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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 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
mdprc 010 04 22 000Draeger Medical Systems IncInfinity CentralStationBfArM
mdprc 006 04 22 000Dentsply Sirona, IncTeneo Treatment CentersBfArM
mdprc 005 04 22 000Osatu S.Coop.Electrodes for Defibrillation "Bexen Cardio"BfArM
mdprc 004 04 22 000Schiller AGFRED easyport plus defibrillatorBfArM
mdprc 045 03 22 000Hill Rom IncCompella Bariatric Bed Systems and Therapy Air Supply UnitsBfArM
mdprc 044 03 22 000Safe OrthopaedicsOriginal and Essential Kit Pedicle Screw systemsBfArM
NCMDR
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Reference NumberManufacturerDevice TypeReport Source
mdprc 026 05 22 000OssurVARI-FLEX® JUNIORNCMDR
mdprc 023 05 22 000GE HealthcareCARESCAPE Central Station (CSCS) V2NCMDR
mdprc 022 05 22 000GE HealthcareCentricity Universal Viewer Zero Footprint Client (ZFP), Centricity PACS RA1000 Workstation (RA1000), Centricity Radiology RA600 (RA600), Centricity Cardiology CA1000 (CA1000) and Centricity Enterprise Web (CWeb)NCMDR
mdprc 002 05 22 001Schwarzer Cardiotek GmbH.EP-TRACERNCMDR
mdprc 021 05 22 000Arrow International Inc.Arrow 3-Lumen Central Venous Catheters (CVC) SetNCMDR
mdprc 020 05 22 000Medtronic SAEEA Autosuture Circular Stapler with DST Series Technology, 25mmNCMDR
mdprc 016 05 22 000Becton Dickinson & Co. (BD)BD™ Anti-Kappa (TB28-2) APC, BD™ Anti-Kappa (TB28-2) PE NCMDR
mdprc 015 05 22 000Becton Dickinson & Co. (BD)BD OneFlowNCMDR
mdprc 014 05 22 000Becton Dickinson & Co. (BD)BD Connecta™ Stopcock and BD Nexiva™ with BD Connecta™.NCMDR
mdprc 013 05 22 000MAQUET Inc.VOLISTA StandOp Surgical LightsNCMDR
SFDA
Please click on an item below to view.
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 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
mdprc 033 03 22 000Atrium Medical CorporationAtrium Advanta V12 Covered Stent Systemhttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-00419-1
mdprc 032 03 22 000Siemens Healthcare Diagnostics ProductHuman Chorionic Gonadotropin (HCG) IVDhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00341-1
mdprc 016 03 22 000Siemens Healthcare Diagnostics GmbHVarious Assays on Atellica CH 930 Analyzershttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RChttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-00302-1
mdprc 007 03 22 000SIEMENSARTIS icono biplane, ARTIS icono floor, and ARTIS pheno Systems with syngo Application Softwarehttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-00307-1
mdprc 027 02 22 000Pulsion Medical SystemsPiCCO Monitoring Kit, 150cm line 5/pkghttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00264-1
mdprc 022 02 22 000Instrumentation Laboratory SpAHemosIL AcuStar ADAMTS13 Activityhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00266-1
U.S FDA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
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
mdprc 033 08 21 000Pentax of America IncPentax Medical Video DuodenoscopeFDA