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Note: If your company is listed as a distributor below and you would like a link to your web site or email address please contact
Scott Wedesweiler by email or phone +612 9410 5111

ECRI Number
ECRI Description
Certificate of Conformance No.
Manufacturer
Product
Model No.
Distributor's Name
Standards Applied (AS/NZS)
Exclusions
Certificate Expiry Date
20-334Programmer/Testers1261.0308Codman SarlCodman Valve Programmer82-3192Medifix Pty Ltd AS/NZS 3200.1.0-199848 (Biocomp.) & 52.1 (Programmable Systems)20/03/2011
00-000Unknown1260.0308Cook Australia Pty LtdEmbryo IncubatorK-MINC-1000Cook Australia Pty LtdAS/NZS 3200.1.0-199852.1 (Programmable Systems)20/03/2011
20-395Negative-Pressure Wound Therapy Systems 1259.0308KCI USA Inc.ActiV.A.C. Vacuum Assisted Wound Therapy Unit 60095C KCI Medical Australia Pty LtdAS/NZS 3200.1.0-199848 (Biocomp.) & 52.1 (Programmable Systems)11/03/2011
20-395Negative-Pressure Wound Therapy Systems 1258.0308KCI USA Inc.InfoV.A.C. Vacuum Assisted Wound Therapy Unit60090CKCI Medical Australia Pty LtdAS/NZS 3200.1.0-199848 (Biocomp.) & 52.1 (Programmable Systems)11/03/2011
00-000Unknown1257.0308GynecareMotor Drive UnitMD0100Medifix Pty LtdAS/NZS 3200.1.0-1998Cl 48 (Biocomp.) & 52.1 (Programmable Systems)7/03/2011
00-00Unknown1256.0308CHI LIN Technology Co. LTD.NEC LCD MonitorMD205MGNEC Australia Pty. Ltd. - Display and Home GroupAS/NZS 3200.1.0-1998Nil6/03/2011
00-000vUnknown1255.0208HalqenMedical equipment TrolleySP602 Case CartConmed Linvatec Australia Pty Ltd AS/NZS 3200.1.0-1998Nil20/02/2011
00-000Unknown1254.0208Conseng Pty LtdInvisa-Beam Bed Monitor 8AConseng Pty LtdAS/NZS 3200.1.0-199848 (Biocomp.) & 52.1 (Programmable Systems)18/02/2011
00-000Unknown1253.0208Ventracor LimitedVentrAssist Left Ventricular Assist SystemVA-LVA3 & VA-LVA4Ventracor LimitedAS/NZS 3200.1.0-1998Cl 36 (EMC), 48 (Biocomp.) & 52.1 (Programmable Systems)5/02/2011
00-000Unknown1252.1207Biomedtech Australia Pty LtdPortable HypoxicatorGO2AltitudeBiomedtech Australia Pty LtdAS/NZS 3200.1.0-1998Cl 36 (EMC), 48 (Biocomp.) & 52.1 (Programmable Systems)6/12/2010
16-405Apheresis Units1251.1107Cobe BCT Inc.Apheresis UnitTrima accelGambro Pty LtdAS/NZS 3200.1.0:198848 (Biocomp.) & 52.1 (Programmable Systems4/12/2010
18-229Electrosurgical Units, Monopolar1250.1107Coltene/Whaledent Inc.PerFect TCS II Electrosurgical Unit S8240Coltene Whaledent Inc.AS/NZS 3200.1.0-1998
AS/NZS 3200.2.2-1999
48 (Biocomp.) & 52.1 (Programmable Systems)21/11/2010
16-917Electrical Conversion Kits, Mechanical Bed1249.1107LINAK A/SActuator SystemCBJ2/CHJ2Linak Australia Pty. Ltd.AS/NZS 3200.1.0-1998Cl 36 (EMC), 48 (Biocomp.) & 52.1 (Programmable Systems)26/11/2010
12-873Oxygen Concentrators1248.1107Sunrise Medical, Respiratory Products DivisionDeViILBISS iFill Personal Oxygen Station535ISunrise Medical Pty LimitedAS/NZS 3200.1.0-199848 (Biocomp.) & 52.1 (Programmable Systems)21/11/2010
11-218Hemodialysis Units1247.1007Gambro Lundia ABHemodialysis UnitPrismaflexGambro Pty LtdAS/NZS 3200.1.0-1998
AS/NZS 3200.2.16-1999
48 (Biocomp.) & 52.1 (Programmable Systems)15/10/2010
16-405Apheresis Units1246.1007Gambro BCTApheresis unitSpectra OptiaGambro Pty LtdAS/NZS 3200.1.0-1998
AS/NZS 3200.2.16-1999
48 (Biocomp.) & 52.1 (Programmable Systems)15/10/2010
10-208Aspirators1245.1007Clements medical equipment Pty LtdPoratble suction pumpsSUC 81014, SUC 81010, SUC 81019 & SUC 81022Clements medical equipment Pty LtdAS/NZS 3200.1.0-199848 (Biocomp.)12/10/2010
16-001Surgical Facility Booms, Ceiling-Mounted1244.1007Medical Design Innovations Pty LtdCeiling Mounted Operating Room PendantHDAMedical Design Innovations Pty LtdAS/NZS 3200.1.0-1998Cl 36 (EMC)4/10/2010
