BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    R-BIOPHARM AG

    Reg #: 3004061467 · FEI: 3004061467 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    R-BIOPHARM AG
    Registration Number
    3004061467
    FEI Number
    3004061467
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    An der neuen Bergstrasse 17
    City
    DARMSTADT Hesse
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K171511

    Owner / Operator

    Firm Name
    R-BIOPHARM AG
    Operator Number
    9058209
    Address
    An der neuen Bergstrasse 17, --
    City
    Darmstadt
    State
    Hesse
    Postal Code
    D-64297
    Country
    DE
    Correspondent
    Fernanda Heiss

    US Agent

    Business Name
    QUARAS, LLC
    Contact Name
    Roshana Ahmed
    Address
    2101 Camino Rey
    City
    Fullerton
    State
    CA
    ZIP
    92833
    Country
    US
    Email
    [email protected]
    Phone
    657 2487361

    Products

    Device Name Product Code
    Protein, Complement, Antigen, Antiserum, Control DHL
    Reagents For Detection Of Norovirus Nucleic Acid PIQ
    Real Time Nucleic Acid Amplification System OOI
    P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin JNN

    Proprietary Names

    RIDA® CCD-Inhibitor RIDA®GENE Norovirus GI/GII RIDASCREEN® Pancreatic Elastase ELISA

    Establishment Types

    Manufacture Medical Device