Australian register of therapeutic goods certificate issued to conmed linvatec australia pty ltd for approval to supply musculoskeletal tissue conmed linvatec australia pty ltd artg identifier 299298 artg start date 2022018 product category biologicalincludedclass 2 intended use 1. Registration or listing of therapeutic goods australian. Australian register of therapeutic goods certificate. For a medical device included in the register under chapter 4 and imported into australia, the sponsor. Australian register of therapeutic goods certificate issued to unicare health for approval to supply unicare health cushion, artg identifier 227895 artg start date 12092014 product category medical deviceincludedclass 1 gmdn 11093 gmdn term cushion. It provides information on therapeutic goods that can be supplied in australia. Australian register of therapeutic goods certificate issued to niagara therapy a division of ct healthcare pty ltd for approval to supply niagara therapy a division of ct healthcare pty ltd massager, electrical, home use artg identifier 151787 artg start date 22042008 product category medical deviceincludedclass iia gmdn 34662. Australian register of therapeutic goods certificate issued to bioconcept australia pty ltd for approval to supply bioconcept australia pty ltd saw blade, surgical, powered, reciprocating artg identifier 315111 artg start date 5032019 product category medical deviceincludedclass iia gmdn 44985 gmdn term saw blade, surgical, powered. Australian register of therapeutic goods certificate issued to ambu australia pty ltd for approval to supply ambu australia pty ltd mask, resuscitation artg identifier 168560 class 1 artg start date 2022010 product category.
Therapeutic goods administration following inclusion of the device in the artg. Australian register of therapeutic goods certificate issued to bzooma pty ltd for approval to supply bzooma pty ltd assistive scooter, electricmotordriven artg identifier 272722 artg start date 10032016 product category medical deviceincludedclass 1 gmdn 45684 gmdn term assistive scooter, electricmotordriven. Medipharm labs australia granted gmp certificate and. In addition to the therapeutic goods administration tga, there are four other key roles. Black storm tablets pose a serious risk to your health. Australian register of therapeutic goods certificate issued to ab dental australia pty ltd for approval to supply ab dental australia pty ltd punch, dental, softtissue, reusable artg identifier 221934 artg start date 2042014 product category medical deviceincludedclass 1 gmdn 45329 gmdn term punch, dental, softtissue, reusable. The artg is a database of information about therapeutic goods for human use approved for supply in, or exported from, australia. Australian register of therapeutic goods certificate issued to inka surgical for approval to supply inka surgical electrode, electrosurgical, active, footcontrolled, reusable artg identifier 114471 artg start date 15112004 product category medical deviceincludedclass iib gmdn 42553.
Australian register of therapeutic goods certificate issued to unicare health for approval to supply unicare health table, overbed artg identifier 229782 artg start date 25102014 product category medical deviceincludedclass 1 gmdn 35395 gmdn term table, overbed intended purpose a table designed to be moved directly over the bed to. Australian register of therapeutic goods certificate inka. Therapeutic goods must be entered on the australian register of therapeutic goods artg before they can be supplied in australia. Australian register of therapeutic goods certificate issued to jane maley consulting for approval to supply. Australian register of therapeutic goods certificate issued to jane maley consulting for approval to supply jane maley consulting physical therapy electrical stimulation system, batterypowered artg identifier 180396 class iia artg start date 24022011 product category.
The therapeutic goods administration determined in november 2011 that dextropropoxyphene should be removed from the australian register of therapeutic goods. View public, sponsor or manufacturer information on the artg. Australian register of therapeutic goods therapeutic. Australian register of therapeutic goods certificate issued to emergo asia pacific pty ltd ta emergo australia for approval to supply emergo asia pacific pty ltd ta emergo australia physical therapy electrical stimulation system, batterypowered artg identifier 216911 artg start date 41120 product category medical deviceincluded. Therapeutic goods act 1989 federal register of legislation. Australian register of therapeutic goods certificate issued to rapp australia pty ltd for approval to supply. Apr 11, 20 australian register of therapeutic goods certificate issued to emergo asia pacific pty ltd ta emergo australia for approval to supply emergo asia pacific pty ltd ta emergo australia physical therapy electrical stimulation system, batterypowered artg identifier 216911 artg start date 41120 product category medical deviceincluded. All the medicine should be registered in australian register of therapeutic goods artg in order to get marketed for sale or distribution.
