BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    CERAMOPTEC GMBH

    Reg #: 3003340844 · FEI: 3003340844 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CERAMOPTEC GMBH
    Registration Number
    3003340844
    FEI Number
    3003340844
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Siemensstrabe 44
    City
    Bonn North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K112253

    Owner / Operator

    Firm Name
    CeramOptec GmbH
    Operator Number
    10075649
    Address
    Siemensstrabe 44
    City
    Bonn
    State
    North Rhine-Westphalia
    Postal Code
    D-53121
    Country
    DE
    Correspondent
    Roland Roland Dreschau

    US Agent

    Business Name
    Wisdom Medical Technologies
    Contact Name
    Tony Jakubowski
    Address
    7791 Aqua Circle, Suite 7G
    City
    Dalton Gardens
    State
    ID
    ZIP
    83815
    Country
    US
    Email
    [email protected]
    Phone
    630 8036383

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    Leonardo PLDD Leonardo® Duster reusable Fibers Leonardo® Duster single-use Fibers Leonardo® Duster

    Establishment Types

    Manufacture Medical Device