00-000Unknown1243.0807CathRx LimitedDiagnostic CatheterCRX-CH-D-CXX(Y) seriesCathRx LimitedAS/NZS 3200.1.0-1998Cl 36 (EMC) & 48 (Biocomp.)23/08/2010
00-000Unknown1242.0807Polartechnics LimitedSkin lesion monitoring systemSolarScan Expert & SolaScan SentryPolartechnics LimitedAS/NZS 3200.1.0:198848 (Biocomp.) & 52.1 (Programmable Systems10/08/2010
15-993Programmer/testers, Implantable Cardiac Pacemaker 1241.0807Medtronic IncPaceart ECG moduleP127Medtronic IncAS/NZS 3200.1.0:1988 AS/NZS3200.2.25:199348 (Biocomp.) & 52.1 (Programmable Systems10/08/2010
10-846Circulatory Assist Units, Cardiac, Intra-Aortic Balloon1240.0807Arrow International IncIntra-Aortic Balloon PumpAutoCAT 2 WaveCecil E Mayo P/LAS/NZS 3200.1.0-199848 (Biocomp.) & 52.1 (Programmable Systems)3/08/2010
17-002Cameras, Video, Endoscope1239.0807ConMed LinvatecHD Video CameraIM4000Conmed Linvatec Australia Pty Ltd AS/NZS 3200.1.0-199848 (Biocomp.) & 52.1 (Programmable Systems)28/08/2010
14-056Tinnitus Therapy Units1238.0807Neuromonics LimitedNeuromonics® Oasis Tinnitus Masker000-0078Neuromonics LimiteAS/NZS 3200.1.0-199848 (Biocomp.) & 52.1 (Programmable Systems)28/08/2010
00-000Unknown1237.0507AtCor Medical Pty Ltd SphygmoCor CvMS SystemEM3 AtCor Medical Pty Ltd AS/NZS 3200.1.0-1998Cl 36 (EMC), 48 (Biocomp.) & 52.1 (Programmable Systems)2/05/2010
17-538Autotransfusion Units, Whole Blood Recovery1236.0407Haemonetics CorporationcardioPAT Cardiovascular Perioperative Autotransfusion System LN 02050-XXXMedtel Pty LimitedAS/NZS 3200.1.0-199848 (Biocomp.) & 52.1 (Programmable Systems)26/04/2010
17-739Electrosurgical Units, Monopolar, Argon-Enhanced Coagulation1235.0407ConMed CorporationSystem 7500 & 7550 Electrosurgical Generator + ABC® Modes60-7500-230 & 60-7550-230Conmed Linvatec Australia Pty LtdAS/NZS 3200.1.0-1998
AS/NZS 3200.2.2:1999
48 (Biocomp.) & 52.1 (Programmable Systems)4/04/2010
10-347Beds, Electric1234.0407Medicraft Australia Pty LtdAged Care Bed (with LINAK CB9 Actuators)HLE8000Medicraft Australia Pty LtdAS/NZS 3200.1.0-1998
AS/NZS 3200.2.38:1997
48 (Biocomp.)3/04/2010
16-917Electrical Conversion Kits, Mechanical Bed1233.0307LINAK A/SActuator SystemCB14Linak Australia Pty. Ltd.AS/NZS 3200.1.0-1998Nil8/03/2010
16-917Electrical Conversion Kits, Mechanical Bed1232.0307LINAKActuator SystemCB6Linak Australia Pty. Ltd.AS/NZS 3200.1.0-1998Cl 36 (EMC)8/03/2010
00-000Unknown1231.0207CathRx LimitedCatheter connection cableCRX-CC-D-04 & CRX-CC-D-10CathRx LimitedAS/NZS 3200.1.0-1998Cl 36 (EMC) & 48 (Biocomp.)7/02/2010
00-000Unknown1230.0207CathRx LimitedDiagnostic catheter handle & integrated extension cable (4 & 10 electrode variants)CRX-CHX-D-R04 & CRX-CHX-D-R10CathRx LimitedAS/NZS 3200.1.0-1998Cl 36 (EMC) & 48 (Biocomp.)7/02/2010
00-000Unknown1229.1206CathRx LimitedDecapolar Diagnostic Catheter Extension CableCRX-XC-D-10CathRx LimitedAS/NZS 3200.1.0-1998Cl 36 (EMC) & 48 (Biocomp.)30/11/2009
00-000Unknown1228.1206CathRx LimitedDecapolar Diagnostic Electrode SheathCRX-ES-D-10CathRx LimitedAS/NZS 3200.1.0-1998Cl 36 (EMC) & 48 (Biocomp.)30/11/2009
20-742Positive Airway Pressure Units1227.1106ResMed LimitedFlow GeneratorVPAP Adapt SVResMed LimitedAS/NZS 3200.1.0-1998Cl 36 (EMC), 48 (Biocomp.) & 52.1 (Programmable Systems)10/11/2009
16-917Electrical Conversion Kits, Mechanical Bed1226.1006Dewert Australia Pty LtdActuator SystemMCL CARE/HOSP (Controller) & Megamat MC4 & MPZ (DC Motors)Dewert Australia Pty LtdAS/NZS 3200.1.0-1998Cl 52.1 (Programmable Systems)1/12/2009
10-347Beds, Electric1225.0906Huntleigh Healthcare Pty LtdHospital Bed Contoura 480Huntleigh Healthcare Pty LtdAS/NZS 3200.1.0-1998
AS/NZS 3200.2.38:1997
48 (Biocomp.) & 52.1 (Programmable Systems)28/09/2009
10-347Beds, Electric1224.0906Huntleigh Healthcare Pty LtdHospital Bed Contoura 380Huntleigh Healthcare Pty LtdAS/NZS 3200.1.0-1998
AS/NZS 3200.2.38:1997
