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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 018 05 23 001Illumina IncNextSeq 550 Dx and MiSeq Dx instrumentsBfArM
mdprc 012 12 23 000Karl Storz Endoscopy UK LtdMultiple products by Karl Storz BfArM
mdprc 042 08 23 000HAMILTON MEDICAL AGHamilton Medical Ventilators HAMILTON-C1/T1/C2/C3 with Neonatal OptionBfArM
mdprc 024 08 23 000ArthrexKNEE SCORPIONBfArM
mdprc 021 08 23 000Diatron MI PlcDiacon 3 hematology control ( (Low) 6x, (Normal), (High) 6 )BfArM
mdprc 020 08 23 000Ethicon, Inc.PDS TM II (polydioxanone) Suture, PDS TM Plus Antibacterial (polydioxanone) SutureBfArM
mdprc 014 08 23 000W.L. Gore & Associates Inc.Gore tips setBfArM
mdprc 012 08 23 000Drager Medical Systems IncFilter/HME TwinStar® PlusBfArM
mdprc 025 07 23 000Omixon Biocomputing Ltd.Omixon HLA Twin BfArM
mdprc 022 07 23 000CellaVision-RAL DiagnosticsBuffer solution for SP automated systemsBfArM
NCMDR
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 026 02 24 000Philips Healthcare (Suzhou) Co., Ltd.DIVA 24 Inch Widescreen LCD Touch DisplayNCMDR
mdprc 025 02 24 000ABIOMED Inc.Impella 5.5® with SmartAssist®
Impella CP® with SmartAssist, Impella CP®
NCMDR
mdprc 024 02 24 000Randox Laboratories Ltd.Cystatin C CalibratorNCMDR
mdprc 023 02 24 000Beckman CoulterAccess SubstrateNCMDR
mdprc 022 02 24 000BioFire Diagnostics IncBIOFIRE FilmArray Pneumonia Panel Plus (Pneumoplus), BIOFIRE FilmArray Pneumonia Panel (Pneumo)NCMDR
mdprc 021 02 24 000Lowenstein Medical GmbH &Co.KGLUISA, TIVAN LS, Life OneNCMDR
mdprc 020 02 24 000bioMerieux IncGastrointestinal (GI) PanelNCMDR
mdprc 019 02 24 000Globus Medical, IncExcelsiusGPSNCMDR
mdprc 023 05 23 001Philips HealthcareMobileDiagnost wDRNCMDR
mdprc 018 02 24 000Arrow International LLCArrow QuickFlash Radial Artery Catheterisation kits and Sets
Arrow® QuickFlash® Radial Artery/Arterial Line Catheterisation Kit
NCMDR
SFDA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 028 01 24 000Shanghai Kinmed Import & Export Co., Ltd.Cotton Wool rollsSFDA
mdprc 024 01 24 000Yiwu Hongqian Technology Industry CompanyGases connector hoseSFDA
mdprc 047 12 23 000Meril Life Sciences Pvt. Ltd.Myval Transcatheter Heart Valve SystemSFDA
mdprc 003 12 23 000Saudi Mais for Medical Products3-Way Stopcock with/witout Extension TubeSFDA
mdprc 040 11 23 000Becton Dickinson & Co. (BD)XenMatrix™ Surgical GraftSFDA
mdprc 029 11 23 000STERIS CorporationSurgical lighting systemSFDA
mdprc 009 11 23 000Kashaf Alkawashef For Industry CompanyPSYCHOACTIVE CLINICAL TOXICOLOGY - Liquid Control UrineSFDA
mdprc 027 10 23 000New.Fa.Dem. SrlHONEYGO Micro-enema - Easylax Enema- Isipeg suppositories- Redulex baby suppositoriesSFDA
mdprc 010 09 23 000ARW Manufacturing CompanyARW Alcohol Prep PadsSFDA
mdprc 009 09 23 000Saudi Mais for Medical ProductsSodium BicarbonateSFDA
Swissmedic
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 013 06 21 001Boston Scientific CorporationINGENIO, VITALIO, and ADVANTIO pacemakers and INLIVEN, INTUA, and INVIVE cardiac resynchronization therapy pacemakers (CRT-Ps)Swissmedic, NCMDR
mdprc 005 02 20 007Roche Diagnostics CorpElecsys CA 19-9NCMDR
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
TGA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 001 10 23 000ICU Medical, IncPlum 360 Infusion System https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00607-1
mdprc 004 09 23 000Shenzhen Mindray Bio-medical Electronics Co., Ltd,SV600/800 Mindray Ventilatorhttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00730-1
mdprc 002 09 23 000Siemens Medical SolutionsACUSON Redwood 2.0 ultrasound systems - 18L6 transducerTGA
mdprc 039 08 23 000Ortho-Clinical DiagnosticsORTHO Sera Anti-Lea Murine Monoclonal IgM.https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00742-1
mdprc 018 08 23 000Instrumentation Laboratory SpA, a Werfen CompanyACL TOP https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00591-1
mdprc 011 08 23 000Draeger Medical Systems IncBabyleo TN500 IncuWarmerhttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00352-1
mdprc 016 10 22 001Siemens Healthcare Diagnostics GmbHAtellica CH 930 Analyzer, Lithium and Lithium_2BfArM
mdprc 002 08 23 000Bio-Rad Laboratories IncLiquichek Pediatric Control. https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00649-1
mdprc 029 07 23 000Ventana Medical SystemsUltraView Universal AP Red Detection Kithttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00561-1
mdprc 033 03 22 001Atrium Medical CorporationAtrium Advanta V12 Covered Stent Systemhttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-00419-1
U.S FDA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 027 06 23 000SIEMENSLuminos Agile Max.
Luminos dRF Max
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=199944
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=199947
mdprc 021 05 23 000DermLite LLCDERMLITE DL4Whttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=199376
mdprc 039 12 22 000Hill Rom IncHill-Rom Progressa Bed SystemFDA
mdprc 021 09 22 001Philips HealthcareDigitalDiagnost C50 1.1 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=195576
mdprc 019 09 22 000ICU Medical, Inc.MicroClavehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=195578
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=195579
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=195572
http://www.accessda
mdprc 017 09 22 000ICU Medical, IncChemoLock Closed System Drug Transfer Devicehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=195731
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=195036
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