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Date of Notification
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Title
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FSN
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30 Jun 2016
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TWINFIX QUICK-T KNOT PUSHER SUTURE CUTTERS, Smith & Nephew Inc (HSA 600:41/01-073/16/17_40)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-16-17_40 FSN123 KB
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30 Jun 2016
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LEGION HK 11,12,13MM BOLT AND SLEEVE, Smith & Nephew Inc (HSA 600:41/01-073/16/16_36)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-16-16_36 FSN137 KB
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29 Jun 2016
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iGuide 2.1.0 and iGuide 2.2.0, Medical Intelligence Medizintechnik GmbH (HSA 600:41/01-101/16/03_37)
Local Contact: Elekta Pte Ltd
Contact no./Email: 62212322
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HSA 6004101-101-16-03_37 FSN39 KB
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29 Jun 2016
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Rocket® R51551 Thoracentesis Catheter, Rocket Medical PLC (HSA 600:41/01-057/16/03_49)
Local Contact: Somnotec (S) Pte Ltd
Contact no./Email: info@somnotec.net
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HSA 6004101-057-16-03_49 FSN38 KB
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29 Jun 2016
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3M PICC/CVC Securement Device + Tegaderm I.V. Advanced Securement Dressing, 3M Health Care (HSA 600:41/01-031/16/01_35)
Local Contact: 3M Technologies (S) Pte Ltd
Contact no./Email: 64508846
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HSA 6004101-031-16-01_35 FSN84 KB
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29 Jun 2016
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ADVIA Chemistry Theophylline_2 Reagent, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/16/30_57)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: 64907374
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HSA 6004101-022-16-30_57 FSN122 KB
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29 Jun 2016
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Triathlon Modular Handle, Howmedica Osteonics Corp aka Stryker Orthopedics (HSA 600:41/01-014/16/08_33)
Local Contact: Stryker Singapore Pte Ltd
Contact no./Email: ASEAN.PMS@stryker.com
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HSA 6004101-014-16-08_33 FSN87 KB
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29 Jun 2016
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Synovis Vascu-Guard Peripheral Vascular Patch, Synovis Surgical Innovations (HSA 600:41/01-001/16/04_45)
Local Contact: Baxter Healthcare(Asia)Pte Ltd
Contact no./Email: 68262616
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HSA 6004101-001-16-04_45 FSN259 KB
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28 Jun 2016
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AIRVO 2 and myAIRVO 2, Fisher & Paykel Healthcare Limited (HSA 600:41/01-263/16/05_09)
Local Contact: Emergo Singapore Consulting Pte Ltd
Contact no./Email: 68325625
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HSA 6004101-263-16-05_09 FSN46 KB
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28 Jun 2016
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Allura Xper R8.2, UNIQ R1.0 X-ray Systems, Philips Medical Systems Nederland BV (HSA 600:41/01-026/16/25_18)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 18007445477
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HSA 6004101-026-16-25_18 FSN286 KB
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28 Jun 2016
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API 3200MD LC/MS/MS system, 3200MD Qtrap LC/MS/MS system, Triple Quad 4500MD LC/MS/MS system and Qtrap LC/MS/MS system, AB SCIEX Pte Ltd (HSA 600:41/01-255/16/03_38)
Local Contact: AB SCIEX Pte Ltd
Contact no./Email: 63043722
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HSA 6004101-255-16-03_38 FSN135 KB
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28 Jun 2016
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Ceramic Hip Prostheses, Smith & Nephew Orthopaedics AG (HSA 600:41/01-073/16/15_25)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-16-15_25 FSN82 KB
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28 Jun 2016
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Nitram DAC MKIII Universal Steriliser, Sirona Dental Systems GmbH (HSA 600:41/01-067/16/01_54)
Local Contact: Fondaco Pte Ltd
Contact no./Email: 63922806
