BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    FEMTO Z8 NEO

    Reg #: 3011197745 · FEI: 3011197725 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SIE AG, Surgical Instrument Engineering
    Registration Number
    3011197745
    FEI Number
    3011197725
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Erlenstrasse 31
    City
    Bruegg Bern
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K213559

    Owner / Operator

    Firm Name
    SIE AG, Surgical Instrument Engineering
    Operator Number
    9084406
    Address
    ALLMENDSTRASSE 11, --
    City
    PORT
    State
    CH-NOTA
    Postal Code
    CH - 2562
    Country
    CH

    US Agent

    Business Name
    REGULATORY INSIGHT, INC.
    Contact Name
    KEVIN WALLS
    Address
    33 Golden Eagle Lane
    City
    Littleton
    State
    CO
    ZIP
    80127
    Country
    US
    Email
    [email protected]
    Phone
    720 9625412

    Products

    Device Name Product Code
    Ophthalmic Femtosecond Laser OOE

    Proprietary Names

    FEMTO Z8 NEO

    Establishment Types

    Manufacture Medical Device