48 (Biocomp.) & 52.1 (Programmable Systems)28/09/2009
10-347Beds, Electric1223.0906Huntleigh Healthcare Pty LtdHospital Bed Joyce Profile® 1000Huntleigh Healthcare Pty LtdAS/NZS 3200.1.0-1998
AS/NZS 3200.2.38:1997
48 (Biocomp.) & 52.1 (Programmable Systems)28/09/2009
17-115Battery Chargers1222.0906Linvatec CorporationBattery ChargerPRO3600Conmed Linvatec Australia Pty LtdAS/NZS 3200.1.0-1998Cl 36 (EMC), 48 (Biocomp.) & 52.1 (Programmable Systems)12/09/2006
Expired
17-949Handpieces, Surgical1221.0906Linvatec CorporationPowerProMax All-Purpose Driver, PowerProMax Reciprocator, MPower Oscillator & Battery PacksPRO6202, PRO6400, PRO6300, PRO3010, PRO3110, PRO3115Conmed Linvatec Australia Pty LtdAS/NZS 3200.1.0-199848 (Biocomp.) & 52.1 (Programmable Systems)12/09/2009
13-209Pumps, Enteral feeding1220.0806Tyco Healthcare Group LPEnteral feeding pumpKangaroo ePumpTyco Healthcare - AustraliaAS/NZS 3200.1.0-1998Cl 48 (Biocomp.) & 52.1 (Programmable Systems)21/05/2010
11-218Hemodialysis units1219.0806Gambro Lundia ABHaemodialysis, Haemofiltration & Haemodiafiltration Machine AK 200 SGanbro Australia Pty. Ltd.AS/NZS 3200.1.0:1998 AS/NZS 3200.2.16:1999Cl 36 (EMC), 48 (Biocomp.) & 52.1 (Programmable Systems)28/08/2009
10-969Circulatory Assist Units, Peripheral Compression, Intermittent1218.0806Tyco Healtyhcare GroupCompression SystemSCD EXPRESSTyco Healthcare AustraliaAS/NZS 3200.1.0-199848 (Biocomp.) & 52.1 (Programmable Systems)4/09/2009
17-634Infusion Pumps, Multichannel1217.0806Baxter Healthcare CorporationVolumetric Infusion PumpColleague 3CX & Colleague CXEBaxter Healthcare Pty LtdAS/NZS 3200.1.0-199848 (Biocomp.) & 52.1 (Programmable Systems)25/08/2009
18-231Electrosurgical Units, Monopolar/Bipolar 1216.0806ConMed ElectrosurgerySystem 2450 Electrosurgical Generator 60-2450-230Linvatec Australia Pty LtdAS/NZS 3200.1.0-1998
AS/NZS 3200.2.2-1999
Cl 36 (EMC), 48 (Biocomp.) & 52.1 (Programmable Systems)25/08/2009
18-176Stereotactic Systems1215.0806Medtronic Surgical Navigation Technologies Treatment Guidance SystemStealthStation Treon-EMMedtronic Australasia Pty. Ltd.AS/NZS 3200.1.0-1998Cl 48 (Biocomp.) & 52.1 (Programmable Systems)17/08/2009
11-218Hemodialysis Units1214.0806Gambro Pty LimitedDialysis Unit AK95SGambro Lundia ABAS/NZS 3200.1.0-1998 & AS/NZS 3200.2.16-1999Cl 48 (Biocomp.) & 52.1 (Programmable Systems)14/08/2009
11-218Hemodialysis Units1213.0706Fresenius Medical Care AGHaemodialysis unit5008Fresenius Medical Care Australia Pty LtdAS/NZS 3200.1.0-1998 & AS/NZS 3200.2.16-199948 (Biocomp.) & 52.1 (Programmable Systems)28/07/2009
16-436Chairs, Dialysis1212.0706Gambro Pty LimitedDialysis ChairGambro Therapy ChairGambro Pty LimitedAS/NZS 3200.1.0-1998Cl 36 (EMC), 48 (Biocomp.) & 52.1 (Programmable Systems)24/07/2009
12-873Oxygen Concentrators1211.0706Sunrise MedicalDeVILBISS Oxygen Concentrator515AKSSunrise Medical Pty. Limited AS/NZS 3200.1.0-1998Cl 48 (Biocomp.) & 52.1 (Programmable Systems)20/07/2009
00-000Unknown1210.0606NEC Display Solutions Ltd.21.3" LCD Monitor MD21GS-3MP-CBNEC Australia Pty. Ltd.AS/NZS 3200.1.0-1998Cl 52.1 (Programmable Systems)19/06/2009
13-209Pumps, Enteral Feeding 1209.0606Nutricia Medical Devices b.v. Enteral Feeding PumpFlocare InfinityNutricia AustraliaAS/NZS 3200.1.0-1998Cl 48 (Biocomp.) & 52.1 (Programmable Systems)8/06/2009
00-000Unknown1208.0506Medmont International Pty LtdAutomated PerimeterM700 USB with options R, C & CR Medmont International Pty Ltd AS/NZS 3200.1.0-1998Cl 36 (EMC), 48 (Biocomp.) & 52.1 (Programmable Systems)25/05/2009
11-939Clippers, Hair1207.0506Allegiance Healthcare Corporation Surgical Clipper & Charging Adapter Stand4413 & 4414KCardinal Health Australia Pty LtdAS/NZS 3200.1.0-199848 (Biocomp.)26/05/2009
18-217Lasers, Nd:YAG, Frequency-Doubled, Ophthalmic1206.0506Ellex Medical Pty. Ltd.ellex Integre Duo Surgical Photocoagulator LaserLP1RGEllex Medical Pty. Ltd.AS/NZS 3200.1.0-1998Cl 36 (EMC), 48 (Biocomp.) & 52.1 (Programmable Systems)23/05/2009
18-855Smoke Evacuation Systems, Surgical, Mobile/Portable1205.0406ConMed CorporationSystem 1200 Smoke Evacuator60-8050-002Linvatec Australia Pty LtdAS/NZS 3200.1.0-199848 (Biocomp.) & 52.1 (Programmable Systems)26/04/2009
10-134Anesthesia Units1204.0406BleaseAnaesthetic MachineSirius 3000Medtel Pty LimitedAS/NZS 3200.1.0-199848 (Biocomp.) & 52.1 (Programmable Systems)6/04/2009
10-615Cardiac Output Units, Thermal Dilution1203.0406Pulsion Medical Systems AGPatient Monitor CeVOXPULSION Pacific Pty LtdAS/NZS 3200.1.0-199848 (Biocomp.) & 52.1 (Programmable Systems)6/04/2009
18-179Stereotactic Systems, Neurosurgical, Frameless 1202.0406RadionicsSurgical Guidance SystemOmniSight EXcelMedtel Pty LimitedAS/NZS 3200.1.0-199848 (Biocomp.) & 52.1 (Programmable Systems)6/04/2009
17-538Autotransfusion Units, Whole Blood Recovery1201.0306Transfusion Technologies Corp.OrthoPAT Orthopedic Perioperative Autotransfusion System1050-240-XXX Medtel Pty LimitedAS/NZS 3200.1.0-199848 (Biocomp.) & 52.1 (Programmable Systems)30/03/2009
13-754Stethoscopes, Electronic 1200.03063M Health CareLittmann Electronic Stethoscopes4100 & 30003M Pharmaceuticals Pty LtdAS/NZS 3200.1.0-199848 (Biocomp.) & 52.1 (Programmable Systems)30/03/2009
14-423Ventilators, Portable/Home Care1199.0306VersaMed Medical Systems Inc.VentilatoriVent201 ICTaleb MedicalAS/NZS 3200.1.0-199848 (Biocomp.) & 52.1 (Programmable Systems)15/03/2009
11-179Dermatomes 1198.0306Zimmer Orthopaedic Surgical ProductsElectric DermatomeElectric DermatomeZimmer Pty LtdAS/NZS 3200.1.0-199848 (Biocomp.) & 52.1 (Programmable Systems)17/03/2009
17-233Irrigation/Distension Systems, Arthroscopic1197.0306Linvatec CorporationIrrigation System10kLinvatec Australia Pty Ltd AS/NZS 3200.1.0-199848 (Biocomp.) & 52.1 (Programmable Systems)8/03/2009
15-993Programmer/Testers, Implantable Cardiac Pacemaker 1196.0206Guidant CorporationZoom Latitude Programming System 3120Guidant Australia Pty LtdAS/NZS 3200.1.0-199848 (Biocomp.) & 52.1 (Programmable Systems)28/02/2009
00-000Unknown1195.0206Ventracor LimitedVentrAssist Left Ventricular Assist SystemVA-LVA3Ventracor LimitedAS/NZS 3200.1.0-1998Cl 36 (EMC), 48 (Biocomp.) & 52.1 (Programmable Systems)2/02/2009
--2001.1005Advanced Sterilization ProductsPlasma sterilizerSterrad NXMedifix Pty LtdAS 61010.1:2003 and AS/NZS CISPR 11:2004Nil11.10.2008
11-001Positive Airway Pressure Units, Continuous1194.1005ResMed LimitedFlow GeneratorS8 Classic, S8 Escape, S8 Compact, S8 Lightweight ResMed LimitedAS/NZS 3200.1.0-1998Cl 36 (EMC), 48 (Biocomp.) & 52.1 (Programmable Systems)19/10/2008
12-047Humidifiers1193.1005ResMed LimitedHumidifierHumidAire 2iResMed LimitedAS/NZS 3200.1.0-1998Cl 36 (EMC), 48 (Biocomp.) & 52.1 (Programmable Systems)19/10/2008
00-000Unknown1192.1005Conseng Pty LtdInvisa-Beam Bed Monitoring System8Conseng Pty LtdAS/NZS 3200.1.0-1998Cl 48 (Biocomp.)27/06/2008
00-000Unknown1191.1005Neuromonics LimitedNeuromonics Processor 100Neuromonics LimitedAS/NZS 3200.1.0-1998Cl 36 (EMC), 48 (Biocomp.) & 52.1 (Programmable Systems)5/10/2008
17-969Injectors, Contrast Media, Computed Tomography1190.0905Tecnovate Pty LtdMagnetic Resonance Imaging/Computerised Tomography Contrast Injector AquajectTecnovate Pty LtdAS/NZS 3200.1.0-1998Cl 36 (EMC), 48 (Biocomp.) & 52.1 (Programmable Systems)7/09/2008
17-808Lasers, Diode, Ophthalmic1189.0805Laserex (a division of Ellex Medical Pty. Ltd.)Opthalmic LaserLP4532Laserex (a division of Ellex Medical Pty. Ltd.)AS/NZS 3200.1.0-1998Cl 36 (EMC), 48 (Biocomp.) & 52.1 (Programmable Systems)15/08/2008
15-967Video Systems, Endoscopic1188.0805Pentax CorporationConfocal Endomicroscopy SystemPentax ISC-1000C.R. Kennedy & Company Pty. Ltd.AS/NZS 3200.1.0-1998Cl 48 (Biocomp.)8/08/2008
00-000Unknown1187.0805Advan Inetrnational Corporation19" SV-2 Flat Panel Monitor 240-030-920Stryker Australia Pty LtdAS/NZS 3200.1.0-1998Nil6/08/2008
18-337Plethysmographs, Segmental, Brain1186.0705Cortical Dynamics Pty LimitedBrain Anaesthesia Response Monitor B401-064 Cortical Dynamics Pty LimitedAS/NZS 3200.1.0-1998
AS/NZS 3200.2.26-1995
Cl 36 (EMC), 48 (Biocomp.) & 52.1 (Programmable Systems)21/02/2009
13-217Infusion Pumps, Syringe1185.0705acromed agSyramed Infusion PumpsuVP7000Tuta Healthcare Pty LtdAS/NZS 3200.1.0-1998
AS/NZS 3200.2.24-1998
48 (Biocomp.) & 52.1 (Programmable Systems)20/07/2008
13-217Infusion Pumps, Syringe1184.0705acromed agSyramed Infusion PumpsuSP6000, uSP6000 Anesthesia & uSP6000 LITETuta Healthcare Pty LtdAS/NZS 3200.1.0-1998
AS/NZS 3200.2.24-1999
48 (Biocomp.) & 52.1 (Programmable Systems)20/07/2008
10-134Anesthesia Units1183.0605Ulco Engineering Pty. Ltd.Anesthesia WorkstationSIGNETUlco Engineering Pty. Ltd.AS/NZS 3200.1.0-1998Cl 48 (Biocomp.)27/06/2008
13-209Pumps, Enteral Feeding1182.0605Nutricia Medical DevicesEnteral Feeding PumpFlocare 800Nutricia AustraliaAS/NZS 3200.1.0-199848 (Biocomp.) & 52.1 (Programmable Systems)8/06/2008
11-001Positive Airway Pressure Units, Continuous1181.0505Sunrise MedicalDeVILBISS RPM-bilevel CPAP9055D & 9054DSunrise Mrdical Pty LtdAS/NZS 3200.1.0-199848 (Biocomp.) & 52.1 (Programmable Systems)1/04/2008
10-846Circulatory Assist Units, Cardiac, Intra-Aortic Balloon1180.0405Datascope Inc.Intra Aortic Balloon PumpCS100i &CS100Medtel Pty LimitedAS/NZS 3200.1.0-199848 (Biocomp.) & 52.1 (Programmable Systems)6/04/2008
00-000Unknown1179.0405Coltene/Whaledent Inc.Cordless Curing LightColtolux LEDColtene Whaledent Inc.AS/NZS 3200.1.0-199848 (Biocomp.) & 52.1 (Programmable Systems)27/04/2008
12-047Humidifiers1178.0405ResMed LimitedHumidifier HumidAire 3iResMed LimitedAS/NZS 3200.1.0-1998Cl 36 (EMC), 48 (Biocomp.) & 52.1 (Programmable Systems)15/04/2008
00-000Unknown1177.0405ITL Asia Pacific Sdn. Bhd.Nasal Airflow Recorder FW001DiagnoseIT Pty LimitedAS/NZS 3200.1.0-1998Cl 48 (Biocomp.)5/04/2008
18-326Sphygmomanometers, Electronic, Automatic, Oscillometric 1176.0405Rossmax International LimitedBlood Pressure MonitorMD 42049Medion Australia Pty LtdAS/NZS 3200.1.0-1998Cl 36 (EMC), 48 (Biocomp.) & 52.1 (Programmable Systems)15/04/2005
Expired
17-887Thermometers, Electronic, Infrared, Ear1175.0405Radiant Innovation Inc.Digital Ear ThermometerMD 42693Medion Australia Pty LtdAS/NZS 3200.1.0-1998Cl 36 (EMC) & 48 (Biocomp.)4/04/2008
11-218Hemodialysis Unit1174.0305Baxter Healthcare CorporationAurora Haemodialysis MachineSYS1000Baxter Healthcare Pty. Ltd. AS/NZS 3200.1.0-1998
AS/NZS 3200.2.16-1999
48 (Biocomp.) & 52.1 (Programmable Systems)23/03/2008
00-000Unknown1173.0305Pauldrach Medical GmbHEndo-Jet Endoscopic IrrigatorEJC.R. Kennedy & Company Pty. Ltd.AS/NZS 3200.1.0-1998Cl 48 (Biocomp.)16/03/2008
14-263Ultrasound Cleaning Systems1172.0305Coltene/Whaledent Inc.Ultrasonic CleanerUC100XD240Coltene Whaledent Inc.AS/NZS 3200.1.0-1998Cl 36 (EMC)14/03/2008
18-563Transformers, Isolation1171.0205Stryker Australia Pty LtdVideo Cart0240-099-0XXStryker Australia Pty LtdAS/NZS 3200.1.0-1998Cl 36 (EMC)23/02/2008
00-000Unknown1169.0105Medmont Pty LtdColour Vision TesterC100Medmont Pty LtdAS/NZS 3200.1.0-1998Cl 48 (Biocomp.)7/02/2008
00-000Unknown1168.0105Conseng Pty LtdInvisa-Beam Bed Monitoring System7Conseng Pty LtdAS/NZS 3200.1.0-1998Cl 48 (Biocomp.)27/01/2008
11-001Continuous Positive Airway Pressure Units1167.1204ResMed LimitedFlow GeneratorS8 Escape & S8 Compact ResMed LimitedAS/NZS 3200.1.0-1998Cl 36 (EMC), 48 (Biocomp.) & 52.1 (Programmable Systems)7/12/2007
11-001Continuous Positive Airway Pressure Units1166.0704ResMed LimitedFlow GeneratorS8 ClassicResMed LimitedAS/NZS 3200.1.0-1998Cl 36 (EMC), 48 (Biocomp.) & 52.1 (Programmable Systems)20/07/2007
00-000Unknown1165.0804ResMed LimitedDC/DC ConverterDC-12ResMed LimitedAS/NZS 3200.1.0-1998Cl 36 (EMC)27/08/2007
11-001Continuous Positive Airway Pressure Units1164.0904ResMed LimitedFlow GeneratorS8 ClassicResMed LimitedAS/NZS 3200.1.0-1998Cl 36 (EMC), 48 (Biocomp.) & 52.1 (Programmable Systems)13/09/2007
12-047Humidifiers1163.0804ResMed LimitedHumidifier HumidAire 3iResMed LimitedAS/NZS 3200.1.0-1998Cl 36 (EMC), 48 (Biocomp.) & 52.1 (Programmable Systems)2/08/2007
00-000Unknown1161.1104Ventrex IncAutologous Cell Harvesting KitRPU-02C3 Operations Pty LtdAS/NZS 3200.1.0-199848 (Biocomp.) & 52.1 (Programmable Systems)8/11/2007
11-001Continuous Positive Airway Pressure Units1160.1104ResMed LimitedFlow GeneratorS8 AutoSet Spirit, S8 AutoSet Vantage, S8 AutoSet EliteResMed LimitedAS/NZS 3200.1.0-1998Cl 36 (EMC), 48 (Biocomp.) & 52.1 (Programmable Systems)8/11/2007
12-281Slit Lamps1159.1104VISX Inc.Slit Lamp & ChargerCV SI-1 & CV SI-1 ChargerVISX Inc.AS/NZS 3200.1.0-1998Nil4/11/2007
16-831Light Sources, Fiberoptic, Rigid Endoscopic/Multipurpose1157.1004Linvatec CorporationLight SourceLS7500Linvatec Australia Pty LtdAS/NZS 3200.1.0-1998Cl 48 (Biocomp.) & 52.1 (Programmable Systems)16/10/2007
15-748Cameras, Endoscopic1156.1004Linvatec Corporation3CCD Digital CameraIM3301Linvatec Australia Pty LtdAS/NZS 3200.1.0-1998Cl 48 (Biocomp.)01/10/2007
12-712Nebulizers1155.0904Sunrise MedicalDevilbiss Pulmo-Aide Compact Compressor 3655A Sunrise Medical Pty. LimitedAS/NZS 3200.1.0-1998Cl 48 (Biocomp.)23/09/2007
10-348Beds, Electric, Flotation Therapy1154.0904Kinetic Concepts Inc. Hospital BedTheraPulse IIKCI Medical Australia Pty LtdAS/NZS 3200.1.0-1998Nil15/09/2007
16-035Stimulators, Electrical, Auditory, Cochlear1153.0904Cochlear LimitedSpeech ProcessorSpeech ProcessorSP12Cochlear LimitedAS/NZS 3200.1.0-1998Nil10/09/2007
00-000Unknown1152.0804Ventrex IncReCell Autologous Cell Harvesting KitRPU-01C3 Operations Pty LtdAS/NZS 3200.1.0-1998Cl 48 (Biocomp.) & 52.1 (Programmable Systems)24/08/2007
15-976Scanning Systems, Ultrasonic, General-Purpose1151.0804Philips UltrasoundDiagnostic Ultrasound SystemiU22Philips Medical Systems Australasia Pty LtdAS/NZS 3200.1.0-1998Cl 48 (Biocomp.) & 52.1 (Programmable Systems)20/08/2007
00-000Unknown1150.0604Nascor Pty LtdOxygen/Air Mixer & Oxygen AnalyserOxymix & FiONANascor Pty LtdAS/NZS 3200.1.0-1998Cl 48 (Biocomp.) & 52.1 (Programmable Systems)15/06/2007
Expired
00-000Unknown1149.0604UscomUltrasonic Cardiac Output MonitorUSCOM 1A UscomAS/NZS 3200.1.0-1998Cl 36 (EMC), 48 (Biocomp.) & 52.1 (Programmable Systems)18/12/2006
Expired
18-176Stereotactic Systems1148.0504Medtronic Surgical Navigation TechnologiesTreatment Guidance SystemStealthstation TreonMedtronic Sofamor Danek Australia Pty LtdAS/NZS 3200.1.0-1998Cl 48 (Biocomp.) & 52.1 (Programmable Systems)21/05/2007
Expired
16-917Electrical Conversion Kits, Mechanical Bed1147.0504LINAK A/SActuator SystemCB12 seriesLinak Australia Pty. Ltd.AS/NZS 3200.1.0-1998Nil03/04/2010
16-917Electrical Conversion Kits, Mechanical Bed1146.0404LINAK A/SActuator System CB9 seriesLinak Australia Pty. Ltd.AS/NZS 3200.1.0-1998Nil13/07/2010
17-116Defibrillators, External, Automated1145.0404ZOLL Medical CorporationAutomated External Defibrillator AED PLUSZOLL Medical Australia Pty LtdAS/NZS 3200.1.0-1998
AS/NZS 3200.2.4-1993
CI 52.1 (Programmable Systems)16/04/2007
Expired
11-490Electrosurgical Units1144.0104Mitek Worldwide, ETHICON, Inc. VAPR3 Electrosurgery Generator225021Medifix Pty Ltd AS/NZS 3200.1.0-1998
AS/NZS 3200.2.2-1999
Cl 48 (Biocomp.) & 52.1 (Programmable Systems)28/07/2007
17-429Ventilators, Intensive Care1143.0104Drager Medical AG & Co. KGaAEvita XL Intensive Care Ventilator8411950Draeger Medical Australia Pty LtdAS/NZS 3200.1.0-1998Cl 48 (Biocomp.) & 52.1 (Programmable Systems)28/01/2007
Expired
16-035Stimulators, Electrical, Auditory, Cochlear1141.0104Cochlear LimitedSpeech Processor & Implant ESPrit 3G + CI24RECochlear LimitedAS/NZS 3200.1.0-1998Nil07/01/2007
Expired
16-849Insufflators, Laparoscopic1140.1203Linvatec CorporationAbdominal InsufflatorGS1000 & GS1002Linvatec Australia Pty LtdAS/NZS 3200.1.0-1998CI 48 (Biocomp.)28/12/2006
Expired
00-000Unknown1139.1203S.S.H. Medical LimitedVeda-Scope Examination SystemWS-XII S.S.H. Medical LimitedAS/NZS 3200.1.0-1998Cl 48 (Biocomp.) & 52.1 (Programmable Systems)15/12/2006
Expired
14-447Warming Units, Blood/Solution1138.1203Gaymar Industries Inc.Medi-Temp III Blood/Fluid Warmer FW603 Baxter Healthcare Pty. Ltd. AS/NZS 3200.1.0-1998Cl 48 (Biocomp.) & 52.1 (Programmable Systems)03/12/2006
Expired
17-907Infusion Pumps, High-Flow, Warming1137.1203Belmont Instrument CorporationFluid Management SystemFMS 2000Medtel Pty LimitedAS/NZS 3200.1.0-1998Cl 48 (Biocomp.) & 52.1 (Programmable Systems)05/12/2006
Expired
11-969Heart-Lung Bypass Units 1136.1203Terumo Cardiovascular SystemsAdvanced Perfusion System1Terumo CorporationAS/NZS 3200.1.0-1998Cl 48 (Biocomp.) & 52.1 (Programmable Systems)03/12/2006
Expired
00-000Unknown1135.1103Vita Medical LimitedTechnegas Crucible Heater15000Vita Medical Limited3200.1.0-1998Nil06/11/2006
Expired
00-000Unknown1134.0903SDI Pty LimitedDental Curing Hand PieceradiiSDI Pty Limited3200.1.0-1998Cl 48 (Biocomp.) & 52.1 (Programmable Systems)29/09/2006
Expired
18-231Electrosurgical Unit, Monopolar/Bipolar1133.0903ConMed ElectrosurgeryElectrosurgical GeneratorSystem 2500Linvatec Australia Pty Ltd3200.1.0-1998
3200.2.2-1999
Cl 48 (Biocomp.), 52.1 (Programmable Systems) of AS/NZS 3200.1.0 & Cl 36 (EMC) of AS/NZS 3200.2.209/09/2006
Expired
18-231Electrosurgical Units, Monopolar/Bipolar1132.0903ConMed ElectrosurgeryElectrosurgical GeneratorSystem 5000Linvatec Australia Pty Ltd3200.1.0-1998
3200.2.2-1999
Cl 48 (Biocomp.), 52.1 (Programmable Systems) of AS/NZS 3200.1.0 & Cl 36 (EMC) of AS/NZS 3200.2.209/09/2006
Expired
11-002Continuous Positive Airway Pressure Units1131.0903ResMed LimitedFlow GeneratorVPAP III ST-AResMed Limited3200.1.0-1998Cl 36 (EMC), 48 (Biocomp.) & 52.1 (Programmable Systems)02/09/2006
Expired
18-217
16-947
Lasers, Nd:YAG, Frequency-Doubled, Ophthalmic
Lasers, Nd:YAG, Ophthalmic
1130.0803CustomVisOphthalmic LaserPulzar Z1CustomVis3200.1.0-1998
3200.2.22-1997
Cl 36 (EMC), 48 (Biocomp.) & 52.1 (Programmable Systems)19/08/2006
Expired
10-347Beds, Electric1129.0803Medicraft Australia Pty LtdElectric Hospital BedFE 5000,
FE 5000 T
Medicraft Australia Pty Ltd3200.1.0-1998
3200.2.38-1997
Cl 36 (EMC), 48 (Biocomp.) & The Linak equipment13/08/2006
Expired
14-074Tourniquets, Pheumatic1128.0803Zimmer Orthopaedic Surgical ProductsATS 1200 Automatic Tourniquet System60-1200-101-00Zimmer Pty Ltd3200.1.0-1998Cl 48 (Biocomp.) & 52.1 (Programmable Systems)06/08/2006
Expired
18-839Lasers, Er:YAG, Deramtologic1127.0703Norwood Abbey LtdLight-Assisted Anaesthetic Delivery (LAD) SystemLAD-06Norwood Abbey Ltd3200.1.0-1998
3200.2.22-1997
Cl 36 (EMC), 48 (Biocomp.) & 52.1 (Programmable Systems)28/07/2006
Expired
12-282Lights, Surgical1126.0703Mediland Enterprises Co. Ltd.MediLux 600Surgical LightML600/SDevice Technologies Australia Pty Ltd3200.1.0-1998Cl 36 (EMC), 48 (Biocomp.) & 52.1 (Programmable Systems)25/07/2006
Expired
00-000Unknown1125.0603ResMed LimitedData Transfer DeviceResControl IIResMed Limited3200.1.0-1998Cl 36 (EMC), 48 (Biocomp.) & 52.1 (Programmable Systems)23/06/2006
Expired