Australian register of therapeutic goods certificate issued to emergo asia pacific pty ltd ta emergo australia for approval to supply specimen receptacle ivds artg identifier 279167 artg start date 15082016 product category medical deviceincluded ivdclass 1 gmdn ct936 gmdn term specimen receptacle ivds. Australian register of therapeutic goods certificate issued to ezyas abc pty ltd for approval to supply ezyas abc pty ltd applicator, artg identifier 164835 artg start date 1092009 product category medical deviceincludedclass 1 gmdn 10172 gmdn term applicator. The standard conditions that are imposed under section 41 fo of the therapeutic goods act 1989 when kinds of medical devices are included in the register are as set out in the following paragraphs. Australian register of therapeutic goods certificate issued to medics for life ta lifevac australia for approval to supply medics for life ta lifevac australia lifevac antichoking device suction unit, artg identifier 285082 artg start date 31012017 product category medical deviceincludedclass 1 gmdn 36776. Australian register of therapeutic goods certificate issued to jb medical supplies pty ltd for approval to supply jb medical supplies pty ltd speculum, vaginal, single use artg identifier 193434 artg start date 23122011 product category medical deviceincludedclass is gmdn 37468 gmdn term speculum, vaginal, single use. Medical deviceincludedclass 1 gmdn 36066 gmdn term mask, resuscitation. Australian register of therapeutic goods certificate issued to rapp australia pty ltd for approval to supply rapp australia pty ltd lift, patient transfer, slingharnessstrap artg identifier 197234 class 1 artg start date 6052012 product category.
Australian register of therapeutic goods certificate issued to pro medicus ltd for approval to supply pro medicus ltd radiology picture archiving and communication system application software artg identifier 226741 artg start date 9082014 product category medical. Searching the australian register of therapeutic goods artg tga. Australian register of therapeutic goods certificate issued to unicare health for approval to supply unicare health bed, generalpurpose, electrical artg identifier 229788 artg start date 25102014 product category medical deviceincludedclass 1 gmdn 34870 gmdn term bed, generalpurpose, electrical. Medical device included class 1 gmdn 40535 gmdn term lift, patient transfer, slingharnessstrap. In australia, therapeutic goods are regulated by the therapeutic goods administration tga. Australian register of therapeutic goods certificate issued to niagara therapy a division of ct healthcare pty ltd for approval to supply niagara therapy a division of ct healthcare pty ltd massager, electrical, bedchair artg identifier 1733 artg start date 52010 product category medical deviceincludedclass iia gmdn 34488. Australian register of therapeutic goods certificate issued to life healthcare pty ltd for approval to supply life healthcare pty ltd adhesive, soft tissue approximation artg identifier 1524 class iia artg start date 1042008 product category. Australian register of therapeutic goods certificate issued to emergo asia pacific pty ltd ta emergo australia for approval to supply emergo asia pacific pty ltd ta emergo australia surgical planningnavigationenhancement system artg identifier 275800 artg start date 25052016 product category medical deviceincludedclass iia gmdn 61496. This is consistent with this drugs removal from the market in many other developed countries. Australian register of therapeutic goods certificate issued to inka surgical for approval to supply inka surgical gouge, surgical artg identifier 126620 artg start date 4042006 product category medical device included class 1 gmdn 35090 gmdn term gouge, surgical intended purpose a heavy surgical instrument, usually made of stainless steel. Australian register of therapeutic goods certificate issued to unicare health for approval to supply unicare health chair, artg identifier 229784 artg start date 25102014 product category medical deviceincludedclass 1 gmdn 10787 gmdn term chair, intended purpose a device designed to be sat upon by a patient or. The tga has approved the following tests for inclusion in the australian register of therapeutic goods artg. Australian register of therapeutic goods certificate issued to bird healthcare pty ltd for approval to supply bird healthcare pty ltd pulmonary function analysis system, adult artg identifier 220187 artg start date 15022014 product category medical deviceincludedclass iia gmdn 35282 gmdn term pulmonary function analysis system, adult. On track to ramp up and fulfill new supply agreements globenewswire may 07, 2020 barrie, ontario, may.
Australian register of therapeutic goods certificate issued to bzooma pty ltd for approval to supply bzooma pty ltd assistive scooter, electricmotordriven artg identifier 272723 artg start date 10032016 product category medical deviceincludedclass 1 gmdn 45684 gmdn term assistive scooter, electricmotordriven. 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. Medipharm labs australia granted gmp certificate and licence to manufacture therapeutic goods. Australian register of therapeutic goods certificate issued to emergo asia pacific pty ltd ta emergo australia for approval to supply emergo asia pacific pty ltd ta emergo australia dermatological optical coherence tomography system artg identifier 297159 artg start date 4122017 product category medical deviceincludedclass iia gmdn. Australian register of therapeutic goods certificate issued to uscom ltd for approval to supply uscom ltd cardiac output unit, ultrasonic artg identifier 7337 artg start date 11042007 product category medical deviceincludedclass iia gmdn 17190 gmdn term cardiac output unit, ultrasonic. Australian register of therapeutic goods certificate issued to active medical supplies pty ltd for approval to supply active medical supplies pty ltd lift, patient transfer, artg identifier 202986 artg start date 14112012 product category medical deviceincludedclass 1 gmdn 31169 gmdn term lift, patient transfer.
