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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 011 08 22 000FUJIFILM Healthcare CorporationSCENARIA View / Supria / SpeediaBfArM
mdprc 010 08 22 000Waldemar LINK GmbH & CoEndo-Model-M and Endo-Model SL (Tibial Components)BfArM
mdprc 009 08 22 000Siemens Healthcare Diagnostics ProductIMMULITE 2000, IMMULITE 2000 XpiBfArM
mdprc 025 07 22 000Schiller AGDEFIGARD Touch7BfArM
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
NCMDR
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Reference NumberManufacturerDevice TypeReport Source
mdprc 012 08 22 000bioMerieux Inc.VITEK® 2 SystemNCMDR
mdprc 008 08 22 000Gelita Medical GmbHGELITA-SPON® STANDARD, GELITA-SPON® RAPID3, GELITA® ENT X-BLOD, GELITA® ENT X-DENSE, GELITA® ENT X-PAND, GELITA® ENT X-PASTE, GELITA-SPON® POWDERNCMDR
mdprc 025 06 22 001Medtronic SAMedtronic Cobalt XT™, Cobalt™ and Crome™ Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds)NCMDR
mdprc 039 03 19 002GE HealthcareGiraffe Bedded Warmer/Panda iRes Warmer NCMDR
mdprc 007 08 22 000GetingeInsertion Kit for use with SENSATION PLUS 8Fr. 50cc IAB, SENSATION PLUS 8Fr. 50cc IAB Catheter, MEGA 8Fr. 50cc IAB Catheter.NCMDR
mdprc 006 08 22 000Philips HealthcareAmara View Minimal Contact Full-Face Mask, DreamWear Full Face Mask, DreamWisp Nasal Mask with Over the Nose Cushion, Wisp Nasal Masks and Wisp Youth Nasal Masks, Therapy Mask 3100 NC/SPNCMDR
mdprc 005 08 22 000Smiths Medical International LimitedLevel 1® H-2 Pressure ChambersNCMDR
mdprc 003 08 22 000Intuitive Surgical Inc.da Vinci EndoWrist Clip Applier InstrumentsNCMDR
mdprc 002 08 22 000Immucor GmbH.Automated immuClone Anti-K (Kell) IgM.NCMDR
mdprc 001 08 22 000Randox Laboratories Ltd.Evidence + AnalyserNCMDR
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
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 004 08 22 000SIEMENSAXIOM Sensis XP, Sensis / Sensis Lite or Sensis Vibe Combohttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-00969-1
mdprc 032 07 22 000Smiths Medical International LimitedLevel 1 Fast Fluid Flow Fluid Warmershttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-00850-1
mdprc 026 07 22 000Tandem Diabetes Care, Inct:slim X2 Insulin Pumphttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00627-1
mdprc 008 07 22 0003Shape Medical A/S.3Shape Implant Studio softwarehttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00835-1
mdprc 007 07 22 000DiaMed GmbH.ID-DiaPanel Plus 6https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00844-1
mdprc 006 07 22 000Sysmex Corporation JapanSP-50 slidemaker-stainerhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00724-1
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
U.S FDA
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Reference NumberManufacturerDevice TypeReport Source
mdprc 021 06 22 001Instrumentation Laboratory SpA, a Werfen CompanyACL TOP 300 CTS, ACL TOP 350 CTS, ACL TOP 500 CTS, ACL TOP 550 CTS, and ACL TOP 970 CLFDA, NCMDR
mdprc 011 07 22 000Diagnos Inc.CARA (Computer Assisted Retinal Analysis)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=192285
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