BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    BreathID Hp Lab System, BreathID Smart System

    Reg #: 3005772418 · FEI: 3005772418 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Meridian Bioscience Israel Ltd.
    Registration Number
    3005772418
    FEI Number
    3005772418
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4 HaMaayan St
    City
    Modiin Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K220494

    Owner / Operator

    Firm Name
    Meridian Bioscience Israel Ltd.
    Operator Number
    9088923
    Address
    4 HaMaayan St, --
    City
    Modiin
    State
    Central
    Postal Code
    7177872
    Country
    IL
    Correspondent
    Raffi - Werner

    US Agent

    Business Name
    Meridian Bioscience
    Contact Name
    Susan Bogar
    Address
    3471 River Hills Drive
    City
    Cincinnati
    State
    OH
    ZIP
    45244
    Country
    US
    Email
    [email protected]
    Phone
    513 2713700 ext. 10124

    Products

    Device Name Product Code
    Test, Urea (Breath Or Blood) MSQ
    Colorimeter, Photometer, Spectrophotometer For Clinical Use JJQ

    Proprietary Names

    BreathID Hp Lab System, BreathID Smart System

    Establishment Types

    Manufacture Medical Device