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Date of Notification
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Title
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FSN
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29 Mar 2019
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Geistlich Bio-Oss Pen, Geistlich Pharma AG (HSA 600:41/01-335/19/02_50)
Local Contact: Raydent Supplies Pte Ltd
Contact No./Email: 6741 5411
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HSA 6004101-335-19-02_50_FSN_Redacted2648 KB
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27 Mar 2019
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GE Revolution CT with SmartStep Option (HSA 600:41/01-010/19/08_63)
Local Contact: GE Healthcare
Contact No./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-19-08_63 FSN_Redacted141 KB
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27 Mar 2019
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COBAS P 501 / 701 POST-ANALYTICAL UNITS, Roche Diagnostics GmbH (HSA 600:41/01-016/19/04_78)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact No./Email: sg.regulatory@roche.com
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HSA 6004101-016-19-04_78 FSN_Redacted6493 KB
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27 Mar 2019
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Cios Spin, Siemens Healthcare GmbH (HSA 600:41/01-022/19/08_76)
Local Contact: Siemens Healthcare Pte Ltd
Contact No./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-19-08_76 FSN_Redacted218 KB
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27 Mar 2019
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Draeger VentStar Helix Heated breathing circuit & Set2go, Draegerwerk AG & Co. KGaA (HSA 600:41/01-063/19/02_71)
Local Contact: Draeger Singapore Pte Ltd
Contact No./Email: 6872 9288 / draeger.sg@draeger.com
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HSA 6004101-063-19-02_71 FSN_Redacted307 KB
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27 Mar 2019
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Performance Series Sagittal Blade, Stryker Instruments (HSA 600:41/01-014/19/02_56)
Local Contact: Stryker Singapore Pte Ltd
Contact No./Email: asean.pms@stryker.com
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HSA 6004101-014-19-02_56 FSN_Redacted158 KB
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26 Mar 2019
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Cios Alpha VA30, Siemens Healthcare GmbH (HSA 600:41/01-022/19/07_64)
Local Contact: Siemens Healthcare Pte Ltd (HSA 600:41/01-022/19/07_64)
Contact No./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-19-07_64 FSN_Redacted239 KB
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26 Mar 2019
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Procell II M (used on cobas e 801 module/analytical unit), Roche Diagnostics GmbH (HSA 600:41/01-016/19/03_34)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact No./Email: sg.regulatory@roche.com
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HSA 6004101-016-19-03_34 FSN489 KB
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26 Mar 2019
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Ethicon ETHIBOND EXCEL Polyester Suture, Size 2-0, Ethicon, Inc / Ethicon LLC (HSA 600:41/01-002/19/05_79)
Local Contact: Johnson & Johnson Pte Ltd
Contact No./Email: 6918 6717
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HSA 6004101-002-19-05_79 FSN_Redacted157 KB
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25 Mar 2019
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SpiderFX Embolic Protection Devices, eV3 Inc. (HSA 600:41/01-046/19/03_74)
Local Contact: Covidien Pte Ltd
Contact No./Email: 6439 6974
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HSA 6004101-046-19-03_74 FSN223 KB
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25 Mar 2019
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Giraffe Bedded Warmer & Panda iRes Warmer, Datex-Ohmeda Inc (HSA 600:41/01-010/19/07_35)
Local Contact: GE Healthcare Pte Ltd
Contact No./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-19-07_35 FSN_Redacted260 KB
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25 Mar 2019
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Cordis Vista Brite Tip® & ADROITTM Guiding Catheters, Cordis Corporation (HSA 600:41/01-307/19/01_38)
Local Contact: Cardinal Health Singapore 225 Pte Ltd
