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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
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Reference NumberManufacturerDevice TypeReport Source
mdprc 095 06 19 000DiaSys Diagnostic Systems GmbH.Calibrator TruCal U BfArM
mdprc 094 06 19 000Siemens Healthcare DiagnosticsStratus CS Acute Care cTnI TestPakBfArM
mdprc 093 06 19 000Zimmer, INC….DVR Crosslock ePAK Screw Driver, DVR Crosslock ePAK Depth Gauge, K-Wire Trochar TipBfArM
mdprc 065 06 19 000Teleflex MedicalHudson RCI Air Cushion Face MaskBfArM
mdprc 064 06 19 000TEC COM GmbH.TECOtherm NEO.BfArM
NCMDR
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Reference NumberManufacturerDevice TypeReport Source
mdprc 091 06 19 000Sekisui DiagnosticsCP3000 w/ CTS 120V, CP3000 w/ CTS 230V, CP3000 w/o CTS 120V, CP3000 w/o CTS 230VNCMDR
mdprc 090 06 19 000St. Jude Medical IncEllipse ICDNCMDR
mdprc 079 06 19 000MAQUET Cardiovascular LLCDatascope Intra-Aortic Balloon PumpsNCMDR
mdprc 078 06 19 000Roche Diagnostics CorpTina-quant Myoglobin Gen.2 MYO2NCMDR
mdprc 098 04 19 001Medtronic6 Fr Sherpa Active CathetersSwissmedic
SFDA
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Reference NumberManufacturerDevice TypeReport Source
mdprc 126 05 18 000Philips HealthcareHeartStart FRx, HeartStart Home, and Heartstart OnSite AEDsSFDA
Swissmedic
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Reference NumberManufacturerDevice TypeReport Source
mdprc 048 04 19 001Roche Diagnostics CorpBILD2 (Bilirubin direct Gen.2) and cobas c 701 / 702NCMDR
mdprc 088 06 19 000DexCom IncG4 Platinum System, Dexcom G5 MobileSwissmedic
mdprc 087 06 19 000Magnisense SEMiAG|cTnI Swissmedic
mdprc 086 06 19 000Dedienne Santéorientation guide SYMBOL CUP Instrum, SYMBOL STEM, ADES, SHIVA, TRICCC and SMS InstrumentsSwissmedic
mdprc 085 06 19 000Intrinsic Therapeutics Inc.Barricaid ProsthesisSwissmedic
TGA
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Reference NumberManufacturerDevice TypeReport Source
mdprc 092 06 19 000Medical Innovation Developpement SASMID-Tube, Orogastric calibration Tubehttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00985-1
mdprc 089 06 19 000Arjo HuntleighTenor Passive Floor Lifthttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00978-1
mdprc 018 06 19 001Teleflex MedicalSheridan Endotracheal Tubeshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173225
mdprc 069 06 19 000RSR LtdACHRAb RIA kits. http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00918-1
mdprc 068 06 19 000ZimmerComprehensive Reverse Shoulder Instrument Caseshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00922-1
U.S FDA
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Reference NumberManufacturerDevice TypeReport Source
mdprc 081 06 19 000TecanFreedom EVO 200https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172787
mdprc 080 06 19 000Thermo FisherFisher Scientific Isotemp -General Purpose Water Bathhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173202
mdprc 075 06 19 000Zimmer, INC….The MobiC Cervical Disc Prosthesis (MobiC; MobiC 14mm Distraction Screwhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173314
mdprc 074 06 19 000Ethicon Inc.Ethicon ETHIBOND EXCEL Polyester Sutureshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173104
mdprc 073 06 19 000CooperSurgical Inc..LEEP Precision Integrated Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172775