BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    LEICA MICROSYSTEMS (SCHWEIZ) AG

    Reg #: 3003974370 · FEI: 3003974370 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    35
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    LEICA MICROSYSTEMS (SCHWEIZ) AG
    Registration Number
    3003974370
    FEI Number
    3003974370
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    MAX SCHMIDHEINY-STRASSE 201
    City
    HEERBRUGG Sankt Gallen
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K170239

    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
    Microscope, Operating & Accessories, Ac-Powered, Ophthalmic HRM
    Microscope, Surgical EPT
    Diagnostic Neurosurgical Microscope Filter QFX
    Microscope, Surgical, General & Plastic Surgery FSO

    Proprietary Names

    Leica FL560 Leica FL560 Procedure Kit Leica ToricEyePiece PROVEO 8 F42 Leica RUV800 WD175 Leica M822 CT40 Leica M822 F20 Leica Wireless Footswitch, 12 Functions Leica Wireless Footswitch, 14 Functions Leica M822 F40 Leica RUV800 WD200 PROVEO 8 CT42 PROVEO 8x Leica FL800 Leica FL400 Leica FL800 ULT GLOW800 Leica M844 F40 Leica M844 F20 Leica M220 F12 Leica M844 CT40 Leica M530 OHX Leica M320 W12 Leica M320 C12 Leica M320 TC12 Leica M525 F20 Leica M320 LW12 Leica M320 TP12 Leica M320 FP12 Leica M320 F12 Surgical Microscope Air Removal System (SMARS) PROvido ARveo 8 MyVeo ARveo 8x

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility