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Date of Notification
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Title
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FSN
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31 May 2018
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M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv® Technology, Zimmer Inc. (HSA 600:41/01-008/18/09_52)
Local Contact:Zimmer Pte Ltd
Contact no./Email: 6854 7222 / cs.singapore@zimmerbiomet.com
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HSA 6004101-008-18-09_52 FSN_Redacted149 KB
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30 May 2018
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SuperDimension™ Navigation System, Covidien llc (HSA 600:41/01-046/18/07_56)
Local Contact:Covidien Private Limited
Contact no./Email: 6439 6933
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HSA 6004101-046-18-07_56 FSN164 KB
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30 May 2018
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TruClear Sheath 5C, Smith & Nephew Inc (HSA 600:41/01-046/18/06_45)
Local Contact:Covidien Pte Ltd
Contact no./Email: 6439 6933
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HSA 6004101-046-18-06_45 FSN_Redacted453 KB
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30 May 2018
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Hoya Pentax Video Endoscopes System, Hoya Corporation (HSA 600:41/01-106/18/02_54)
Local Contact:Pentax Medical Singapore Pte Ltd
Contact no./Email: 6507 9266 / vigilanceAsia@pentaxmedical.com
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HSA 6004101-106-18-02_54 FSN_Redacted1266 KB
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28 May 2018
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Gentamicin (GENT) Flex® reagent cartridge, Siemens Healthcare Diagnostic Inc (HSA 600:41/01-022/18/13_31)
Local Contact:Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-18-13_31 FSN118 KB
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28 May 2018
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Philips Xper Flex Cardio Patient Monitoring System , INVIVO, a division of Philips Medical Systems (HSA 600:41/01-026/18/17_38)
Local Contact: Philips Electronics Singapore Pte Ltd
Contact no./Email: 1800 744 5477
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HSA 6004101-026-18-17_38 FSN_Redacted83 KB
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25 May 2018
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M320 Microscope System, Leica Microsystems (Schweiz) AG (HSA 600:41/01-126/18/02_52)
Local Contact: Leica Instruments (Singapore) Pte Ltd
Contact no./Email: 6569 1828
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HSA 6004101-126-18-02_52 FSN_Redacted1257 KB
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25 May 2018
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VECTRIS™ TRIAL SCREENING LEAD KITS, VECTRIS™ SURESCAN® LEAD KITS, Medtronic, Inc (HSA 600:41/01-009/18/06_71)
Local Contact: Medtronic International Ltd
Contact no./Email: 6436 5000
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HSA 6004101-009-18-06_71 FSN576 KB
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24 May 2018
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LFITTM Anatomic CoCr V40TM Femoral Heads, Howmedica Ostenics Corp (HSA 600:41/01-014/18/06_43)
Local Contact: Stryker Singapore Pte Ltd
Contact no./Email: ASEAN.PMS@Stryker.com
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HSA 6004101-014-18-06_43 FSN1526 KB
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23 May 2018
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ArjoHuntleigh Akron Tilt Table, ArjoHuntleigh AB (HSA 600:41/01-065/18/02_63)
Local Contact: Arjo South East Asia Pte. Ltd.
Contact no./Email: 6202 7366 / singapore@arjo.com
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HSA 6004101-065-18-02_63 FSN_Redacted119 KB
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23 May 2018
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PENTAX Duodenoscope ED-3490TK, Hoya Corporation (HSA 600:41/01-106/18/01_68)
Local Contact: Pentax Medical Singapore Pte Ltd
Contact no./Email: 6507 9266 / vigilanceAsia@pentaxmedical.com
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HSA 6004101-106-18-01_68 FSN107 KB
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23 May 2018
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Drager Fabius GS Premium Anaesthetic Workstation, Drager Fabius MRI, Drager Fabius Anaesthetic System, Dragerwerk AG & Co. KGaA (HSA 600:41/01-063/18/05_46)
Local Contact: Draeger Singapore Pte Ltd
Contact no./Email: 6872 9288 / draeger.sg@draeger.com
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HSA 6004101-063-18-05_46 FSN_Redacted4798 KB
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21 May 2018
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cobas m 511 integrated hematology analyser, Roche Diagnostics GmbH (HSA 600:41/01-016/18/09_59)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email:sg.regulatory@roche.com
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HSA 6004101-016-18-09_59 FSN500 KB
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21 May 2018
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Biomet® Primary Tibial Plate with Locking Bar, Biomet Orthopaedics (HSA 600:41/01-008/18/08_50)
Local Contact: Zimmer Pte Ltd
Contact no./Email: 6854 7111 / cs.singapore@zimmerbiomet.com
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HSA 6004101-008-18-08_50 FSN_Redacted111 KB
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18 May 2018
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Thermo Scientific™ Remel™ Salmonella paratyphi A-H Stained Suspension, Remel Europe Ltd (HSA 600:41/01-178/18/04_58)
Local Contact:Thermo Scientific Microbiology Pte Ltd
Contact no./Email: 6362 9390
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HSA 6004101-178-18-04_58 FSN_Redacted236 KB
