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Date of Notification
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Title
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FSN
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29 May 2015
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Astraia Software, Astraia Software GmbH (HSA 600:41/01-170/15/01_17)
Local contact: Medisol Pte Ltd
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HSA 6004101-170-15-01_17 FSN
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29 May 2015
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HeartWare® Ventricular Assist System (HVAD), HeartWare Inc (HSA 600:41/01-207/15/02_18)
Local contact: Singcare Medical Pte Ltd
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HSA 6004101-207-15-02_18 FSN
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28 May 2015
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AllSet+ Gold and UniTray, Life Technologies Corporation (HSA 600:41/01-220/15/02_19)
Local contact: Life Technologies Holdings Pte Ltd
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HSA 6004101-220-15-02_19 FSN
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28 May 2015
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S3 and S2 Fluid Packs, Roche Diagnostics GmbH (HSA 600:41/01-016/15/10_20)
Local contact: Roche Diagnostics Asia Pacific Pte Ltd
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HSA 6004101-016-15-10_20 FSN
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27 May 2015
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LifeCycle for Prenatal Screening, Wallac Oy (HSA 600:41/01-127/15/02_17)
Local contact: PerkinElmer Singapore Pte Ltd
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HSA 6004101-127-15-02_17 FSN
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26 May 2015
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EVIS EXERA II Duodenovideoscope, Olympus Medical Systems Corporation (HSA 600:41/01-004/15/04_16)
Local contact: Olympus Singapore Pte Ltd
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HSA 6004101-004-15-04_16 FSN
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25 May 2015
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Tibial Alignment Guide – iAssist Knee System, Zimmer CAS (HSA 600:41/01-008/15/07_19)
Local contact: Zimmer Pte Ltd
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HSA 6004101-008-15-07_19 FSN
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25 May 2015
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Omrix Pressure Regulator, Omrix Biopharmaceuticals Ltd (HSA 600:41/01-002/15/22_20)
Local contact: Johnson & Johnson Pte Ltd
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HSA 6004101-002-15-22_20 FSN
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22 May 2015
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Siemens Artis Zee Family System, Siemens AG (HSA 600:41/01-022/15/27_18)
Local contact: Siemens Pte Ltd
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HSA 6004101-022-15-27_18 FSN
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22 May 2015
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ADVIA Centaur Tnl-Ultra, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/15/26_17)
Local contact: Siemens Pte Ltd
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HSA 6004101-022-15-26_17 FSN
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21 May 2015
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Tubeset Declog Diego Elite and Tubeset Standard Diego Elite, Gyrus ACMI Inc (HSA 600:41/01-004/15/03_09)
Local contact: Olympus Singapore Pte Ltd
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HSA 6004101-004-15-03_09 FSN
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21 May 2015
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Hamilton Medical lnfant Flow Sensor, single use, Hamilton Medical AG (HSA 600:41/01-248/15/02_16)
Local contact: MeDeus (S) Pte Ltd
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HSA 6004101-248-15-02-16 FSN
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21 May 2015
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Wand STA Handpiece, Milestone Scientific Inc (HSA 600:41/01-276/15/01_01)
Local contact: Eastland Dental Supplies Pte Ltd
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HSA 6004101-276-15-01_01 FSN
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21 May 2015
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Oncentra Brachy, Nucletron BV (HSA 600:41/01-101/15/05_24)
Local contact: Elekta Pte Ltd
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HSA 6004101-101-15-05_24 FSN
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21 May 2015
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Nellcor OxiMax N-65 Handheld Pulse Oximeter and Nellcor OxiMax N-560 Pulse Oximeter, Covidien llc (HSA 600:41/01-046/15/06_25)
Local contact: Covidien Private Limited
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HSA 6004101-046-15-06_25 FSN
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21 May 2015
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Invivo Expression MRI Patient Monitoring System, Invivo Corporation (HSA 600:41/01-026/15/17_08)
Local contact: Philips Electronics (S) Pte Ltd
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HSA 6004101-026-15-17_08 FSN
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19 May 2015
