BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    PC Direct

    Reg #: 3018783526 · FEI: 3018783526 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CEVA LOGISTICS NETHERLANDS BV (Venray)
    Registration Number
    3018783526
    FEI Number
    3018783526
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Edisonstraat 2-6
    City
    Oostrum Limburgh
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K090539

    Owner / Operator

    Firm Name
    CEVA Logistics Netherlands BV
    Operator Number
    10086416
    Address
    Edisonstraat 10-12
    City
    Oostrum LB
    State
    NL-NOTA
    Postal Code
    5807 GG
    Country
    NL

    US Agent

    Business Name
    CEVA Logistics US, Inc.
    Contact Name
    Kay Knox
    Address
    4097 E Marquette Ave
    City
    Terre Haute
    State
    IN
    ZIP
    47805
    Country
    US
    Email
    [email protected]
    Phone
    614 4895164

    Products

    Device Name Product Code
    Ventilator, Continuous, Non-Life-Supporting MNS

    Proprietary Names

    PC Direct DreamStation BiPAP AVAPS w/ & w/o Humidifier System One CPAP w/ & w/o Humidifier DreamStation BiPAP autoSV w/ & w/o Humidifier BiPAP autoSV ADV w/Hum 30cm (RIST) BiPAP autoSV Advanced Omnilab Advanced/Advanced + DreamStation BiPAP S/T w/ & w/o Humidifier Omnilab Direct System One BiPAP w/ & w/o Humidifier

    Establishment Types

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