Australia - Inggeris - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 46573 - physical therapy electrical stimulation system, battery-powered - neuromuscular stimulation devices intended to: . increase blood circulation . for the prevention of venous thrombosis . for the prevention and treatment of oedema . for promoting wound healing . for the promotion of healing of tendon and ligament injuries . for the treatment of venous insufficiency and ischemia . accelerate the removal of metabolic waste . speed up leg muscle recovery . reduce doms (delayed onset muscle soreness) within 24 hours following strenuous exercise in healthy individuals.

Australia - Inggeris - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 58434 - intraocular telescope - the implantable miniature telescope is indicated for improvement of visual acuity in patients with bilateral moderate to profound central vision impairment due to age-related macular degeneration.

Australia - Inggeris - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 36553 - patient monitor module, multifunction - the sensing unit is intended for continuous measurement of respiration rate, heart rate and movement, in an automatic contact-less manner at home, in hospital or clinic setting. the system is indicated for use in children, adolescents and adults.

Australia - Inggeris - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 33586 - single-patient physiologic monitoring system - the earlysense system 2.0 is intended for continuous measurement of respiration rate, heart rate and movement, in an automatic contact-less manner in hospital or clinic setting. the system is indicated for use in children, adolescents and adults. in addition, earlysense system can continuously monitor oxygen saturation of arterial hemoglobin (spo2) using pulse oximetry in pediatric (ages 2 years and older), adolescents, and adults in hospital, or clinical settings. the system consists of a bedside unit and sensor.

Australia - Inggeris - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 38470 - patient monitor, central unit - the earlysense central display station is intended to provide remote central monitoring and display of information as recorded by multiple earlysense bedside units, on a central remote screen. the system can be used in hospitals or hospital type and clinic environment.

Australia - Inggeris - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 61563 - mesh-sleeve carotid artery stent - the system delivers a self-expanding stent to carotid arteries using a rapid exchange (rx) delivery system. the stent is constructed of nitinol and covered by a permanent protective mesh (micronet). it is compressed and loaded into the rx delivery system, delivered to the lesion site and expanded by retraction of a protective sheath. stent and mesh remain as a permanent vessel scaffolding implant. upon deployment, stent imparts an outward radial force on the arterial lumen to establish patency. the cguard eps is indicated for improving carotid luminal diameter in patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet both criteria outlined below: ? patients with neurological symptoms and greater than 50 percent stenosis of the common or internal carotid artery by either ultrasound or angiogram or patients without neurological symptoms and greater than 80 percent stenosis of the common or internal carotid artery by either ultrasound or angiogram. ? patients having a vessel with reference diameters between 4.8 mm and 9.0 mm at the target lesion.

Australia - Inggeris - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 33586 - single-patient physiologic monitoring system - the earlysense insight system is intended for continuous measurement of respiratory rate, heart rate and movement, in an automatic contact-less manner, at home, in hospital or clinic setting. the system is indicated for use in children, adolescents and adults. the system consists of a sensing unit and insight device.

Australia - Inggeris - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 31109 - measuring instrument, conductivity, skin - the disposable sensor is connected to a finger probe in order to acquire and transmit signals for the purposes of monitoring skin conductivity levels.

Australia - Inggeris - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 33586 - single-patient physiologic monitoring system - the system is intended to be used for assessing changes in pain levels by monitoring the physiological responses to pain, using a relative pain index (nol index) from 0-100, whereas 0 represents no nociception/pain and 100 represents high nociception/pain level. the system consists of a non-invasive finger probe and bedside monitor.

Australia - Inggeris - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 47841 - soft corrective contact lens, daily-disposable - the device is indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-disease eyes. the lenses may be worn by people who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. the device also helps protect against varying levels of harmful uv radiation or blue light transmission to the cornea and into the eye.