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ORTHO VISION™ Analyzer, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-002/15/20_21)
Local contact: Johnson & Johnson Pte Ltd
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HSA 6004101-002-15-20_21 FSN
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19 May 2015
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CELLSEARCH® Circulating Tumor Cell Kits, Janssen Diagnostics llc (HSA 600:41/01-002/15/21_23)
Local contact: Johnson & Johnson Pte Ltd
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HSA 6004101-002-15-21_23 FSN
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19 May 2015
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Pulsar-18 and Pulsar-35 Self Expanding Peripheral Stent System, Biotronik AG (HSA 600:41/01-269/15/02_22)
Local contact: Biotronik Asia Pacific Pte Ltd
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HSA 6004101-269-15-02_22 FSN
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19 May 2015
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Boston Scientific Reliance 4-Front single coil defibrillation leads, Boston Scientific Corporation (HSA 600:41/01-007/15/03_08)
Local contact: Boston Scientific Asia Pacific Pte Ltd
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HSA 6004101-007-15-03_08 FSN
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18 May 2015
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Philips IntelliVue Information Center iX, Philips Medical Systems (HSA 600:41/01-026/15/16_09)
Local contact: Philips Electronics (S) Pte Ltd
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HSA 6004101-026-15-16_09 FSN
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15 May 2015
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Philips Dura Diagnost X-ray system, Philips Healthcare (Suzhou) Co Ltd (HSA 600:41/01-026/15/14_01)
Local contact: Philips Electronics (S) Pte Ltd
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HSA 6004101-026-15-14_01 FSN
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15 May 2015
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Philips Digital Diagnost Radiography System, Philips Medical Systems, DMC GmbH (HSA 600:41/01-026/15/13_18)
Local contact: Philips Electronics (S) Pte Ltd
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HSA 6004101-026-15-13_18 FSN
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15 May 2015
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Philips AFFINITI 50 Ultrasound System, Philips Ultrasound Inc (HSA 600:41/01-026/15/15_08)
Local contact: Philips Electronics (S) Pte Ltd
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HSA 6004101-026-15-15_08 FSN1
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15 May 2015
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Philips AFFINITI 70 Ultrasound System, Philips Ultrasound Inc (HSA 600:41/01-026/15/15_08)
Local contact: Philips Electronics (S) Pte Ltd
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HSA 6004101-026-15-15_08 FSN2
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15 May 2015
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Biometrix Thorametrix Thoracic Drainage System, Biometrix Ltd (HSA 600:41/01-051/15/02_08)
Local contact: Star Medical Co Pte Ltd
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HSA 6004101-051-15-02_08 FSN
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14 May 2015
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Eon™ Wall Charger Model 3701 and Eon™ Portable Charger Model 3711, St. Jude Medical (HSA 600:41/01-025/15/02_09)
Local contact: St. Jude Medical (Singapore) Pte Ltd
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HSA 6004101-025-15-02_09 FSN
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14 May 2015
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EVOTECH® Endoscope Cleaner and Reprocessor (ECR), Advanced Sterilization Products (HSA 600:41/01-002/15/19_17)
Local contact: Johnson & Johnson Pte Ltd
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HSA 6004101-002-15-19_17 FSN
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14 May 2015
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GE Corometrics Models 171, 172, 173 and 174 series monitors, GE Medical Systems Information Technologies Inc (HSA 600:41/01-010/15/09_11)
Local contact: GE Healthcare Pte Ltd
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HSA 6004101-010-15-09-11 FSN
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14 May 2015
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AirCurve 10 CS PaceWave, S9 VPAP Adapt/Adapt PaceWave, S9 VPAP Tx, S9 AutoSet CS/CS-A/CS Easv, AutoSet CS/CS-2/CS-A, VPAP Adapt/Adapt SV, VPAP Tx, Lumis Tx, ResMed Ltd (HSA 600:41/01-275/15/01_16)
Local contact: ResMed Asia Operations Pte Ltd (Singapore Branch)
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HSA 6004101-275-15-01_16 FSN
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13 May 2015
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Abbott Clinical Chemistry Alkaline Wash, Abbott Laboratories (HSA 600:41/01-005/15/03_18)
Local contact: Abbott Laboratories (S) Pte Ltd
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HSA 6004101-005-15-03_18 FSN
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13 May 2015
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VITROS Chemistry Products Performance Verifier I, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-002/15/18_20)
Local contact: Johnson & Johnson Pte Ltd
