BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Leica Microsystems NC, Inc.

    Reg #: 3006809695 · FEI: 3006809695 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Leica Microsystems NC, Inc.
    Registration Number
    3006809695
    FEI Number
    3006809695
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4222 Emperor Blvd, Suite 390
    City
    Durham
    State
    NC
    ZIP
    27703
    Country
    US

    Regulatory Submissions

    510(k) Number
    K162783

    Owner / Operator

    Firm Name
    Leica Microsystems CMS GmbH
    Operator Number
    10054809
    Address
    Ernst-Leitz-Strasse 17-37
    City
    Wetzlar
    State
    Hesse
    Postal Code
    35578
    Country
    DE
    Correspondent
    Roland Jehle

    Products

    Device Name Product Code
    Tomography, Optical Coherence OBO
    Ophthalmoscope, Ac-Powered HLI

    Proprietary Names

    9070-10088 EnFocus 2300 Integrated OCT System 9070-10100 EnFocus 2300 Integtrated OCT System 9070-10084 EnFocus 2300 System, 100V 9070-10070 EnFocus 2300 System, 120V 9070-10071 EnFocus 2300 System, 230V

    Establishment Types

    Manufacture Medical Device