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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 030 02 21 000Schiller AGFRED Easy defibrillator, FRED Easy Skity defibrillatorBfArM
mdprc 029 02 21 000Recipe Chemicals & Instruments GMBHClinCal Whole Blood Calibrator for ImmunosuppressantsBfArM
mdprc 025 02 21 000WeinmannMEDUMAT Transport emergency and transport ventilatorBfArM
mdprc 017 02 21 000Molnlycke Health Care AB.Mölnlycke® Procedure Trays & Single Packed Sterile TrocarsBfArM
mdprc 016 02 21 000Nuvasive Specialized Orthopaedics Inc.All Precice System DevicesBfArM
NCMDR
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Reference NumberManufacturerDevice TypeReport Source
mdprc 003 03 21 000Ortho-Clinical DiagnosticsVITROS® Chemistry Products TIBC KitNCMDR
mdprc 001 03 21 000StrykerLIFEPAK® CR2 DefibrillatorNCMDR
mdprc 009 10 20 001Acutronic Medical Systems AGfabian HFO and fabian +nCPAP evolution ventilatorsNCMDR, Swissmedic
mdprc 028 02 21 000Biosense Webster Inc.CARTO VIZIGO 8.5F Bi-Directional Guiding SheathNCMDR
mdprc 026 02 21 000Roche Diagnostics CorpAnti-Xa (cobas t 511 / cobas t 711)NCMDR
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 002 03 21 000OlympusOLYMPUS DUODENOVIDEOSCOPE, OLYMPUS EVIS EXERA III DUODENOVIDEOSCOPE, EVIS LUCERA ELITE DUODENOVIDEOSCOPE, and SINGLE USE DISTAL COVERSwissmedic
mdprc 027 02 21 000MicroVention EuropePHIL (Precipitating Hydrophobic Injectable liquid)Swissmedic
mdprc 005 02 20 005Roche Diagnostics CorpElecsys CA 19-9NCMDR
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
TGA
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Reference NumberManufacturerDevice TypeReport Source
mdprc 036 12 20 001Radiometer MedicalAll AQT90 FLEX analyzers with serial numbers of 393-838R0564 onwards and all E3800 spare part CPU units, 910-415BfArM
mdprc 007 06 20 001Siemens Healthcare Diagnostics GmbHAtellica IM 1300 Analyser / Atellica IM 1600 AnalyserTGA, Swissmedic
mdprc 020 02 21 000SIEMENSsyngo.via software update VB20Ahttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00360-1
mdprc 018 02 21 000Siemens Healthcare Diagnostics GmbHDimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex Reagent Cartridgehttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00323-1
mdprc 015 02 21 000SIEMENSSOMATOM CT scanners running on syngo CT VB20A_SP3https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00352-1
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