BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    Leica FL800

    Reg #: 1000204638 · FEI: 1000204638 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    LEICA INSTRUMENTS (SINGAPORE) PTE LTD.
    Registration Number
    1000204638
    FEI Number
    1000204638
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    15 TUKANG INNOVATION DRIVE
    City
    SINGAPORE South West
    Country
    SG

    Regulatory Submissions

    510(k) Number
    K061871

    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, Surgical EPT

    Proprietary Names

    Leica FL800

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)