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HSA 6004101-002-15-18_20 FSN
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12 May 2015
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Karl Storz Laparoscopic Power Morcellators, Karl Storz GmbH & Co KG (HSA 600:41/01-133/15/01_19)
Local contact: Karl Storz Endoscopy Singapore Sales Pte Ltd
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HSA 6004101-133-15-01_19 FSN
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12 May 2015
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Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless and Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff, Covidien llc (HSA 600:41/01-046/15/05_17)
Local contact: Covidien Private Limited
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HSA 6004101-046-15-05_17 FSN
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11 May 2015
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Ysio Max, Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Siemens AG (HSA 600:41/01-022/15/25_09)
Local contact: Siemens Pte Ltd
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HSA 6004101-022-15-25_09 FSN
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8 May 2015
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CREA plus, CREP2, LACT2, Lactate, GLU, TRIGL/TG, TRIGGB, TRIG/GB, CHOL/CHOL2, HDL-C plus 3rd generation/HDLC3, LDL_C plus 2nd generation/LDL_C, UA2/UA plus, Roche Diagnostics GmbH (HSA 600:41/01-016/15/09_16)
Local contact: Roche Diagnostics Asia Pacific Pte Ltd
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HSA 6004101-016-15-09_16 FSN
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8 May 2015
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Philips EPIQ 5 Ultrasound System, Philips Ultrasound Inc (HSA 600:41/01-026/15/12_20)
Local contact: Philips Electronics (S) Pte Ltd
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HSA 6004101-026-15-12_20 FSN1
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8 May 2015
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Philips EPIQ 7 Ultrasound System, Philips Ultrasound Inc (HSA 600:41/01-026/15/12_20)
Local contact: Philips Electronics (S) Pte Ltd
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HSA 6004101-026-15-12_20 FSN2
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7 May 2015
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Cios Alpha mobile C-arm X-ray System, Siemens AG (HSA 600:41/01-022/15/24_18)
Local contact: Siemens Pte Ltd
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HSA 6004101-022-15-24_18 FSN
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7 May 2015
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Camlog Screw-Line Implant, Altatec GmbH (HSA 600:41/01-274/15/01_08)
Local contact: Implantate Pte Ltd
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HSA 6004101-274-15-01_08 FSN
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7 May 2015
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RAPIDLab 1260/ 1265 Blood Gas Analyzers, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/15/23_24)
Local contact: Siemens Pte Ltd
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HSA 6004101-022-15-23_24 FSN
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7 May 2015
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M/DN 4.5mm Cortical Screws, Zimmer Inc (HSA 600:41/01-008/15/06_17)
Local contact: Zimmer Pte Ltd
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HSA 6004101-008-15-06_17 FSN
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6 May 2015
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ORTHO VISION™ Analyzer for ORTHO BioVue® Cassettes, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-002/15/17_25)
Local contact: Johnson & Johnson Pte Ltd
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HSA 6004101-002-15-17_25 FSN
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6 May 2015
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Sekisui Diagnostics MULTIGENT Acetaminophen Assay, Sekisui Diagnostics (HSA 600:41/01-005/15/02_16)
Local contact: Abbott Laboratories (S) Pte Ltd
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HSA 6004101-005-15-02-16 FSN
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6 May 2015
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Beta-2-Microglobulin PET Kit, Dako Denmark A/S (HSA 600:41/01-086/15/02_01)
Local contact: SPD Scientific Pte Ltd
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HSA 6004101-086-15-02_01 FSN
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5 May 2015
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ULTRA FAST-FIX Knot Pusher Suture Cutters, Smith & Nephew Inc (HSA 600:41/01-073/15/04_23)
Local contact: Smith & Nephew Pte Ltd
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HSA 6004101-073-15-04_23 FSN
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4 May 2015
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PRI Femoral Impactor Head, Zimmer Inc (HSA 600:41/01-008/15/05_21)
Local contact: Zimmer Pte Ltd
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HSA 6004101-008-15-05_21 FSN
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4 May 2015
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COULTER DxH Diluent, Beckman Coulter Inc (HSA 600:41/01-052/15/02_22)
Local contact: Beckman Coulter Singapore Pte Ltd
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HSA 6004101-052-15-02_22 FSN
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