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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 003 07 19 001Edwards LifesciencesIntraClude Intra-Aortic Occlusion Devices NCMDR
mdprc 055 07 19 000Fast Track Diagnostics Luxembourg S.à.r.l.FTD Neuro 9BfArM
mdprc 054 07 19 000Fast Track Diagnostics Luxembourg S.à.r.l.FTlyo diverseBfArM
mdprc 053 07 19 000Ortho-Clinical DiagnosticsORTHO AutoVue Innova Ultra & VISION or VISION MaxBfArM
mdprc 052 07 19 000Samsung ElectronicsUltrasonic Diagnostic Apparatus WS80A and HS70ABfArM
NCMDR
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Reference NumberManufacturerDevice TypeReport Source
mdprc 061 07 19 000AbbottAlinity c Lithium Reagent Kit NCMDR
mdprc 060 07 19 000Roche Diagnostics ONLINE TDM Vancomycin Gen.3 (VANC3) NCMDR
mdprc 040 07 19 000Elekta Inc.Monaco NCMDR
mdprc 039 07 19 000Zimmer Surgical, IncPulsavac® Plus Wound Debridement SystemsNCMDR
mdprc 037 07 19 000Statcorp MedicalUltraCheck ABP Blood Pressure CuffsNCMDR
SFDA
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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 032 07 19 000Amplitude GmbHBroach HandleSwissmedic
mdprc 031 07 19 000GBUK Enteral Ltd also trading as Enteral UKNutricare Infant Clear Nasogastric Feeding Tube 6Fr 50cm SterileSwissmedic
mdprc 030 07 19 000Edwards LifesciencesEdwards CENTERA Transcatheter Heart Valve SystemSwissmedic
mdprc 029 07 19 000Oertli Instrumente AGTITANIUM TIP EASYTIP 2.2MM 30°Swissmedic
mdprc 024 07 19 000REPROLIFEWarming Solution Set 205, Warming Kit 102, Vitrification Solution Set 110, Vitrification Kit 101Swissmedic
TGA
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Reference NumberManufacturerDevice TypeReport Source
mdprc 031 03 19 001BioFire Diagnostics Inc.FilmArray Gastrointestinal (GI) Panel.NCMDR
mdprc 064 07 19 000Getinge GETINGE Steam Steriliser http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01071-1
mdprc 043 07 19 000Phadia LtdPhadia 1000 instrument http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01055-1
mdprc 042 07 19 000Morcher GmbHMorcher Capsular Tension Rings Type 13 Right, Type 13A Right and Type 13B Right http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00995-1
mdprc 041 07 19 000BD BiosciencesBD Connecta Plus3 White (3 way stopcock) http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01049-1
U.S FDA
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Reference NumberManufacturerDevice TypeReport Source
mdprc 065 07 19 000DeRoyal Industries Inc.CRANI PACKhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173848
mdprc 063 07 19 000Teleflex Medical..HUDSON RDI NEONATAL ConchaSmart Breathing Circuithttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173297
mdprc 062 07 19 000Cooper Surgical, Inc.Advincula Delineator Uterine Manipulators with Soft Koh-Efficient ,https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173714
mdprc 059 07 19 000Pharmaceutical Innovations, Inc.ElectroMisthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174062
mdprc 058 07 19 000GE HealthcareUltrasound Probe RIC59D and Repair RIC59ARShttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174509