BEUDAMED
    FDA Registration Active 🇨🇳 China

    Chemiluminescence Immunoassay Analyzer(Model: Ellume-A)

    Reg #: 3017121083 · FEI: 3017121083 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GOLDSITE DIAGNOSTICS INC.
    Registration Number
    3017121083
    FEI Number
    3017121083
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 1001, Building No.1, GOLDSITE Mansion, No. 9 Rongtian Road, Kengzi, Pingshan District
    City
    Shenzhen Guangdong
    Country
    CN

    Owner / Operator

    Firm Name
    Goldsite Diagnostics Inc.
    Operator Number
    10084489
    Address
    No. 1001, Building No.1, GOLDSITE Mansion, No. 9 Rongtian Road, Kengzi, Pingshan District
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518122
    Country
    CN
    Correspondent
    Ji Zhou

    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
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE

    Proprietary Names

    Chemiluminescence Immunoassay Analyzer(Model: Ellume-A) Integrated Clinical Chemistry and Immunoassay Analyzer (Model: ONTOP) Clinical Chemistry Analyzer(Model: GBA-1000) Chemiluminescence Immunoassay Analyzer(Model: Kemilo)

    Establishment Types

    Manufacture Medical Device