Australien - engelska - Department of Health (Therapeutic Goods Administration)

prolotus australia pty ltd atf davis family trust t/a atx medical solutions - 37606 - x-ray generator, diagnostic, portable - portable x-ray generator for the purposes of generating x-rays for diagnositc imaging.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

australian medical systems pty ltd - 40761 - ultrasound system, imaging, general-purpose - a battery-powered, hand-held device, designed to scan the external body surface for collection, display and analysis of ultrasound information during a variety of diagnostic ultrasound imaging procedures including obstetrics (ob), gynecology (gy) and general imaging. it consists of an ultrasound transducer and includes an integrated image processing system. it may include an integrated display or be intended to wirelessly transmit images to a computer or portable computer device with dedicated, equipment specific, ultrasound imaging software installed, that is supplied as an integral component of the device.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

genesis biotech pty ltd - 45617 - automatic-inflation electronic sphygmomanometer, portable, arm/wrist - portable non-invasive digital blood pressure self monitoring device intended to be used to measure and display arterial blood pressure and heartbeat rate of an adult by an inflatable cuff wrapped around the upper arm or the wrist, and store results. these devices detect the appearance of irregular heartbeats during measurement and give a warning signal with readings

Australien - engelska - Department of Health (Therapeutic Goods Administration)

allen mason international pty ltd - 31321 - portable oxygen concentrator - the products cover owgels oxygen concentrators. these oxygen concentrators provide supplementary oxygen for oxygen therapy through a high-pressure humidifier oxygen concentrator

Australien - engelska - Department of Health (Therapeutic Goods Administration)

acteon australia/new zealand - 63672 - intraoral camera - this is a portable dental x-ray that is intended to be used as a diagnostic x-ray system for use in a variety of routine dental diagnostic imaging situations.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

lowenstein medical australia pty ltd - 47083 - portable ventilator, electric - the luisa ventilator is for patients who require life support and/or non-life support mechanical ventilation. suitable for paediatric and adult patients.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 31321 - portable oxygen concentrator - the inogen pocs provide a high concentration of supplemental oxygen to patients requiring respiratory therapy on a prescriptive basis.

Sydafrika - engelska - South African Health Products Regulatory Authority (SAHPRA)

bm_squib -

Australien - engelska - Department of Health (Therapeutic Goods Administration)

william a cook australia pty ltd - 64175 - endoscopic portal pressure measurement system - the intended use of the echotip? insight? portosystemic pressure gradient procedure pack is to provide mutually compatible medical devices to allow for direct pressure measurement and monitoring in the hepatic and portal veins in patients with portal hypertension.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 37649 - x-ray system, diagnostic, fluoroscopic, general-purpose, portable, digital - a portable (movable from one location to another, and easily reassembled) general-purpose diagnostic fluoroscopic x-ray system that uses real-time digital techniques for image capture, display and manipulation and is specifically designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging.