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Date of Notification
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Title
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FSN
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28 Feb 2017
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Abbott Cell-Dyn Ruby, Abbott Laboratories (HSA 600:41/01-005/17/02_61)
Local Contact: Abbott Laboratories (S) Pte Ltd
Contact no./Email: FSN@enquiry@abbott.com
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HSA 6004101-005-17-02_61 FSN96 KB
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28 Feb 2017
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Philips Brilliance Computed Tomography X-Ray System, Philips Medical Systems Inc (HSA 600:41/01-026/17/02_40)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477
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HSA 6004101-026-17-02_40 FSN_Redacted214 KB
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27 Feb 2017
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BUHLMANN CALEX CAP, Buhlmann Laboratories AG (HSA 600:41/01-137/17/02_65)
Local Contact: All Eights (Singapore) Pte Ltd
Contact no./Email: 6288 6388 / alleight@alleight.com
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HSA 6004101-137_17-02_65 FSN_Redacted3008 KB
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27 Feb 2017
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CT Asphina 409MP, Carl Zeiss Meditec Ag (HSA 600:41/01-136/17/02_49)
Local Contact: Carl Zeiss Pte Ltd
Contact no./Email: info@zeiss.com.sg
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HSA 6004101-136-17-02_49 FSN_Redacted79 KB
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27 Feb 2017
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Gambro Prismaflex Haemodialysis Control Unit, Gambro Lundia AB (HSA 600:41/01-001/17/01_48)
Local Contact: Baxter Healthcare (Asia) Pte. Ltd.
Contact no./Email: 6826 2616
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HSA 6004101-001-17-01_48 FSN_Redacted719 KB
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24 Feb 2017
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Endurant/ Endurant II Bifurcated Stent Graft Systems, Medtronic Inc (HSA 600:41/01-009/17/03_56)
Local Contact: Medtronic International Limited
Contact no./Email: 6436 5000 / dl.sgreg@medtronic.com
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HSA 6004101-009-17-03_56 FSN_Redacted169 KB
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24 Feb 2017
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Boston Scientific Lotus Valve System and Accessories, Boston Scientific Corporation (HSA 600:41/01-007/17/02_46)
Local Contact: Boston Scientific Asia Pacific Pte Ltd
Contact no./Email: Singapore_ FSCA _ Query@bsci.com
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HSA 6004101-007-17-02_46 FSN_Redacted1726 KB
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24 Feb 2017
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Ortho Clinical VITROS Chemistry Products VANC Reagent, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/17/04_58)
Local Contact: Ortho-Clinical Diagnostics Singapore Pte Ltd
Contact no./Email: 6486 1151
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HSA 60041-01-303-17-04_58 FSN_Redacted538 KB
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23 Feb 2017
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CORDIS SMART FLEX VASCULAR STENT SYSTEM, Cordis Cashel (HSA 600:41/01-307/17/01_54)
Local Contact: CARDINAL HEALTH SINGAPORE 225 PTE. LTD.
Fax: 6230 2360
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HSA 6004101-307-17-01_54 FSN_Redacted205 KB
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22 Feb 2017
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Liquichek Diabetes Control, Bio-Rad Laboratories (HSA 600:41/01-027/17/03_61)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 6490 4262
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HSA 6004101-027-17-03_61 FSN94 KB
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22 Feb 2017
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Siemens Artis systems, Siemens Healthcare GmbH (HSA 600:41/01-022/17/11_43)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com
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HSA 6004101-022-17-11_43 FSN_Redacted2806 KB
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22 Feb 2017
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Olympus ENDOEYE HD II Video Telescope, Olympus Winter & Ibe GmbH (HSA 600:41/01-004/17/01_52)
Local Contact:Olympus Singapore Pte Ltd.