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HSA 6004101-067-16-01_54 FSN396 KB
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28 Jun 2016
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PHIL (PRECIPITATING HYDROPHOBIC INJECTABLE LIQUID) NON-ADHESIVE LIQUID EMBOLIC SYSTEM, MicroVention Europe, S.A.R.L (HSA 600:41/01-057/16/02_19)
Local Contact: Somnotec (S) Pte Ltd
Contact no./Email: 68440002
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HSA 6004101-057-16-02_19 FSN148 KB
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28 Jun 2016
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Femoral Nail A/R Ø 11x280 and T2 SCN Ø9x300, Stryker Trauma GmbH (HSA 600:41/01-014/16/07_17)
Local Contact: Stryker Singapore Pte Ltd
Contact no./Email: ASEAN.PMS@stryker.com
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HSA 6004101-014-16-07_17 FSN68 KB
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27 Jun 2016
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PRO-PICC and PRO-LINE Devices, Medcomp (HSA 600:41/01-278/16/02_48)
Local Contact: SingMed Healthcare Systems
Contact no./Email: 65474916
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HSA 6004101-278-16-02_48 FSN1283 KB
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27 Jun 2016
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Alaris System Infusion PC Unit, CareFusion 303 Inc (HSA 600:41/01-087/16/02_46)
Local Contact: Scanmed Technology (S) Pte Ltd
Contact no./Email: 68723660
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HSA 6004101-087-16-02_46 FSN5661 KB
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27 Jun 2016
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Philips DuraDiagnost X-Ray System, Phillips Healthcare (Suzhou) Co Ltd (HSA 600:41/01-026/16/24_56)
Local Contact: Phllips Electronics (S) Pte Ltd
Contact no./Email: 62068526
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HSA 6004101-026-16-24_56 FSN139 KB
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27 Jun 2016
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Alaris System Infusion PC Unit, CareFusion 303 Inc (HSA 600:41/01-003/16/05_46)
Local Contact: Becton Dickinson Holdings Pte Ltd
Contact no./Email: 64322048
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HSA 6004101-003-16-05_46 FSN5661 KB
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24 Jun 2016
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neoBLUE® LED Phototherapy System, Natus Medical Inc (HSA 600:41/01-113/16/01_54)
Local Contact: Equip Medical Pte Ltd
Contact no./Email: 65623008
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HSA 6004101-113-16-01_54 FSN220 KB
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24 Jun 2016
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XARIO 200 and XARIO 100, Toshiba Medical Systems Corporation (HSA 600:41/01-064/16/03_63)
Local Contact: Toshiba Medical Systems Asia Pte Ltd
Contact no./Email: 62729766
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HSA 6004101-064-16-03_63 FSN225 KB
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24 Jun 2016
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Cortex Screw Ø 2.7 mm, self-tapping, length 18mm, Pure Titanium, Synthes GmbH (HSA 600:41/01-002/16/25_52)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 67504213
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HSA 6004101-002-16-25_52 FSN192 KB
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23 Jun 2016
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BD PhoenixSpec Calibrator Kit, Becton, Dickinson and Company (HSA 600:41/01-003/16/04_23)
Local Contact: Becton Dickinson Holdings Pte Ltd
Contact no./Email: 64322048
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HSA 6004101-003-16-04_23 FSN1617 KB
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22 Jun 2016
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Diapanel, DiaMed GmbH (HSA 600:41/01-027/16/07_20)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 64904262
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HSA 6004101-027-16-07_20 FSN1818 KB
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22 Jun 2016
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V-PRO® 1, V-PRO® 1 Plus, and V-PRO® maX Low Temperature Sterilization Systems, Steris Corporation (HSA 600:41/01-162/16/01_41)
Local Contact: ITS Science & Medical Pte Ltd
Contact no./Email: info@its-sciencemedical.com
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HSA 6004101-162-16-01_41 FSN209 KB
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21 Jun 2016
