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Date of Notification
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Title
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FSN
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29 Jun 2018
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Terumo® Advanced Perfusion System 1, Terumo Cardivascular Systems Corporation (HSA 600:41/01-028/18/03_71)
Local Contact: Terumo Singapore Pte Ltd
Contact no./Email: 62913603
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HSA 6004101-028-18-03_71 FSN959 KB
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28 Jun 2018
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Neonatal Flow Sensor Cable, Datex-Ohmeda Inc (HSA 600:41/01-010/18/15_64)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-18-15_64 FSN_Redacted387 KB
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27 Jun 2018
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EnTrust® and Escudo® VR/DR/AT ICDs, Medtronic Inc (HSA 600:41/01-009/18/10_68)
Local Contact: Medtronic International Limited
Contact no./Email: 6436 5077
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HSA 6004101-009-18-10_68 FSN_Redacted404 KB
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26 Jun 2018
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Schiller Medical DEFIGARD Touch 7, Schiller Medical S.A.S. (HSA 600:41/01-056/18/03_71)
Local Contact: Gold Lite Pte Ltd
Contact no./Email: 62730487
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HSA 6004101-056-18-03_71 FSN_Redacted240 KB
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26 Jun 2018
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CARESCAPE Monitor B650, GE Healthcare Finland Oy (HSA 600:41/01-010/18/14_56)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 62777668 / svc@ge.com
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HSA 6004101-010-18-14_56 FSN_Redacted344 KB
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26 Jun 2018
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Dialine ALAT (ALT/GPT), Dialine CK-MB, BioRex ALAT (ALT/GPT), Dialine Diagnostic Systems Pte Ltd, BioREX MANNHEIM Diagnostics (HSA 600:41/01-326/18/02_31)
Local Contact: Dialine Diagnostic Systems Pte Ltd
Contact no./Email: 6747 2009
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HSA 6004101-326-18-02_31 FSN149 KB
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26 Jun 2018
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Arctic Sun 5000 Temperature Management Systems, Medivance, Inc (HSA 600:41/01-050/18/04_62)
Local Contact: Bard Singapore Pte Ltd
Contact no./Email: 6580 5988 / Complaints.Singapore@crbard.com
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HSA 6004101-050-18-04_62 FSN_Redacted435 KB
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26 Jun 2018
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Arrow® HANDS-OFF® Thermodilution Catheter, Arrow International (HSA 600:41/01-139/18/02_51)
Local Contact: Teleflex Medical Asia Pte Ltd
Contact no./Email: 6439 3046
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HSA 6004101-139-18-02_51 FSN_Redacted153 KB
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26 Jun 2018
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Percepta™ CRT-P MRI SureScan™ and Percepta™ Quad CRT-P MRI SureScan™ Pacemakers, Medtronic Inc (HSA 600:41/01-009/18/09_38)
Local Contact: Medtronic International Limited
Contact no./Email: 6436 5077
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HSA 6004101-009-18-09_38 FSN_Redacted257 KB
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26 Jun 2018
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ATP Hexokinase FS, DiaSys Diagnostic Systems GmbH (HSA 600:41/01‐326/18/01_23)
Local Contact: Dialine Diagnostic Systems Pte Ltd
Contact no./Email: 6747 2009
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HSA 6004101-326-18-01_23 FSN263 KB
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25 Jun 2018
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MAC-LAB, CARDIOLAB, COMBOLAB AND SPECIALSLAB RECORDING SYSTEMS, GE Medical Systems Information Technologies (HSA 600:41/01‐010/18/13_66)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-18-13_66 FSN_Redacted331 KB
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22 Jun 2018
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MobileDiagnost wDR, Philips Medical Systems (HSA 600:41/01-026/18/19_68)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email:1800 744 5477
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HSA 6004101-026-18-19_68 FSN_Redacted61 KB
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22 Jun 2018
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Philips Digital Diagnost Radiography System, Philips Medical Systems DMC GmbH (HSA 600:41/01-026/18/20_46)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477
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HSA 6004101-026-18-20_46 FSN_Redacted1251 KB
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22 Jun 2018
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Single Chamber Temporary External Pacemaker 53401, Medtronic Inc (HSA 600:41/01-009/18/08_18)
