Clarius Mobile Health Corp

Ultrasound Scanners

Australian ARTG Registration Clarius Ultrasound Number 285246 ARTG Goods Certificate Feb 2017

ARTG Goods Certificate

2 Pages

Australian Register of Therapeutic Goods Certificate Issued to  Emergo Asia Pacific Pty Ltd T/a Emergo Australia for approval to supply  Emergo Asia Pacific Pty Ltd T/a Emergo Australia - General ultrasound imaging system, battery-powered ARTG Identifier  285246  ARTG Start date  6/02/2017  Product Category  Medical Device Included Class IIa  GMDN  60924  GMDN Term  General ultrasound imaging system, battery-powered  Intended Purpose  The ultrasound system is a software-based ultrasound imaging system and accessories intended for use in Point-of-Care Imaging of Medical Conditions on the general public. Point-of-Care clinical applications include: · Emergency triage exam to look at trauma conditions; · Procedure guidance to guide needles into the body; and · The ultrasound system is intended for use in environments where healthcare is provided by trained medical professionals. The device is not intended for use in emergency medical service, ambulance, or aircraft. · Other targeted diagnostic and measurement applications: fetal, fetal echo, abdominal, small organ, musculo-skeletal (conventional), musculo-skeletal (superficial), urology, gynecology, cardiac adult, cardiac pediatric, peripheral vessel, pediatric, carotid. Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for nerve block procedures.  Manufacturer Details  Address  Certificate number(s)  Clarius Mobile Health Corp  3605 Gilmore Way Suites 350 & 102 Burnaby, British Columbia, V5G 4X5 Canada  DV-2017-MC-00945-1  ARTG Standard Conditions The above Medical Device Included Class IIa has been entered on the Register subject to the following conditions: · The automatic conditions applicable to the inclusion of all kinds of medical devices in the Register are as specified in section 41FN of the Therapeutic Goods Act 1989. · The standard conditions that are imposed under section 41FO of the Therapeutic Goods Act 1989 when kinds of medical devices are included in the Register are as set out in the following paragraphs. · For a medical device included in the Register under Chapter 4 and imported into Australia, the Sponsor must ensure that information about the Sponsor is provided in such a way as to allow the sponsor to be identified. · Each sponsor shall retain records of the distribution of all of the sponsor's medical devices included in the Register under Chapter 4. In the case of records relating to a Class AIMD medical device, Class III medical device, or Class IIb medical device that is an implantable medical device, the distribution records shall be retained for a minimum period of 10 years. In the case of records relating to any other device, the distribution records shall be retained for a minimum period of 5 years. · The sponsor of a medical device included in the Register under Chapter 4 shall keep an up to date log of information of the kind specified in Regulation 5.8. · It is a condition of inclusion in the ARTG that the sponsor of a medical device that is an AIMD, Class III or implantable Class IIb provides three consecutive annual reports to the Head of the Office of Product
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