent
    Holiven - Ji

    US Agent

    Business Name
    Amsino International Inc.
    Contact Name
    Richard Lee
    Address
    708 Corporate Center Drive
    City
    Pomona
    State
    CA
    ZIP
    91768
    Country
    US
    Email
    [email protected]
    Phone
    909 6265888

    Products

    Device Name Product Code
    Catheter, Retention Type, Balloon EZL

    Proprietary Names

    AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER

    Establishment Types

    Manufacture Medical Device