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DATE OF NOTIFICATION
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TITLE
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FSN
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29 Nov 2016
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ALARIS SYSTEM PC UNIT MODELS 8000 and 8015, CareFusion 303 Inc (HSA 600:41/01-003/16/10_35)
Local Contact: Becton Dickinson Holdings Pte Ltd
Contact no./Email: 64322048
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HSA 6004101-003-16-10_35 FSN62 KB
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25 Nov 2016
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AK98 Dialysis Machine, Gambro Lundai AB (HSA 600:41/01-001/16/05_37)
Local Contact: Baxter Healthcare (Asia) Pte Ltd
Contact no./Email: 68262616
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HSA 6004101-001-16-05_37 FSN72 KB
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25 Nov 2016
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Roche Diagnostics cobas b 123 POC system, Roche Diagnostics GmbH (HSA 600:41/01-016/16/19_34)
Local Contact: Roche Diagnostics Pte Ltd
Contact no./Email: sg.regulatory@roche.com
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HSA 6004101-016-16-19_34 FSN575 KB
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25 Nov 2016
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NucliSENS® easyMAG®, NucliSENS® miniMAG® and eMAG, bioMérieux SA (HSA 600:41/01-146/16/10_57)
Local Contact: Biomerieux Singapore Pte Ltd
Contact no./Email: 68016706
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HSA 6004101-146-16-10_57 FSN375 KB
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24 Nov 2016
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SEQUENT PLEASE 2.0X20MM, B. Braun Melsungen AG (HSA 600:41/01-012/16/11_19)
Local Contact: B. Braun Singapore Pte Ltd
Contact no./Email: 62130943
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HSA 6004101-012-16-11_19 FSN815 KB
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24 Nov 2016
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IMMULITE® 2000/ IMMULITE® 2000 XPi Intact PTH, Siemens Healthcare Diagnostics Products Limited (HSA 600:41/01-022/16/52_22)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com
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HSA 6004101-022-16-52_22 FSN83 KB
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24 Nov 2016
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Straumann Dental Surgical Instruments, Institut Straumann AG (HSA 600:41/01-260/16/01_45)
Local Contact: Implant Focus
Contact no./Email: 67415411
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HSA 6004101-260-16-01_45 FSN111 KB
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24 Nov 2016
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QUINN'S ADVANTAGE MEDIUM WITH HEPES, Cooper Surgical Inc (HSA 600:41/01-262/16/01_25)
Local Contact: Neuvital Pte Ltd
Contact no./Email: 62766088
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HSA 6004101-262-16-01_25 FSN388 KB
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24 Nov 2016
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Ortho Vision Analyser and Ortho Vision Max Analyser for Ortho BioVue Cassettes, Ortho Clinical Diagnostics Inc (HSA 600:41/01-303/16/05_31)
Local Contact: Ortho Clinical Diagnostics Singapore Pte Ltd
Contact no./Email: 64861151
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HSA 6004101-303-16-05_31 FSN503 KB
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24 Nov 2016
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IMMULITE/ IMMULITE 1000/ 2000/ 2000 XPi PSA, Siemens Healthcare Diagnostics Products Limited (HSA 600:41/01-022/16/53_24)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com
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HSA 6004101-022-16-53_24 FSN92 KB
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23 Nov 2016
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Bio-Rad TPHA 200, Lab21 Healthcare Limited (HSA 600:41/01-027/16/13_65)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 64904262
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HSA 6004101-027-16-13_65 FSN 1152 KB
HSA 6004101-027-16-13_65 FSN 273 KB
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23 Nov 2016
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GE Healthcare MRI systems, GE Medical Systems, LLC (HSA 600:41/01-010/16/21_18)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: svc@ge.com
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HSA 6004101-010-16-21_18 FSN370 KB
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22 Nov 2016
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Weck Visistat Skin Stapler, Teleflex Medical (HSA 600:41/01-139/16/08_08)
Local Contact: Teleflex Medical Asia Pte Ltd
Contact no./Email: 64390000
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HSA 6004101-139-16-08_08 FSN181 KB
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21 Nov 2016
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Reflection Dead Blow Mallet, Smith & Nephew Inc (HSA 600:41/01-073/16/28_64)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-16-28_64 FSN81 KB
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21 Nov 2016
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JMS Infusion Set T200 W/21G, JMS Singapore Pte Ltd (HSA 600:41/01-306/16/01_09)
Local Contact: JMS Singapore Pte Ltd
Contact no./Email: sales@jmss.com.sg
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HSA 6004101-306-16-01_09 FSN162 KB
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16 Nov 2016
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ARCHITECT Toxo IgM, Abbott GmbH & Co. KG (HSA 600:41/01-005/16/11_61)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact no./Email: FSN_enquiry@abbott.com
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HSA 6004101-005-16-11_61_FSN72 KB
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16 Nov 2016
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Lateral Shoulder Connection Bar, Smith & Nephew Inc (HSA 600:41/01-073/16/27_56)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-16-27_56 FSN61 KB
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10 Nov 2016
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Arrow OnControl Bone Marrow Biopsy System, Aspiration System and Bone Lesion Biopsy System, Teleflex Medical (HSA 600:41/01-139/16/07_48)
Local Contact: Teleflex Medical Asia Pte Ltd
Contact no./Email: 64393000
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HSA 6004101-139-16-07_48 FSN297 KB
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09 Nov 2016
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Source Administration Sets with Medrad Intego PET Infusion System, Bayer Medical Care (HSA 600:41/01-069/16/01_46)
Local Contact: O'Connor's Singapore Pte Ltd
Contact no./Email: enquiries@oconnors.wbl.com.sg
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HSA 6004101-069-16-01_46 FSN67 KB
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8 Nov 2016
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Surefuser+, Nipro Corporation (HSA 600:41/01-233/16/03_52)
Local Contact: Nipro Asia Pte Ltd
Contact no./Email: 6588 2281
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HSA 6004101-233-16-03_52 FSN1107 KB
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7 Nov 2016
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GAM Kirschner Wire, T2 K-Wire, T2 K-Wire Recon, Stryker Trauma GmbH (HSA 600:41/01-014/16/15_63)
Local Contact: Stryker Singapore Pte Ltd
Contact no./Email: asean.pms@stryker.com
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HSA 6004101-014-16-15_63 FSN333 KB
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4 Nov 2016
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Ortho Reagent Red Blood Cell (RRBC) products, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/16/04_60)
Local Contact: Ortho-Clinical Diagnostics Singapore Pte Ltd
Contact no./Email: 6486 1151
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HSA 6004101-303-16-04_60 FSN572 KB
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4 Nov 2016
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Lullaby Warmer, Wipro GE Healthcare Private Ltd (HSA 600:41/01-010/16/20_51)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: svc@ge.com
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HSA 6004101-010-16-20_51 FSN484 KB
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4 Nov 2016
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Medtronic O-arm™ O2 Imaging System, Medtronic Navigation, Inc (Littleton) (HSA 600:41/01-009/16/17_50)
Local Contact: Medtronic International Limited
Contact no./Email: 6436 5000
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HSA 6004101-009-16-17_50 FSN35 KB
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3 Nov 2016
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LMA Mucosal Atomization Devices, Wolf Tory Medical, Inc (HSA 600:41/01-139/16/06_41)
Local Contact: Teleflex Medical Asia Pte Ltd
Contact no./Email: 64393000
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HSA 6004101-139-16-06_41 FSN165 KB
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3 Nov 2016
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Orthomatch quick connect handle, Smith & Nephew Inc (HSA 600:41/01-073/16/26_40)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-16-26_40 FSN59 KB
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3 Nov 2016
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Defibrillation electrode Schiller 0-21-0040 & 2.155065, Schiller Medical S.A.S (HSA 600:41/01-056/16/07_36)
Local Contact: Gold Lite Pte Ltd
Contact no./Email: 62730487
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HSA 6004101-056-16-07_36 FSN2400 KB
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3 Nov 2016
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Exactech Equinoxe Reverse Shoulder System -Fixed Angle Torque Defining Screw Kit, Exactech Inc (HSA 600:41/01-257/16/03_44)
Local Contact: Exactech Pte Ltd
Contact no./Email: 6273 0091
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HSA 6004101-257-16-03_44 FSN205 KB
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2 Nov 2016
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RPR kit, Bio-Rad France (HSA 600:41/01-027/16/12_59)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 6490 4262
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HSA 6004101-027-16-12_59 FSN65 KB
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2 Nov 2016
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Lullaby Led Phototherapy System, Wipro GE Healthcare Private Ltd (HSA 600:41/01-010/16/19_49)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: svc@ge.com
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HSA 6004101-010-16-19_49 FSN62 KB
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1 Nov 2016
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Nellix EndoVascular Aneurysm Sealing System, Endologix International Holdings B.V (HSA 600:41/01-148/16/02_54)
Local Contact: DKSH Singapore Pte Ltd
Contact no./Email: hec-ra.Sin@dksh.com
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HSA 6004101-148-16-02_54 FSN365 KB
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1 Nov 2016
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Innova X100, GE Medical Systems SCS (HSA 600:41/01-010/16/17_37)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: svc@ge.com
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HSA 6004101-010-16-17_37 FSN439 KB
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1 Nov 2016
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Avance, Avance CS2 and Amingo, Datex-Ohmeda, Inc. (HSA 600:41/01-010/16/18_35)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: svc@ge.com
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HSA 6004101-010-16-18_35 FSN322 KB
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1 Nov 2016
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Beckman Coulter Access Ostase, Beckman Coulter Inc. (HSA 600:41/01-052/16/12_58)
Local Contact: Beckman Coulter Singapore Pte Ltd
Contact no./Email: khwong@beckman.com
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HSA 6004101-052-16-12_58 FSN75 KB
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13 Oct 2016
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Ortho-Clinical VITROS Immunodiagnostic Products Intact PTH Reagent Pack, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/16/01_65)
Local Contact: Ortho-Clinical Diagnostics Singapore Pte Ltd
Contact no./Email: 64861151
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HSA 6004101-303-16-01_65_FSN_21393 KB
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28 Mar 2016
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DiaMed Diaclon Anti-N, DiaMed GmbH (HSA 600:41/01-027/16/03_22)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 64904262
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HSA 6004101-027-16-03_22 FSN81 KB
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