BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Video Ureteroscope

    Reg #: 8010418 · FEI: 3007130719 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    HENKE-SASS WOLF, GMBH.
    Registration Number
    8010418
    FEI Number
    3007130719
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    KELTENSTRASSE 1
    City
    TUTTLINGEN Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K121112

    Owner / Operator

    Firm Name
    HENKE-SASS WOLF, GMBH.
    Operator Number
    8010418
    Address
    Keltenstrasse 1, --
    City
    TUTTLINGEN
    State
    Baden-Wurttemberg
    Postal Code
    D-78532
    Country
    DE
    Correspondent
    MICHAEL - HERZOG

    US Agent

    Business Name
    HENKE-SASS, WOLF OF AMERICA
    Contact Name
    Loretta MCHUGH
    Address
    135 SCHOFIELD AVENUE
    City
    Dudley
    State
    MA
    ZIP
    01571
    Country
    US
    Email
    [email protected]
    Phone
    508 6719356

    Products

    Device Name Product Code
    Ureteroscope And Accessories, Flexible/Rigid FGB

    Proprietary Names

    Video Ureteroscope

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device for Another Party (Contract Manufacturer)