BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Atellica Sampler Handler - SH Additional

    Reg #: 8020888 · FEI: 3007019572 · Expires 2025
    View on FDA
    Products
    7
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    7

    Registration Details

    Registration Name
    Siemens Healthcare Diagnostics Manufacturing Ltd.
    Registration Number
    8020888
    FEI Number
    3007019572
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    CHAPEL LANE
    City
    SWORDS Dublin
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K161954

    Owner / Operator

    Firm Name
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Operator Number
    9096044
    Address
    Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue
    City
    Tarrytown
    State
    NY
    Postal Code
    10591
    Country
    US
    Correspondent
    Mary Seeger

    Products

    Device Name Product Code
    Electrode, Ion-Specific, Chloride CGZ
    Electrode, Ion Specific, Potassium CEM
    Electrode, Ion Specific, Sodium JGS
    Radioimmunoassay, Thyroid-Stimulating Hormone JLW
    Bromcresol Purple Dye-Binding, Albumin CJW
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Radioimmunoassay, Vancomycin LEH

    Proprietary Names

    Atellica Sampler Handler - SH Additional Atellica CH Reaction Cuvette Segment Atellica CH Dilution Cuvette Segment Atellica Tube Top Sample Cup Atellica Sampler Handler - SH Prime

    Establishment Types

    Manufacture Medical Device