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Date of Notification
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Title
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FSN
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30 Apr 2018
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MagNA Pure 24 System, Roche Diagnostics GmbH (HSA 600:41/01-016/18/05_67)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com
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HSA 6004101-016-18-05_67 FSN377 KB
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30 Apr 2018
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Intuitive Surgical’s da Vinci Xi Stapler 45 Blue and Green Reloads, Intuitive Surgical, Inc (HSA 600:41/01-070/18/06_35)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6477 6101 / regulatory@transmedicgroup.com
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HSA 6004101-070-18-06_35 FSN386 KB
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30 Apr 2018
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Aurinio L 110, L 120, L 150 and L 160, Aurinio OR lights series, Trilux Medical GmbH & Co. KG (HSA 600:41/01-099/18/01_45)
Local Contact: Leedon Technology Pte Ltd
Contact no./Email: 6284 8382/ leedon28@singnet.com.sg
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HSA 6004101-099-18-01_45 FSN_Redacted3054 KB
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28 Apr 2018
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T2 Femur and Tibia Nailing System, Stryker Trauma GmbH (HSA 600:41/01-014/18/05_66)
Local Contact: Stryker Singapore Pte Ltd
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HSA 6004101-014-18-05_66 FSN_Redacted128 KB
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27 Apr 2018
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Artis Zee Family System, Siemens Healthcare GmbH (HSA 600:41/01-022/18/10_45)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-18-10_45 FSN_Redacted1100 KB
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27 Apr 2018
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Covidien ENDO GIA™ UNIVERSAL Stapler and Duet TRS™ Single Use Loading Units with Tissue Reinforcement, Covidien Endo GIA™ Ultra Universal Stapler and Endo GIA™ Reload with Tri-Staple™ Technology, Covidien llc (HSA 600:41/01-046/18/05_18)
Local Contact: Covidien Pte Ltd
Contact no./Email: 6439 6933
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HSA 6004101-046-18-05_18 FSN_Redacted4214 KB
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27 Apr 2018
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Urisys 1100 , Roche Diagnostics GmbH (HSA 600:41/01-016/18/04_61)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com
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HSA 6004101-016-18-04_61 FSN118 KB
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26 Apr 2018
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Elements Obturation Unit with Buchanan Heat Pluggers, SybronEndo (HSA 600:41/01-168/18/01_71)
Local Contact: KaVo Dental Asia Pacific Pte Ltd
Contact no./Email: 6296 1790
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HSA 6004101-168-18-01_71 FSN_Redacted306 KB
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26 Apr 2018
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CLARUS 500, Carl Zeiss Meditec Inc. (HSA 600:41/01-136/18/01_64)
Local Contact: Carl Zeiss Pte. Ltd.
Contact no./Email: 6741 9600 / info@zeiss.com.sg
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HSA 6004101-136-18-01_64 FSN112 KB
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25 Apr 2018
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Acid Concentrate for Bicarbonate Haemodialysis, Fresenius Medical Care Production Sdn Bhd (HSA 600:41/01-062/18/01_68)
Local Contact: Fresenius Medical Care Singapore Pte Ltd
Contact no./Email: 6837 3113
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HSA 6004101-062-18-01_68 FSN_Redacted1282 KB
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25 Apr 2018
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Bard Seeker Crossing Support Catheter, Bard Peripheral Vascular, Inc (HSA 600:41/01-050/18/02_18)
Local Contact: Bard Singapore Pte Ltd
Contact no./Email: 6580 5988 / complaints.singapore@crbard.com
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HSA 6004101-050-18-02_18 FSN_Redacted382 KB
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25 Apr 2018
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ThermoScientific Oxoid OX1 Oxacillin, Oxoid Limited (HSA 600:41/01-178/18/02_34)
Local Contact: Thermo Scientific Microbiology Pte Ltd
Contact no./Email: 6362 9390
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HSA 6004101-178-18-02_34 FSN_Redacted116 KB
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24 Apr 2018
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Alinity I HBsAg Calibrator, Abbott Ireland Diagnostics Division (HSA 600:41/01-005/18/05_59)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact no./Email: 6914 8000 / FSN@enquiry@abbott.com
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HSA 6004101-005-18-05_59 FSN98 KB
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24 Apr 2018
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ASKINA CALGITROL PASTE 15 G, B. Braun Hospicare Ltd (HSA 600:41/01-012/18/02_56)
Local Contact: B. Braun Singapore Pte Ltd
Contact no./Email: 6213 0933 / press.sg@bbraun.com
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HSA 6004101-012-18-02_56 FSN52 KB
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24 Apr 2018
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BD Vacutainer® EDTA Blood Collection Tubes, Becton, Dickinson and Company (BD) (HSA 600:41/01-003/18/05_58)
Local Contact: Becton Dickinson Holdings Pte Ltd
Contact no./Email: 6690 8423
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HSA 6004101-003-18-05_58 FSN_Redacted208 KB
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24 Apr 2018
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CPFA Coupled Plasma Filtration Adsorption™, Covidien llc (HSA 600:41/01-046/18/04_46)
Local Contact: Covidien Pte Ltd
Contact no./Email: Tel: 64396974
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HSA 6004101-046-18-04_46 FSN_Redacted696 KB
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20 Apr 2018
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5mm ENDOPATH® XCEL™ Trocars with Optiview Technology, Ethicon Endo-Surgery, LLC (HSA 600:41/01-002/18/04_63)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 6918 8304
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HSA 6004101-002-18-04_63 FSN_Redacted630 KB
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20 Apr 2018
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AdvanceTM Low Profile PTA Balloon Dilatation Catheter, Cook Incorporated (HSA 600:41/01-013/18/04_51)
Local Contact: Cook South East Asia Pte Ltd
Contact no./Email: 6812 7400 / SNG-RegulatoryAffairs@cookmedical.com
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HSA 6004101-013-18-04_51 FSN_Redacted127 KB
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20 Apr 2018
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CHISEL MICRO CURVED VULCAN INTEGRATED; CHISEL MICRO VULCAN ANGLED INTEGRATED, Smith & Nephew, Inc. (HSA 600:41/01-073/18/09_63)
Local Contact: Smith & Nephew Pte Limited
Contact no./Email: singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-18-09_63 FSN191 KB
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20 Apr 2018
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Smith & Nephew TAYLOR SPATIAL FRAME External Fixator, Smith & Nephew, Inc. (HSA 600:41/01-073/18/10_50)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-18-10_50 FSN174 KB
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20 Apr 2018
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SOMA TOM go.Up and SOMA TOM go.Now, Siemens Shanghai Medical Equipment Ltd (HSA 600:41/01-022/18/09_46)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-18-09_46 FSN_Redacted2486 KB
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19 Apr 2018
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1. Merlin PCS 3650 Software Upgrade Kit
2. Merlin@home Transmitter Software
3. High Voltage Device ICD and CRT-D (model name Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™, Unify Quadra™, Promote Quadra™ and Ellipse™)
St. Jude Medical, Cardiac Rhythm Management Division (HSA 600:41/01-025/18/01_51)
Local Contact: St Jude Medical (Singapore) Pte Ltd
Contact no./Email: 6643 2800
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HSA 6004101-025-18-01_51 FSN_Redacted548 KB
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19 Apr 2018
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Cardiovit AT-102 Plus, Schiller AG (HSA 600:41/01-056/18/02_50)
Local Contact: Gold Lite Pte Ltd
Contact no./Email: 6273 0487
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HSA 6004101-056-18-02_50 FSN_Redacted469 KB
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18 Apr 2018
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MyLab Twice, Esaote (HSA 600:41/01-288/18/01_64)
Local Contact: Medical Plus Pte Ltd
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HSA 6004101-288-18-01_64 FSN_Redacted107 KB
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17 Apr 2018
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Portex Thoracic Catheter and Connecting Tube, Smiths Medical International, Ltd. (HSA 600:41/01-017/18/02_40)
Local Contact: IDS Medical Systems (S) Pte Ltd
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HSA 6004101-017-18-02_40 FSN322 KB
