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Date of Notification
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Title
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FSN
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31 May 2017
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Boston Scientific ILab Ultrasound Imaging System (FFR Link), Boston Scientific Corporation(HSA 600:41/01-007/17/03_48)
Local Contact: BOSTON SCIENTIFIC ASIA PACIFIC PTE. LTD.
Contact no./Email: 6418 8888 / Singapore_FSCA_Query@bsci.com
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HSA 6004101-007-17-03_48 FSN_Redacted75 KB
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31 May 2017
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Boston Scientific Zurpaz™ Steerable Sheath Set, Boston Scientific Corporation(HSA 600:41/01-007/17/04_44)
Local Contact: BOSTON SCIENTIFIC ASIA PACIFIC PTE. LTD.
Contact no./Email: 6418 8888 / Singapore_FSCA_Query@bsci.com
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HSA 6004101-007-17-04_44 FSN32 KB
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30 May 2017
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MiniMed 640G Insulin Pump, Medtronic MiniMed (HSA 600:41/01-009/17/09_49)
Local Contact: Medtronic International Limited
Contact no./Email: 6436 5000
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HSA 6004101-009-17-09_49 FSN_Redacted878 KB
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30 May 2017
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Exactech LPI Fit Tibial Tamp Head, Exactech Inc (HSA 600:41/01-257/17/01_51)
Local Contact: Exactech Pte Ltd
Contact no./Email: 6273 0091
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HSA 6004101-257-17-01_51 FSN_Redacted96 KB
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30 May 2017
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Siemens ACUSON SC2000 ultrasound system, syngo SC2000 Workplace, ACUSON X700 ultrasound system, ACUSON P500 ultrasound system, and ACUSON P300 ultrasound system, Siemens Medical Solutions USA, Inc (HSA 600:41/01-022/17/17_36)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-17-17_36 FSN171 KB
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30 May 2017
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Philips Dura Diagnost X-Ray system, Philips Healthcare Suzhou Co. Ltd (HSA 600:41/01-026/17/10_64)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477
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HSA 6004101-026-17-10_64 FSN_Redacted105 KB
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29 May 2017
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Radifocus IntroducerⅡ, Radifocus IntroducerⅡ M coat and Glidesheath Slender, TERUMO CORPORATION (HSA 600:41/01-028/17/01_35)
Local Contact: TERUMO SINGAPORE PTE LTD
Contact no./Email: 6291 3603
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HSA 6004101-028-17-01_35_FSN1050 KB
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29 May 2017
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BD Insulin Syringes with the BD Ultra-FineTM needle ½ mL 12.7mm 30G, Becton, Dickinson and Company (HSA 600:41/01-003/17/09_43)
Local Contact: Becton Dickinson Holdings Pte. Ltd. (BD)
Contact no./Email: 6432 2048
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HSA 6004101-003-17-09_43 FSN_Redacted153 KB
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27 May 2017
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Stryker System G® handpieces, Stryker Instruments (HSA 600:41/01-014/17/03_45)
Local Contact:Stryker Singapore Pte Ltd
Contact no./Email: ASEAN.PMS@stryker.com
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HSA 6004101-014-17-03_45 FSN_Redacted160 KB
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26 May 2017
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Trypticase™ Soy Agar with 5% Sheep Blood, Becton, Dickinson and Company (HSA 600:41/01-003/17/08_67)
Local Contact: Becton Dickinson Holdings Pte Ltd (BD)
Contact no./Email: 6432 2048
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HSA 6004101-003-17-08_67 FSN_Redacted1125 KB
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25 May 2017
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LX3 Microscope Floor Stand, Alcon Laboratories Inc (HSA 600:41/01-135/17/01_35)
Local Contact: Alcon Pte Ltd
Contact no./Email: 6722 6010
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HSA 6004101-135-17-01_35 FSN212 KB
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25 May 2017
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Cementless Oxford Partial Knee Unicompartmental Knee Replacement System, Biomet UK Ltd (HSA 600:41/01-008/17/05_19)
Local Contact: Zimmer Pte Ltd
Contact no./Email: 6854 7250
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HSA 6004101-008-17-05_19 FSN_Redacted238 KB
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24 May 2017
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bioMerieux VITEK 2 Antimicrobial Automated Susceptibility Test, BioMerieux Inc. (HSA 600:41/01-146/17/07_67)
Local Contact: BioMerieux Singapore Pte Ltd
Contact no./Email: 6801 6700
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HSA 6004101-146-17-07_67 FSN133 KB
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23 May 2018
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Elekta Neuromag Triux, Elekta Oy (HSA 600:41/01-101/17/01_37)
Local Contact: Elekta Pte Ltd
Contact no./Email: 6221 2322 / elekta_global_pms@elekta.com
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HSA 6004101-010-17-01_37 FSN324 KB
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23 May 2017
