BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    MAKAR CONSULTING PTY LTD

    Reg #: 3010703925 · FEI: 3010703925 · Expires 2026
    View on FDA
    Products
    42
    Proprietary Names
    51
    Establishment Types
    1
    Classifications
    42

    Registration Details

    Registration Name
    MAKAR CONSULTING PTY LTD
    Registration Number
    3010703925
    FEI Number
    3010703925
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1 Garigal Road
    City
    Belrose New South Wales
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K160621
    PMA Number
    P990066

    Owner / Operator

    Firm Name
    Makar Consulting Pty Ltd
    Operator Number
    10062928
    Address
    1 Garigal Road
    City
    Belrose
    State
    New South Wales
    Postal Code
    2085
    Country
    AU
    Correspondent
    Richard J Blunden

    US Agent

    Business Name
    Vomark Technologies, Inc
    Contact Name
    Peter Pekalski
    Address
    406 Diens Drive
    City
    Wheeling
    State
    IL
    ZIP
    60090
    Country
    US
    Email
    [email protected]
    Phone
    312 2539892

    Products

    Device Name Product Code
    Coil, Magnetic Resonance, Specialty MOS
    System, Nuclear Magnetic Resonance Imaging LNH
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    Full Field Digital, System, X-Ray, Mammographic MUE
    Interventional Fluoroscopic X-Ray System OWB
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    Densitometer, Bone KGI
    Compressor, Cardiac, External DRM
    Stretcher, Wheeled FPO
    System, X-Ray, Mammographic IZH
    Console, Heart-Lung Machine, Cardiopulmonary Bypass DTQ
    Assembly, Tube Housing, X-Ray, Diagnostic ITY
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    System, X-Ray, Tomography, Computed JAK
    Endoscope, Accessories, Narrow Band Spectrum NWB
    Colonoscope And Accessories, Flexible/Rigid FDF
    Gastroscope And Accessories, Flexible/Rigid FDS
    Laparoscope, General & Plastic Surgery GCJ
    System, Tomography, Computed, Emission KPS
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Computer, Blood-Pressure DSK
    Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) DRO
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Dc-Defibrillator, Low-Energy, (Including Paddles) LDD
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Automated External Defibrillators (Non-Wearable) MKJ
    Oximeter DQA
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    Detector And Alarm, Arrhythmia DSI
    System, Network And Communication, Physiological Monitors MSX
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Monitor, St Segment With Alarm MLD
    Adaptor, Lead Switching, Electrocardiograph DRW
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Collimator, Automatic, Radiographic IZW
    Gas-Machine, Anesthesia BSZ
    Automated Radiological Image Processing Software QIH
    Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment KIJ
    Digital Breast Tomosynthesis OTE
    Endoscope, Accessories, Image Post-Processing For Color Enhancement PEA

    Proprietary Names

    GE MRI Coil GE Logiq P8 Hologic Selenia Dimensions Mammo GE Senographe Essential Siemens Cios C-Arm Hologic Horizon GE Logiq Fortis Lucas 3 Chest Compressor Power Load Cot Fastener Hologic Affirm Prone Sorin Heart Lung Hologic Mammo 113T tube GE Healthcare GE Venue Fit Philips Veradius C-Arm GE CT Scanner Olympus Stryker 1488 Siemens Perspective CT KPS - System, tomography, computed, emission Versana Active Siemens Biograph Siemens Emotion 16 Lifepak Philips Medical Siemens Symbia 16T Logiq P10 Datex-Ohmeda Toshiba Medical OEC Elite Philips Brilliance 64 Siemens Inspiration Mammo Selenia Dimensions Mammography System Siemens Vivid E95 GE Venue Go Philips Ingenuity CT GE Optima 660 GE Lunar Prodigy Philips Healthcare Logiq E10 Epiq Ultrasounds Lucas 2 Chest Compressor Logiq Fortis Versana Balance Stryker GE Ultrasound Hologic Selenia Dimensions Mammography Senographe Essential Affiniti 70 Pentax Gastroenterology

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device