BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    PRODUKT SERVICE ERDT GMBH

    Reg #: 3013496958 · FEI: 3013496958 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    19
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    PRODUKT SERVICE ERDT GMBH
    Registration Number
    3013496958
    FEI Number
    3013496958
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Fritz-Haber-Str. 6
    City
    Viernheim Hesse
    Country
    DE

    Owner / Operator

    Firm Name
    Produkt Service Erdt GmbH
    Operator Number
    10052296
    Address
    Fritz-Haber-Strasse 6
    City
    Viernheim
    State
    Hesse
    Postal Code
    68519
    Country
    DE
    Correspondent
    Torsten Kuehlwein

    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
    Clinical Sample Concentrator JJH
    Monitor, Microbial Growth JTA
    General Purpose Reagent PPM

    Proprietary Names

    MagNA Pure 96 DNA and Viral NA SV Kit MagNA Pure 96 External Lysis Buffer MagNA Pure 96 DNA and Viral NA LV Kit MagNA Pure 96 Bacterial Lysis Buffer MagNA Pure 96 DNA Tissue Lysis Buffer cobas Microbial Inactivation Solution MagNA Pure LC Total Nucelid Acid Isolation Kit LV MAGNA PURE COMPACT RNA ISO KIT MPLC DNA Isol. Kit II [Tissue] MagNA Pure LC Total Nucelid Acid Isolation Kit MPLC Total Nucleic Acid Isolation KIt MagNA Pure LC DNA ISO KIT-LG VOL MagNA Pure LC RNA KIT HP MagNA Pure LC Total Nucleic Acid Isolation Kit-High Perf MagNA Pure LC TNA Kit I Lysis MagNA Pure LC RNA Kit III MagNA PURE DNA TISSUE LYSIS BUFFER MagNA Pure LC DNA KIT I MagNA Pure 24 Total NA Isolation Kit

    Establishment Types

    Repack or Relabel Medical Device