BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    HE4 CC 5 Elecsys

    Reg #: 9610126 · FEI: 3002806559 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    ROCHE DIAGNOSTICS GMBH
    Registration Number
    9610126
    FEI Number
    3002806559
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    SANDHOFER STRASSE 116
    City
    MANNHEIM Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K112624

    Owner / Operator

    Firm Name
    Roche Diagnostics Operations Inc.
    Operator Number
    9039767
    Address
    9115 Hague Road
    City
    Indianapolis
    State
    IN
    Postal Code
    46250
    Country
    US

    US Agent

    Business Name
    Roche Diagnostics Operations Inc
    Contact Name
    Brian Frazier
    Address
    9115 Hague Rd
    City
    Indianapolis
    State
    IN
    ZIP
    46256
    Country
    US
    Email
    [email protected]
    Phone
    317 5214603

    Products

    Device Name Product Code
    Calibrator, Secondary JIT
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Test, Epithelial Ovarian Tumor Associated Antigen (He4) OIU

    Proprietary Names

    HE4 CC 5 Elecsys HE4 Elecsys E2G 100 HE4 Elecsys cobas e 100 HE4 CS Elecsys HE4 PC Elecsys ELECSYS HE4 CALCHECK 5 ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4

    Establishment Types

    Manufacture Medical Device