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SOMATOM Definition Flash, SOMATOM Definition Edge and SOMATOM Definition AS, Siemens Healthcare GmbH (HSA 600:41/01-022/16/28_36)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com
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HSA 6004101-022-16-28_36 FSN156 KB
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21 Jun 2016
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AutoPlex® System, Stryker Instruments (HSA 600:41/01-014/16/04_35)
Local Contact: Stryker Singapore Pte Ltd
Contact no./Email: ASEAN.PMS@stryker.com
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HSA 6004101-014-16-04_35 FSN191 KB
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21 Jun 2016
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Stryker Round Fluted Burs, Stryker Instruments (HSA 600:41/01-014/16/05_49)
Local Contact: Stryker Singapore Pte Ltd
Contact no./Email: ASEAN.PMS@stryker.com
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HSA 6004101-014-16-05_49 FSN108 KB
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21 Jun 2016
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Big Bore Oncology, Big Bore Radiology, Philips Medical Systems Inc (HSA 600:41/01-026/16/23_40)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 18007445477
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HSA 6004101-026-16-23_40 FSN71 KB
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21 Jun 2016
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Monolisa HCV Ag-Ab ULTRA V2, DiaMed GmbH (HSA 600:41/01-027/16/06_60)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 64904262
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HSA 6004101-027_16_06_60 FSN168 KB
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21 Jun 2016
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Access Free T3 Reagent Kit, Beckman Coulter (HSA 600:41/01-052/16/09_59)
Local Contact: Beckman Coulter Singapore PteLtd
Contact no./Email: 63407126
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HSA 6004101-052-16-09_59 FSN37 KB
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21 Jun 2016
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AllSet+ Gold SSP, One Lambda Inc (HSA 600:41/01-220/16/01_61)
Local Contact: Life Technologies Holding
Contact no./Email: 63629643
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HSA 6004101-220-16-01_61 FSN63 KB
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21 Jun 2016
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Mandible Distractor, Monoaxial and Proximal Foot Plate, Synthes GmbH (HSA 600:41/01-002/16/24_44)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 68276135
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HSA 6004101-002-16-24_44 FSN78 KB
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20 Jun 2016
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Activa® PC, Activa® SC, Activa® RC and Activa® PC+S Devices, Medtronic Inc (HSA 600:41/01-009/16/08_33)
Local Contact: Medtronic International Limited
Contact no./Email: 64365000
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HSA 6004101-009-16-08_33 FSN151 KB
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20 Jun 2016
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Deep Brain Stimulation Therapy, Medtronic Inc (HSA 600:41/01-009/16/09_37)
Local Contact: Medtronic International Limited
Contact no./Email: 64365000
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HSA 6004101-009-16-09_37 FSN108 KB
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17 Jun 2016
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Stryker Neurovascular Target Detachable Coils, Stryker Neurovascular (HSA 600:41/01-014/16/03_45)
Local Contact: Stryker Singapore Pte Ltd
Contact no./Email: iris.lim@stryker.com
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HSA 6004101-014-16-03_45 FSN254 KB
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15 Jun 2016
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Fluorocell PLT, Sysmex Corporation (HSA 600:41/01-032/16/05_57)
Local Contact: Sysmex Asia Pacific Pte Ltd
Contact no./Email: 6221 3629 / RA@sysmex-ap.com
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HSA 6004101-032-16-05_57 FSN1791 KB
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15 Jun 2016
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Point 4, Kerr Corporation (HSA 600:41/01-168/16/02_19)
Local Contact: KaVo Dental Supply
Contact no./Email: 62961790
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HSA 6004101-168-16-02_19 FSN153 KB
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14 Jun 2016
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MyCareLink Patient Monitor, Medtronic Inc. (HSA 600:41/01-009/16/07_25)
Local Contact: Medtronic International Ltd.
