BEUDAMED
    FDA Registration Active 🇨🇳 China

    PANABAY

    Reg #: 3026848661 · FEI: 3026848661 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Shanghai Yunze Biotechnology Co., Ltd.
    Registration Number
    3026848661
    FEI Number
    3026848661
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Room 301, 302-1, 401-1, Building 10, 760 Xinjun Ring Road
    City
    Minhang Disctrict Shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K203833

    Owner / Operator

    Firm Name
    Shanghai Yunze Biotechnology Co., Ltd.
    Operator Number
    10087388
    Address
    Room 301, 302-1, 401-1, Building 10, 760 Xinjun Ring Road,
    City
    Minhang Disctrict
    State
    Shanghai
    Postal Code
    201112
    Country
    CN

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Enzyme Immunoassay, Tracrolimus MLM

    Proprietary Names

    PANABAY

    Establishment Types

    Manufacture Medical Device