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Date of Notification
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Title
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FSN
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31 Dec 2019
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TruLab Protein Level 1, DiaSys Diagnostic Systems GmbH (HSA 600:41/01-032/19/08_73)
Local Contact: Sysmex Asia Pacific Pte Ltd
Contact no./Email: 6221 3629 / RA@sysmex-ap.com
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HSA 6004101-032-19-08_73 FSN2427 KB
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31 Dec 2019
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VITROS® Chemistry Products Calibrator Kit 2, Ortho-Clinical Diagnostic (HSA 600:41/01-303/19/10_89)
Local Contact: ORTHO-Clinical Diagnostics Singapore Pte. Ltd
Contact no./Email: 6486 1151
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HSA 6004101-303-19-10_89 FSN230 KB
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30 Dec 2019
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Cook Medical Dawson-Mueller Drainage Catheter, Cook Incorporated (HSA 600:41/01-013/19/13_51)
Local Contact: Cook South East Asia Pte Ltd
Contact no./Email: 6812 7400 / SNG-RegulatoryAffairs@CookMedical.com
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HSA 6004101-013-19-13_51-FSN65 KB
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30 Dec 2019
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Revolution EVO, Optima CT660 and Optima CT680 CT, GE Healthcare Japan Corporation (HSA 600:41/01-010/19/35_50)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-19-35_50 FSN530 KB
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| 26 Dec 2019 |
Dade Actin Activated Cephaloplastin Reagent, Siemens Healthcare Diagnostics Products GmbH (HSA 600:41/01-032/19/07_34)
Local Contact: Sysmex Asia
Contact no./Email:6221 3629 / RA@sysmex-ap.com
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HSA 6004101-032-19-07_34 FSN1141 KB |
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26 Dec 2019
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1-DAY ACUVUE® TruEye® Brand Contact Lenses, Johnson & Johnson Vision Care (HSA 600:41/01-140/19/02_66)
Local Contact: Johnson & Johnson Vision Care, Singapore
Contact no./Email: support@acuvue.com.sg
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HSA 6004101-140-19-02_66 FSN91 KB
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24 Dec 2019
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ADVIA Chemistry Lipase, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/19/33_59)
Local Contact: Siemens Healthcare Pte. Ltd.
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-19-33_59 FSN33 KB
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23 Dec 2019
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Artis Pheno Systems, Siemens Healthcare GmbH (HSA 600:41/01-022/19/32_37)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-19-32_37 FSN818 KB
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20 Dec 2019
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Synthes Craniomaxillofacial (CMF) Distraction System, Synthes GmbH (HSA 600:41/01-002/19/19_79)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 6918 6717
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HSA 6004101-002-19-19_79_FSN206 KB
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20 Dec 2019
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SLE 6000 Infant Ventilator, SLE Limited (HSA 600:41/01-199/19/05_50)
Local Contact: Junnimed Services Pte Ltd
Contact no./Email: 6546 7737
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HSA 6004101-199-19-05_50 FSN669 KB
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| 20 Dec 2019 |
Hanaulux Sterilizable Handle Hub, Maquet SAS (HSA 600:41/01-224/19/17_44)
Local Contact: Getinge South East Asia Pte Ltd
Contact no./Email: 6296 1992
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HSA 60041-01-224-19-17_44_FSN1529 KB |
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20 Dec 2019
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Philips CombiDiagnost R90, Philips Medical System DMC GmbH (HSA 600:41/01-026/19/41_56)
Local Contact: Philips Electronics (Singapore) Pte Ltd
Contact no./Email: 1800 744 5477
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HSA 6004101-026-19-41_56 FSN244 KB
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| 19 Dec 2019 |
Hemosphere Oximetry Cable, Edwards Lifesciences LLC (HSA 600:41/01-060/19/11_82)
Local Contact: Edwards Lifesciences (Asia) Pte Ltd
Contact no./Email: 6548 5923
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HSA 6004101-060-19-11_82 FSN294 KB |
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19 Dec 2019
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Polysorb™ braided and Biosyn™ monofilament absorbable sutures, Covidien llc (HSA 600:41/01-046/19/10_71)
Local Contact: Covidien Pte Ltd
Contact no./Email: 6489 6974
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HSA 6004101-046-19-10_71 FSN230 KB
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19 Dec 2019
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ATELLICA IM NT-PROBNP, ADVIA Centaur NT-proBNP, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/19/31_67)
Local Contact: Siemens Healthcare Pte. Ltd.
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-19-31_67 FSN379 KB
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19 Dec 2019
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ADVIA® CHEMISTRY ENZYMATIC CREATININE_2 (ECRE_2), ATELLICA CH ECRE_2 & EZCR FLEX® REAGENT CARTRIDGE, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/19/30_67)
Local Contact: Siemens Healthcare Pte. Ltd.
