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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 053 08 19 000SENTINEL CH. SpALithium, Alinity c Lithium Reagent KitBfArM
mdprc 052 08 19 000Remel Inc.Salmonella paratyphi B-H phase 1 Flagellar antigenBfArM
mdprc 051 08 19 000Grace Medical IncCartilage Microtome Systems and Cartilage Microtome Replacement HandlesBfArM
mdprc 046 08 19 000SIEMENSSOMATOM go.Up, go.NOW, go.TOP, go.ALLBfArM
mdprc 045 08 19 000Shimadzu Medical Systems.Mobile X-Ray System MobileDaRt EvolutionBfArM
NCMDR
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Reference NumberManufacturerDevice TypeReport Source
mdprc 055 08 19 000SIEMENSCellognost Echinococcosis NCMDR
mdprc 054 08 19 000ICU Medical, IncPlum & Sapphire Microbore Infusion Sets with Inline FiltersNCMDR
mdprc 049 08 19 000Philips HealthcareEfficia DFM100 Defibrillator/Monitor NCMDR
mdprc 048 08 19 000Medtronic Medtronic Micra™ Delivery System NCMDR
mdprc 047 08 19 000GE HealthcareProteus XR/a fixed RAD systemsNCMDR
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 078 05 19 001SenTec AG.Membrane Changers and their InsertsUS. FDA
mdprc 026 08 19 000Occlutech Holding AGOcclutech Delivery Set..Swissmedic
mdprc 025 08 19 000Siemens Healthcare Diagnostics GmbHDimension Ferritin Flex reagent cartridgeSwissmedic
mdprc 024 08 19 000Intersurgical LimitedVarious Breathing Systems and ComponentsSwissmedic
mdprc 023 08 19 000Air Liquide Medical SystemsMONNAL T60, T60 JP, T75, T75 JP, T75 CO2 , T50, T50 JP, T50 DE , T40, T40 DESwissmedic
TGA
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Reference NumberManufacturerDevice TypeReport Source
mdprc 038 08 18 001Medtronic BIS Vista and BIS View Monitoring SystemsNCMDR
mdprc 012 07 19 001Varian Medical SystemsStainless Steel Interstitial Needles, 17 Gauge http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01003-1
mdprc 008 03 19 001Biomet 3i Inc. 3.4mm Certain BellaTek Abutment, ILDAT3https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171233
mdprc 089 05 19 001Apollo Endosurgery Inc.Orbera Intragastric Balloon System and BIB Intragastric Balloon System https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00675-1
mdprc 009 08 19 000SIEMENSMAMMOMAT Revelation VC10 with Biopsy Option http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01129-1
U.S FDA
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Reference NumberManufacturerDevice TypeReport Source
mdprc 050 08 19 000Integra LifeSciencesCodman ISOCOOL Bipolar Forcepshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175411
mdprc 043 08 19 000Centurion Medical ProductsVarious Products: Speculum, vaginal, metal, Dressing tray, Circumcision trayhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174737
mdprc 042 08 19 000Ortho-Clinical DiagnosticsVITROS 250, 250AT, 350, 4600, 5600 and 5,1 FS chemistry systems. clinical chemistry analyzerhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174829
mdprc 041 08 19 000Ortho-Clinical DiagnosticsVITROS Chemistry Products GLU Slideshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174082
mdprc 040 08 19 000Ad-Tech Medical Instrument CorpLSB Style Anchor Bolthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174373