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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
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Reference NumberManufacturerDevice TypeReport Source
mdprc 001 02 23 000Schiller AGAT-102 / AT-102 plus / AT-10 plus /AT-104 PC / AT-104 PC ErgoSpiro MS-2007 / MS-2010 / MS-2015 / CS-200 / CS-200 ErgoSpiroBfArM
mdprc 014 01 23 000Draeger Medical Systems IncNovaStar plus and Nova Star TSBfArM
mdprc 013 01 23 000WeinmannMEDUMAT Standard²BfArM
mdprc 009 01 23 000FUJIFILM Medical SystemsDR-XD 1000(FDR Nano) BfArM
mdprc 041 12 22 000Draeger Medical Systems IncZeus, Zeus IE, and Zeus Kit C500 Anesthesia Workstations with DIVA Sevoflurane ModulesBfArM
mdprc 038 12 22 000Leica Biosystems Newcastle LtdNovocastra Liquid Mouse Monoclonal Antibody Muscle Specific ActinBfArM
mdprc 032 12 22 000Cooper Surgical Inc.NEO-fit Neonatal Endotracheal Tube GripBfArM
mdprc 022 12 22 000Ivoclar Vivadent AG..VivaPen Snap-On Cannula and Adhese Universal in the VivapenBfArM
mdprc 021 12 22 000ENDO-FLEX GmbHBiopsy Forceps SUBfArM
mdprc 014 12 22 000HUMAN Gesellschaft für Biochemica und Diagnostica GmbHHumaTex RF complete kit & RF Latex ReagentBfArM
NCMDR
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 020 01 23 000Intuitive Surgical Inc.da Vinci X/Xi SureForm 45 and SureForm 60 StaplersNCMDR
mdprc 020 03 22 001Abbott Molecular Inc.Alinity m HBV AMP Kit and Alinity m HBV Application Specification FileNCMDR
mdprc 002 10 22 001Becton Dickinson & Co. (BD)BD Trucount™ TubesNCMDR
mdprc 019 01 23 000Becton Dickinson & Co. (BD)BD Alaris™ System PC Unit 8015; Alaris™ PC Unit 8015NCMDR
mdprc 079 06 19 002MAQUET Cardiovascular LLCDatascope Intra-Aortic Balloon PumpsNCMDR
mdprc 004 06 22 002Philips HealthcarePhilips V680 VentilatorNCMDR
mdprc 018 01 23 000Dragerwerk AG & Co. KGaAAnesthes ia Set Flex, Anesthesia Set Flex CHN, Vent Set FlexNCMDR
mdprc 017 01 23 000Beckman CoulterAccess 2 Immunoassay Analyzer, Access 2 Section, DxC 600iNCMDR
mdprc 016 01 23 000Siemens Healthcare Diagnostics Atellica IM FolateNCMDR
mdprc 015 01 23 000Siemens Healthcare Diagnostics Inc.ADVIA Centaur® XP, ADVIA Centaur® XPTNCMDR
SFDA
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Reference NumberManufacturerDevice TypeReport Source
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
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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
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Reference NumberManufacturerDevice TypeReport Source
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
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
U.S FDA
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Reference NumberManufacturerDevice TypeReport Source
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
mdprc 006 03 22 000Hill Rom IncNaviCare and Voalte Nurse Call Systemshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=189999