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Date of Notification
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Title
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FSN
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29 Sep 2017
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Draeger Infinity MCable Dual Hemo Pod, Draeger Medical Systems Inc (HSA 600:41/01-063/17/04_52)
Local Contact: Draeger Singapore Pte Ltd
Contact no./Email: 6872 9288 / draeger.sg@draeger.com
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HSA 6004101-063-17-04_52 FSN_Redacted1311 KB
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28 Sep 2017
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BARD ® MAX-CORE ® Disposable Core Biopsy Instrument, Bard Peripheral Vascular, Inc (HSA 600:41/01-050/17/02_18)
Local Contact: Bard Singapore Pte Ltd
Contact no./Email: 6580 5988 / complaints.singapore@crbard.com
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HSA 6004101-050-17-02_18 FSN_Redacted249 KB
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28 Sep 2017
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Legion Screw-on Wedge Size 4, Smith & Nephew Inc. (HSA 600:41/01-073/17/13_40)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-17-13_40 FSN172 KB
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28 Sep 2017
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Elekta ERGO++ RTP Software, IMPAC Inc (HSA 600:41/01-101/17/08_64)
Local Contact: Elekta Pte Ltd
Contact no./Email: 62212322 / Elekta_Global_PMS@elekta.com
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HSA 6004101-101-17-08_64 FSN1165 KB
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28 Sep 2017
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VICRYL RAPIDE™ (POLYGLACTIN 910) SUTURE, Ethicon LLC, Johnson & Johnson Pte Ltd (HSA 600:41/01-002/17/11_19)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: Tel: 6918 7781
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HSA 6004101-002-17-11_19 FSN_Redacted215 KB
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27 Sep 2017
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LENTIS IOL, Oculentis B.V. (HSA 600:41/01-261/17/01_62)
Local Contact: Swissmed Pte Ltd
Contact no./Email: 6635 6080 / info@swissmed.asia
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HSA 6004101-261-17-01_62 FSN_Redacted7675 KB
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27 Sep 2017
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Smart HIV 1/2 RPT Device, Cell ID Pte Ltd (HSA 600:41/01-316/17/01_38)
Local Contact: Cell ID Pte Ltd
Contact no./Email: 6635 7351
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HSA 6004101-316-17-01_38 FSN_Redacted594 KB
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26 Sep 2017
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Hill-Rom Progressa Bed System, Hill-Rom, Inc. (HSA 600:41/01-017/17/04_48)
Local Contact: IDS Medical Systems (S) Pte Ltd
Contact no./Email: 6690 7330
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HSA 6004101-017-17-04_48 FSN615 KB
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26 Sep 2017
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DCA Barcode Reader Kit for DCA Vantage Analyzer and CLINITEK Status Connect System, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/17/28_23)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-17-28_23 FSN217 KB
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26 Sep 2017
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Bio-Rad Antiserum Salmonella Monovalent H Antisera H:z, Bio-Rad Antiserum Salmonella Monovalent H Antisera H:x, Bio-Rad Antiserum Salmonella Polyvalent H Antisera HMB (e,h+e,n,x+e,n,z15+G), Bio-Rad Antiserum Salmonella Polyvalent H A, Bio-Rad Laboratories (HSA 600:41/01-027/17-06_65)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: Tel: 6490 4262
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HSA 6004101-027-17-06_65 FSN70 KB
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22 Sep 2017
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Covidien GastriSail™ Gastric Positioning System, Covidien llc (HSA 600:41/01-046/17/08_56)
Local Contact: Covidien Pte Ltd
Contact no./Email: 6439 6933
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HSA 6004101-046-17-08_56 FSN_Redacted1624 KB
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21 Sep 2017
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Hill-Rom Progressa Bed System, Hill-Rom, Inc. (HSA 600:41/01-182/17/01_48)
Local Contact: Hill-Rom Services Pte. Ltd.
