BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    EvERX PTY LTD

    Reg #: 3008496839 · FEI: 3008496839 · Expires 2026
    View on FDA
    Products
    25
    Proprietary Names
    66
    Establishment Types
    1
    Classifications
    25

    Registration Details

    Registration Name
    EvERX PTY LTD
    Registration Number
    3008496839
    FEI Number
    3008496839
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3 / 185 Briens Rd, Northmead
    City
    Sydney New South Wales
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K040066
    PMA Number
    P160031

    Owner / Operator

    Firm Name
    EverX / Bindra
    Operator Number
    10033159
    Address
    3 / 185 Briens Rd, Northmead
    City
    Sydney
    State
    New South Wales
    Postal Code
    2152
    Country
    AU
    Correspondent
    Ravinder S Bindra

    US Agent

    Business Name
    EverX USA LLC
    Contact Name
    Hamish Dunn
    Address
    2410 LA MIRADA DRIVE
    City
    Vista
    State
    CA
    ZIP
    92081
    Country
    US
    Email
    [email protected]
    Phone
    760 4297019

    Products

    Device Name Product Code
    Digital Breast Tomosynthesis OTE
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    System, X-Ray, Tomography, Computed JAK
    System, Nuclear Magnetic Resonance Imaging LNH
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Ventilator, Continuous, Facility Use CBK
    System, Tomography, Computed, Emission KPS
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Angiographic IZI
    Densitometer, Bone KGI
    Automated Radiological Image Processing Software QIH
    Catheter, Ultrasound, Intravascular OBJ
    System, X-Ray, Mobile IZL
    Full Field Digital, System, X-Ray, Mammographic MUE
    System, X-Ray, Mammographic IZH
    System, X-Ray, Stationary KPR
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, X-Ray, Tomographic IZF
    Instrument, Biopsy KNW
    System, Balloon, Intra-Aortic And Control DSP
    System, Image Processing, Radiological LLZ
    Biopsy Needle Guide Kit OIJ

    Proprietary Names

    FUJI AMULETINNOVALITY DIGITAL BREAST TOMOSYNTHESIS SIEMENS ARCADIS VARIC Hologic SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM SIEMENS SOMATOM PERSPECTIVE 16 Siemens Magnetom Symphony MRI Siemens Acuson S2000 ABVS Siemens Definition AS 64-Slice Siemens Scope CT Scanner AVEA 17310 VENTILATOR GE OPTIMA MR450W OPTIMA NM/CT 640 Siemens Somatom Definition Flash GE INNOVA IGS 520 GE LUNAR PRODIGY SIEMENS E.CAM Siemens Somatom Definition Edge GE DISCOVERY CT750HD GE OEC MINI 6800 Philips Epiq 7G Shimadzu Mobile Dart Evolution GE LOGIQ E9 Hologic Selenia Dimensions System GE INNOVA 2100 CATHLAB TOSHIBA APLIO 500 MODEL TUS-A500 GE Seno DS Digital GE OEC 9900 ELITE C-ARM Siemens Mammomat Inspiration Prime CAREFUSION AVEA VENTILATOR Toshiba Aquilion 64-Slice CT, Model TSX-101A GE LIGHTSPEED VCT 64 SLICE Philips Azurion 7 Cathlab GE OEC 9800 C-ARM GE Optima CT580 SIEMENS ACUSON S2000 DISCOVERY MODEL NM/CT 670 SIEMENS INSPIRATION DIGITAL MAMMOGRAPHY HOLOGIC FLUOROSCAN INSIGHT FD MINI C-ARM GE SENO ESSENTIAL W/ TOMO SIEMENS SOMATOM EMOTION 16 GE Brivo XR385(DR X-Ray) GE OPTIMA 660 128-SLICE CT GE Discovery XR650 X-Ray Toshiba Aquilion One Vision CT ENCOR BREAST BIOPSY SYSTEM GE Discovery PET/CT 690 Siemens Artis Zee Angiographic System GE Infinia Hawkeye IV SIEMENS ARCADIS AVANTIC SIEMENS MAGNETOM SKYRA SIEMENS MAGNETOM VERIO MRI AUTOCAT2 WAVE INTRA AORTIC BALLOON PUMP GE BrightSpeed 16-Slice CT GE OPTIMA CT520 Philips Sectra MicroDose L30 PHILIPS BV PULSERA SONOSITE M-TURBO PURITAN BENNETI 840 VENTILATOR GE OPTIMA CT660 64-SLICE GE LOGIQ S8 Toshiba Aquilion Prime CT 80-Slice Planmed Clarity S Mammography Siemens Symbia T2 SPECT System Toshiba Vantage Titan 1.5T MRI GE AMX4 Plus GE Senographe Essential Mammograpy SIEMENS ACUSON S1000

    Establishment Types

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