Contact No./Email: 6230 2362
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HSA 6004101-307-19-01_38 FSN_Redacted218 KB
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22 Mar 2019
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BioFire Diagnostics FilmArray Blood Culture Identification (BCID) Panel, BioFire Diagnostics LLC (HSA 600:41/01-146/19/03_78)
Local Contact: BioMerieux Singapore Pte Ltd
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HSA 6004101-146-19-03_78 FSN_Redacted716 KB
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22 Mar 2019
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Cryostats Leica CM1950, Leica CM1860/UV, Leica CM1520, Leica CM3050 S, Leica CM1850UV, Leica CM1850, Leica CM1510 S, Leica CM1100, Leica Biosystems Nussloch GmbH (HSA 600:41/01-126/19/01_61)
Local Contact: Leica Microsystems (SEA) Pte Ltd
Contact No./Email: 6550 5511
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HSA 6004101-126-19-01_61 FSN_Redacted8911 KB
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22 Mar 2019
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VITROS XT 7600 Integrated System, Ortho-Clinical Diagnostics (HSA 600:41/01-303/19/03_75)
Local Contact: ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD
Contact No./Email: 6486 1151
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HSA 6004101-303-19-03_75 FSN_Redacted156 KB
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22 Mar 2019
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Miller Balloon and Fogarty Dilation Atrioseptostomy Catheters, Edwards Lifesciences LLC (HSA 600:41/01-060/19/03_54)
Local Contact: Edwards Lifesciences (Asia) Pte Ltd
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HSA 6004101-060-19-03_54 FSN_Redacted145 KB
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22 Mar 2019
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Dejimimi 3 in-the-ear hearing aids, Sivantos GmbH (HSA 600:41/01-337/19/01_62)
Local Contact: Sivantos Pte Ltd
Contact No./Email: 6370 9666 / Sicherheitsbeauftragter@sivantos.com
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HSA 6004101-337-19-01_62 FSN Redacted147 KB
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21 Mar 2019
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Connection lead SP (12V) for Infusomat Space, Infusomat Space P and Perfusor Space, B.Braun Melsungen AG (HSA 600:41/01-012/19/02_68)
Local Contact: B. Braun Singapore Pte Ltd
Contact No./Email: 6213 0933 / press.sg@bbraun.com
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HSA 6004101-012-19-02_68 FSN_Redacted2640 KB
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20 Mar 2019
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Innova IGS 6 and Innova IGS 630 Systems, GE Medical Systems SCS (HSA 600:41/01-010/19/06_18)
Local Contact: GE Healthcare Pte Ltd
Contact No./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-19-06_18 FSN_Redacted156 KB
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20 Mar 2019
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Carestream Onsight 3D Extremity System, Carestream Health, Inc. (HSA 600:41/01-012/19/02_68)
Local Contact: Carestream Singapore Pte. Ltd.
Contact No./Email: 6501 5007
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HSA 6004101-187-19-01_74 FSN_Redacted89 KB
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20 Mar 2019
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NOxBOXi, Bedfont Scientific Ltd. (HSA 600:41/01-199/19/01_18)
Local Contact: Junnimed Services Pte Ltd
Contact No./Email: 6546 7737
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HSA 6004101-199-19-01_18 FSN_Redacted166 KB
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20 Mar 2019
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Coviden Endo Grasp™ Auto Suture™ Grasper; Covidien Endo Clinch™ II Auto Suture™ Grasper, Covidien llc (HSA 600:41/01-046/19/02_46)
Local Contact: Covidien Pte Ltd
Contact No./Email: 6439 6974
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HSA 6004101-046-19-02_46 FSN_Redacted366 KB
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19 Mar 2019
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3T Heater-Cooler Devices, LivaNova Deutschland GmbH (HSA 600:41/01-299/19/01_25)
Local Contact: LivaNova Singapore Pte Ltd
Contact No./Email: 6293 1033
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HSA 6004101-299-19-01_25 FSN_Redacted49 KB
