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Date of Notification
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Title
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FSN
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30 May 2016
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Larynx-Tubus LTS-D/Size 4, Single use, Sterile, VBM Medizintechnik GmbH (HSA 600:41/01-278/16/01_50)
Local Contact: SingMed Healthcare Systems
Contact No.: 97509526
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HSA 6004101-278-16-01_50 FSN101 KB
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30 May 2016
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BrightView X Imaging System, BrightView XCT Imaging System, Philips Medical Systems (Cleveland), Inc (HSA 600:41/01-026/16/20_51)
Local Contact: Philips Electronics (S) Pte Ltd
Contact No.: 62068526
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HSA 6004101-026-16-20_51 FSN110 KB
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30 May 2016
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CareFusion AVEA Ventilator, CareFusion/BD (HSA 600:41/01-056-16/05_41)
Local Contact: Gold Lite Pte Ltd
Contact No.: 62730487
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HSA 6004101-056-16-05_41 FSN1424 KB
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27 May 2016
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PTS Panels® CHOL+HDL+GLU Test Strips, Polymer Technology Systems Inc (HSA 600:41/01-186/16/01_58)
Local Contact: Kingston Medical Supplies Pte Ltd
Contact No.: 67453922
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HSA 6004101-186-16-01_58 FSN341 KB
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26 May 2016
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Adora X-ray Systems, NRT-NORDISK RONTGEN TEKNIK A/S (HSA 600:41/01-238/16/01_40)
Local Contact: QST Technologies Pte Ltd
Contact No.: 62706260
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HSA 6004101-238-16-01_40 FSN2752 KB
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26 May 2016
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ImmunoCAP Specific IgG/IgG4 i1 Control H, Thermofisher Scientific (HSA 600:41/01-033/16/04_38)
Local Contact: Biomed Diagnostics Pte Ltd
Contact No.: 65087663
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HSA 6004101-033-16-04_38 FSN214 KB
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26 May 2016
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SERVO-i and SERVO-s ventilators, Maquet Critical Care AB (HSA 600:41/01-081/16/01_36)
Local Contact: Maquet South East Asia Pte Ltd
Contact No.: 62961992
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HSA 6004101-081-16-01_36 FSN331 KB
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26 May 2016
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Knee and Trauma Implant (Various), Zimmer Biomet (HSA 600:40/01-008/16/06_33)
Local Contact: Zimmer Pte Ltd
Contact No.: 68547081
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HSA 6004101-008-16-06_33 FSN103 KB
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26 May 2016
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Edwards EV1000 Clinical Platform, Edwards Lifesciences LLC (HSA 600:41/01-060/16/02_49)
Local Contact: Edwards Lifesciences (Asia) Pte Ltd
Contact No.: pei_pei_chow@edwards.com
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HSA 6004101-060-16-02_49 FSN883 KB
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26 May 2016
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Flexible Shaft Ø 8.0mm, L 360 mm for Extraction System for Solid Medullary Nails, Synthes GmbH (HSA 600:41/01-002/16/23_44)
Local Contact: Johnson & Johnson Pte Ltd
Contact No.: 68276135
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HSA 6004101-002-16-23_44 FSN70 KB
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25 May 2016
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3.0T 6 Channel Flex Coil for MR750, MR750W and 3.0T HDxT (including HD23), GE Medical Systems LLC (HSA 600:41/01-010/15/22_36)
Local Contact: GE Healthcare Pte Ltd
Contact No.: 62777668
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HSA 6004101-010-15-22_36 FSN359 KB
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25 May 2016
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da Vinci Xi 5 mm-8 mm Universal Cannula Seal, da Vinci Xi 12 mm & Stapler Universal Cannula Seal, Intuitive Surgical Inc (HSA 600:41/01-070/16/15_29)
Local Contact: Transmedic Pte Ltd
Contact No.: 64776101
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HSA 6004101-070-16-15_29 FSN152 KB
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25 May 2016
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Disposable paediatric ventilation circuit VentStar Oxylog3000F (P) 190 for Oxylog 3000 and Oxylog 3000 plus, Dragerwerk AG & Co. KGaA (HSA 600:41/01-063/16/02_17)
Local Contact: Draeger Medical SEA Pte Ltd
Contact No.: 68729306
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HSA 6004101-063-16-02_17 FSN716 KB
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25 May 2016
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TIGR Matrix Surgical Mesh, Novus Scientific AB (HSA 600:41/01-298/16/01_37)
Local Contact: Novus Scientific Pte Ltd
Contact No.: 65497871
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HSA 6004101-298-16-01_37 FSN1450 KB
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25 May 2016
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ETHICON PHYSIOMESH™ Flexible Composite Mesh, Johnson & Johnson International (HSA 600:41/01-002/16/22_35)
Local Contact: Johnson & Johnson Pte Ltd
Contact No.: 68276135
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HSA 6004101-002-16-22_35 FSN220 KB
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24 May 2016
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VITROS® Chemistry Products Ca Slides Generation 29, Ortho Clinical Diagnostics (HSA 600:41/01-002/16/21_20)
Local Contact: Johnson & Johnson Pte Ltd
Contact No.: 68276135
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HSA 6004101-002-16-21_20 FSN128 KB
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24 May 2016
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UniCel DxH 800 & UniCel DxH 600 Coulter Cellular Analysis System, Beckman Coulter Inc (HSA 600:41/01-052/16/07_57)
Local Contact: Beckman Coulter Singapore Pte Ltd
Contact No.: 63407126
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HSA 6004101-052-16-07_57 FSN76 KB
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24 May 2016
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LIFECODES HLA-C eRES SSO Typing Kit, Immucor Inc (HSA 600:41/01-070/16/14_22)
Local Contact: Transmedic Pte Ltd
Contact No.: regulatory@transmedicgroup.com
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HSA 6004101-070-16-14_22 FSN224 KB
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24 May 2016
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Teosyal® Ultimate and Teosyal® PureSense Ultimate, Teoxane SA (HSA 600:41/01-297/16/01_08)
Local Contact: Parvus (S) Pte Ltd
Contact No.: epplussg@epplusgroup.com
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HSA 6004101-297-16-01_08 FSN119 KB
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23 May 2016
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Vancomycin, Roche Diagnostics GmbH (HSA 600:41/01-016/16/09_61)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact No.:sg.regulatory@roche.com
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HSA 6004101-016-16-09_61 FSN90 KB
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23 May 2016
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Bio-Rad Liquichek Cardiac Markers Plus Controls LT & Liquichek Cardiac Markers Plus Control, Bio-Rad Laboratories Diagnostics Group (HSA 600:41/01-027/16/05_60)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact No.: 64904262
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HSA 6004101-027-16-05_60 FSN179 KB
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23 May 2016
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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.: sg.regulatory@roche.com
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HSA 6004101-016-16-08_59 FSN476 KB
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20 May 2016
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Saw Sagittal, Saw Sagittal Refurbished, Saw Sagittal Finger & Saw Sagittal Finger Refurbished, Medtronic Xomed (HSA 600:41/01-009/16/05_09)
Local Contact: Medtronic International Limited
Contact No.: 64365077
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HSA 6004101-009-16-05_09 FSN1705 KB
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19 May 2016
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VITROS Immunodiagnostic Products AFP Reagent Pack & AFP Calibrators, Ortho Clinical Diagnostics (HSA 600:41/01-002/16/20_57)
Local Contact: Johnson & Johnson Pte Ltd
Contact No.: 67504213
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HSA 6004101-002-16-20_57 FSN135 KB
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19 May 2016
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Optima 1.5T MR430s, GE Healthcare (HSA 600:41/01-010/16/09_56)
Local Contact: GE Healthcare Pte Ltd
Contact No.: svc@ge.com
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HSA 6004101-010-16-09_56 FSN281 KB
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18 May 2016
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Siemens Cios Alpha mobile C-arm X-Ray System, Siemens AG (HSA 600:41/01-022/16/25_48)
Local Contact: Siemens Healthcare Pte Ltd
Contact No.: ui-handling.sg@siemens.com
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HSA 6004101-022-16-25_48 FSN84 KB
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18 May 2016
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Oxoid Microbact Haemolysin Reagent MB1249A, Oxoid Limited (HSA 600:41/01-178/16/03_34)
Local Contact: Thermo Scientific Microbiology Pte Ltd
Contact No.: 64999993
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HSA 6004101-178-16-03_34 FSN76 KB
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18 May 2016
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Monaco RTP System, IMPAC Medical Systems Inc (HSA 600:41/01-101/16/02_54)
Local Contact: Elekta Pte Ltd
Contact No.: Elekta_Global_PMS@elekta.com
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HSA 6004101-101-16-02_54 FSN122 KB
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17 May 2016
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ELISIO-19H, Nipro Medical (Hefei) Co. Ltd (HSA 600:41/01-233/16/02_63)
Local Contact: Nipro Asia Pte Ltd
Contact No.: 65882281
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HSA 6004101-233-16-02_63 FSN2809 KB
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17 May 2016
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TRUEresult (GDH-FAD) Blood Glucose Test Strips, Nipro Diagnostics Inc (HSA 600:41/01-233/16/03_31)
Local Contact: Nipro Asia Pte Ltd
Contact No.: 65882281
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HSA 6004101-233-16-03_31 FSN65 KB
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16 May 2016
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cobas b 123 Sensor Cartridge BG/ISE, Roche Diagnostics GmbH (Ref: HSA 600:41/01-016/16/07_23)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact No.: 6272 7500
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HSA 6004101-016-16-07_23 FSN785 KB
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16 May 2016
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Medtronic RestoreSensor Implantable Neurostimulators, Medtronic Inc. (Ref: HSA 600:41/01-009/16/04_51)
Local Contact: Medtronic International Limited
Contact No.: jason.ee@medtronic.com
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HSA 6004101-009-16-04_51 FSN216 KB
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13 May 2016
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COSEAL Surgical Sealant Kit, 2mL, COSEAL Surgical Sealant Kit, 4mL, Baxter Healthcare SA (Ref: HSA 600:41/01-001/16/03_41)
Local Contact: Baxter Healthcare (Asia) Pte Ltd
Contact No.: 68262616
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HSA 6004101-001-16-03_41 FSN464 KB
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12 May 2016
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ORTHO VISION® Max Analyzer for ORTHO BioVue® Cassettes, Ortho Clinical Diagnostics (Ref: HSA 600:41/01-002/16/19_22)
Local Contact: Johnson & Johnson Pte Ltd
Contact No.: 68276135
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HSA 6004101-002-16-19_22 FSN61 KB
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12 May 2016
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Threader Monorail Micro-Dilation Catheters and Threader Over the Wire Micro-Dilatation Catheters, Boston Scientific Corporation (Ref: HSA 600:41/01-007/16/03_40)
Local Contact: Boston Scientific Asia Pacific Pte Ltd
Contact No.: singapore_FSCA_Query@bsci.com
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HSA 6004101-007-16-03_40 FSN1841 KB
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12 May 2016
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Dimension Enzyme II Calibrator, Siemens Healthcare Diagnostics Inc. (Ref: HSA 600:41/01-022/16/24_60)
Local Contact: Siemens Healthcare Pte Ltd
Contact No.: ui-handling.sg@siemens.com
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HSA 6004101-022-16-24_60 FSN85 KB
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12 May 2016
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Cook Catheter with Beacon Tip
FluoroSet® Radiographic Tubal Assessment Set
Transluminal Biliary Biopsy Forceps Set, Cook Incorporated (Ref: HSA 600:41/01-013/16/03_25)
Local Contact: Cook South East Asia Pte Ltd
Contact No.: jennifer.chin@cookmedical.com
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HSA 6004101-013-16-03_25 FSN444 KB
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12 May 2016
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LIFECODES LifeScreen Deluxe (LMX), Immucor, Inc (Ref: HSA 600:41/01-070/16/13_20)
Local Contact: Transmedic Pte Ltd
Contact No.: regulatory@transmedicgroup.com
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HSA 6004101-070-16-13_20 FSN222 KB
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11 May 2016
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STATLOCK IAB Stabilization Device, Datascope Corp (Ref: HSA 600:41/01-017/16/04_37)
Local Contact: IDS Medical Systems (S) Pte Ltd
Contact No.: kennethow@idsmed.com
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HSA 6004101-017-16-04_37 FSN103 KB
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11 May 2016
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Beckman Coulter Digitoxin, Beckman Coulter Inc. (Ref: HSA 600:41/01-052/16/06_58)
Local Contact: Beckman Coulter Singapore Pte Ltd
Contact No.: 63407126
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HSA 6004101-052-16-06_58 FSN85 KB
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11 May 2016
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EliA CCP Positive Control, Thermofisher Scientific (Ref: HSA 600:41/01-033/16/03_59)
Local Contact: Biomed Diagnostics Pte Ltd
Contact No.: teresa.wong@biomed.com.sg
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HSA 6004101-033-16-03_59 FSN287 KB
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11 May 2016
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Optimed Zelos PTA Balloon catheter, Optimed Medizinische Instrumente GmbH (Ref: HSA 600:41/01-045/16/01_33)
Local Contact: Malex Medical Asia (S) Pte Ltd
Contact No.: 62229622
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HSA 6004101-045-16-01_33 FSN4054 KB
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10 May 2016
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Brillance 64, Ingenuity Core,Ingenuity Core 128 , Software version 3.5.4, Philips Medical Systems (Cleveland), Inc (Ref: HSA 600:41/01-026/16/17_29)
Local Contact: Philips Electronics (S) Pte Ltd
Contact No.: 18007445477
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HSA 6004101-026-16-17_29 FSN31 KB
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10 May 2016
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1) Philips Brilliance Computed Tomography X-ray System
2) Philips Ingenuity CT System, Philips Medical Systems (Cleveland), Inc (Ref: HSA 600:41/01-026/16/18_45)
Local Contact: Philips Electronics (S) Pte Ltd
Contact No.: 18007445477
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HSA 6004101-026-16-18_45 FSN_1167 KB
HSA 6004101-026-16-18_45 FSN_2254 KB
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10 May 2016
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INGENUITY CT, INGENUITY CORE, INGENUITY CORE 128, Philips Medical Systems (Cleveland), Inc (Ref: HSA 600:41/01-026/16/16_19)
Local Contact: Philips Electronics (S) Pte Ltd
Contact No.: 18007445477
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HSA 6004101-026-16-16_19 FSN405 KB
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10 May 2016
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Novocastra Liquid Mouse Monoclonal Antibody Calretinin, Leica Biosystems Newcastle Ltd (Ref: HSA 600:41/01-126/16/04_57)
Local Contact: Leica Microsystems (SEA) Pte Ltd
Contact No.: 96631640
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HSA 6004101-126-16-04_57 FSN1675 KB
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10 May 2016
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CADD® ADMINISTRATION SETS WITH FLOW STOP, Smiths Medical ASD, Inc. (Ref: HSA 600:41/01-017/16/03_18)
Local Contact: IDS Medical Systems (S) Pte Ltd
Contact No.: 66907378
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HSA 6004101-017-16-03_18 FSN169 KB
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09 May 2016
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FilmArray Blood Culture Identification (BCID) Panel reagents, BCID kits (RFIT-ASY-0126, RFIT-AST-0127, BioFire Diagnostics, LLC (Ref: HSA 600:41/01-146/16/02_38)
Local Contact: BioMérieux Singapore Pte Ltd
Contact No.: 68016706
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HSA 6004101-146-16-02_38 FSN499 KB
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06 May 2016
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Philips DuraDiagnost X-ray system, Philips Healthcare (Suzhou) Co., Ltd (Ref: HSA 600:41/01-026/16/14_56)
Local Contact: Philips Electronics (S) Pte Ltd
Contact No.: 1800 744 5477
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HSA 6004101-026-16-14_56 FSN 197 KB
HSA 6004101-026-16-14_56 FSN 296 KB
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06 May 2016
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Philips MX 16-slice CT x-ray system software v1.1.4.21426, Philips Medical Systems (Cleveland), Inc (Ref: HSA 600:41/01-026/16/15_09)
Local Contact: Philips Electronics (S) Pte Ltd
Contact No.: 1800 744 5477
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HSA 6004101-026-16-15_09 FSN308 KB
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05 May 2016
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ADVIA Chemistry XPT System, Siemens Healthcare Diagnostics Inc (Ref: HSA 600:41/01-022/16/23_34)
Local Contact: Siemens Healthcare Pte Ltd
Contact No.:ui-handling.sg@siemens.com
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HSA 6004101-022-16-23_34 FSN76 KB
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05 May 2016
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Agfa HealthCare DX-D600 Direct Radiography (DR) System, Agfa HealthCare N.V. (Ref: HSA 600:41/01-184/16/02_48)
Local Contact: Agfa HealthCare Singapore Pte Ltd
Contact No.: 62140622
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HSA 6004101-184-16-02_48 FSN61 KB
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05 May 2016
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CENTURION® FMS (Fluidics Management System) Pack for CENTURION® Vision System, Alcon Laboratories Inc (Ref: HSA 600:41/01-135/16/03_52)
Local Contact: Alcon Pte Ltd
Contact No.:67221255
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HSA 6004101-135-16-03_52 FSN185 KB
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05 May 2016
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Cordis PRECISE® PRO RX Nitinol Stent System (Carotid), Cordis (Ref: HSA 600:41/01-002/16/18_46)
Local Contact: Johnson & Johnson Pte Ltd
Contact No.: 68276135
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HSA 6004101-002-16-18_46 FSN210 KB
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05 May 2016
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ADVIA Centaur XPT System, Siemens Healthcare Diagnostics Inc (Ref: HSA 600:41/01-022/16/22_31)
Local Contact: Siemens Healthcare Pte Ltd
Contact No.:ui-handling.sg@siemens.com
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HSA 6004101-022-16-22_31 FSN74 KB
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04 May 2016
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VersaCut+ Tissue Morcellator, Lumenis Singapore Pte Ltd (HSA 600:41/01-295/16/01_50)
Local Contact: Lumenis Singapore Pte Ltd.
Contact no./Email: 877-LUMENIS
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HSA 6004101-295-16-01_50 FSN121 KB
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04 May 2016
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R3 0 Degree XLPE Acetabular Liner 32mm ID X OD 48mm, Smith & Nephew Inc (HSA 600:41/01-073/16/13_51)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: Singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-16-13_51 FSN79 KB
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04 May 2016
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G-scan Brio Magnetic Resonance System, Esaote SpA (HSA 600:41/01-263/16/03_43)
Local Contact: Emergo Consulting Pte Ltd
Contact no./Email: 68325625
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HSA 6004101-263-16-03_43 FSN2042 KB
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04 May 2016
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ADVIA Centaur Tnl_Ultra Assay [CC 16-12], Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/16/21_23)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com
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HSA 6004101-022-16-21_23 FSN109 KB
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03 May 2016
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Beckman Coulter Lactate, Uric Acid, Cholesterol, Enzymatic Creatinine, Lipase, Triglyceride, Beckman Coulter Inc. (HSA 600:41/01-052/16/05_22)
Local Contact: Beckman Coulter Singapore Pte Ltd
Contact no./Email: 6340 7126
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HSA 6004101-052-16-05_22 FSN_Updated161 KB
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03 May 2016
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Volcano s5, s5i, CORE and CORE Mobile systems with software versions v3.2.x, v3.3 and v3.4, Volcano Corporation (HSA 600:41/01-070/16/12_41)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 64776101
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HSA 6004101-070-16-12_41 FSN1062 KB
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03 May 2016
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Surefuser+, Nipro Corporation (HSA 600:41/01-233/16/01_49)
Local Contact: Nipro Asia Pte Ltd
Contact no./Email: 65-65882281
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HSA 6004101-233-16-01_49 FSN98 KB
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