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Date of Notification
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Title
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FSN
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31 July 2019
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BD Kiestra InoqulA / InoqulA+, Becton, Dickinson and Company (HSA 600:41/01-003/19/09_78)
Local Contact: Becton Dickinson Holdings Pte. Ltd.
Contact No./Email: 6664 2784
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HSA 6004101-003-19-09_78 FSN8323 KB |
| 31 July 2019 |
BD Alaris Pump Module, CareFusion (HSA 600:41/01-003/19/10_85)
Local Contact: Becton Dickinson Holdings Pte. Ltd.
Contact No./Email: 6432 2049
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HSA 6004101-003-19-10_85 FSN1507 KB |
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31 July 2019
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ZOLL Pro-padz Liquid Gel Radiolucent, ZOLL Medical Corporation (HSA 600:41/01-256/19/02_77)
Local Contact: ZOLL Medical Singapore Pte Ltd
Contact No./Email: 6807 1631
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HSA 6004101-256-19-02_77 FSN223 KB |
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31 July 2019
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Atellica® CH 930 Analyzer, Siemens Healthcare Diagnostic Inc. (HSA 600:41/01-022/19/18_75)
Local Contact: Siemens Healthcare Pte Ltd
Contact No./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-19-18_75 FSN140 KB |
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31 July 2019
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Remel™ Salmonella paratyphi B-H phase 1 Flagellar antigen b Stained Suspension, Remel Europe Ltd
Local Contact: Thermo Scientific Microbiology Pte Ltd
Contact No./Email: 6499 9999 / cs.mbd.sg@thermofisher.com
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HSA 6004101-178-19-03_61 FSN144 KB |
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31 July 2019
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Biocell textured breast implants and Biocell textured tissue expanders, Allergan Ltd (HSA 600:41/01-147/19/01_38)
Local Contact: Allergan Singapore Pte Ltd
Contact No./Email: 6411 5442
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HSA 6004101-147-19-01_38 FSN2912 KB |
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31 July 2019
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Rotem ex-tem, Tem Innovations GmbH (HSA 600:41/01-118/19/01_73)
Local Contact: Unimed Healthcare Pte Ltd
Contact No./Email: 6456 9989 / enquiry@unimed.com.sg
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HSA 6004101-118-19-01_73 FSN2456 KB |
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30 July 2019
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Patient table of Artis Zee and Artis Q Systems, Siemens Healthcare GmbH (HSA 600:41/01-022/19/17_86)
Local Contact: Siemens Healthcare Pte Ltd
Contact No./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-19-17_86 FSN722 KB |
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29 July 2019
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Reusable Surgical Panetti and Acoustic Neurinoma Instruments, SPIGGLE & THEIS Medizintechnik GmbH (HSA 600:41/01-104/19/02_80)
Local Contact: SurgiPro Pte Ltd
Contact No./Email: 6894 6038 / sales@surgipro.com.sg
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HSA 6004101-104-19-02_80 FSN1295 KB |
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29 July 2019
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Xhale Assurance Nasal Alar SpO2 Sensor, Xhale Assurance, Inc. (HSA 600:41/01-026/19/25_43)
Local Contact: Philips Electronics (Singapore) Pte Ltd
Contact No./Email: 1800 744 5477
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HSA 6004101-026-19-25_43 FSN131 KB |
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26 July 2019
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cobas t 711 coagulation analyzer and Cuvette COBAS INTEGRA, Roche Diagnostics GmbH (HSA 600:41/01-016/19/15_31)
Local Contact: Roche Diagnostic Asia Pacific Pte Ltd
Contact No./Email: sg.regulatory@roche.com
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HSA 6004101-016-19-15_31 FSN425 KB |
| 26 July 2019 |
QIAsymphony SP, QIAGEN GmbH (HSA 600:41/01-179/19/01_59)
Local Contact: QIAGEN Singapore Pte Ltd
Contact No./Email: 6854 8100
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HSA 6004101-179-19-01_59 FSN438 KB |
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26 July 2019
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Aespire/Aestiva Anesthesia System, Datex-Ohmeda (HSA 600:41/01-010/19/21_50)
Local Contact: GE Healthcare Pte Ltd
Contact No./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-19-21_50 FSN138 KB |
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26 July 2019
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BD MAX™ Reagents, Becton Dickinson and Company (HSA 600:41/01-003/19/08_73)
Local Contact: Becton Dickinson Holdings Pte Ltd
Contact No./Email: 6664 2784
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HSA 6004101-003-19-08_73 FSN194 KB |
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25 July 2019
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ADIVA Centaur Homocysteine Assay [Folate (100 Test Kit), Folate (500 Test Kit], Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/19/16_67)
Local Contact: Siemens Healthcare Pte Ltd
Contact No./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-19-16_67 FSN181 KB |
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25 July 2019