Contact no./Email:mes-ra.osp@olympus-ap.com
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HSA 6004101-004-17-01_52 FSN_Redacted544 KB
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21 Feb 2017
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Artis Q Family System, Siemens Healthcare GmbH (HSA 600:41/01-022/17/10_51)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com
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HSA 6004101-022-17-10_51 FSN_Redacted2779 KB
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20 Feb 2017
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ADVIA 560 Hematology System, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/17/09_59)
Local Contact:Siemens Healthcare Pte Ltd
Contact no./Email:ui-handling.sg@siemens.com
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HSA 6004101-022-17-09_59 FSN77 KB
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15 Feb 2017
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Respironics V60 Ventilator, Respironics California Inc. (HSA 600:41/01-026/17/01_19)
Local Contact:Philips Electronics (S) Pte Ltd
Contact no./Email:1800 744 5477
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HSA 6004101-026-17-01_19 FSN242 KB
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15 Feb 2017
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ADVIA Chemistry LDLP and LDPL, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/17/08_59)
Local Contact:Siemens Healthcare Pte Ltd
Contact no./Email:ui-handling.sg@siemens.com
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HSA 6004101-022-17-08_59 FSN87 KB
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15 Feb 2017
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Bio-Rad DiaMed ID-Card LISS/Coombs, DiaMed GmbH (HSA 600:41/01-027/17/02_60)
Local Contact:Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email:6490 4262
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HSA 6004101-027-17-02_60 FSN Part 2_Redacted3255 KB
HSA 6004101-027-17-02_60 FSN_Redacted1236 KB
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14 Feb 2017
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Proteus 235 Proton Therapy System, Ion Beam Applications S.A. (HSA 600:41/01-070/17/03_56)
Local Contact:Transmedic Pte Ltd
Contact no./Email:regulatory@transmedicgroup.com
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HSA 6004101-070-17-03_56 FSN343 KB
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13 Feb 2017
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Hoya Pentax Video Endoscopes System, Hoya Corporation (HSA 600:41/01-106/17/03_50)
Local Contact:Pentax Medical Singapore Pte Ltd
Contact no./Email:vigilanceAsia@pentaxmedical.com
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HSA 6004101-106-17-03_50 FSN_Redacted504 KB
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10 Feb 2017
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VisuMax Laser Keratome, Carl Zeiss Meditec AG (HSA 600:41/01-136/17/01_40)
Local Contact:Carl Zeiss Pte Ltd
Contact no./Email:info@zeiss.com.sg
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HSA 6004101-136-17-01_40 FSN_Redacted907 KB
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10 Feb 2017
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VITROS Chemistry Products PHYT Slides, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/17/03_58)
Local Contact:Ortho-Clinical Diagnostics Singapore Pte Ltd
Contact no./Email:6486 1151
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HSA 6004101-303-17-03_58 FSN_Redacted959 KB
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10 Feb 2017
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OF-BI13 (IRRIGATION TUBE), OE-B5 (INJECTION TUBE), HOYA Corporation (HSA 600:41/01-106/17/02_41)
Local Contact:Pentax Medical Singapore Pte. Ltd.