Contact no./Email:6499 7395
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HSA 6004101-182-17-01_48 FSN237 KB
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21 Sep 2017
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VITROS Chemistry Products DAT Performance Verifiers, Ortho- Clinical Diagnostics Inc (HSA 600:41/01-303/17/11_31)
Local Contact: Ortho-Clinical Diagnostics Singapore Pte Ltd
Contact no./Email: 6486 1151
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HSA 6004101-303-17-11_31 FSN_Redacted3082 KB
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20 Sep 2017
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Artis Zee and Artis Q Family System, Siemens Healthcare GmbH (HSA 600:41/01-022/17/27_46)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-17-27_46 FSN_Redacted232 KB
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20 Sep 2017
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DELTA XTEND™ Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants, Depuy France S.A.S (HSA 600:41/01-002/17/10_43)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 6918 7781
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HSA 6004101-002-17-10_43 FSN_Redacted219 KB
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20 Sep 2017
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Philips SureSigns VSi Vital Signs Monitor, Philips SureSigns VS2+ Vital Signs Monitor, Philips Medical Systems (HSA 600:41/01-026/17/16_56)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477
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HSA 6004101-026-17-16_56 FSN_Redacted33 KB
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19 Sep 2017
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Neuray Surgical Patties And Strips, Merocel Neurosurgical Patties And Packing, Medtronic Xomed (HSA 600:41/01-009/17/19_63)
Local Contact: Medtronic International Ltd.
Contact no./Email: 6436 5000
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HSA 6004101-009-17-19_63 FSN_Redacted334 KB
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18 Sep 2017
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IRISpec CA/CB/CC, Iris Diagnostics (HSA 600:41/01-052/17/11_67)
Local Contact: Beckman Coulter Singapore Pte Ltd
Contact no./Email: 6340 7126
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HSA 6004101-052-17-11_67 FSN_Redacted265 KB
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15 Sep 2017
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Permobil Powered Wheelchair, Permobil AB (HSA 600:41/01-150/17/01_51)
Local Contact: Greenstyle Pte Ltd
Contact no./Email: 6250 0555 / mail@rehabmart.sg
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HSA 6004101-150-17-01_51 FSN_Redacted618 KB
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15 Sep 2017
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ETEST POLYMYXIN B PO 1024 WW B100/VANCOMYCIN VA 256 WW F100/BENZYLPENICIL PG 256 WW F100/VANCOMYCIN VA 256 WW S30 (9302553)/ETEST AMPHOTERICIN-B AP 32 WW B100/OXIDASE 50 AMP bioMérieux SA (HSA 600:41/01-146/17/10_65)
Local Contact: BioMerieux Singapore Pte Ltd
Contact no./Email: 6801 6700
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HSA 6004101-146-17-10_65 FSN399 KB
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15 Sep 2017
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Covidien Endo GIA™ Ultra Universal Stapler and Endo GIA™ Reload with Tri-Staple™ Technology, Covidien llc (HSA 600:41/01-046/17/07_50)
Local Contact: Covidien Pte Ltd
Contact no./Email: 6439 6933
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HSA 6004101-046-17-07_50 FSN_Redacted3631 KB
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14 Sep 2017
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da Vinci Xi Surgical System, Intuitive Surgical, Inc (HSA 600:41/01-070/17/16_54)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6477 6101 / regulatory@transmedicgroup.com
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HSA 6004101-070-17-16_54 FSN283 KB
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14 Sep 2017
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APTUS HELI-FX THORACIC ENDOANCHOR SYSTEM HELI-FX GUIDE 42MM, Medtronic Inc (HSA 600:41/01-009/17/18_18)
Local Contact: Medronic International Limited
Contact no./Email: 6436 5077
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HSA 6004101-009-17-18_18 FSN_Redacted140 KB
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13 Sep 2017
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Revolve Advanced Adipose System (Revolve System) , Lifecell Corporation (HSA 600:41/01-315/17/01_40)
Local Contact: Allergan Singapore Pte Ltd on behalf of KCI MEDICAL ASIA PTE. LTD.
Contact no./Email: 6411 0627
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HSA 6004101-315-17-01_40 FSN372 KB
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13 Sep 2017
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Fluorocell PLT, Sysmex Corporation (HSA 600:41/01-032/17/04_61)
Local Contact: Sysmex Asia Pacific Pte Ltd
Contact no./Email: 6221 3629 / RA@sysmex-ap.com
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HSA 6004101-032-17-04_61 FSN_Redacted626 KB
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12 Sep 2017
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Medtronic MiniMed Infusion Sets, Medtronic MiniMed (HSA 600:41/01-009/17/17_19)
Local Contact: Medtronic International Limited
Contact no./Email: 6439 6932
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HSA 6004101-009-17-17_19 FSN_Redacted513 KB
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08 Sep 2017
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Oxoid CAZIO CEFTAZIDIME, CT1629B, OXOID LIMITED (HSA 600:41/01-178/17/05_60)
Local Contact: Thermo Scientific Microbiology Pte Ltd
Contact no./Email: 6499 9999 / cs.mbd.sg@thermofisher.com
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HSA 6004101-178-17-05_60 FSN_Redacted123 KB
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08 Sep 2017
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Smiths Medical CADD® Medication Cassette Reservoir, Smiths Medical MD, Inc. (HSA 600:41/01-017/17/03_60)
Local Contact: IDS Medical Systems (S) Pte Ltd
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HSA 6004101-017-17-03_60 FSN931 KB
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08 Sep 2017
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Slit Lamp, Carl Zeiss Meditec Ag (HSA 600:41/01-136/17/03_25)
Local Contact: Carl Zeiss Pte Ltd
Contact no./Email: 6741 9600 / info@zeiss.com.sg
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HSA 6004101-136-17-03_25 FSN32 KB
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07 Sep 2017
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Carl Zeiss VisuMax Laser Keratome, Carl Zeiss Meditec AG (HSA 600:41/01-136/17/04_50)
Local Contact: CARL ZEISS PTE. LTD.
Contact no./Email: 67419600 / info@zeiss.com.sg
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HSA 6004101-136-17-04_50 FSN28 KB
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07 Sep 2017
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Intrabeam System, Carl Zeiss Meditec Ag (HSA 600:41/01-136/17/05_46)
Local Contact: Carl Zeiss Pte Ltd
Contact no./Email:6741 9600 / info@zeiss.com.sg
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HSA 6004101-136-17-05_46 FSN71 KB
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06 Sep 2017
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cobas u cuvette, Roche Diagnostics GmbH (HSA 600:41/01-016/17/17_61)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com
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HSA 6004101-016-17-17_61 FSN451 KB
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06 Sep 2017
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Siemens Artis Zee & Artis Q Family System, Siemens Healthcare GmbH (HSA 600:41/01-022/17/26_64)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-17-26_64 FSN_Redacted204 KB
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06 Sep 2017
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Alinity hq Analyzer, Abbott GmbH (HSA 600:41/01-005/17/14_59)
Local Contact: Abbott Laboratories (S) Pte Ltd
Contact no./Email: 6914 8290; FSN_enquiry@abbott.com
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HSA 6004101-005-17-14_59 FSN97 KB
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05 Sep 2017
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Bio-Rad DiaMed ID-Card LISS/Coombs, DiaMed GmbH (HSA 600:41/01-027/17/06_58)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 6490 4262
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HSA 6004101-027-17-06_58 FSN_Redacted2341 KB
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04 Sep 2017
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Model 53912 External Pulse Generator (EPG) Extension Cable, Reusable Model 53912A EPG Extension Cable, packaged with Model 5391 EPG, Model 53912D EPG Extension Cable, Disposable, Medtronic Inc (HSA 600:41/01-009/17/16_18)
Local Contact: Medtronic International Limited
Contact no./Email: 6436 5077
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HSA 6004101-009-17-16_18 FSN_Redacted73 KB
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04 Sep 2017
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Philips Digital Diagnost Radiography System, DMC GmbH (HSA 600:41/01-026/17/14_46)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477
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HSA 6004101-026-17-14_46 FSN_Redacted102 KB
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04 Sep 2017
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Alaris LVP (Large Volume Pump) model 8100, CareFusion 303 Inc (HSA 600:41/01-003/17/18_63)
Local Contact: Becton Dickinson Holdings Pte. Ltd. (BD)
Contact no./Email: 6432 2048
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HSA 6004101-003-17-18_63 FSN_Redacted1702 KB
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04 Sep 2017
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BD Insulin Syringe, Becton, Dickinson and Company (BD) (HSA 600:41/01-003/17/17_25)
Local Contact: Becton Dickinson Holdings Pte. Ltd. (BD)
Contact no./Email: Tel: 6432 2048
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HSA 6004101-003-17-17_25 FSN_Redacted283 KB
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04 Sep 2017
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ID-DiaCell l-ll-III, DiaMed GmbH (HSA 600:41/01-027/17/05_59)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 6490 4262
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HSA 6004101-027-17-05_59 FSN_Redacted2931 KB
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04 Sep 2017
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IMPAC Monaco RTP System, IMPAC, Inc (HSA 600:41/01-101/17/07_56)
Local Contact: Elekta Pte Ltd
Contact no./Email: 6221 2322; Elekta_Global_PMS@elekta.com
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HSA 6004101-101-17-07_56 FSN_Redacted233 KB
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09 Aug 2017
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Trident, Accolade, Accolade II and Restoration Modular implants, Howmedica Ostenics Corp (HSA 600:41/01-014/17/05_56)
Local Contact: Stryker Singapore Pte Ltd
Contact no./Email: asean.pms@stryker.com
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HSA 6004101-014-17-05_56 FSN (updated)_Redacted174 KB
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