BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    MassTrak

    Reg #: 3003951180 · FEI: 3003951180 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH
    Registration Number
    3003951180
    FEI Number
    3003951180
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Am Haag 12
    City
    Gräfelfing Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K063868

    Owner / Operator

    Firm Name
    CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH
    Operator Number
    9067715
    Address
    Am Haag 12, --
    City
    Graefelfing
    State
    DE-NOTA
    Postal Code
    82166
    Country
    DE

    US Agent

    Business Name
    confinis USA Inc.
    Contact Name
    Alfred Lerch
    Address
    600 Park Offices Drive Suite 300, Unit #50
    City
    Durham
    State
    NC
    ZIP
    27709
    Country
    US
    Email
    [email protected]
    Phone
    910 2289391

    Products

    Device Name Product Code
    Calibrator, Secondary JIT
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Enzyme Immunoassay, Tracrolimus MLM

    Proprietary Names

    MassTrak

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)