BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    NeuroLF (Basic)

    Reg #: 3032577207 · FEI: 3032577207 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    4
    Classifications
    1

    Registration Details

    Registration Name
    POSITRIGO AG
    Registration Number
    3032577207
    FEI Number
    3032577207
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Technoparkstrasse 1
    City
    Zurich
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K241751

    Owner / Operator

    Firm Name
    Positrigo AG
    Operator Number
    10091382
    Address
    Technoparkstrasse 1
    City
    Zurich
    State
    CH-ZH
    Postal Code
    8005
    Country
    CH
    Correspondent
    Jannis Fischer

    US Agent

    Business Name
    Positrigo Inc.
    Contact Name
    Ronald Lissak
    Address
    106 Center Hill Rd
    City
    Manchester Center
    State
    VT
    ZIP
    05255
    Country
    US
    Email
    [email protected]
    Phone
    917 7633694

    Products

    Device Name Product Code
    System, Tomography, Computed, Emission KPS

    Proprietary Names

    NeuroLF (Basic) NeuroLF (Advanced) NeuroLF (Pro) NeuroLF Seat

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device