X
OK Your changes have been successfully saved
SFDA Home Page
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 008 06 23 000UFSK-International OSYS GmbhTreatment chairs 500 XLEBfArM
mdprc 019 05 23 000Huntleigh HealthcareTeam3 Fetal MonitorBfArM
mdprc 018 05 23 000Illumina IncNextSeq 550 Dx and MiSeq Dx instrumentsBfArM
mdprc 011 05 23 000PTW-Freiburg Physikalisch-Technische Werkstatten Dr. Pychlau GmbHPTW ArrayCal - module of BeamAdjustBfArM
mdprc 016 04 23 000Draeger Medical Systems IncSeattle PAP plus, Neo disposable breathing systems, Coax ventilation hoses, Pediatric disposable breathing systems, Set2Go & Pack2GoBfArM
mdprc 014 04 23 000Instrumentation Laboratory SpA, a Werfen CompanyACL ELITE/ELITE PRO HEMOSTASIS TESTING SYSTEMSBfArM
mdprc 013 04 23 000Reproline medical GmbHSOFT DENUDATION TIPS AND FOLLICLE PUNCTION SYSTEMSBfArM
mdprc 012 04 23 000Samsung ElectronicsDigital Diagnostic Mobile X-ray System GM85BfArM
mdprc 024 03 23 000Draeger Medical Systems IncInfinity CentralStation, Infinity M300/M300+BfArM
mdprc 023 03 23 000ColoplastTitan Inflatable Penile ProsthesisBfArM
NCMDR
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 010 06 23 000Sentinel.CH.SpACALiaGold® Calibrator, CALiaGold® Control Set, CALiaGold® Sample DiluentNCMDR
mdprc 009 06 23 000Neurologica Corp.OmniTom and OmniTom EliteNCMDR
mdprc 005 06 23 000Philips HealthcareIntelliVue G7m Anesthesia Gas ModulesNCMDR
mdprc 032 06 22 001Medtronic SAHeartWare™ Ventricular Assist Device (HVAD™) SystemNCMDR
mdprc 004 06 23 000Full Vision, Inc.Treadmill TMX428 110V, Treadmill TMX428 220V, Treadmill TMX428CP 110V, Treadmill TMX428CP 220VNCMDR
mdprc 003 06 23 000Siemens Healthcare Diagnostics Inc.Aptio AutomationNCMDR
mdprc 002 06 23 000Siemens Healthcare Diagnostics GmbHAptio AutomationNCMDR
mdprc 001 06 23 000Cook Medical Europe LimitedHemospray Endoscopic HemostatNCMDR
mdprc 031 05 23 000Gyrus ACMIUroPass® Ureteral Access SheathNCMDR
mdprc 029 05 23 000Philips HealthcareINTELLIVUE MX40 PATIENT MONITORNCMDR
SFDA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 012 06 23 000Guilin Woodpecker Medical Instrument Co., LtdI-sensor/H2SFDA
mdprc 006 06 23 000Unknown (Not registered)Articulating PaperSFDA-0021-2023
mdprc 008 04 23 000Saudi Mais for Medical ProductsSyringeSFDA
mdprc 008 02 23 000Pregna International Ltd.Silverline Cu 380 AgSFDA
mdprc 027 12 22 000APOLLOTi-Base (Uniabutment)SFDA
mdprc 015 12 22 000MEDEXFlowSensSFDA
mdprc 012 12 22 000Shifaa United for Medical DevicesUnomed Calcium Alginate DressingSFDA
mdprc 003 12 22 000OPTOFLEX S.r.lCOMFORT PLUS Soft+HA (CONTACT LENSES SOUOLTUION)SFDA
mdprc 050 03 22 000Cardia Innovation ABCarbonAid Co2 DiffuserSFDA
mdprc 126 05 18 000Philips HealthcareHeartStart FRx, HeartStart Home, and Heartstart OnSite AEDsSFDA
Swissmedic
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
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
mdprc 001 01 22 000AbbottAlinity m SystemSwissmedic
TGA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 030 05 23 000Biocartis NV.BRAF Mutation Assayhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00328-1
mdprc 009 03 23 000SebiaCAPILLARYS 3 TERA, CAPILLARYS 3 OCTAhttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01399-1
mdprc 029 11 22 001SIEMENSSyngo.via with VB20, VB30, VB40, VB60 and VB70 softwarehttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00043-1
mdprc 006 01 23 000Agilent Technologies, Inc.Dako CoverStainer CS10030https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-01581-1
mdprc 044 12 22 000AGFA Corp.Enterprise Imaging XERO Viewerhttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01511-1
mdprc 040 12 22 000Philips HealthcarePhilips 12-Lead Chest Lead-sethttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01345-1
mdprc 013 12 22 000DiaMed GmbH.ID-DiaPanelhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-01445-1
mdprc 008 12 22 000Ortho-Clinical DiagnosticsVITROS Immunodiagnostic Products Intact PTH Reagent Packhttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01472-1
mdprc 007 12 22 000OlympusEndoeye Flex 3d Deflectable Videoscope, LTF-190-10-3Dhttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01441-1
mdprc 006 12 22 000SIEMENSSensis, Sensis Vibe Hemo, Sensis Vibe Combohttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-01459-1
U.S FDA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
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
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