BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Atellica IM 1600 Analyzer (Refurbished)

    Reg #: 8020888 · FEI: 3007019572 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    3

    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
    K151792

    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
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Radioimmunoassay, Thyroid-Stimulating Hormone JLW
    Calibrator, Secondary JIT

    Proprietary Names

    Atellica IM 1600 Analyzer (Refurbished) Atellica IM 1600 Analyzer Atellica IM Acid/Base Atellica IM 1300 Analyzer Atellica IM Cleaner Atellica IM Wash Atellica IM Acid Atellica IM Base Atellica IM Ancillary Seal Kit Atellica IM 1300 Analyzer (Refurbished)

    Establishment Types

    Manufacture Medical Device