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17 Apr 2018
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TerumoBCT Spectra Optia® Apheresis System, TerumoBCT (HSA 600:41/01-155/18/01_36)
Local Contact: TERUMO BCT ASIA PTE. LTD
Contact no./Email: 67739051 / apac.communications@terumobct.com
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HSA 6004101-155-18-01_36 FSN_Redacted408 KB
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17 Apr 2018
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Peri-Loc 3.5MM Posterolateral Distal Fibula Locking Plate, Smith & Nephew Inc. (HSA 600:41/01-073/18/08_43)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-18-08_43 FSN174 KB
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16 Apr 2018
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Sciatic Nerve Retractors, Synthes GmbH (HSA 600:41/01-002/18/03_49)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 6918 8304
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HSA 6004101-002-18-03_49 FSN_Redacted252 KB
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13 Apr 2018
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Various Arrow Products, Arrow International, Inc (HSA 600:41/01-139/18/01_35)
Local Contact: Teleflex Medical Asia Pte Ltd
Contact no./Email: 6439 3046
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HSA 6004101-139-18-01_35 FSN_Redacted316 KB
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13 Apr 2018
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Bio-Rad DiaMed ID-Card LISS Coombs and Bio-Rad DiaMed ID-Card Anti-IgG, DiaMed GmbH (HSA 600:41/01-027/18/04_58)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 6490 4262
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HSA 60041-01-027-18-04_58 FSN_Redacted3444 KB
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12 Apr 2018
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Connecting Tube – Female to Male Luer Lock, Cook Incorporated (HSA 600:41/01-013/18/03_35)
Local Contact: Cook South East Asia Pte Ltd
Contact no./Email: 6812 7400 / SNG-RegulatoryAffairs@cookmedical.com
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HSA 6004101-013-18-03_35 FSN_Redacted113 KB
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12 Apr 2018
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Ethicon Generator Gen11, Ethicon Endo-Surgery, LLC (HSA 600:41/01-002/18/02_37)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 6918 7781
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HSA 6004101-002-18-02_37 FSN_Redacted531 KB
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12 Apr 2018
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Flexor Tuohy Borst Side-Arm Introducer Shuttle SL, Cook Incorporated (HSA 600:41/01-013/18/02_62)
Local Contact: Cook South East Asia Pte Ltd
Contact no./Email: 6812 7400 / SNG-RegulatoryAffairs@cookmedical.com
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HSA 6004101-013-18-02_62 FSN_Redacted110 KB
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11 Apr 2018
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Gentinge Volista StandOP and TRIOP, Maquet SAS (HSA 600:41/01-081/18/04_45)
Local Contact: Maquet South East Asia Pte Ltd
Contact no./Email: 6296 1992
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HSA 6004101-081-18-04_45 FSN201 KB
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10 Apr 2018
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ARCHITECT Total T4 Calibrators, Abbott Ireland, Diagnostics Division (HSA 600:41/01-005/18/04_38)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact no./Email: 6914 / 8000 / FSN@enquiry@abbott.com
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HSA 6004101-005-18-04_38 FSN109 KB
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10 Apr 2018
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Covidien EEA™ Hemorrhoid and Prolapse Stapler Set with DST Series™ Technology, Covidien llc (HSA 600:41/01-046/18/03_66)
Local Contact: Covidien Pte Ltd
Contact no./Email: 6439 6933
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HSA 6004101-046-18-03_66 FSN_Redacted1397 KB
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10 Apr 2018
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BD Vacutainer Blood Collection Tubes, Becton, Dickinson and Company (BD) (HSA 600:41/01-003/18/04_31)
Local Contact: Becton Dickinson Holdings Pte Ltd
Contact no./Email: 6690 8423
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HSA 6004101-003-18-04_31 FSN_Redacted293 KB
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10 Apr 2018
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DISCOVERY IGS 730/740, INNOVA IGS 620/630/520/530/540 SYSTEMS, Datex-Ohmeda Inc. (HSA 600:41/01-010/18/08_25)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-18-08_25 FSN_Redacted466 KB
