BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    SPIES 3D System

    Reg #: 3010707607 · FEI: 3010707607 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    KARL STORZ SE & CO. KG
    Registration Number
    3010707607
    FEI Number
    3010707607
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    TAKE-OFF GEWERBEPARK 83
    City
    NEUHAUSEN OBECK Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K150525

    Owner / Operator

    Firm Name
    KARL STORZ SE & CO KG
    Operator Number
    8010119
    Address
    Dr.-Karl-Storz-Strasse 34,
    City
    TUTTLINGEN
    State
    Baden-Wurttemberg
    Postal Code
    78532
    Country
    DE

    US Agent

    Business Name
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Contact Name
    Anja Fair
    Address
    2151 E Grand Ave
    City
    El Segundo
    State
    CA
    ZIP
    90245
    Country
    US
    Email
    [email protected]
    Phone
    346 8168200

    Products

    Device Name Product Code
    Ureteroscope And Accessories, Flexible/Rigid FGB
    Laparoscope, Gynecologic (And Accessories) HET
    Laparoscope, General & Plastic Surgery GCJ

    Proprietary Names

    SPIES 3D System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)