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19 Mar 2019
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EV1000 Clinical Platform, Edwards Lifesciences LLC (HSA 600:41/01-060/19/02_43)
Local Contact: Edwards Lifesciences (ASIA) Pte Ltd
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HSA 6004101-060-19-02_43 FSN_Redacted217 KB
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19 Mar 2019
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Johnson & Johnson 1-Day Acuvue Define Brand Contact Lenses with Lacreon (etafilcon A), Johnson & Johnson Vision Inc. (HSA 600:41/01-002/19/03_46)
Local Contact: Johnson & Johnson Vision Care
Contact No./Email: 6918 7295
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HSA 6004101-002-19-03_46 FSN_Redacted151 KB
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19 Mar 2019
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1-DAY ACUVUE® MOIST® for Astigmatism, Johnson & Johnson Vision Inc (HSA 600:41/01-002/19/04_50)
Local Contact: Johnson & Johnson Pte Ltd
Contact No./Email: 6918 7295
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HSA 6004101-002-19-04_50 FSN_Redacted205 KB
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18 Mar 2019
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ACUVUE® OASYS for ASTIGMATISM Brand Contact Lenses, Johnson & Johnson Vision Inc (HSA 600:41/01-002/19/02_63)
Local Contact: Johnson & Johnson Pte Ltd
Contact No./Email: 6918 7295
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HSA 6004101-002-19-02_63 FSN_Redacted345 KB
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18 Mar 2019
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ICU Medical ChemoLock Needlefree Closed System Drug Transfer Device, ICU Medical, Inc (HSA 600:41/01-145/19/02_62)
Local Contact: Medquest Marketing Pte Ltd
Contact No./Email: 6805 1250
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HSA 6004101-145-19-02_62 FSN_Redacted6664 KB
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18 Mar 2019
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syngo.CT Cardiac Function used in Syngo.via VA20A, VA30A, VB10A, and syngo.CT Cardiac Planning used n syngo.via VB20A, VB30A, Siemens Healthcare GmbH (HSA 600:41/01-022/19/06_50)
Local Contact: Siemens Healthcare Pte Ltd
Contact No./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-19-06_50 FSN_Redacted2471 KB
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18 Mar 2019
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Digital Linear Accelerators of type ARTISTE™, ONCOR™ and PRIMUS™, Siemens Healthcare GmbH (HSA 600:41/01-022/19/05_77)
Local Contact: Siemens Healthcare Pte Ltd
Contact No./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-19-05_77 FSN_Redacted1440 KB
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18 Mar 2019
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Alinity s System, Abbott GmbH & Co KG (HSA 600:41/01-005/19/10_73)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact No./Email: 6914 8000 / FSN_enquiry@abbott.com
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HSA 6004101-005-19-10_73 FSN340 KB
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15 Mar 2019
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Philips Azurion R2.0, Philips Medical Systems Nederland BV (HSA 600:41/01-026/19/08_48)
Local Contact: Philips Electronics (Singapore) Pte Ltd
Contact No./Email: 1800 744 5477
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HSA 6004101-026-19-08_48 FSN_Redacted843 KB
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14 Mar 2019
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VICRYL Suture, VICRYL Plus Suture, PDS Suture and PDS Plus Suture Products, Johnson & Johnson International, Ethicon LLC (HSA 600:41/01-002/19/01_51)
Local Contact: Johnson & Johnson Pte Ltd
Contact No./Email: 6918 6717
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HSA 6004101-002-19-01_51 FSN_Redacted311 KB
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14 Mar 2019
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Cios Alpha VA20, Siemens Healthcare GmbH (HSA 600:41/01-022/19/04_71)
Local Contact: Siemens Healthcare Pte Ltd
Contact No./Email: ui-handling.sg.dl@siemens-hleathineers.com
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HSA 6004101-022-19-04_71 FSN_Redacted787 KB
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14 Mar 2019