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09 Apr 2018
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Pulsar-18, Peripheral self-expanding Nitinol stent system, Biotronik AG (HSA 600:41/01-269/18/01_37)
Local Contact: Biotronik Asia Pacific Pte Ltd
Contact no./Email: 6228 9869
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HSA 6004101-269-18-01_37 FSN86 KB
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09 Apr 2018
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Draeger Jaundice Meter, Model JM-103 & Draeger Jaundice Meter JM-105, Draeger Medical Systems, Inc. (HSA 600:41/01-063/18/04_71)
Local Contact: Draeger Singapore Pte Ltd
Contact no./Email: 6872 9288 / draeger.sg@draeger.com
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HSA 6004101-063-18-04_71 FSN-01_Redacted5350 KB
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06 Apr 2018
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Thoratec HeartMate III™ LVAS Implant Kit, Thoratec Corporation (HSA 600:41/01-070/18/05_68)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6477 6101 / regulatory@transmedicgroup.com
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HSA 6004101-070-18-05_68 FSN_Redacted68 KB
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06 Apr 2018
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LEICA PROVEO 8 OPHTHALMIC MICROSCOPE SYSTEM, Leica Microsystems AG (HSA 600:41/01-126/18/01_64)
Local Contact: Leica Instruments Pte Ltd
Contact no./Email: 6550 5912
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HSA 6004101-126-18-01_64 FSN_Redacted1462 KB
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06 Apr 2018
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ADVIA® Chemistry Systems Urea Nitrogen (UN), Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/18/08_23)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-18-08_23 FSN130 KB
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05 Apr 2018
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Heartware Left Ventricular Assist Device, HeartWare Inc. (HSA 600:41/01-263/18/01_18)
Local Contact: Emergo Consulting Pte Ltd
Contact no./Email: 6832 5625 / SEAvigilance@emergogroup.com
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HSA 6004101-263-18-01_18 FSN_Redacted141 KB
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05 Apr 2018
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Brilliance Big Bore/Ingenuity CT/Ingenuity Core/Ingenuity Core 128, Philips Medical Systems (Cleveland), Inc (HSA 600:41/01-026/18/14_52)
Local Contact: Philips Electronics(s) Pte Ltd
Contact no./Email: 1800 744 5477
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HSA 6004101-026-18-14_52 FSN_Redacted517 KB
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05 Apr 2018
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T2100 Treadmill Microflex drive, GE Medical Systems Information Technologies, Inc. (HSA 600:41/01-010/18/07_62)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-18-07_62 FSN_Redacted420 KB
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05 Apr 2018
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PR4100 Magellan Software, Bio-Rad Laboratories Inc (HSA 600:41/01-027/18/03_70)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 6490 4262
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HSA 6004101-027-18-03_70 FSN93 KB
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04 Apr 2018
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BD Vacutainer Plus Citrate Plasma Tube, Becton Dickinson & Company (HSA 600:41/01-003/18/03_70)
Local Contact: Becton Dickinson Holdings Pte Ltd
Contact no./Email: 6690 8423
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HSA 6004101-003-18-03_70 FSN_Redacted3236 KB
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03 Apr 2018
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Legion CR High Flex XLPE, Smith & Nephew Inc. (HSA 600:41/01-073/18/07_40)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-18-07_40 FSN174 KB
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02 Apr 2018
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Vivid and LOGIQ ultrasound systems, GE Vingmed Ultrasound / GE Medical Systems (HSA 600:41/01-010/18/06_56)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-18-06_56 FSN_Redacted308 KB
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02 Apr 2018
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Apple Medical Hunt Secondary Cannula/ Trocar, CooperSurgical (HSA 600:41/01-057/18/01_46)
Local Contact: Somnotec (S) Pte Ltd
Contact no./Email: 6844 0002 / info@somnotec.net
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HSA 6004101-057-18-01_46 FSN_Redacted3498 KB
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