BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    Neo ADVISE software

    Reg #: 3025343017 · FEI: 3025343017 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    COMERGE AG
    Registration Number
    3025343017
    FEI Number
    3025343017
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Bubenbergstrasse 1
    City
    Zurich
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K230195

    Owner / Operator

    Firm Name
    Comerge AG
    Operator Number
    10086348
    Address
    Bubenbergstrasse 1
    City
    Zürich
    State
    Zurich
    Postal Code
    8045
    Country
    CH
    Correspondent
    Samuel Hertig

    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
    Orthopedic Stereotaxic Instrument OLO

    Proprietary Names

    Neo ADVISE software

    Establishment Types

    Manufacture Medical Device