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NobelActive Internal NP 3.5x15mm, Nobel Biocare AB (HSA 600:41/01-168/19/02_35)
Local Contact: Kavo Dental Supply
Contact No./Email: 6311 9842
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HSA 6004101-168-19-02_35 FSN73 KB |
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25 July 2019
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Portico Solo™ Re-Collapsible Access System, Onset Medical Corporation (HSA 600:41/01-339/19/03_66)
Local Contact: Abbott Medical (Singapore) Pte Ltd
Contact No./Email: 6914 8000
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HSA 6004101-339-19-03_66 FSN162 KB |
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24 July 2019
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Mammomat Revelation VC10 with Biopsy Option, Siemens Healthcare GmbH (HSA 600:41/01-022/19/15_71)
Local Contact: Siemens Healthcare Pte Ltd
Contact No./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-19-15_71 FSN1707 KB |
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24 July 2019
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High pressure solenoid valve (cobas 8000 modular analyzer series [cobas 8000 ISE module, cobas c 701 module, cobas c 702 module, cobas c 502 module, cobas e 602 module, cobas e 801 module, cobas e 801 analytical unit], cobas 6000 analyzer series [cobas c 501 module, cobas e 601 module], cobas pro integrated solutions [cobas pro ISE analytical unit, cobas c 503 analytical unit], cobas c 513 analyzer and cobas c 311 analyzer), Roche Diagnostic GmbH (HSA 600:41/01-016/19/14_69)
Local Contact: Roche Diagnostic Asia Pacific Pte Ltd
Contact No./Email: sg.regulatory@roche.com
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HSA 6004101-016-19-14_69 FSN244 KB |
| 24 July 2019 |
Double Swivel Elbow 15M- Double Flip Top Cap with Seal 22M/15F, and Superset Double Swivel Catheter Mount 22F-Double Flip Top Cap 22M/15F, 70-150mm, Intersurgical Ltd (HSA 600:41/01-209/19/01_76)
Local Contact: T.E. Medicare Pte Ltd
Contact No./Email: 6567 0276 / temed@singnet.com.sg
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HSA 6004101-209-19-01_76 FSN507 KB |
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23 July 2019
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Spectra Optia Apheresis System, Terumo BCT Inc HSA 600:41/01-155/19/02_37)
Local Contact: Terumo BCT Asia Pte Ltd
Contact No./Email: 6715 3778 / Regulatory.Affairs@TerumoBCT.com
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HSA 6004101-155-19-02_37 FSN184 KB |
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19 July 2019
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BD 18Gx1-1/2IN Thin Wall (TW) Precision Glide Needles, Becton Dickinson Medical (S) Pte Ltd (HSA 600:41/01-003/19/07_64)
Local Contact: Becton Dickinson Medical (S) Pte Ltd
Contact No./Email: 6799 8163
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HSA 6004101-003-19-07_64 FSN139 KB |
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18 July 2019
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Philips Heartstart MRx Defibrillator/Monitor, Philips Medical Systems (HSA 600:41/01-026/19/24_71)
Local Contact: Philips Electronics (Singapore) Pte Ltd
Contact No./Email: 1800 744 5477
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HSA 6004101-026-19-24_71 FSN647 KB |
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18 July 2019
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ORTHO VISION® Analyser for ORTHO BioVue® Cassettes & ORTHO VISION® Max Analyser for ORTHO BioVue® Cassettes, Ortho-Clinical Diagnostic (HSA 600:41/01-303/19/05_61)
Local Contact: Ortho-Clinical Diagnostics Singapore Pte Ltd
Contact No./Email: 6486 1151
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HSA 6004101-303-19-05_61 FSN156 KB |
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18 July 2019
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Rusch Imex Gold 2 WAY 5 cc -Rubber Valve and Rusch Gold 2WAY 5 cc Plastic Valve, Teleflex Medical Private Limited (HSA 600:41/01-139/19/03_37)
Local Contact: Teleflex Medical Asia Pte Ltd
Contact No./Email: 6439 3046
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HSA 6004101-139-19-03_37 FSN195 KB |
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18 July 2019
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BIB / Orbera Intragastric Balloon Systems, Apollo Endosurgery, Inc. (HSA 600:41/01-263/19/03_35)
Local Contact: Emergo Consulting Pte Ltd
Contact No./Email: 6854 7976 / SEAsiaVigilance@ul.com
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HSA 60041-01-263-19-03_35 FSN206 KB |
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16 July 2019
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deltastream DP3 3/8" pump head, MEDOS Medizintechnik AG (HSA 600:41/01-112/19/01_56)
Local Contact: Rainbow Care Pte Ltd
Contact No./Email: 6223 0904 / sales@rainbowcare.com.sg
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HSA 6004101-112-19-01_56 FSN413 KB |
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15 July 2019
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Elecsys Anti-CCP, Roche Diagnostics GmbH (HSA 600:41/01-016/19/13_78)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact No./Email: sg.regulatory@roche.com
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HSA 6004101-016-19-13_78 FSN112 KB |
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15 July 2019
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Nurse Control Panel Arm (Long), KeyMed (Medical & Industrial Equipment) Ltd (HSA 600:41/01-004/19/04_66)
Local Contact: Olympus Singapore Pte Ltd
Contact No./Email: mes-ra.osp@olympus-ap.com
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HSA 6004101-004-19-04_66 FSN1748 KB |
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15 July 2019
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RIC5-9-D and RIC5-9A-RS, GE Healthcare Austria GmbH & Co OG (HSA 600:41/01-010/19/20_79)
Local Contact: GE Healthcare Pte Ltd
Contact No./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-19-20_79 FSN111 KB |
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15 July 2019
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Ellipse Implantable Cardioverter Defibrillators (ICDs), St. Jude Medical (HSA 600:41/01-339/19/02_74)
Local Contact: Abbott Medical (Singapore) Pte Ltd
Contact No./Email: 6914 8000
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HSA 6004101-339-19-02_74 FSN32 KB |
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15 July 2019
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Cobas t711 Coagulation Analyzer, Roche Diagnostic GmbH (HSA 600:41/01-016/19/12_73)
Local Contact: Roche Diagnostic Asia Pacific Pte Ltd
Contact No./Email: sg.regulatory@roche.com
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HSA 6004101-016-19-12_73 FSN452 KB |
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12 July 2019
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Pressure Transmitter, Getinge Sterilization AB (HSA 600:41/01-224/19/09_62)
Local Contact: Getinge Singapore Pte Ltd
Contact No./Email: 6296 1992 ext 118
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HSA 6004101-224-19-09_62 FSN1930 KB |
| 12 July 2019 |
Individual GRIPPER® Needles and PORT-A-CATH® Trays Containing GRIPPER® Needles, Smiths Medical ASD, Inc. (HSA 600:41/01-017/19/02_48)
Local Contact: IDS Medical Systems (Singapore) Pte Ltd
Contact No./Email: 6690 7330
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HSA 60041-01-017-19-02_48 FSN60 KB |
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12 July 2019
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Multigent Lithium and Alinity c Lithium Reagent Kit, Sentinel Diagnostic (HSA 600:41/01-005/19/27_70)
Local Contact: Abbott Laboratories (Singapore) Pte Ltd
Contact No./Email: 6914 8000 / FSN_enquiry@abbott.com
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HSA 6004101-005-19-27_70 FSN931 KB |
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12 July 2019
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PR4100 Magellan Software Version 7.0 (Code 94195), Bio-Rad Laboratories Inc. (HSA 600:41/01-027/19/05_75)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact No./Email: 6490 4262
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HSA 6004101-027-19-05_75 FSN151 KB |
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12 July 2019
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Comprehensive Reverse Shoulder Instrument Case – Outer (Outer Case Vault Only) & Total (Outer Case Vault Only), Biomet Orthopedics (HSA 600:41/01-008/19/05_50)
Local Contact: Zimmer Pte Ltd
Contact No./Email: 6854 7222 / cs.singapore@zimmerbiomet.com
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HSA 6004101-008-19-05_50 FSN310 KB |
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11 July 2019
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Brilliance iCT, Brilliance 64, Ingenuity Core, Ingenuity Core 128, Philips Medical Systems (Cleveland), Inc (HSA 600:41/01-026/19/23_86)
Local Contact: Philips Electronics (Singapore) Pte Ltd
Contact No./Email: 1800 744 5477
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HSA 6004101-026-19-23_86 FSN495 KB |
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11 July 2019
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Rx Daytona Plus Analyser and RX Imola Analyser, Randox Laboratories Ltd (HSA 600:41/01-213/19/02_34)
Local Contact: BioMedix Singapore Pte Ltd
Contact No./Email: 6547 5591 / sales_enquiry@biomedix.com.sg
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HSA 6004101-213-19-02_34 FSN2969 KB |
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11 July 2019
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Cook Acuject Variable Injection Needle, Wilson-Cook Medical, Inc. (HSA 600:41/01-013/19/08_80)
Local Contact: Cook South East Asia Pte Ltd
Contact No./Email: 6812 7400
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HSA 6004101-013-19-08_80 FSN982 KB |
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10 July 2019
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Platelia Toxo IgA TMB, Bio-Rad Laboratories (HSA 600:41/01-027/19/04_67)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact No./Email: 6490 4262
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HSA 6004101-027-19-04_67 FSN154 KB |
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10 July 2019
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Immundiagnostik Remsima® Monitor Total ADA ELISA, Immundiagnostik AG (HSA 600:41/01-342/19/01_31)
Local Contact: Celltrion Healthcare SG Pte Ltd
Contact No./Email: 6836 5524 / ra.sg@pharmeng.com
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HSA 6004101-342-19-01_31 FSN259 KB |
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8 July 2019
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ICS Chartr EP 200, GN Otometrics A/S (HSA 600:41/01-104/19/01_68)
Local Contact: SurgiPro Pte Ltd
Contact No./Email: 6894 6038 / sales@surgipro.com.sg
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HSA 6004101-104-19-01_68 FSN7679 KB |
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8 July 2019
|
Monaco, Elekta, Inc. (HSA 600:41/01-101/19/01_74)
Local Contact: Elekta Pte. Ltd.
Contact No./Email: 6221 2322 / Elekta_Global_PMS@elekta.com
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HSA 6004101-101-19-01_74 FSN1194 KB |
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8 July 2019
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TechnegasPlus Generator, Cyclomedica Australia Pty Ltd (HSA 600:41/01-087/19/03_52)
Local Contact: SCANMED TECHNOLOGY (S) PTE LTD
Contact No./Email: 6872 3660 / info@scanmed.com.sg
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HSA 6004101-087-19-03_52 FSN5776 KB |
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5 July 2019
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Philips Azurion Interventional Fluoroscopic X-ray system, with software version 1.2, Philips Medical Systems Nederland B.V. (HSA 600:41/01-026/19/21_43)
Local Contact: Philips Electronics (Singapore) Pte Ltd
Contact No./Email: 1800 744 5477
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HSA 6004101-026-19-21_43 FSN171 KB |
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4 July 2019
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Covidien Emprint™ Ablation Systems (Emprint™ Ablation Generator, Ablation Reusable Cable, Ablation Pump, RF Ablation Footswitch, Remote Temparature Probe), Covidien llc (HSA 600:41/01-046/19/08_64)
Local Contact: Covidien Pte Ltd
Contact No./Email: 6439 6974
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HSA 6004101-046-19-08_64 FSN191 KB |
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4 July 2019
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AXIUS Blower Mister, Maquet Cardiovascular, LLC (HSA 600:41/01-224/19/08_63)
Local Contact: Getinge South East Asia Pte Ltd
Contact No./Email: 6296 1992
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HSA 6004101-224-19-08_63 FSN96 KB |
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3 July 2019
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LANTIS Oncology Information System Server, Siemens Healthcare GmbH (HSA 600:41/01-022/19/14_86)
Local Contact: Siemens Healthcare Pte Ltd
Contact No./Email: ui-handling.sg.dl@siemens-healthineers.com
|
HSA 6004101-022-19-14_86 FSN50 KB |
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3 July 2019
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MAC™ VU360 System, GE Medical Systems Information Technologies, Inc. (HSA 600:41/01-010/19/19_51)
Local Contact: GE Healthcare Pte Ltd
Contact No./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-19-19_51 FSN195 KB |
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11 Jun 2019
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BrightView SPECT, BrightView X, BrightView XCT Handcontroller, Philips Medical Systems (Cleveland), Inc. (HSA 600:41/01-026/19/17_38)
Local Contact: Philips Electronics (Singapore) Pte Ltd
Contact No./Email: 1800 744 5477
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HSA 6004101-026-19-17_38 FSN490 KB
This FSN is an update to the original FSN published in June 2019.
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27 May 2019
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HeartStart MRx Defibrillator/ Monitor, Philips Medical Systems (HSA 600:41/01-026/19/15_68)
Local Contact: Philips Electronics (Singapore) Pte Ltd
Contact No./Email: 1800 744 5477
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HSA 6004101-026-19-15_68 FSN455 KB
This FSN is an update to the original FSN published in May 2019.
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11 Apr 2019
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Dornier Standard Diode and Nd:YAG Lightguides, Dornier MedTech GmbH (HSA 600:41/01-161/19/01_38)
Local Contact: Dornier Dornier MedTech Asia Pte Ltd
Contact No./Email: 65726056 / asiaregulatory@dornier.com
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HSA 6004101-161-19-01_38 FSN1108 KB
This FSN is an update to the original FSN published in April 2019.
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9 Apr 2019
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Philips IntelliVue MX40, Philips Medical Systems (HSA 600:41/01-026/19/11_48)
Local Contact: Philips Electronic (Singapore) Pte Ltd
Contact No./Email: 1800 744 5477
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HSA 6004101-026-19-11_48 FSN250 KB
This FSN is an update to the original FSN published in April 2019.
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23 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 FSN2584 KB
This FSN is an update to the original FSN published in March 2019.
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