Contact no./Email:vigilanceAsia@pentaxmedical.com
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HSA 6004101-106-17-02_41 FSN_Redacted384 KB
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10 Feb 2017
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OS4 Surgery System with Endolaser, Oertli Instrumente AG (HSA 600:41/01-110/17/01_45)
Local Contact:Mandarin Opto-Medic Co Pte Ltd
Contact no./Email:6747 8777
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HSA 6004101-110-17-01_45 FSN_Redacted3475 KB
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10 Feb 2017
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Physio-Control LIFEPAK® 15 Defibrillator Monitor System, Physio-Control, Inc (HSA 600:41/01-056/17/04_54)
Local Contact:Gold Lite Pte Ltd
Contact no./Email:6273 0487
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HSA 6004101-056-17-04_54 FSN_Redacted41 KB
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09 Feb 2017
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GENTAMICIN, Roche Diagnostics GmbH (HSA 600:41/01-016/16/08_59)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email:sg.regulatory@roche.com
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HSA 6004101-016-16-08_59 FSN (Updated)215 KB
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09 Feb 2017
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Roche Diagnostics Elecsys® Anti-HAV, Roche Diagnostics GmbH (HSA 600:41/01-016/17/03_57)
Local Contact:Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email:sg.regulatory@roche.com
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HSA 6004101-016-17-03_57 FSN351 KB
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09 Feb 2017
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LifePack 1000 Defibrillator, Physio-Control, Inc (HSA 600:41/01-056/17/03_37)
Local Contact:Gold Lite Pte Ltd
Contact no./Email:6273 0487
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HSA 6004101-056-17-03_37 FSN_Redacted510 KB
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09 Feb 2017
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Medtronic Strata™ II / Strata™ NSC valves (includes Burr Hole and Lumboperitoneal. Excludes StrataMR™), Medtronic Inc (HSA 600:41/01-009/17/02_44)
Local Contact:Medtronic International Limited
Contact no./Email:6439 6932
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HSA 6004101-009-17-02_44 FSN_Redacted1445 KB
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09 Feb 2017
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BD Plastipak™ 100mL Syringe, Catheter tip with Luer slip adaptor, Becton, Dickinson and Company Limited (BD) (HSA 600:41/01-003/17/04_35)
Local Contact: Becton Dickinson Holdings Pte Ltd (BD)
Contact no./Email: 6432 2048
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HSA 6004101-003-17-04_35 FSN Part 1_Redacted63 KB
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09 Feb 2017
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VITROS Chemistry Products Li Slides, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/17/02_38)
Local Contact:Ortho-Clinical Diagnostics Singapore Pte Ltd
Contact no./Email:6486 1151
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HSA 6004101-303-17-02_38 FSN_Redacted1683 KB
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08 Feb 2017
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Artis systems with software versions VC14, VC21, VD10, VD11 and VE10, Siemens Healthcare GmbH (HSA 600:41/01-022/17/07_19)
Local Contact:Siemens Healthcare Pte Ltd
Contact no./Email:ui-handling.sg@siemens.com
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HSA 6004101-022-17-07_19 FSN_Redacted107 KB
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08 Feb 2017
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StarClose SE Vascular Closure System, Abbott Vasscular (HSA 600:41/01-005/17/01_45)
Local Contact:Abbott Laboratories (S) Pte Ltd
Contact no./Email:FSN_Inquiry@abbott.com
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HSA 6004101-005-17-01_45 FSN_Redacted251 KB
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07 Feb 2017
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Roche Diagnostics cobas® 4800 HIV-1 Test & Roche Diagnostics cobas®HBV Test, Roche Diagnostics GmbH (HSA 600:41/01-016/17/02_38)
Local Contact:Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email:sg.regulatory@roche.com
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HSA 6004101-016-17-02_38_FSN322 KB
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06 Feb 2017
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MiniMedTM 640G Insulin Infusion Pump, Medtronic MiniMed (HSA 600:41/01-009/17/01_18)
Local Contact:Medtronic International Limited
Contact no./Email:6436 5000
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HSA 6004101-009-17-01_18 FSN61 KB
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06 Feb 2017
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iChemVELOCITY AUTOMATED URINE CHEMISTRY SYSTEMS, Iris Diagnostics (HSA 600:41/01-052/17/01_34)
Local Contact:Beckman Coulter Singapore Pte Ltd
Contact no./Email:6340 7126
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HSA 6004101-052-17-01_34 FSN_Redacted41 KB
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06 Feb 2017
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ValleyLab Laparoscopic Handset, Four-Function, Covidien llc (HSA 600:41/01-046/17/01_25)
Local Contact:Covidien Pte Ltd
Contact no./Email:6439 6974
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HSA 6004101-046-17-01_25 FSN_Redacted1792 KB
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06 Feb 2017
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ADVIA Centaur XPT System, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/17/06_31)
Local Contact:Siemens Healthcare Pte Ltd
Contact no./Email:ui-handling.sg@siemens.com
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HSA 6004101-022-17-06_31 FSN88 KB
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03 Feb 2017
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Smith & Nephew OSTEORAPTOR™ Suture Anchor, Smith & Nephew Inc. (HSA 600:41/01-073/17/04_17)
Local Contact:Smith & Nephew Pte Ltd
Contact no./Email:singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-17-04_17 FSN59 KB
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02 Feb 2017
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AngioJet Ultra 5000A Console - Foot Switch, Boston Scientific Corporation (HSA 600:41/01-070/17/02_08)
Local Contact:Transmedic Pte Ltd
Contact no./Email:regulatory@transmedicgroup.com
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HSA 6004101-070-17-02_08_FSN22 KB
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02 Feb 2017
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LEGION CRUCIATE RETAINING NARROW Femoral Component SZ 5 RT, Smith & Nephew Inc. (HSA 600:41/01-073/17/03_64)
Local Contact:Smith & Nephew Pte Limited
Contact no./Email:singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-17-03_64 FSN75 KB
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02 Feb 2017
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ETEST® XM256 (Cefuroxime), bioMérieux SA (HSA 600:41/01-146/17/02_23)
Local Contact:Biomerieux Singapore Pte Ltd
Contact no./Email:6734 1701
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HSA 6004101-146-17-02_23 FSN438 KB
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02 Feb 2017
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Brainlab Offset Cup Impactor Universal, BrainLab AG (HSA 600:41/01-047/17/01_09)
Local Contact:BrainLab Limited (Singapore Branch)
Contact no./Email:6734 1701
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HSA 6004101-047-17-01_09 FSN_Redacted143 KB
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01 Feb 2017
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ARTISTE™, ONCOR™ and PRIMUS™ Digital Linear Accelerators, Siemens Healthcare GmbH (HSA 600:41/01-022/17/04_48)
Local Contact:Siemens Healthcare Pte Ltd
Contact no./Email:ui-handling.sg@siemens.com
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HSA 6004101-022-17-04_48 FSN20 KB
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01 Feb 2017
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Xcela PICC With PASV Valve, Navilyst Medical (HSA 600:41/01-057/17/02_56)
Local Contact:Somnotec (s) Pte Ltd
Contact no./Email:6844 0002
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HSA 6004101-057-17-02_56 FSN_Redacted362 KB
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01 Feb 2017
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IMMULITE 2000/IMMULITE 2000 XPi SHBG, Siemens Healthcare Diagnostics Products Limited (HSA 600:41/01-022/17/05_22)
Local Contact:Siemens Healthcare Pte Ltd
Contact no./Email:ui-handling.sg@siemens.com
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HSA 6004101-022-17-05_22 FSN82 KB
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08 Mar 2016
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Analyst MD Software - Component of API 3200MD LC/MS/MS System, 3200MD QTRAP LC/MS/MS System, Triple Quad 4500MD LC/MS/MS System, and QTRAP 4500MD LC/MS/MS System, AB SCIEX Pte Ltd (HSA 600:41/01-255/16/01_24)
Local Contact:AB SCIEX Pte Ltd
Contact no./Email:6304 3722
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HSA 6004101-255-16-01_24 FSN_Redacted682 KB
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04 Mar 2014
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Medtronic SynchroMed® II Programmable Pump System and Accessories, Medtronic Inc (HSA 600:41/01-009/14/04_09)
Local Contact:Medtronic International Limited
Contact no./Email:6436 5000
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HSA 6004101-009-14-04_09 FSN_Redacted1532 KB |
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28 May 2013
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Medtronic Synchromed® II Programmable Drug Infusion System,Medtronic Inc (HSA 600:41/01-009/13/12_02)
Local Contact:Medtronic International Limited
Contact no./Email:6439 6849
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HSA 6004101-009-13-12_02 FSN_Redacted1876 KB |