12-647Monitoring Systems, Physiologic, Acute Care1124.0603Nihon Kohden CorporationLife Scope A Bedside MonitorBSM-5135KMedtel Pty Limited3200.1.0-1998 3200.2.25-1993 3200.2.27-1996Cl 36 (EMC), 48 (Biocomp.) & 52.1 (Programmable Systems)20/06/2006
Expired
10-134Anesthesia Units1123.0603Drager Medical AG & Co. KGaA Anesthesia WorkstationPrimusDraeger Medical Australia Pty Ltd3200.1.0-1998Cl 48 (Biocomp.) & 52.1 (Programmable Systems)26/06/2006
Expired
16-405Apheresis Units1122.0603Biosafe SABlood Cell SeperatorSepax S-100Medtel Pty Limited3200.1.0-1998Cl 48 (Biocomp.)13/06/2006
Expired
17-676Irrigation/Distention Systems1121.0603Biosense Wenster, Inc.CoolFlow Irrigation PumpM-5401-00Medifix Pty Ltd3200.1.0-1998Cl 48 (Biocomp.) & 52.1 (Programmable Systems)16/06/2006
Expired
11-001Continuous Positive Airway Pressure Units1120.0503ResMed LimitedFlow GeneratorVPAP III & VPAP III STResMed Limited3200.1.0-1998Cl 36 (EMC), 48 (Biocomp.) & 52.1 (Programmable Systems)19/05/2006
Expired
17-433Warming Units, Patient, Radiant, Infant, Mobile1119.0503Medical Sales & Service Pty LtdInfant Radiant WarmerTM2003Medical Sales & Service Pty Ltd3200.1.0-1998
3200.2.21-1994
Cl 48 (Biocomp.) & 52.1 (Programmable Systems)28/05/2006
Expired
13-209Pumps, Enteral Feeding1118.0503Nutricia Medical DevicesEnteral Feeding PumpFlocare MicroMAX 200iNutricia Australia3200.1.0-1998Cl 48 (Biocomp.) & 52.1 (Programmable Systems)16/05/2006
Expired
12-712Nebulizers1117.0503Sunrise MedicalNebuliser3655 ASunrise Medical Pty. Ltd.3200.1.0-1998Cl 48 (Biocomp.)05/05/2006
Expired
18-038Corneal Topography Systems1116.0403Medmont Pty LtdCorneal TopographerE 300Medmont Pty Ltd3200.1.0-1998Cl 48 (Biocomp.) & 52.1 (Programmable Systems)30/04/2006
Expired
18-563Transformers, Isolation1115.0403Harbuch Electronics Pty LtdIsolation TransformerTR2450Medmont Pty Ltd3200.1.0-1998Cl 36 (EMC)30/04/2006
Expired
18-830Hydrothermal Ablation Systems, Endometrial1114.0403GynecareThermachoice II Uterine Balloon Therapy SystemE AS2000-1Medifix Pty Ltd3200.1.0-1998Cl 48 (Biocomp.) & 52.1 (Programmable Systems)22/10/2010
13-217Infusion Pumps, Syringe1113.0403Terumo CorporationSyringe PumpTE-331 & TE-332Terumo Corporation3200.1.0-1998
3200.2.24-1999
Cl 48 (Biocomp.) & 52.1 (Programmable Systems)17/04/2006
Expired
00-000Unknown1112.0403Asahi Optical Co. Ltd.Processor SelectorP SW-2200C.R. Kennedy & Company Pty Ltd3200.1.0-1998Cl 36 (EMC), 48 (Biocomp.) & 52.1 (Programmable Systems)14/04/2006
Expired
00-000Unknown1111.0403J. Morita Mfg. Corp.Penscope Intraoral CameraVIS-27Halas Dental Limited3200.1.0-1998Cl 48 (Biocomp.)28/03/2006
Expired
12-678Monitors, Bedside, Respiration, Ventilation/Apnea1110.0303eVent Medical LtdVentilatorInspirationFairmont Medical Products Pty Limited3200.1.0-1998Cl 36 (EMC), 48 (Biocomp.) & 52.1 (Programmable Systems)28/03/2006
Expired
17-116Defibrillators, External, Automated1108.0303Medical Research Laboratories, Inc.Automatic External DefibrillatorJump StartFerno Australia Pty Ltd3200.1.0-1998
3200.2.4-1993
Cl 48 (Biocomp.) & 52.1 (Programmable Systems)06/03/2006
Expired
10-034Video Image Processors, Endoscopic1107.0203Stryker EndoscopyStryker Digital CaptureSDC Pro 2Stryker Australia Pty Ltd3200.1.0-1998Cl 36 (EMC)20/02/2006
Expired
10-348Beds, Electric, Flotation Therapy1106.0203Kinetic Concepts Inc.Hospital BedTriadyne ProventaKCI Medical Australia Pty Ltd3200.1.0-1998
3200.2.38-1997
Cl 36 (EMC), 48 (Biocomp.) & 52.1 (Programmable Systems)20/02/2006
Expired
18-034Video Image Processors, Endoscopic1105.0103Asahi Optical Co. Ltd.Pentax Video ProcessorEPK-1000C.R. Kennedy & Company Pty. Ltd.3200.1.0-1998Cl 48 (Biocomp.)29/01/2006
Expired
12-585Alarms, Occupancy, Bed1104.0103DCT Associates Pty LtdBed Occupancy MonitorVigil-AideDCT Associates Pty Ltd3200.1.0-1998Cl 36 (EMC)21/01/2006
Expired
10-208Aspirators1103.0103Sunrise Medical HHG Inc.Suction Unit