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-19-30_67 FSN71 KB
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19 Dec 2019
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CombiDiagnost R90, Philips Medical System DMC GmbH (HSA 600:41/01-026/19/40_87)
Local Contact: Philips Electronics (Singapore) Pte Ltd
Contact no./Email: 1800 744 5477
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HSA 6004101-026-19-40_87 FSN280 KB
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19 Dec 2019
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DEFIGARD Touch7, Schiller Medical S.A.S (HSA 600:41/01-340/19/04_91)
Local Contact: Evolve Medical Pte Ltd
Contact no./Email: 6250 7108 / ra@evolvemedical.com.sg
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HSA 6004101-340-19-04_91 FSN2088 KB
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19 Dec 2019
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Edwards QuickDraw Venous Cannula with Insertion Kit, Edwards Lifesciences LLC (HSA 600:41/01-060/19/12_88)
Local Contact: Edwards Lifesciences (Asia) Pte. Ltd
Contact no./Email: 6548 5923
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HSA 6004101-060-19-12_88 FSN239 KB
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18 Dec 2019
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FTD CE-IVD kits, Fast-Track Diagnostics S.a.r.l. (HSA 600:41/01-022/19/29_34)
Local Contact: Siemens Healthcare Pte. Ltd.
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-19-29_34 FSN253 KB
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18 Dec 2019
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Iradimed 3860+Mridium MRI IV Pump, Iradimed Corporation (HSA 600:41/01-227/19/01_64)
Local Contact: QT Instruments (S) Pte Ltd
Contact no./Email: sales@qtinstruments.com
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HSA 6004101-227-19-01_64 FSN1007 KB
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18 Dec 2019
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FTD CE IVD Kits, Fast Track Diagnostics Luxembourg (HSA 600:41/01-137/19/02_61)
Local Contact: All Eights (S) Pte Ltd
Contact no./Email: 6288 6388 / alleight@alleight.com
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HSA 6004101-137-19-02_61 FSN298 KB
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18 Dec 2019
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PatientOnLine Software Version 6.2, Fresenius Medical Care AG & Co. kGaA (HSA 600:41/01-062/19/02_85)
Local Contact: Fresenius Medical Care Singapore Pte Ltd
Contact no./Email: 6837 3113
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HSA 6004101-062-19-02_85 FSN1209 KB
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18 Dec 2019
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Outrigger Targeting Guide, Arthrex Inc. (HSA 600:41/01-333/19/04_37)
Local Contact: Arthrex Singapore Pte Ltd
Contact no./Email: 6714 1618 / RA.ASEAN@Arthrex.sg
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HSA 6004101-333-19-04_37 FSN348 KB
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17 Dec 2019
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Carestation 620/650/650c A1, Carestation 620/650/650c A2 Anesthesia Systems, Datex-Ohmeda, Inc (HSA 600:41/01-010/19/34_35)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-19-34_35 FSN243 KB
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17 Dec 2019
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Optipac, Biomet France (HSA 600:41/01-008/19/08_64)
Local Contact: Zimmer Pte Ltd
Contact no./Email: 6854 7222 / MG-PAC-SG-RegulatoryContact@zimmerbiomet.com
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HSA 6004101-008-19-08_64 FSN350 KB
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17 Dec 2019
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LEGION AP FEMORAL CUTTING BLOCKS, Smith & Nephew Inc (HSA 600:41/01-073/19/11_62)
Local Contact: Smith & Nephew Pte Limited
Contact no./Email: 6270 0552 / singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-19-11_62 FSN231 KB
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16 Dec 2019
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Centricity High Acuity Anesthesia and Centricity High Acuity Critical Care Systems, GE Healthcare (HSA 600:41/01-010/19/32_44)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-19-32_44 FSN272 KB
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16 Dec 2019
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Centricity Universal Viewer 6.0 SP10 or higher versions, GE Healthcare (HSA 600:41/01-010/19/33_56)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-19-33_56 FSN237 KB
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16 Dec 2019
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VesselNavigator application in combination with Azurion R1.2.x and R2.0.x, Philips Medical Systems Nederland B.V. (HSA 600:41/01-026/19/39_43)
Local Contact: Philips Electronics (Singapore) Pte Ltd
Contact no./Email: 1800 744 5477
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HSA 6004101-026-19-39_43 FSN131 KB
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12 Dec 2019
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Discovery MR750w 3.0T, Discovery MR750 3.0T, Optima MR450w 1.5T, Discovery, MR450 1.5T, SIGNA Architect, SIGNA Artist and SIGNA PET/MR, GE Medical Systems, LLC (HSA 600:41/01-010/19/31_51)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-19-31_51 FSN215 KB
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11 Dec 2019
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Fast-Cath Hemostasis Introducer, St. Jude Medical (HSA 600:41/01-339/19/08_43)
Local Contact: Abbott Medical (Singapore) Pte Ltd
Contact no./Email: 6914 8000
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HSA 6004101-339-19-08_43 FSN419 KB
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09 Dec 2019
