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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 028 06 21 000Accelerate Diagnostics IncAccelerate Pheno system.BfArM
mdprc 020 06 21 000G. Heinemann Medizintechnik GmbHMODULA series ENT treatment unitsBfArM
mdprc 016 06 21 000Delta Med spaMedical devices within shelf life that were sterilized at Steril Milano.BfArM
mdprc 007 06 21 000ConMed CorporationBuffalo Filter® LaparoVue® Visibility SystemBfArM
mdprc 003 06 21 000CeramOptec GmbH Sub biolitec AGFiLaC® Fistula Kit, LHP® Procedure Kit, HeLP® Procedure KitBfArM
NCMDR
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Reference NumberManufacturerDevice TypeReport Source
mdprc 037 06 21 000HTL-STREFA S.A.Droplet pen needleNCMDR
mdprc 036 06 21 000AbbottSecondary Tubes (Push)NCMDR
mdprc 035 06 21 000GE HealthcareRevolution CT systemNCMDR
mdprc 034 06 21 000Philips HealthcareV60/V60 Plus VentilatorsNCMDR
mdprc 031 06 21 000DiaSorin IncLIAISON IGF-INCMDR
SFDA
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Reference NumberManufacturerDevice TypeReport Source
mdprc 126 05 18 000Philips HealthcareHeartStart FRx, HeartStart Home, and Heartstart OnSite AEDsSFDA
Swissmedic
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Reference NumberManufacturerDevice TypeReport Source
mdprc 023 06 21 000Randox Laboratories Ltd.NEFA (Non-esterified fatty acid)Swissmedic
mdprc 022 06 21 000Cerus CorporationINTERCEPT Blood System for Plasma, Processing Set for PlasmaSwissmedic
mdprc 035 08 20 001Siemens Healthcare Diagnostics GmbHDimension® EXL™ integrated chemistry system, LOCI Module Swissmedic
mdprc 017 06 21 000bioMerieux IncVIDAS® Anti-HBs Total IISwissmedic
mdprc 013 06 21 000Boston Scientific CorporationINGENIO, VITALIO, and ADVANTIO pacemakers and INLIVEN, INTUA, and INVIVE cardiac resynchronization therapy pacemakers (CRT-Ps)Swissmedic
TGA
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Reference NumberManufacturerDevice TypeReport Source
mdprc 032 06 21 000Siemens Healthcare Diagnostics GmbHAtellica CH 930 Analyser, Atellica IM 1300 Analyser and Atellica IM 1600 Analyserhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01278-1
mdprc 011 06 21 000Siemens Healthcare DiagnosticsAtellica UAS 800 Urine Sediment Analyser and Atellica 1500 Automated Urinalysis Systemhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01232-1
mdprc 016 05 21 000Beckman CoulterAccess Sensitive Estradiolhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01015-1
mdprc 009 05 21 000Beckman CoulterAccess 25(OH) Vitamin D Total for use in Access 2 and DxI Immunoassay systemshttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00958-1
mdprc 008 05 21 000Beckman CoulterAccess Sensitive Estradiolhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00961-1
U.S FDA
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Reference NumberManufacturerDevice TypeReport Source
mdprc 033 06 21 000Fujifilm Medical Systems U.S.A., Inc.Synapse PACS - Radiological Image Processing Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=186333
mdprc 021 06 21 000Terumo Cardiovascular Systems CorporationSarns TCM II and TCM & Terumo HX2 Temperature Management SystemU.S. FDA
mdprc 019 10 20 001ESAOTE S.P.AAC/DC POWER SUPPLY for 7400NCMDR
mdprc 036 10 20 000Quidel CorporationSofia SARS Antigen FIA Package Inserthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=183267
mdprc 034 10 20 000Gentian AS.Gentian Cystatin C Immunoassayhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=183752