BEUDAMED
    FDA Registration Active 🇳🇴 Norway

    Medistim MiraQ system

    Reg #: 9613067 · FEI: 3010790133 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    MEDISTIM ASA
    Registration Number
    9613067
    FEI Number
    3010790133
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Oekernveien 94
    City
    OSLO
    Country
    NO

    Regulatory Submissions

    510(k) Number
    K102595

    Owner / Operator

    Firm Name
    Medistim ASA
    Operator Number
    9038441
    Address
    Oekernveien 94
    City
    Oslo
    State
    NO-NOTA
    Postal Code
    N-0579
    Country
    NO
    Correspondent
    Tone Veiteberg

    US Agent

    Business Name
    Medistim USA, Inc
    Contact Name
    Mike Farbelow
    Address
    14000 25th Ave. N. Ste. 108
    City
    Minneapolis
    State
    MN
    ZIP
    55447
    Country
    US
    Email
    [email protected]
    Phone
    763 2089852 ext. 105

    Products

    Device Name Product Code
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Flowmeter, Blood, Cardiovascular DPW

    Proprietary Names

    Medistim MiraQ system Medistim VeriQC system Medistim Imaging probe

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility