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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
Competent Authorities Composite Listing
BfArM
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 021 03 19 001DiaSys Diagnostic Systems GmbH.Reagent CRP FSSwissmedic
mdprc 120 09 19 000W.O.M. World of Medicine GmbH (hereafter “WOM” .Aquilex Fluid Control SystemsBfArM
mdprc 119 09 19 000Ecken & Ziegler BEBIG GmbHRu-106 AugenapplikatorenBfArM
mdprc 108 09 19 000Quality Electrodynamics, LLC (QED)TxRx Knee Coil 1.5T and 3T for Use on Siemens MR SystemsBfArM
mdprc 107 09 19 000JSC "MEDSIL"Medsil Intragastric BalloonBfArM
NCMDR
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Reference NumberManufacturerDevice TypeReport Source
mdprc 078 06 19 002Roche Diagnostics CorpTina-quant Myoglobin Gen.2 MYO2Swissmedic
mdprc 089 10 18 001Medtronic CareLink 2090 and CareLink Encore 29901/29901A ProgrammersNCMDR
mdprc 112 09 19 000Philips HealthcareV60 and V600 VentilatorNCMDR
mdprc 111 09 19 000Medtronic CT900 Clinician Programmer NCMDR
mdprc 110 09 19 000HUMAN Gesellschaft für Biochemica und Diagnostica GmbHIM Quick Test NCMDR
SFDA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 126 05 18 000Philips HealthcareHeartStart FRx, HeartStart Home, and Heartstart OnSite AEDsSFDA
Swissmedic
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 020 08 19 001Radiometer America IncAQURE system..Swissmedic
mdprc 073 03 19 001OlympusMAJ-209 Single-Use Suction ValveNCMDR
mdprc 087 09 19 000Dedienne SantéSYMBOL CUP DM: SCREWSwissmedic
mdprc 086 09 19 000Caesarea Medical Electronics LtdT34 Ambulatory Syringe PumpsSwissmedic
mdprc 085 09 19 000Thoratec CorpCentriMag MotorsSwissmedic
TGA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 118 09 19 000OriGen BiomedicalOriGen Products TissueVault O-Wrap and accessories http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01361-1
mdprc 117 09 19 000Medifab Medical FabricationShuttle Discovery with 4 Wheel Verve Stroller http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01325-1
mdprc 116 09 19 000MAQUET Cardiopulmonary VHK and VKMO(D) Adult/Small Adult Accessories http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01380-1
mdprc 115 09 19 000MAQUET Cardiopulmonary VHK and VKMO Adult/Small Adult http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01381-1
mdprc 114 09 19 000CODAN Swan-Lock Needle-Free Connector http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01362-1
U.S FDA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 098 09 19 000MAQUET Cardiopulmonary GmbHHLS Set Advanced 7.0 Deviceshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174814
mdprc 097 09 19 000Ad-Tech Medical Instrument CorpADTECH Drill Sleeve Guideshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175964
mdprc 094 09 19 000Dynex Technologies LtdDynex DSX Instrumenthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175187
mdprc 093 09 19 000ExactechThreaded Offset Cup Impactorhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175607
mdprc 092 09 19 000Teleflex Medical..Hudson RCI Sheridan LTShttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175293