Local Contact: Medtronic International Limited
Contact no./Email: 6436 5077
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HSA 6004101-009-18-08_18 FSN_Redacted1156 KB
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21 Jun 2018
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ArtisQ and Artis Pheno system, Siemens Healthcare GmbH (HSA 600:41/01-022/18/14_50)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-18-14_50 FSN Redacted2361 KB
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20 Jun 2018
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Vigileo, Vigilance II and EV1000A Monitor, Edwards Lifesciences LLC (HSA 600:41/01-060/18/01_44)
Local Contact: Edwards Lifesciences (Asia) Pte Ltd
Contact no./Email: 8128 0211
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HSA 6004101-060-18-01_44 FSN_Redacted1036 KB
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20 Jun 2018
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LEGION HK TIBIAL BASE SZ 5 LEFT, Smith & Nephew, Inc. (HSA 600:41/01-073/18/15_46)
Local Contact: SMITH & NEPHEW PTE LIMITED
Contact no./Email:6270 0552 / singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-18-15_46 FSN116 KB
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20 Jun 2018
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Maestro 4000 Cardiac Ablation System Optional Foot Switch, Boston Scientific Corporation (HSA 600:41/01-007/18/04_63)
Local Contact: Boston Scientific Asia Pacific Pte Ltd
Contact no./Email: 6418 8888 / Singapore_FSCA_Query@bsci.com
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HSA 6004101-007-18-04_63 FSN_Redacted316 KB
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20 Jun 2018
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Intertan 11.5mmx18cm 125D, Smith & Nephew, Inc.(HSA 600:41/01-073/18/14_50)
Local Contact: SMITH & NEPHEW PTE LIMITED
Contact no./Email:6270 0552 / singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-18-14_50 FSN117 KB
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19 Jun 2018
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Discovery MR750w, GE Healthcare (HSA 600:41/01-010/18/12_35)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-18-12_35 FSN_Redacted295 KB
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15 Jun 2018
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Stryker Synchro² Guidewires, Stryker Neurovascular (HSA 600:41/01-070/18/09_37)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6477 6101 / regulatory@transmedicgroup.com
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HSA 6004101-070-18-09_37 FSN_Redacted1654 KB
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14 Jun 2018
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Covidien Puritan-Bennett 800 Series Ventilator System, Covidien Newport e360 Ventilator, Covidien llc (HSA 600:41/01-046/18/08_44)
Local Contact: Covidien Pte Ltd
Contact no./Email: 6439 6974
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HSA 6004101-046-18-08_44 FSN90 KB
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13 Jun 2018
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Allura Xper, UNIQ and Centron, Philips Medical Systems Nederland BV (HSA 600:41/01-026/18/18_45)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477
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HSA 6004101-026-18-18_45 FSN Redacted1457 KB
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12 Jun 2018
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B.Braun Novosyn® Absorbable Surgical Suture and B.Braun Safil® Absorbable Surgical Suture, B. Braun Surgical SA (HSA 600:41/01-012/18/03_43)
Local Contact: B. Braun Singapore Pte Ltd
Contact no./Email: 6213 0933 / press.sg@bbraun.com
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HSA 6004101-012-18-03_43 FSN Redacted862 KB
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12 Jun 2018
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Cardinal Health Hydroline Trumpet Valves, Cardinal Health (HSA 600:41/01-307/18/01_18)
Local Contact: Cardinal Health Singapore 225 Pte Ltd
Contact no./Email: 6230 2362
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HSA 6004101-307-18-01_18 FSN_Redacted69 KB
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12 Jun 2018
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Neomed Enteral Feeding Tubes, NeoMed Inc (HSA 600:41/01-012/18/04_64)
Local Contact: B. Braun Singapore Pte Ltd
Contact no./Email: 6213 0941
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HSA 6004101-012-18-04_64 FSN_Redacted2968 KB
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11 Jun 2018
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GE Healthcare A1 Panel for CT and CT/PET scanners, GE Healthcare (HSA 600:41/01-010/18/11_51)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 62777668 / svc@ge.com
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HSA 6004101-010-18-11_51 FSN_Redacted623 KB
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11 Jun 2018
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VITROS Chemistry Products Na+ Slides, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/18/07_49)
Local Contact: Ortho-Clinical Diagnostics Singapore Pte Ltd
Contact no./Email: 6486 1151
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HSA 6004101-303-18-07_49 FSN_Redacted2771 KB
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08 Jun 2018
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150cm Y Extension Tube Dual Check Valve, Imaxeon Pty Ltd (HSA 600:41/01-069/18/01_66)
Local Contact: O’Connor’s Singapore Pte Ltd
Contact no./Email:6470 2000 / enquiries@oconnors.wbl.com.sg
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HSA 6004101-069-18-01_66 FSN_Redacted110 KB
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07 Jun 2018
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Volista Bracket, Maquet SAS (HSA 600:41/01-081/18/06_64)
Local Contact: IDS Medical System (Singapore) Pte Ltd
Contact no./Email: 6296 1992
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HSA 6004101-081-18-06_64 FSN305 KB
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07 Jun 2018
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Tina-quant IgG Gen.2 on cobas c 311/501/502 analyzers, Roche Diagnostics GmbH (HSA 600:41/01-016/18/10_67)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com
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HSA 6004101-016-18-10_67 FSN341 KB
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07 Jun 2018
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Mega Power Electrosurgical Generator, Megadyne Medical Products Inc (HSA 600:41/01-325/18/01_71)
Local Contact: GiGATT International Marketing Pte Ltd
Contact no./Email: 65471713 / gigatt@gigatt.net
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HSA 6004101-325-18-01_71 FSN Redacted14562 KB
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07 Jun 2018
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qUAntify Control, qUAntify Plus Control, Bio-Rad Laboratories Inc (HSA 600:41/01-027/18/07_70)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 6490 4262
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HSA 6004101-027-18-07_70 FSN112 KB
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06 Jun 2018
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Visera Elite II Video System Center OTV-S200 / OTV-S300, Olympus Medical Systems Corp (HSA 600:41/01-004/18/02_46)
Local Contact: Olympus Singapore Pte Ltd
Contact no./Email: 6833 4214 / mes-ra.osp@olympus-ap.com
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HSA 6004101-004-18-02_46 FSN_Redacted1201 KB
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06 Jun 2018
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CORAIL® AMT Neck Trials Surgical Instruments, Depuy (Ireland) (HSA 600:41/01-002/18/06_38)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 6918 8304
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HSA 6004101-002-18-06_38 FSN_Redacted370 KB
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06 Jun 2018
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Suture Anchor Devices, Suture Passer Devices and Coblation Wands, Smith & Nephew Inc (HSA 600:41/01-073/18/13_35)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: 6270 0552 / singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-18-13_35 FSN195 KB
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06 Jun 2018
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Sysmex AUTOMATED HEMATOLOGY ANALYZER XN SERIES XN-10 AND XN-20, Sysmex Corporation (HSA 600:41/01-032/18/01_57)
Local Contact: Sysmex Asia Pacific Pte. Ltd.
Contact no./Email: 6221 3629 / RA@sysmex-ap.com
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HSA 6004101-032-18-01_57 FSN_Redacted3833 KB
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05 Jun 2018
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MRSA Select II agar, Bio-Rad (HSA 600:41/01‐027/18/06_61)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 6490 4262
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HSA 6004101-027-18-06_61 FSN_Redacted136 KB
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04 Jun 2018
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GE Healthcare A1 Panel for Nuclear scanners, GE Medical Systems Israel, Functional Imaging (HSA 600:41/01-010/18/10_62)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-18-10_62 FSN_Redacted388 KB
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01 Jun 2018
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FHC Depth Stop Adapter, FHC Inc (HSA 600:41/01‐009/18/07_54)
Local Contact: Medtronic International Ltd
Contact no./Email: 6439 5000
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HSA 6004101009-18-07_54 FSN_Redacted615 KB
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01 Jun 2018
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ALAT (GPT) FS (IFCC mod.), ATP Hexokinase FS, CK-MB FS, GLDH FS DGKC, DiaSys Diagnostic Systems Gmb (HSA 600:41/01-032/17/07_34)
Local Contact: Sysmex Asia Pacific Pte. Ltd.
Contact no./Email: 6221 3629 / RA@sysmex-ap.com
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HSA 6004101-032-17-07_34 FSN267 KB
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