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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 035 11 22 000Lohmann & RauscherVliwaktiv Absorbent activated charcoal dressingBfArM
mdprc 034 11 22 000Draeger Medical Systems IncPolaris MultimediaBfArM
mdprc 022 11 22 000Roche Diagnostics GmbHVENTANA PD-L1BfArM
mdprc 002 11 22 001Regen Lab SAA-CP Kits Family, RegenKit-BCT FamilyBfArM
mdprc 012 11 22 000Siemens Healthcare Diagnostics ProductIMMULITE and IMMULITE 1000BfArM
mdprc 001 11 22 000Huntleigh HealthcareSonicaid FreedomBfArM
mdprc 018 10 22 000Siemens Healthcare Diagnostics IncAtellica CH 930 AnalyzerBfArM
mdprc 015 10 22 000Nutricia Medical DevicesNutricia Flocare Infinity II enteral feeding pumpBfArM
mdprc 020 09 22 000Lowenstein Medical GmbH &Co.KGelisa 600/800/800VIT ventilatorBfArM
mdprc 014 06 22 001Lohmann & RauscherGauze compresses with x-ray threadBfArM, NCMDR
NCMDR
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 033 11 22 000BioMerieux Inc.VIDAS PC software NCMDR
mdprc 032 11 22 000Nucletron B.V.Oncentra BrachyNCMDR
mdprc 031 11 22 000Medtronic MiniMed.Guardian AppNCMDR
mdprc 030 11 22 000Tanaka Sangyo Co. Ltd.KBM Digital Blood Pressure MonitorNCMDR
mdprc 028 11 22 000Randox Laboratories Ltd.Specific Protein Control Level 1-3NCMDR
mdprc 003 09 22 001Philips Respironics.Amara 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 027 11 22 000Philips Healthcare.Philips Fetal Spiral ElectrodeNCMDR
mdprc 026 11 22 000Philips Healthcare.Ingenia Elition, SmartPath to Ingenia Elition X, MR 7700 and ‘Upgrade to MR 7700’ MR systemsNCMDR
mdprc 025 11 22 000GE Healthcare.Centricity Universal Viewer with PACS-IW foundationNCMDR
mdprc 024 11 22 000Becton Dickinson & Co. (BD)BD Alaris Infusion DevicesNCMDR
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
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 029 11 22 000SIEMENSSyngo.via with VB20, VB30, VB40, VB60 and VB70 softwarehttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01330-1
mdprc 026 10 22 000FUJIFILM Medical SystemsSynapse PACS Version 5.xhttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01311-1
mdprc 020 10 22 001Phadia LtdImmunoCAP Allergen f76.https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01308-1
mdprc 016 10 22 000Siemens Healthcare Diagnostics GmbHAtellica CH 930 Analyzer, Lithium and Lithium_2https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01290-1
mdprc 014 10 22 000CepheidXpert EVhttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01236-1
mdprc 005 10 22 000ZOLL Medical CorpLi-ion Battery Model 100 (AutoPulse brand) used with ZOLL’s AutoPulse Resuscitation Systemhttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01270-1
mdprc 007 03 22 001SIEMENSARTIS icono biplane, ARTIS icono floor, and ARTIS pheno Systems with syngo Application Softwarehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=194235
mdprc 009 09 22 000Siemens Healthcare Diagnostics GmbHDimension Magnesium (MG) Flex reagent cartridge.https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01197-1
mdprc 008 09 22 000bioMerieux IncVIDAS 3 systemhttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01198-1
mdprc 006 09 22 000SIEMENSArtis systemTGA
U.S FDA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
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
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