BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Bruker Daltonics

    Reg #: 3010191749 · FEI: 3010191749 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    23
    Establishment Types
    3
    Classifications
    3

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    Registration Details

    Registration Name
    Bruker Daltonics
    Registration Number
    3010191749
    FEI Number
    3010191749
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Fahrenheitstrasse 4
    City
    Bremen
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K193419

    Owner / Operator

    Firm Name
    Bruker Scientific LLC
    Operator Number
    10044152
    Address
    40 Manning Road
    City
    Billerica
    State
    MA
    Postal Code
    01821
    Country
    US

    US Agent

    Business Name
    BRUKER SCIENTIFIC LLC
    Contact Name
    Doug Roderick
    Address
    40 Manning Road
    City
    Billerica
    State
    MA
    ZIP
    01821
    Country
    US
    Email
    [email protected]
    Phone
    978 6633660 ext. 1216

    Products

    Device Name Product Code
    Mass Spectrometry, Microorganism Identification, Blood Culture QNJ
    System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates PEX
    Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates QBN

    Proprietary Names

    MBT Pilot System US IVD MBT Sepsityper MBT Sepsityper Kit US IVD MBT Biotarget 96 US IVD MALDI Biotyper-BD sirius CA System MALDI Biotyper sirius CA System MBT-BD sirius one CA System MBT-BD sirius CA System MALDI Biotyper sirius one CA System MBT sirius one CA System MALDI Biotyper-BD sirius one CA System MBT sirius CA System US IVD HCCA Portioned for MBT Galaxy MBT-CA System BD Bruker MALDI Biotyper CA System US IVD 48 Spot Target MALDI Biotyper CA System US IVD HCCA Portioned BD Bruker MBT-CA System US IVD BTS MBT HT Sepsityper CA Module MBT FAST Shuttle US IVD MBT Compass HT CA Software

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Repack or Relabel Medical Device