BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Siemens Healthcare Diagnostics Inc.

    Reg #: 3003601075 · FEI: 3003601075 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    BIT Analytical Instruments GmbH
    Registration Number
    3003601075
    FEI Number
    3003601075
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    AM KRONBERGER HANG 3
    City
    SCHWALBACH/TAUNUS Hesse
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K943997

    Owner / Operator

    Firm Name
    BIT Analytical Instruments GmbH
    Operator Number
    9072503
    Address
    Am Kronberger Hang 3, --
    City
    Schwalbach/Taunus
    State
    DE-NOTA
    Postal Code
    DE-65824
    Country
    DE
    Correspondent
    Karin - Listringhaus

    US Agent

    Business Name
    BIT Analytical Instruments GmbH
    Contact Name
    Katrin Rienecker
    Address
    2 Enterprise
    City
    Aliso Viejo
    State
    CA
    ZIP
    92656
    Country
    US
    Email
    [email protected]
    Phone
    657 6391761

    Products

    Device Name Product Code
    Radioimmunoassay, Immunoglobulins (G, A, M) CFQ
    Antistreptolysin - Titer/Streptolysin O Reagent GTQ
    Igg, Antigen, Antiserum, Control DEW
    Iga, Antigen, Antiserum, Control CZP
    System, Test, C-Reactive Protein, Rhodamine DCH

    Proprietary Names

    Siemens Healthcare Diagnostics Inc.

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)