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Model 53912 External Pulse Generator (EPG) Extension Cable, Reusable Model 53912A EPG Extension Cable, packaged with Model 5391 EPG, Medtronic Inc (HSA 600:41/01-009/17/08_18)
Local Contact: Medtronic International Limited
Contact no./Email: 6436 5077
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HSA 6004101-009-17-08_18 FSN_Redacted38 KB
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19 May 2017
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Thoratec HeartMate III LVAS Implant kit ,Thoratec HeartMate III Sealed Outflow Graft with Bend Relief, Thoratec Corporation (HSA 600:41/01-070/17/10_64)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6477 6101 / regulatory@transmedicgroup.com
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HSA 6004101-070-17-10_64 FSN_Redacted1125 KB
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19 May 2017
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Access Total T3, Access Thyroglobulin, Access Free T4, Access GI Monitor, Beckman Coulter Inc (HSA 600:41/01-052/17/06_61)
Local Contact: Beckman Coulter Singapore Pte Ltd
Contact no./Email: 6340 7126
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HSA 6004101-052-17-06_61 FSN_Redacted77 KB
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19 May 2017
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N Protein Standard SL and N/T Protein Controls SL, Siemens Healthcare Diagnostics Products GmbH (HSA 600:41/01-022/17/16_65)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-17-16_65 FSN18 KB
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18 May 2017
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DRX Revolution Mobile X-Ray System, Carestream Health Inc. (HSA 600:41/01-187/17/02_46)
Local Contact: Carestream Health Singapore Pte Ltd
Contact no./Email:6501 5000
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HSA 6004101-187-17-02_46 FSN79 KB
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18 May 2017
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Aplio 300, Aplio 400, Aplio 1800 Ultrasound, Toshiba Medical Systems Corporation (HSA 600:41/01-064/17/02_62)
Local Contact: Toshiba Medical Systems Asia Pte Ltd
Contact no./Email: 6272 9766 / fsca@toshiba-tma.com.sg
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HSA 6004101-064-17-02_62 FSN_Redacted5461 KB
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18 May 2017
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Trima Accel® AUTOMATED BLOOD COLLECTION SYSTEM, TerumoBCT (HSA 600:41/01-155/17/01_36)
Local Contact: Terumo BCT Asia Pte Ltd
Contact no./Email: 6773 9051 / apac.communications@terumobct.com
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HSA 6004101-155-17-01_36 FSN_Redacted170 KB
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17 May 2017
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SPECTRA OPTIA® APHERESIS SYSTEM, Terumo BCT Inc (HSA 600:41/01-155/17/02_52)
Local Contact: Terumo BCT Asia Pte Ltd
Contact no./Email: 6773 9051 / apac.communications@terumobct.com
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HSA 6004101-155-17-02_52 FSN217 KB
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17 May 2017
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Pedicle Access Kit (PAK) Needles, Medtronic Sofamor Danek USA, Inc. (HSA 600:41/01-009/17/07_62)
Local Contact: Medtronic International Limited
Contact no./Email: 6436 6932
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HSA 6004101-009-17-07_62 FSN54 KB
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17 May 2017
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COBAS P512 PRE-ANALYTICAL SYSTEM/COBAS P612 PRE-ANALYTICAL SYSTEM, Roche Diagnostics GmbH (HSA 600:41/01-016/17/11_65)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com
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HSA 6004101-016-17-11_65 FSN357 KB
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17 May 2017
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Cobas MPX test & DPX test, Roche Diagnostics GmbH (HSA 600:41/01-016/17/10_34)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com
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HSA 6004101-016-17-10_34 FSN432 KB
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15 May 2017
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Shimadzu Radspeed X-ray system; CH-200 / CH-200M Ceiling Tube Support, Shimadzu Corporation (HSA 600:41/01-281/17/01_51)
Local Contact: Shimadzu (Asia Pacific) Pte Ltd
Contact no./Email: 67786280
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HSA 6004101-281-17-01_51 FSN_Redacted4423 KB
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15 May 2017
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Cobalt Chrome 12/14 Taper Femoral Head 28mm +4, Smith & Nephew Inc. (HSA 600:41/01-073/17/08_37)
Local Contact:Smith & Nephew Pte Limited
Contact no./Email: singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-17-08_37 FSN124 KB
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14 May 2017
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Dynabeads™ HLA Class II, Thermo Fisher Scientific Baltics UAB (HSA 600:41/01-033/17/02_60)
Local Contact: Biomed Diagnostics Pte Ltd
Contact no./Email: 6298 4347 / biomed.regulatory@biomed-global.com
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HSA 6004101-033-17-02_60 FSN291 KB
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12 May 2017
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Smith & Nephew Birmingham Hip Resurfacing Acetabular Cup, Smith & Nephew Orthopaedics (HSA 600:41/01-073/17/09_25)
Local Contact: Smith & Nephew Pte Limited
Contact no./Email: Singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-17-09_25 FSN291 KB
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12 May 2017