Contact no./Email: Sherry.ann.panes@medtronic.com
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HSA 6004101-009-16-07_25 FSN201 KB
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13 Jun 2016
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Babytherm 8004/8010 open care units, Dragerwerk AG & Co. KGaA (HSA 600:41/01-063/16/03_17)
Local Contact: Draeger Medical SEA Pte Ltd
Contact no./Email: ryan.yeo@draeger.com
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HSA 6004101-063-16-03_17 FSN8072 KB
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13 Jun 2016
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DISCOVERY MR750W 3.0T MRI SYSTEM, GE Medical Systems LLC (HSA 600:41/01-010/16/10_18)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 62777668
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HSA 6004101-010-16-10_18 FSN66 KB
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10 Jun 2016
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COBAS B 123 SENSOR CARTRIDGE BG/ISE/GLU/LAC, Roche Diagnostics GmbH (HSA 600:41/01-016/16/11_38)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com
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HSA 6004101-016-16-11_38 FSN739 KB
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09 Jun 2016
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Dornier Medilas H Holmium Laser System,Dornier Medilas H30 (Medilas H Solvo) holmium: YAG pulsed laser system, Dornier MedTech GmbH (HSA 600:41/01-161/16/01_08)
Local Contact: Dornier MedTech Asia Pte Ltd
Contact no./Email: 65726068
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HSA 6004101-161-16-01_08 FSN3850 KB
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09 Jun 2016
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Dornier Medilas HRM (Medilas H UroPulse) holmium:YAG pulsed laser system, Dornier MedTech GmbH (HSA 600:41/01-161/16/02_08)
Local Contact: Dornier MedTech Asia Pte Ltd
Contact no./Email: 65726068
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HSA 6004101-161-16-02_08 FSN204 KB
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08 Jun 2016
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Multiplate® Analyzer, Roche Diagnostics GmbH (HSA 600:41/01-016/16/10_24)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com
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HSA 6004101-016-16-10_24 FSN83 KB
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08 Jun 2016
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Dimension® clinical chemistry system,Dimension® Creatinine (CRE2) Flex® reagent cartridge, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/16/27_34)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com
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HSA 6004101-022-16-27_34 FSN97 KB
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08 Jun 2016
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Zimmer Natural Nail® Cephalomedullary Nails (ZNN CMN Nails), Zimmer GmbH (HSA 600:41/01-008/16/07_09)
Local Contact: Zimmer Pte Ltd
Contact no./Email: 68547081
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HSA 6004101-008-16-07_09 FSN292 KB
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07 Jun 2016
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Quantia Digitoxin Reagent, BioKit S.A. (HSA 600:41/01-005/16/07_23)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact no./Email: 68859103
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HSA 6004101-005-16-07_23 FSN875 KB
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06 Jun 2016
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Alere TESTPACK + Plus STREP A with OBC, Alere Medical Co., Ltd. (HSA 600:41/01-111/16/02_22)
Local Contact: Unison Collaborative Pte Ltd
Contact no./Email: info@unicoll.com.sg
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HSA 6004101-111-16-02_22 FSN49 KB
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03 Jun 2016
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Resolute Integrity Zotarolimus-Eluting Coronary Stent System, Medtronic Inc. (HSA 600:41/01-009/16/06_46)
Local Contact: Medtronic International Limited
Contact no./Email: boon.yee.ng@medtronic.com
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HSA 6004101-009-16-06_46 FSN53 KB
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03 Jun 2016
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PINNACLE® DESTINATION® Guiding Sheath, Terumo Medical Corporation (HSA 600:41/01-028/16/04_56)
Local Contact: Terumo Singapore Pte Ltd
Contact no./Email: 62913603
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HSA 6004101-028-16-04_56 FSN454 KB
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02 Jun 2016
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Philips Sonalleve MR-HIFU system, Philips Oy (HSA 600:41/01-026/16/21_54)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477
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HSA 6004101-026-16-21_54 FSN33 KB
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02 Jun 2016
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ALT OSR6X07, Glucose-Stat OSR6X40, Beckman Coulter Inc. (HSA 600:41/01-052/16/08_60)
Local Contact: Beckman Coulter Singapore Pte Ltd
Contact no./Email: 63407126
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HSA 6004101-052-16-08_60 FSN110 KB
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01 Jun 2016
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LEGION HINGE KNEE FEMORAL ASSEMBLY, Smith & Nephew Inc (HSA 600:41/01-073/16/14_52)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: Singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-16-14_52 FSN109 KB
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01 Jun 2016
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Alaris™ System PC unit model 8015 withsoftware versions 9.17 and 9.19, CareFusion 303 Inc (HSA 600:41/01-003/16/03_63)
Local Contact: Becton Dickinson Holdings Pte. Ltd.
Contact no./Email: 64322048
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HSA 6004101-003-16-03_63 FSN1342 KB
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16 Dec 2015
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3.0T 6ch Flex Coil (M0050SS), GE Medical Systems LLC (HSA 600:41/01-010/15/22_36)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 62777668
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HSA 6004101-010-15-22_36 FSN54 KB
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