BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    GLOW800

    Reg #: 3003974370 · FEI: 3003974370 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    LEICA MICROSYSTEMS (SCHWEIZ) AG
    Registration Number
    3003974370
    FEI Number
    3003974370
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    MAX SCHMIDHEINY-STRASSE 201
    City
    HEERBRUGG Sankt Gallen
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K181537

    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

    US Agent

    Business Name
    LEICA MICROSYSTEMS NC, INC.
    Contact Name
    Iris Pohl
    Address
    4222 Emperor Blvd, Suite 390
    City
    Durham
    State
    NC
    ZIP
    27703
    Country
    US
    Email
    [email protected]
    Phone
    919 5951274

    Products

    Device Name Product Code
    System, X-Ray, Angiographic IZI

    Proprietary Names

    GLOW800

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility