BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    BIT Analytical Solutions GmbH

    Reg #: 3003601075 · FEI: 3003601075 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    12

    Registration Details

    Registration Name
    BIT Analytical Solutions GmbH
    Registration Number
    3003601075
    FEI Number
    3003601075
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    AM KRONBERGER HANG 3
    City
    SCHWALBACH/TAUNUS Hesse
    Country
    DE

    Owner / Operator

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

    US Agent

    Business Name
    Keystone Regulatory Services, LLC
    Contact Name
    Bill McLain
    Address
    342 E Main St Ste 207
    City
    Leola
    State
    PA
    ZIP
    17540
    Country
    US
    Email
    [email protected]
    Phone
    717 6569656

    Products

    Device Name Product Code
    Slide Stainer, Automated KPA
    Nephelometer JZW
    System, Automated Platelet Aggregation JOZ
    Counter, Differential Cell GKZ
    System, Multipurpose For In Vitro Coagulation Studies JPA
    Test, Qualitative And Quantitative Factor Deficiency GGP
    Reagent, Russel Viper Venom GIR
    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. Agilent Technologies Memphis Abbott Laboratories Beckman Coulter, Inc.

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)