BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    StrokeViewer LVO Triaging

    Reg #: 3021915828 · FEI: 3021915828 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NICo-Lab B.V.
    Registration Number
    3021915828
    FEI Number
    3021915828
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Paasheuvelweg 25
    City
    Amsterdam Noord-Holland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K200873

    Owner / Operator

    Firm Name
    NICo-lab B.V.
    Operator Number
    10084560
    Address
    Paasheuvelweg 25
    City
    Amsterdam
    State
    Noord-Holland
    Postal Code
    1105 BP
    Country
    NL
    Correspondent
    Ralf-Peter Herber

    US Agent

    Business Name
    Pragmatic Compliance dba FDAbasics
    Contact Name
    Jerry Doane
    Address
    15815 SW 11th Court Rd
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Radiological Computer-Assisted Triage And Notification Software QAS

    Proprietary Names

    StrokeViewer LVO Triaging

    Establishment Types

    Manufacture Medical Device