BEUDAMED
    FDA Registration Active 🇨🇳 China

    Y2000 Resuscitator

    Reg #: 9710391 · FEI: 3003202124 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    POLYMED (XIAMEN) PLASTIC INDUSTRIAL CO.,LTD.
    Registration Number
    9710391
    FEI Number
    3003202124
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Unit B, 1-5F, No. G, Warehouse & process, complex building, XIANGYU F.T.Z., XIANGYU F.T.Z.
    City
    XIAMEN Fujian
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K003927

    Owner / Operator

    Firm Name
    POLYMED (XIAMEN) PLASTIC INDUSTRIAL CO.,LTD.
    Operator Number
    9044088
    Address
    Unit B, 1-5F, No. G, Warehouse & process, complex building, XIANGYU F.T.Z.
    City
    XIAMEN
    State
    Fujian
    Postal Code
    361006
    Country
    CN
    Correspondent
    EUNICE WU

    US Agent

    Business Name
    SPICA MEDTECH CORP
    Contact Name
    Creekon Yang
    Address
    1020 LINCOLN ST
    City
    Denver
    State
    CO
    ZIP
    80203
    Country
    US
    Email
    [email protected]
    Phone
    720 6176666

    Products

    Device Name Product Code
    Ventilator, Emergency, Manual (Resuscitator) BTM

    Proprietary Names

    Y2000 Resuscitator

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)