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18 May 2018
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Medical Intelligence HexaPOD™ evo RT System, Medical Intelligence Medizintechnik GmbH (HSA 600:41/01-101/18/03_50)
Local Contact:Elekta Pte Ltd
Contact no./Email: 6221 2322 / elekta_global_pms@elekta.com
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HSA 6004101-101-18-03_50 FSN_Redacted164 KB
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17 May 2018
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Xper Flex Cardio Patient Monitoring System, INVIVO, a division of Philips Medical Systems (HSA 600:41/01-026/18/16_37)
Local Contact: Philips Electronics Singapore Pte Ltd
Contact No./Email: 1800 744 5477
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HSA 6004101-026-18-16_37 FSN_Redacted93 KB
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17 May 2018
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Mako RIO System Irrigation Clip, MAKO Surgical Corp. (HSA 600:41/01-070/18/08_51)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6477 6101 / regulatory@transmedicsgroup.com
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HSA 6004101-070-18-08_51 FSN_Redacted195 KB
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17 May 2018
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Arctic Sun 5000 Temperature Management System, Medivance, Inc (HSA 600:41/01-050/18/03_44)
Local Contact: Bard Singapore Pte Ltd
Contact no./Email: 6580 5988 / complaints.singapore.crbard.com
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HSA 6004101-050-18-03_44 FSN_Redacted1488 KB
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16 May 2018
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D-RAD SMART PACK 4 HOLE RIGHT STANDARD PLATE, Smith & Nephew, Inc. (HSA 600:41/01-073/18/12_63)
Local Contact: Smith & Nephew Pte. Ltd.
Contact no./Email: 6270 0552 / singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-18-12_63 FSN174 KB
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15 May 2018
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Ortho Vision Analyser & Ortho Vision Max Analyser, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/18/06_34)
Local Contact:Ortho-Clinical Diagnostics Singapore Pte Ltd
Contact no./Email: 6486 1151
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HSA 6004101-303-18-06_34 FSN_Redacted1893 KB
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15 May 2018
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Symbia T and Symbia Intevo, Siemens Medical Solutions USA, Inc. (HSA 600:41/01-022/18/12_45)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-18-12_45 FSN_Redacted3974 KB
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14 May 2018
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VITROS Chemistry Products PHYT Slides, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/18/05_61)
Local Contact: Ortho-Clinical Diagnostics Singapore Pte Ltd
Contact no./Email: 6486 1151
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HSA 6004101-303-18-05_61 FSN_Redacted1260 KB
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14 May 2018
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Biograph mCT - S/ mCT -X , Biograph mCT Flow, Biograph Horizon, Biograph Truepoint, Siemens Medical Solutions USA, Inc (HSA 600:41/01-022/18/11_66)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-18-11_66 FSN_Redacted179 KB
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14 May 2018
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da Vinci® Xi EndoWrist Stapler Release Kit, Intuitive Surgical, Inc. (HSA 600:41/01-070/18/07_68)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6477 6101 / regulatory@transmedicgroup.com
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HSA 6004101-070-18-07_68 FSN343 KB
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14 May 2018
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Vantage Elan, Canon Medical Systems Corporation (HSA 600:41/01-324/18/01_71)
Local Contact: Canon Medical Asia Systems Pte Ltd
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HSA 6004101-324-18-01_71 FSN_Redacted1349 KB
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11 May 2018
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CLARITI 1 DAY (SOMOFILCON A) 56% ASPHERE SOFT CONTACT LENSES, Coopervision Manufacturing Ltd. (HSA 600:41/01-176/18/01_51)
Local Contact: Coopervision Singapore Pte Ltd
Contact no./Email: 6304 1871 / RAQA_SEA_ANZ@coopervision.com
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HSA 6004101-176-18-01_51 FSN_Redacted24 KB
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11 May 2018
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GENESIS II 13MM TIBIAL PUNCH , Smith & Nephew, Inc. (HSA 600:41/01-073/18/11_43)
Local Contact: Smith & Nephew Pte. Ltd.
Contact no./Email: 6270 0552 / singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-18-11_43 FSN191 KB
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10 May 2018
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HARMONIC ACE®+ Shears with Adaptive Tissue Technology, Ethicon Endo-Surgery, LLC (HSA 600:41/01-002/18/05_64)
Local Contact:Johnson & Johnson Pte Ltd
Contact no./Email: 6918 7386
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HSA 6004101-002-18-05_64 FSN_Redacted469 KB
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10 May 2018
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Liquichek Urine Chemistry Control, Bio-Rad Laboratories, Inc (HSA 600:41/01-027/18/05_23)
Local Contact:Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 6490 4262
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HSA 6004101-027-18-05_23 FSN136 KB
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07 May 2018
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Datascope CARDIOSAVE Intra-Aortic Balloon Pump (IABP), Datascope Corp (HSA 600:41/01-081/18/05_62)
Local Contact:MAQUET SOUTH EAST ASIA PTE. LTD.