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Alinity hq Analyser and Alinity hs Slide Maker Stainer Module, Abbott GmbH & Co. KG (HSA 600:41/01-005/19/08_49)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact No./Email: 6914 8000 / FSN_enquiry@abbott.com
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HSA 6004101-005-19-08_49 FSN160 KB
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14 Mar 2019
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The Infinity Acute Care System (IACS) amd Standalone Infinity M540 Patient Monitor, Draeger Medical Systems, Inc. (HSA 600:41/01-063/19/01_76)
Local Contact: Draeger Singapore Pte Ltd
Contact No./Email: 6872 9288 / draeger.sg@draeger.com
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HSA 6004101-063-19-01_76 FSN_Redacted154 KB
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14 Mar 2019
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LOGIQ P5 MODEL BT06/BT08 AND LOGIQ A5 BT08 SCANNERS, GE Ultrasound Korea, Ltd (HSA 600:41/01-010/19/05_76)
Local Contact: GE Healthcare Pte Ltd
Contact No./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-19-05_76 FSN_Redacted139 KB
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14 Mar 2019
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Alinity ci-series System Control Module (SCM), Abbott GmbH & Co. KG (HSA 600:41/01-005/19/09_73)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact No./Email: 6914 8000 / FSN_enquiry@abbott.com
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HSA 6004101-005-19-09_73 FSN399 KB
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14 Mar 2019
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Thoratec HeartMate 3 Coring Tool, Thoratec Corporation (HSA 600:41/01-070/19/04_54)
Local Contact: Transmedic Pte Ltd
Contact No./Email: 6737 1945
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HSA 6004101-070-19-04_54 FSN_Redacted105 KB
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12 Mar 2019
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Alinity s System, Abbott GmbH & Co. KG (HSA 600:41/01-005/19/07_34)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact No./Email: 6914 8000 / FSN_enquiry@abbott.com
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HSA 6004101-005-19-07_34 FSN347 KB
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12 Mar 2019
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Pneumosure Heated Tubeset with RTP, High Flow Tubeset with RTP, and High Flow II Tubeset, Stryker Endoscopy (HSA 600:41/01-014/19/01_77)
Local Contact: Stryker Singapore Pte Ltd
Contact No./Email: asean.pms@stryker.com
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HSA 6004101-014-19-01_77 FSN_Redacted272 KB
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12 Mar 2019
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Ortho-Clinical VITROS XT 7600 Integrated System, Ortho-Clinical Diagnostics (HSA 600:41/01-303/19/02_70)
Local Contact: Ortho-Clinical Diagnostics Singapore Pte. Ltd.
Contact No./Email: 6486 1151
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HSA 6004101-303-19-02_70 FSN_Redacted186 KB
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11 Mar 2019
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29901 CareLink Encore™ Programmer Power Supply Model 26907, Medtronic Inc (HSA 600:41/01-009/19/04_43)
Local Contact: Medtronic International Limited
Contact No./Email: 6436 5077
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HSA 6004101-009-19-04_43 FSN_Redacted710 KB
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11 Mar 2019
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Certofix Quattro, B. Braun Melsungen AG (HSA 600:41/01-012/19/01_35)
Local Contact: B. Braun Singapore Pte Ltd
Contact No./Email: 6213 0933 / press.sg@bbraun.com
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HSA 6004101-012-19-01_35 FSN_Redacted2111 KB
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8 Mar 2019
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BioFire Diagnostics FilmArray Gastrointestinal (GI) Panel, BioFire Diagnostics LLC (HSA 600:41/01-146/19/02_70)
Local Contact: Biomerieux Singapore Pte Ltd
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HSA 6004101-146-19-02_70 FSN_Redacted816 KB
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8 Mar 2019
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Atellica Solution System Software, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/19/03_31)
Local Contact: Siemens Healthcare Pte. Ltd.
