BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    rTOP

    Reg #: 3038189169 · FEI: 3038189169 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ROCLUB GMBH
    Registration Number
    3038189169
    FEI Number
    3038189169
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Bismarckstrasse 10-12
    City
    Berlin
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K243333

    Owner / Operator

    Firm Name
    roclub GmbH
    Operator Number
    10092986
    Address
    Bismarckstrasse 10-12
    City
    Berlin
    State
    DE-BE
    Postal Code
    10625
    Country
    DE
    Correspondent
    Mario Schrenk

    US Agent

    Business Name
    roclub Americas Inc.
    Contact Name
    Joshua Seyler
    Address
    80 Pine St Fl 24
    City
    New York
    State
    NY
    ZIP
    10005
    Country
    US
    Email
    [email protected]
    Phone
    910 9310093

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    rTOP

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device