Singapore - English - HSA (Health Sciences Authority)

abbott medical (singapore), pte. ltd. - cardiovascular - the ultrasound system is intended for use by a qualified physician for ultrasound evaluation of ophthalmic; fetal; abdominal (renal, gyn/pelvic); intra-operative (abdominal, thoracic(cardiac), and vascular); intra-operative (neuro); laparoscopic; pediatric; small organ (thyroid, breast, testes, etc); neonatal cephalic; adult cephalic/transcranial; trans-rectal; trans-vaginal; trans-esoph.(non-card); musculoskeletal (conventional); musculoskeletal (superficial); cardiac adult; cardiac pediatric; trans-esoph. (cardiac); intra-cardiac; peripheral vessel.

Singapore - English - HSA (Health Sciences Authority)

scanmed technology (s) pte ltd - general hospital - it is intended for use in gynecology, obstetrics, abdomen, intraoperative, pediatric, small parts, cephalic, musculo-skeletal, cardiac, vascular, urology, pediatric hip, nerve, ocular, thoracic/pleural exams.

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

mindray medical australia pty ltd - 48047 - non-rechargeable public automated external defibrillator - the defibrillator is intended to be used on adults and children in a sudden cardiac arrest. the patients must be - unresponsive - not breathing or not breathing normally the equipment also guides the operator throughout cardiopulmonary resuscitation (cpr) with voice and/or visual guidance. the equipment is to be used in public places and facilities by persons who have been trained in its operation. the operator should be trained in basic life support, advanced cardiac life support or other emergency medical response.

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

mindray medical australia pty ltd - 17882 - physiologic-monitoring defibrillation system - an assembly of electrically-powered devices designed to defibrillate the heart that may incorporates additional therapeutic and/or monitoring features intended to resuscitate and/or monitor a cardiac patient. the defibrillator is intended for automatic defibrillation (aed) and/or manual defibrillation treatments. it guides operators through cardiopulmonary resuscitation (cpr). the monitoring functions are for use in pre-hospital settings by qualified medical personnel trained in the operation of the equipment and qualified by training in basic life support, advanced cardiac life support or defibrillation, and may include one or more of the following: electrocardiogram (ecg) monitoring (electrocardiograph), noninvasive cardiac pacing (temporary pacemaker), cardioversion (cv), pulse oximetry (oximeter), invasive and/or noninvasive blood pressure monitoring, and end-tidal carbon dioxide (etco2) monitoring (i.e., a co2 monitor). it may have data recording/printing capabilities.

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

mindray medical australia pty ltd - 38473 - information system, patient record - a system for electronic registration and storage of patient data, which can be collected from inter-connected medical devices, e.g. patient monitoring devices, but which may also be input manually by clinical staff. such systems can present this kind of information as graphic display, trends, laboratory results, patient administration data and notes. it is a specially designed data program application (software) which is usually supplied for installation in existing mainframe or decentralized computers or a computer network.

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

mindray medical australia pty ltd - 42411 - ventilator, adult - the device is intended to be used in intensive care situations within a professional healthcare facility, or during transport within a professional healthcare facility. this product is intended to provide ventilation assistance and breathing support for adult, paediatric and neonate patients. the product should be operated by properly trained and authorised medical personnel. this equipment is not suitable for use in an mri environment.

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

mindray medical australia pty ltd - 40772 - transducer assembly, ultrasound, diagnostic, intracorporeal, rectal - an ultrasound imaging transducer assembly specifically designed to be positioned within the rectum either manually or under endoscopic guidance. included is a variety of single or multiple element transducer assembly configurations that convert electric voltages into an ultrasound beam. it steers, focuses, and detects the ultrasound beam and resulting echoes either mechanically or electronically. also known as a rectal, transrectal, or prostate probe, it may incorporate a biopsy needle guidance channel as part of the transducer casing or housing assembly design. this is a reusable device.

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

mindray medical australia pty ltd - ct943 - instrument/analyser ivds - this equipment is to be used as an in vitro diagnostic medical device (ivd) for processing, examination or analysis using manual or automated processes for the quantitative or qualitative analysis of clinical specimens.

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

mindray medical australia pty ltd - 37891 - transducer assembly, ultrasound, diagnostic, intracorporeal, oesophageal - an ultrasound imaging transducer assembly enclosed in a fluid-resistant, acoustically- and electrically-insulated housing, designed to be inserted and positioned in the oesophagus to obtain ultrasound images of the heart and/or to navigate devices requiring ultrasound guidance and placement (e.g., endoscopy equipment or needle biopsy equipment). also known as an oesophageal endosonography probe or transducer, it is composed of either a single transducer element or an array of transducer elements, i.e., piezoelectric element(s), active element(s), or crystal(s), and associated damping, backing, and matching layer materials. this is a reusable device.

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

mindray medical australia pty ltd - 48048 - rechargeable professional automated external defibrillator - the equipment configured with aed, manual defibrillation and ecg monitoring functions is intended for automatic defibrillation (aed) and manual defibrillation treatments. it guides operators through cardiopulmonary resuscitation (cpr) and can also be used for ecg monitoring. the equipment configured with only aed function is intended for aed. it also guides operators throughout cpr. the equipment is for use in pre-hospital settings by qualified medical personnel trained in the operation of the equipment and qualified by training in basic life support, advanced cardiac life support or defibrillation.