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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 036 06 22 000AbbottMerlin Patient Care System (PCS) and Merlin.net MN 5000 Remote Monitoring ApplicationBfArM
mdprc 028 06 22 000SIEMENSSensis, Sensis Vibe ComboBfArM
mdprc 022 06 22 000Bohus BioTech ABMicrovisc 1%,Microvisc Plus 1,4%,Microvisc Phaco 2,5%BfArM
mdprc 019 06 22 000Instrumentation Laboratory SpA, a Werfen CompanyILab Taurus analyzers with software versions 1.20p (and up) and firmware version 2.06 (and up)BfArM
mdprc 014 06 22 000Lohmann & RauscherGauze compresses with x-ray threadBfArM
mdprc 030 05 22 000Siemens Healthcare Diagnostics GmbHAtellica IM 1300/1600 Analyzer T3 AssayBfArM
mdprc 025 05 22 000Ortho-Clinical DiagnosticsORTHO VISION and ORTHO VISION Max AnalyzersBfArM
mdprc 024 05 22 000Siemens Healthcare Diagnostics ProductADVIA 2120/2120i Hematology Systems. BfArM
mdprc 018 05 22 000UROMED Kurt Drews KGUROMED-Einmal-Nelaton/Tiemann-KatheterBfArM
mdprc 017 05 22 000WEINMANN Emergency Medical Technology GmbH + Co.KG Li-Ion battery for ACCUVAC ProBfArM
NCMDR
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Reference NumberManufacturerDevice TypeReport Source
mdprc 035 06 22 000GE HealthcareAvance CS2, Avance CS2 Pro, and Aisys CS2 Anesthesia SystemsNCMDR
mdprc 034 06 22 000GE HealthcareAisys CS2, Avance CS2, and Avance CS2 Pro Anesthesia SystemsNCMDR
mdprc 033 06 22 000GE HealthcareSIGNA PremierNCMDR
mdprc 032 06 22 000Medtronic SAHeartWare™ Ventricular Assist Device (HVAD™) SystemNCMDR
mdprc 031 06 22 000GE HealthcareVarious CT, PET, NM TablesNCMDR
mdprc 030 06 22 000Maquet Critical Care ABServo-air with High mobile cartNCMDR
mdprc 027 06 22 000GE HealthcareCentricity Universal Viewer Zero Footprint ClientNCMDR
mdprc 026 06 22 000Randox Laboratories Ltd.CholesterolNCMDR
mdprc 025 06 22 000Medtronic SAMedtronic Cobalt XT™, Cobalt™ and Crome™ Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds)NCMDR
mdprc 024 06 22 000Baxter HealthcareAdsorba Hemoperfusion CartridgeNCMDR
SFDA
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Reference NumberManufacturerDevice TypeReport Source
mdprc 050 03 22 000Cardia Innovation ABCarbonAid Co2 DiffuserSFDA
mdprc 126 05 18 000Philips HealthcareHeartStart FRx, HeartStart Home, and Heartstart OnSite AEDsSFDA
Swissmedic
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Reference NumberManufacturerDevice TypeReport Source
mdprc 045 12 20 001DiaMed GmbH.ID-DiaCell; ID-Dia Screen; ID-Dia PanelSwissmedic, NCMDR
mdprc 013 02 22 000bioMerieux IncVIDAS High sensitive Troponin ISwissmedic
mdprc 023 01 22 000Xstrahl LimitedXstrahl X150 / Gulmay Medical 150Swissmedic
mdprc 019 01 22 000ImplantcastAGILON glenoid componentsSwissmedic
mdprc 016 01 22 000Liko ABLiko M220, Liko M230Swissmedic
mdprc 002 03 21 001OlympusOLYMPUS DUODENOVIDEOSCOPE, OLYMPUS EVIS EXERA III DUODENOVIDEOSCOPE, EVIS LUCERA ELITE DUODENOVIDEOSCOPE, and SINGLE USE DISTAL COVERSwissmedic, BfArM
mdprc 004 01 22 000MAQUET Cardiopulmonary GmbHHeater-Cooler Unit HCU 40.Swissmedic
mdprc 002 01 22 003D.O.R.C. Dutch Opthalmic Research CenterEFTIAR Octane, syringes and vial, 5 ml and 7 mlSwissmedic
mdprc 001 01 22 000AbbottAlinity m SystemSwissmedic
mdprc 027 12 21 000AbbottAlinity m SystemSwissmedic
TGA
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Reference NumberManufacturerDevice TypeReport Source
mdprc 029 06 22 000Randox Laboratories Ltd.Calibration Serum Level 3https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00817-1
mdprc 018 06 22 000Draeger Medical Systems IncBiliLux - Spring Armhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00722-1
mdprc 011 06 22 000SIEMENSYsio systems with VC10 softwarehttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00228-1
mdprc 009 06 22 000Radiometer MedicalABL800 Basic and ABL8XX FLEXhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00710-1
mdprc 008 06 22 000Acutronic Medical Systems AG.fabian HFOi ventilators with software version older than 5.2.1https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00569-1
mdprc 014 12 20 001Siemens Healthcare Diagnostics GmbHADVIA 1800 Chemistry System, ADVIA 2400 Chemistry System, ADVIA Chemistry XPT and Atellica CH 930 Analyzer - Gamma-Glutamyl Transferasehttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-01244-1
mdprc 012 04 22 000bioMerieux IncVITEK 2 GP ID Test Kithttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00418-1
mdprc 053 03 22 000Philips HealthcarePhilips CombiDiagnost R90 and ProxiDiagnost N90 Systems with software version 1.1.1 or higherhttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-00344-1
mdprc 051 03 22 000Siemens Healthcare DiagnosticsAtellica UAS 800 Urine Sediment Analyser and Atellica 1500 Automated Urinalysis Systemhttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-00411-1
mdprc 035 03 22 000VOLCANO CORPORATIONIntraSight IVUS Systemshttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-00490-1
U.S FDA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 021 06 22 000Instrumentation Laboratory SpA, a Werfen CompanyACL TOP 300 CTS, ACL TOP 350 CTS, ACL TOP 500 CTS, ACL TOP 550 CTS, and ACL TOP 970 CLhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=192825
mdprc 019 05 22 000SIEMENSSOMATOM with software syngo CT VA30A_SP4https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=192851
mdprc 039 03 22 000Bio-Rad Laboratories IncBioPlex 2200 SYPH T PACK Syphilis Total & RPR Reagent Pack & BioPlex 2200 Syphilis Total & RPR Calibrator Set CALhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=192210
mdprc 021 03 22 000Smiths Medical International Limited.Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumpshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=190636
mdprc 006 03 22 000Hill Rom IncNaviCare and Voalte Nurse Call Systemshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=189999
mdprc 026 12 21 000Wright Medical Technology, Inc.Stryker CLAW II ORTHOLOC and Stryker DARCO Screwhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=190461
mdprc 019 11 21 000Hitachi Ltd.Arietta 850 Ultrasound; Lisendo 880 Ultrasoundhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=189705
mdprc 015 11 21 000Dentech Corp.Rubber Dam Clamp, KSKhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=187238
mdprc 022 09 21 000Siemens Healthcare Diagnostics, IncAtellica IM BR 27.29 (BR) Assay 250 Test KitUS. FDA
mdprc 009 09 21 000Hitachi Medical CorpECHELON MRI Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=188704