BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NORAV HOLTER ANALYSIS SYSTEM

    Reg #: 3008977358 · FEI: 3008977358 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Norav Medical Inc.
    Registration Number
    3008977358
    FEI Number
    3008977358
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    601 N. Congress Ave. # 105
    City
    Delray Beach
    State
    FL
    ZIP
    33445
    Country
    US

    Regulatory Submissions

    510(k) Number
    K012712

    Owner / Operator

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

    Products

    Device Name Product Code
    Electrocardiograph, Ambulatory, With Analysis Algorithm MLO

    Proprietary Names

    NORAV HOLTER ANALYSIS SYSTEM Norav Event Recorder (NER) Norav Medical GmbH NH300

    Establishment Types

    Repack or Relabel Medical Device