BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    NIOX VERO Test Kit 60 (includes 1-60 test sensor and 100 NIOX Filters)

    Reg #: 3025604886 · FEI: 3025604886 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TURNKEY EXPORT COMPLIANCE BV
    Registration Number
    3025604886
    FEI Number
    3025604886
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Van Boshuizenstraat 12
    City
    Amsterdam Noord-Holland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K133898

    Owner / Operator

    Firm Name
    Turnkey Export Compliance BV
    Operator Number
    10086767
    Address
    Van Boshuizenstraat 12
    City
    Amsterdam
    State
    Noord-Holland
    Postal Code
    1083BA
    Country
    NL
    Correspondent
    Julian Lap

    US Agent

    Business Name
    Dawa Medical LLC
    Contact Name
    Stephan Toupin
    Address
    7320 NW 12th Street, Suite 103
    City
    Miami
    State
    FL
    ZIP
    33126
    Country
    US
    Email
    [email protected]
    Phone
    786 7311159

    Products

    Device Name Product Code
    System, Test, Breath Nitric Oxide MXA

    Proprietary Names

    NIOX VERO Test Kit 60 (includes 1-60 test sensor and 100 NIOX Filters)

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device