Australian register of therapeutic goods certificate issued to ainsworth dental company pty ltd for approval to supply ainsworth dental company pty ltd s7 xtra wipes disinfectant, hospital grade artg identifier 232015 artg start date 19122014 product category other therapeutic goodother therapeutic good registered disinfectant. Black storm tablets pose a serious risk to your health and should not be taken. Australian register of therapeutic goods certificate issued to unicare health for approval to supply unicare health bed, generalpurpose, electrical artg identifier 229788 artg start date 25102014 product category medical deviceincludedclass 1 gmdn. Australian register of therapeutic goods certificate issued to life healthcare pty ltd for approval to supply. Australian register of therapeutic goods therapeutic goods. Australian register of therapeutic goods certificate issued to life systems medical pty ltd for approval to supply life systems medical pty ltd patient monitor, electrocardiograph artg identifier 328153 artg start date 2012020 product category medical deviceincludedclass iia gmdn 35195 gmdn term patient monitor, electrocardiograph. Tga investigation potential contamination with nnitrosodimethylamine. The australian therapeutic good register argt captures all medical devices accepted for. Therapeutic goods entered in the australian register of therapeutic goods artg can be lawfully supplied in australia. Listed medicine manufacturer details address manufacturing steps ams laboratories pty limited 8 rachael close silverwater, nsw, 2128 australia. Australian register of therapeutic goods certificate issued to amco australian matting company for approval to supply amco australian matting company detergent, artg identifier 298949 artg start date 25012018 product category medical device included class 1 gmdn 33162 gmdn term detergent.
Australian register of therapeutic goods certificate issued to rapp australia pty ltd for approval to supply rapp australia pty ltd cpapbipap nasal mask, singleuse artg identifier 277 artg start date 90820 product category medical deviceincludedclass iia gmdn 37591 gmdn term cpapbipap nasal mask, singleuse. Conditions have been imposed on the supply of covid19 serologybased point of care tests. How to list or register a medicine in australia pharmout. The notes at the end of this compilation the endnotes include information about amending laws and the amendment history of provisions of the compiled law. Australian register of therapeutic goods certificate issued to emergo asia pacific pty ltd ta emergo australia for approval to supply emergo asia pacific pty ltd ta emergo australia patient monitor, electrocardiograph artg identifier 236084 artg start date 11042015 product category medical deviceincludedclass iib gmdn 35195. Australian register of therapeutic goods certificate issued to uscom ltd for approval to supply uscom ltd sphygmomanometer, electronic, automatic artg identifier 227735 artg start date 9092014 product category medical deviceincludedclass iia gmdn 16173 gmdn term automaticinflation electronic sphygmomanometer, nonportable. Australian register of therapeutic goods certificate issued to hygiex pty ltd for approval to supply hygiex pty ltd pressure alleviation pad, air, alternating contact, system artg identifier 177592 artg start date 15112010 product category medical deviceincludedclass 1 gmdn 38484 gmdn term pressure alleviation pad, air, alternating. Australian register of therapeutic goods certificate issued to synthes australia pty ltd for approval to supply musculoskeletal tissue dbx putty synthes australia pty ltd paste syringe artg identifier 211454 artg start date 260620 product category biologicalincludedclass 3.
Covid19 test kits included in the artg for legal supply. Medical deviceincludedclass iia gmdn 34164 gmdn term adhesive, soft tissue approximation. Jul 12, 2017 this is a compilation of the therapeutic goods medical devices regulations 2002 that shows the text of the law as amended and in force on 1 july 2017 the compilation date. Australian register of therapeutic goods certificate centogene. Australian register of therapeutic goods certificate issued to synthes australia pty ltd. Emergo asia pacific pty ltd ta emergo australia for approval to supply. Australian register of therapeutic goods certificate issued to inka surgical for approval to supply inka surgical gouge, surgical artg identifier 126620 artg start date 4042006 product category medical device included class 1 gmdn 35090 gmdn term gouge, surgical intended purpose a heavy surgical instrument, usually made of stainless steel, used to remove pieces of bone or other hard tissue.
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