Contact No./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-19-03_31 FSN109 KB
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6Mar 2019
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BioRex CRP Cat No. 1450021, Dialine Diagnostic Systems Pte Ltd (HSA 600:41/01-326/19/01_57)
Local Contact: Dialine Diagnostic Systems Pte Ltd
Contact No./Email: 6747 2009
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HSA 6004101-326-19-01_57_FSN93 KB
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5 Mar 2019
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Pall Ultipor 25 Breathing System Filter and Pall Breathing System Filter (for Machine End and Medical Gas Equipment Applications), Pall Medical, A Division of Pall International Sarl (HSA 600:41/01-310/19/01_38)
Local Contact: Pall Filtration Pte Ltd
Contact No./Email: 6389 6500
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HSA 6004101-310-19-01_38 FSN_Redacted3592 KB
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5 Mar 2019
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R3 Variable Angle Drill Guide, Smith & Nephew Inc (HSA 600:41/01-073/19/05_66)
Local Contact: Smith & Nephew Pte Ltd
Contact No./Email: 6270 0552 / singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-19-05_66 FSN74 KB
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5 Mar 2019
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Albumin BCP (for cobas c 701/702 module), Roche Diagnostics GmbH (HSA 600:41/01-016/19/02_49)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact No./Email: sg.regulatory@roche.com
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HSA 6004101-016-19-02_49 FSN679 KB
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4 Mar 2019
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MultiDiagnost-Eleva, Philips Medical Systems Nederland BV (HSA 600:41/01-026/19/07_79)
Local Contact: Philips Electronics (S) Pte Ltd
Contact No./Email: 1800 744 5477
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HSA 6004101-026-19-07_79 FSN_Redacted389 KB
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3 Mar 2019
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VITROS® 5600 Integrated System, VITROS® 3600 Immunoassay System, VITROS® XT 7600 Integrated System & VITROS® ECI/ECIQ Immunodiagnostic System, Ortho-Clinical Diagnostics (HSA 600:41/01-303/19/01_67)
Local Contact: Ortho-Clinical Diagnostics Singapore Pte. Ltd
Contact No./Email: 6486 1151
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HSA 6004101-303-19-01_67 FSN_Redacted669 KB
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1 Mar 2019
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Alinity c Processing Module, Alinity i Processing Module, Abbott GmbH & Co. KG (HSA 600:41/01-005/19/06_23)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact No./Email: 6914 8000 / FSN@enquiry@abbott.com
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HSA 6004101-005-19-06_23 FSN419 KB
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1 Mar 2019
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da Vinci Xi/X Erbe Footswitch, Intuitive Surgical, Inc. (HSA 600:41/01-070/19/03_38)
Local Contact: Transmedic Pte Ltd
Contact No./Email: 6477 6101 / regional.pms@transmedicgroup.com
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HSA 6004101-070-19-03_38 FSN224 KB
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15 Nov 2018
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Carescape R860, Datex-Ohmeda, Inc (HSA 600:41/01-010/18/26_46)
Local Contact: GE Healthcare
Contact No./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-18-26_46 FSN v2_Redacted198 KB
This FSN is an update to the original FSN published in Nov 2018.
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24 July 2018
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RAPIDPoint® 405/500 Systems and RAPIDLab® 1245/1265 Systems, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/18/16_69)
Local Contact: Siemens Healthcare Pte Ltd
Contact No./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-18-16_69 FSN95 KB
This FSN is an update to the original FSN published in July 2018.
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20 Dec 2017
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Cardiac Resynchronization Therapy pacemakers (VALITUDE™, VISIONIST™) and defibrillators (CHARISMA™, MOMENTUM™, RESONATE™, VIGILANT™, AUTOGEN™, DYNAGEN™, INOGEN™, ORIGEN™), Boston Scientific Corporation (HSA 600:41/01-007/17/14_43)
Local Contact: Boston Scientific Asia Pacific Pte Ltd
Contact No./Email: 6418 8888 / Singapore_FSCA_Query@bsci.com
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HSA 6004101-007-17-14_43 FSN Part 3_Redacted273 KB
This FSN is an update to the original FSN published in Dec 2017.
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