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RAPIDLab® 348 / RAPIDLab® 348EX Gas Cartridge Pack, Siemens Healthcare Diagnostics, Inc. (HSA 600:41/01-022/17/15_59)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email:ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-17-15_59 FSN13 KB
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12 May 2017
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VueOptic Visualization Source; Flexor Vue Deflecting Endoscopic System, Cook Incorporated (HSA 600:41/01-013/17/04_52)
Local Contact: Cook South East Asia Pte Ltd
Contact no./Email: 6812 7400 / sng-regulatoryaffairs@cookmedical.com
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HSA 6004101-013-17-04_52 FSN_Redacted2296 KB
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12 May 2017
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VITROS Immunodiagnostic Products NT-proBNP Reagent Pack, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/17/07_31)
Local Contact: Ortho-Clinical Diagnostics Singapore Pte Ltd
Contact no./Email: 6486 1151
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HSA 6004101-303-17-07_31 FSN_Redacted5447 KB
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12 May 2017
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CareFusion Alaris Syringe Pumps, CareFusion Switzerland 317 Sarl (HSA 600:41/01-003/17/07_50)
Local Contact: Becton Dickinson Holdings Pte Ltd
Contact no./Email: 6432 2048
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HSA 6004101-003-17-07_50 FSN_Redacted138 KB
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09 May 2017
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Covidien Endo Peanut 5mm Device, Covidien llc (HSA 600:41/01-046/17/05_41)
Local Contact: Covidien Private Limited
Contact no./Email: 6439 6974
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HSA 6004101-046-17-05_41 FSN _Redacted2384 KB
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09 May 2017
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Monopolar HF Resection Electrodes, Olympus Winter & Ibe GmbH (HSA 600:41/01-004/17/04_40)
Local Contact: Olympus Singapore Pte Ltd
Contact no./Email: 6833 4214 / mes-ra.osp@olympus-ap.com
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HSA 6004101-004-17-04_40 FSN_Redacted1643 KB
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09 May 2017
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Carestation 620 A1, Carestation 650 A1, Carestation 650c A1, DatexOhmeda, Inc (HSA 600:41/01-010/17/03_36)
Local Contact:GE Healthcare
Contact no./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-17-03_36 FSN_Redacted302 KB
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08 May 2017
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SD Bioline HIV Ag/Ab Combo, Standard Diagnostics, Inc (HSA 600:41/01-111/17/01_58)
Local Contact: Unison Collaborative Pte Ltd
Contact no./Email: 6734 5577 / info@unicoll.com.sg
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HSA 6004101-111-17-01_58 FSN_Redacted2952 KB
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04 May 2017
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POLYSORB™, BIOSYN™, MAXON™ and EndoStitch POLYSORB™ Sutures, Covidien LLc (HSA 600:41/01-046/17/04_35)
Local Contact: Covidien Pte Ltd
Contact no./Email: 6439 6974
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HSA 6004101-046-17-04_35 FSN_Redacted2391 KB
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03 May 2017
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ARCHITECT Free T4 Reagent, ABBOTT GmbH & Co.KG (HSA 600:41/01-005/17/06_34)
Local Contact: ABBOTT Laboratories Singapore Pte Ltd
Contact no./Email: 6885 9103 / FSN_enquiry@abbott.com
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HSA 6004101-005-17-06_34 FSN92 KB
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03 May 2017
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Philips Intellivue Neuromuscular Transmission Patient Cable, Philips Medizin Systeme Boblingen GmbH (HSA 600:41/01-026/17/09_45)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477
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HSA 6004101-026-17-09_45 FSN_Redacted188 KB
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02 May 2017
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Elecsys TSH and Elecsys TSH Elecsys PTH (1-84), Roche Diagnostics GmbH (HSA 600:41/01-016/17/09_60)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com
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HSA 6004101-016-17-09_60 FSN333 KB
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02 May 2017
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LapSac Introducer, Cook Incorporated (HSA 600:41/01-013/17/03_19)
Local Contact: Cook South East Asia Pte Ltd
Contact no./Email: 6812 7400 / SNG-RegulatoryAffairs@cookmedical.com
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HSA 6004101-013-17-03_19 FSN_Redacted207 KB
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02 May 2017
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UniCel® DxH™800 and UniCel® DxH™600 Coulter® Cellular Analysis System, Beckman Coulter, Inc. (HSA 600:41/01-052/17/05_38)
Local Contact: BECKMAN COULTER SINGAPORE PTE. LTD.
Contact no./Email: 6340 7146
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HSA 6004101-052-17-05_38 FSN_Redacted244 KB
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02 May 2017
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cobas Connection Modules, Roche Diagnostics GmbH (HSA 600:41/01-016/17/08_61)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com
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HSA 6004101-016-17-08_61 FSN266 KB
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