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ANIOSYME DD1, LABORATOIRES ANIOS (HSA 600:41/01-017/19/04_35)
Local Contact: IDS Medical Systems (Singapore) Pte Ltd
Contact no./Email: 6690 7378 / idsMEDSGPRegulatory@idsmed.com
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HSA 6004101-017-19-04_35 FSN198 KB
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09 Dec 2019
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Fast-Cath Trio Hemostasis Introducer, St. Jude Medical (HSA 600:41/01-339/19/07_37)
Local Contact: Abbott Medical (Singapore) Pte Ltd
Contact no./Email: 6914 8000
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HSA 6004101-339-19-07_37 FSN1814 KB
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| 06 Dec 2019 |
GE Central Stations and ApexPro Telemetry servers, GE Medical Systems Information Technologies, Inc (HSA 600:41/01-010/19/30_51)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-19-30_51 FSN219 KB |
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06 Dec 2019
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bellavista 1000 series ventilators (bellavista 1000e 17,3" ventilator), IMT Medical AG (HSA 600:41/01-353/19/02_91)
Local Contact: IMTMEDICAL Pte Ltd
Contact no./Email: 6254 4110
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HSA 6004101-353-19-02_91 FSN94 KB
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06 Dec 2019
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Imtmedical bellavista 1000 Ventilator, IMT Medical AG (HSA 600:41/01-353/19/01_88)
Local Contact: IMTMEDICAL Pte Ltd
Contact no./Email: 6254 4110
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HSA 6004101-353-19-01_88 FSN152 KB
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06 Dec 2019
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Crossfire 10 Degree Acetabular Insert, Howmedica Osteonics Corporation (HSA 600:41/01-014/19/10_38)
Local Contact: Stryker Singapore Pte Ltd
Contact no./Email: 6662 5930
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HSA 6004101-014-19-10_38 FSN158 KB
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06 Dec 2019
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Stellar 100 and Stellar 150, ResMed Pty Ltd (HSA 600:41/01-275/19/01_90)
Local Contact: ResMed Asia Pte Ltd
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HSA 6004101-275-19-01_90 FSN125 KB
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| 05 Dec 2019 |
Equinoxe Shoulder System, Platform Fracture Humeral Stem Cemented Right 6.5mm and Equinoxe Shoulder System, Platform Fracture Humeral Stem Cemented Right 10.5mm, Exactech Inc (HSA 600:41/01-257/19/02_82)
Local Contact: Exactech Pte Ltd
Contact no./Email: 6273 0091
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HSA 6004101-257-19-02_82 FSN476 KB |
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04 Dec 2019
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USF Healthcare Dental Disinfectants MICRO 10 ENZYME, USF Healthcare (HSA 600:41/01-335/19/04_85)
Local Contact: Raydent Supplies (S) Pte Ltd
Contact no./Email: 6741 5411
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HSA 6004101-335-19-04_85 FSN85 KB
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04 Dec 2019
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Mazor X Surgical System (SST2) – Positioner Type II, Mazor Robotics Ltd. (HSA 600:41/01-009/19/17_38)
Local Contact: Medtronic International Ltd.
Contact no./Email: 6439 6932
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HSA 6004101-009-19-17_38 FSN_393 KB
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03 Dec 2019
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Boston Scientific lnogenTM EL VR Implantable Cardioverter Defibrillator, Boston Scientific lnogen TM EL VR Implantable Cardioverter Defibrillator, Boston Scientific lnogenTM EL DR Implantable Cardioverter Defibrillator, Boston Scientific lnogenTM Cardiac Resynchronisation Therapy Defibrillator, Boston Scientific lngenTM EL DR Implantable Cardioverter Defibrillator, Boston Scientific Corporation (HSA 600:41/01-007/19/12_71)
Local Contact: Boston Scientific Asia Pacific Pte Ltd
Contact no./Email: 6418 8888 / Singapore_FSCA_Query@bsci.com
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HSA 6004101-007-19-12_71 FSN62 KB
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02 Dec 2019
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Healon GV PRO Ophthalmic Viscoelastic Device, AMO Uppsala AB (HSA 600:41/01-018/19/01_56)
Local Contact: AMO Singapore Pte Limited
Contact no./Email: RA-VISAP-JJSV-APAC-C@its.jnj.com
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HSA 6004101-018-19-01_56 FSN186 KB
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02 Dec 2019
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HeartMate Mobile Power Unit, Thoratec Corporation (HSA 600:41/01-339/19/06_86)
Local Contact: Abbott Medical (Singapore) Pte Ltd
Contact no./Email: 6914 8000
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HSA 6004101-339-19-06_86 FSN766 KB
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02 Dec 2019
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HeartMate 3 Modular Cables, HeartMate 3 Left Ventricular Assist System (LVAS), Thoratec Corporation (HSA 600:41/01-339/19/05_80)
Local Contact: Abbott Medical (Singapore) Pte Ltd
Contact no./Email: 6914 8000
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HSA 6004101-339-19-05_80 FSN142 KB
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02 Sep 2019
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ALB2 (Albumin Gen.2) and BILT3 (Bilirubin Total Gen.3), Roche Diagnostics GmbH (HSA 600:41/01-016/19/19_61)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com
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HSA 6004101-016-19-19_61 FSN402 KB
This FSN is an update to the original FSN published in Sep 2019.
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