Contact no./Email: 6296 1992
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HSA 6004101-081-18-05_62 FSN_Redacted568 KB
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07 May 2018
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SAM XT EXTREMITY TOURNIQUET, SAM Medical (HSA 600:41/01-321/18/01_50)
Local Contact:Novatech Resources Pte Ltd
Contact no./Email: 6229 4600
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HSA 6004101-321-18-01_50 FSN_Redacted113 KB
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07 May 2018
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HeartWare™ Ventricular Assist Device (HVAD)™ System, HeartWare (HSA 600:41/01-263/18/02_46)
Local Contact: Emergo Consulting Pte. Ltd
Contact no./Email:6854 7976 / SEAsiaVigilance@ul.com
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HSA 6004101-263-18-02_46 FSN_Redacted585 KB
HSA 6004101-263-18-02_46 FSN update133 KB
(This FSN is an update)
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07 May 2018
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Thermo Scientific™ Remel™ Agglutinating Sera, Remel Europe Ltd (HSA 600:41/01-178/18/03_49)
Local Contact: Thermo Scientific Microbiology Pte Ltd
Contact no./Email: 6362 9390
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HSA 6004101-178-18-03_49 FSN_Redacted226 KB
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05 May 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 600:41/01-323/18/01_35)
Local Contact: Smitech (Asia) Pte Ltd
Contact no./Email: 6339 5277 / smitech@pacific.net.sg
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HSA 6004101-323-18-01_35 FSN982 KB
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04 May 2018
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GE Healthcare Revolution EVO & Optima CT660, CT670, CT680, CT540 Scanner System, GE Healthcare Japan Corporation (HSA 600:41/01-010/18/09_51)
Local Contact:GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-18-09_51 FSN_Redacted587 KB
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04 May 2018
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Prismaflex control units, Gambro Lundia AB (HSA 600:41/01-001/18/02_43)
Local Contact:Baxter Healthcare (Asia) Pte Ltd
Contact no./Email: 6826 2616
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HSA6004101-001-18-02_43 FSN_Redacted3098 KB
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04 May 2018
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Cascadia Interbody System, K2M Inc (HSA 600:41/01-322/18/01_62)
Local Contact: Asia Actual Pte Ltd
Contact no./Email: 6348 0481
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HSA 6004101-322-18-01_62 FSN_Redacted549 KB
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03 May 2018
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Elecsys Vitamin D Total II, Roche Diagnostics GmbH (HSA 600:41/01-016/18/08_70)
Local Contact:Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com
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HSA 6004101-016-18-08_70 FSN338 KB
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02 May 2018
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(1) ROCHE DIABETES CARE ACCU-CHEK® AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM AVIVA TEST STRIPS (AVIVA TEST STRIPS); AND (2) ROCHE DIABETES CARE ACCU-CHEK® PERFORMA GLUCOSE MONITORING SYSTEM ACCU-CHEK® PERFORMA TEST STRIPS (PERFORMAN TEST STRIPS); Roche Diabetes Care GmbH (HSA 600:41/01-016/18/07_57)
Local Contact: Roche Diabetes Care Asia Pacific Pte. Ltd.
Contact no./Email: 6272 9200 / sg.accu-chek@roche.com
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HSA 6004101-016-18-07_57 FSN_Customer_Redacted201 KB
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02 May 2018
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ACCU-CHEK INFORM II STRIPS, Roche Diabetes Care GmbH (HSA 600:41/01-016/18/06_69)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email:sg.regulatory@roche.com
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HSA6004101-016-18-06_69 FSN551 KB
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02 May 2018
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iGuide software 2.2, Medical Intelligence Medizintechnik GmbH (HSA 600:41/01-101/18/01_37)
Local Contact: Elekta Pte Ltd
Contact no./Email: 6221 2322 / elekta_global_pms@elekta.com
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HSA 6004101-101-18-01_37 FSN250 KB
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02 May 2018
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iGuide 2.2, Medical Intelligence Medizintechnik GmbH (HSA 600:41/01-101/18/02_37)
Local Contact: Elekta Pte Ltd
Contact no./Email: 6221 2322 /elekta_global_pms@elekta.com
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HSA 6004101-101-18-02_37 FSN34 KB
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17 Jan 2018
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Medfusion® Syringe Pump Model Series 3500 and 4000, Smiths Medical ASD, Inc (HSA 600:41/01-017/18/01_25)
Local Contact: IDS Medical Systems (S) Pte Ltd
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HSA 6004101-017-18-01_25 FSN_Redacted189 KB
This updated FSN replaces the original FSN published in January 2018
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05 Oct 2017
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Bio-Rad DiaMed ID-Card LISS/Coombs, DiaMed GmbH (HSA 600:41/01-027/17/08_58)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 6827 6135
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HSA 6004101-027-17-08_58 FSN_updated20180413_Redacted3453 KB
This updated FSN replaces the original FSN published in October 2017
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