BEUDAMED
    FDA Registration Active 🇮🇸 Iceland

    NOX MEDICAL

    Reg #: 3007389703 · FEI: 3007389703 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    72
    Establishment Types
    3
    Classifications
    8

    Registration Details

    Registration Name
    NOX MEDICAL
    Registration Number
    3007389703
    FEI Number
    3007389703
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Katrinartuni 2
    City
    Reykjavik
    Country
    IS

    Regulatory Submissions

    510(k) Number
    K241288

    Owner / Operator

    Firm Name
    Nox Medical
    Operator Number
    10027652
    Address
    Katrinartuni 2
    City
    Reykjavik
    State
    IS-55
    Postal Code
    IS-105
    Country
    IS
    Correspondent
    Robert Magnusson

    US Agent

    Business Name
    Nox Health
    Contact Name
    Sigurjon Kristjansson
    Address
    100 Kimball Place, Suite 100
    City
    Alpharetta
    State
    GA
    ZIP
    30009
    Country
    US
    Email
    [email protected]
    Phone
    888 5050280

    Products

    Device Name Product Code
    Standard Polysomnograph With Electroencephalograph OLV
    Automatic Event Detection Software For Polysomnograph With Electroencephalograph OLZ
    Computerized Behavioral Therapy Device For Insomnia QVO
    Oximeter DQA
    Device, Muscle Monitoring KZM
    Ventilatory Effort Recorder MNR
    Cannula, Nasal, Oxygen CAT
    Cable, Electrode IKD

    Proprietary Names

    Noxturnal Web DeepRESP Somryst Somryst - CBT - I Nox A1 System Noxturnal PSG CD Nox A1 Recorder Noxturnal US Nox A1 EEG 5 Lead Gold Electrode Cable Noxturnal PSG Noxturnal App Nox A1 EEG Head Cable Nox C1 Access Point Nox A1 Carry Case Noxturnal US CD Nox C1 Kit Nox A1 Starter Sensor Kit, Pediatric Nox A1 Starter Sensor Kit, Adult Nox C1s Kit Nox A1s System Noxturnal US App Nox A1s Recorder Nox RIP Belts Disposable X-Large 1 set Nox RIP Belts Disposable Medium 20 sets Nox RIP Belts Disposable Pediatric 1 set Nox RIP Belts Disposable Large 1 set Nox RIP Belts and Cannula Kit M Nox T3® Demo System Nox RIP Belts Disposable Small 1 set Nox T3® System Nox RIP Belts Disposable X-Large 14 sets Nox RIP Belts Disposable Large 20 sets Nox RIP Belts Disposable Medium 1 set Nox RIP Belts Disposable Pediatric 20 sets Nox RIP Belts Disposable Small 20 sets Nox RIP Belts and Cannula Kit S/M/L Nox Abdomen Cable - NOX-ATC1PAC1 Nox Abdomen Cable, s Nox Cannula with Luer-lock Adult Nox Cannula with Filter Adult Nox RIP Belts and Cannula Kit, s S/M/L Nox RIP Belts and Cannula Kit, s M Nox Snap on Double Lead 50/100 cm, orange Nox Snap on Double Lead 148/150 cm, black Nox Snap on Lead 30 cm, beige-white Nox Snap on Lead 100 cm, beige-grey Nox Snap on Lead 100 cm, orange Nox Snap on Double Lead 98/100 cm, beige- grey Nox Snap on Double Lead 30/32 cm, beige- white Nox Snap on Lead 50 cm, beige-green Nox Snap on Lead 150 cm, black Nox Snap on Double Lead 50/52 cm, white Nox Snap on Double Lead 98/100 cm, beige- black Nox Snap on Lead 100 cm, green Nox Snap on Lead 150 cm, grey Nox Snap on Lead 100 cm, beige-black Nox Snap on Double Lead 30/50 cm, beige- orang Nox Snap on Double Lead 148/150 cm, grey Nox Snap on Lead 50 cm, white Nox SAS Head Cable Nox SAS Body Cable - Left Nox SAS Body Cable - Right Nox T3® Carry Case Nox T3® Demo Recorder Nox Service Kit Nox Filter Tube Connector Nox Abdomen Cable Nox Mini USB Cable Nox T3® Recorder Nox Service Kit, s Nox T3s System Nox T3s Recorder

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility