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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 007 01 21 000Unimax Medical Systems IncHasson TrocarBfArM
mdprc 022 10 20 001Molnlycke Health Care AB.Procedure Trays & Single Packed Shielded Bladed TrocarsBfArM
mdprc 021 12 20 000SIEMENSArtis zee/Q/Q.zen systems with software version VD11EBfArM
mdprc 016 12 20 000Medos Medizintechnik AG..Novatherm / Deltastream HCBfArM
mdprc 015 12 20 000ImplantcastEcoFit cup cementless / EcoFit cup EPORE cementlessBfArM
NCMDR
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Reference NumberManufacturerDevice TypeReport Source
mdprc 015 01 21 000OlympusColonovideoscope and Gastrointestinal VideoscopeNCMDR
mdprc 014 01 21 000Medtronic Medtronic Strata II, Delta, and CSF-Flow Control Valves and ShuntsNCMDR
mdprc 013 01 21 000OxyNov incFREE O2 Automated Oxygen Therapy DeviceNCMDR
mdprc 012 01 21 000DexCom IncG6 SensorsNCMDR
mdprc 011 01 21 000Cardinal Health Cardinal Health Isolation Gowns, Lab Coats, and Kendall GownsNCMDR
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 024 12 20 001Siemens Healthcare Diagnostics GmbHAtellica IM 1300 Analyzer, Atellica IM 1600 Analyzer, and Atellica CH 930 AnalyzerSwissmedic
mdprc 003 01 21 000QIAGEN LtdQIAstat-Dx Respiratory SARS-CoV-2 PanelSwissmedic
mdprc 045 12 20 000DiaMed GmbH.ID-DiaCell; ID-Dia Screen; ID-Dia PanelSwissmedic
mdprc 044 12 20 000Argon Medical Devices Inc.TLAB Transjugular Liver Biopsy SystemSwissmedic
mdprc 032 12 20 000Becton Dickinson & Co. (BD)BD Syringes and NeedlesSwissmedic
TGA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 004 02 20 003Siemens Healthcare Diagnostics IncAtellica CH Reaction Cuvette SegmentSwissmedic
mdprc 005 01 21 000Becton Dickinson & Co. (BD)Alaris GP Volumetric Pump with Plus softwarehttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-01389-1
mdprc 051 05 19 001Medtronic Medtronic HeartWare Monitor AC Adapter https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-01420-1
mdprc 036 12 20 000Radiometer MedicalAll AQT90 FLEX analyzers with serial numbers of 393-838R0564 onwards and all E3800 spare part CPU units, 910-415https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-01399-1
mdprc 035 12 20 000Terumo BCT IncSpectra Optia Apheresis Systemhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-01359-1
U.S FDA
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Reference NumberManufacturerDevice TypeReport Source
mdprc 036 10 20 000Quidel CorporationSofia SARS Antigen FIA Package Inserthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=183267
mdprc 034 10 20 000Gentian AS.Gentian Cystatin C Immunoassayhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=183752
mdprc 026 10 20 000Beckman CoulterUIBC System reagentU.S. FDA
mdprc 019 10 20 000ESAOTE S.P.AAC/DC POWER SUPPLY for 7400https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=183272
mdprc 002 06 19 003Teleflex MedicalRUSCH LASERTUBE (Rubber)NCMDR