BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NEUROVIRTUAL USA, INC.

    Reg #: 3006125362 · FEI: 3006125362 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    28
    Establishment Types
    3
    Classifications
    7

    Registration Details

    Registration Name
    NEUROVIRTUAL USA, INC.
    Registration Number
    3006125362
    FEI Number
    3006125362
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    3303 W Commercial Blvd, Suite 100
    City
    Fort Lauderdale
    State
    FL
    ZIP
    33309
    Country
    US

    Regulatory Submissions

    510(k) Number
    K112107

    Owner / Operator

    Firm Name
    NEUROVIRTUAL USA, INC.
    Operator Number
    9091724
    Address
    3303 W Commercial Blvd, Suite 100
    City
    Fort Lauderdale
    State
    FL
    Postal Code
    33309
    Country
    US
    Correspondent
    EDUARDO - FARIA

    Products

    Device Name Product Code
    Standard Polysomnograph With Electroencephalograph OLV
    Full-Montage Standard Electroencephalograph GWQ
    Ventilatory Effort Recorder MNR
    Electrode, Cutaneous GXY
    Cannula, Nasal, Oxygen CAT
    Monitor, Breathing Frequency BZQ
    Oximeter DQA

    Proprietary Names

    Neurovirtual BWIII Basics Neurovirtual BWIII EEG Plus Sleepvirtual BWIII PSG Plus Sleepvirtual BWIII PSG Neurovirtual BWIII EEG Maxxi Rip System 3ft Maxxi Rip Pediatric Belt Maxxi Rip System 7ft Maxxi Rip ABD Interface Maxxi Rip Small Belt Maxxi Rip XXLarge Belt Maxxi Rip XLarge Belt Maxxi Rip Adjustable Belt Maxxi Rip Large Belt Maxxi Rip Infant Belt Maxxi Rip THX Interface Maxxi Gold Cup Electrode Maxxi Gold Cutaneous Surface Electrode Maxxi Position Sensor Maxxi Cannula BWMINI PSG BWMINI EEG BWMINI HST BWMINI COMPASS HST BWMINI BASICS Maxxi Flow Sensor Maxxi SpO2 Sensor Maxxi Snore Sensor

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198