BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    NORAV MEDICAL LTD.

    Reg #: 9681548 · FEI: 3002807745 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    30
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    NORAV MEDICAL LTD.
    Registration Number
    9681548
    FEI Number
    3002807745
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4 HAMADA ST.
    City
    YOKNEAM Northern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K000404

    Owner / Operator

    Firm Name
    NORAV MEDICAL
    Operator Number
    9024500
    Address
    4 HAMADA ST., --
    City
    YOKNEAM
    State
    IL-NOTA
    Postal Code
    2069202
    Country
    IL
    Correspondent
    YEHUDA - KANNAR

    US Agent

    Business Name
    Norav Medical Inc
    Contact Name
    Dennis Dockery
    Address
    1300 Wallace Dr
    City
    Delray Beach
    State
    FL
    ZIP
    33444
    Country
    US
    Email
    [email protected]
    Phone
    561 2744242

    Products

    Device Name Product Code
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Electrocardiograph, Ambulatory (Without Analysis) MWJ
    Electrocardiograph, Ambulatory, With Analysis Algorithm MLO

    Proprietary Names

    PCECG-1200System with MEANS Interpretation (I3) NR-1207, NR-1207-3, NR-1207-E, NR-302, NR-314, NR-314-T. NR-314P NH4 NH4a NH-301-0 NH-301 Ambulatory ECG Analysis Software PCECG 1200W PCECG 1200WR Advanced wireless PC based ECG Blue-ECG NM-700BT ECGBT2 PCECG 1200T-03-05-MG NHH1200 PC-ECG 1200M ECGUSB1D-EX PC-ECG 1200S ECGUSB-1 PC-ECG 1200 Norav ECG Management System (NEMS) PC-ECG 1200HR Advanced PC Based ECG System PC-ECG 1200T ECGUSB1D-EXR ECG-LAN (GREEN) PCECG 1200T (Rev. 03) NORAV HOLTER ANALYSIS SYSTEM NH300 Norav Event Recorder (NER) Norav Medical GmbH

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device