BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    CALCULASE HOLMIUM LASE

    Reg #: 9610617 · FEI: 3002808268 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KARL STORZ SE & CO. KG
    Registration Number
    9610617
    FEI Number
    3002808268
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Dr.-Karl-Storz-Str. 11
    City
    TUTTLINGEN Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K052680

    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
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    CALCULASE HOLMIUM LASE CALCULASE HOLMIUM LASER CALCULASE Holmium Laser & Acc.

    Establishment Types

    Repack or Relabel Medical Device