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Competent Authorities Composite Listing
BfArM
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| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 007 01 21 000 | Unimax Medical Systems Inc | Hasson Trocar | BfArM | | mdprc 022 10 20 001 | Molnlycke Health Care AB. | Procedure Trays & Single Packed Shielded Bladed Trocars | BfArM | | mdprc 021 12 20 000 | SIEMENS | Artis zee/Q/Q.zen systems with software version VD11E | BfArM | | mdprc 016 12 20 000 | Medos Medizintechnik AG.. | Novatherm / Deltastream HC | BfArM | | mdprc 015 12 20 000 | Implantcast | EcoFit cup cementless / EcoFit cup EPORE cementless | BfArM |
NCMDR
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| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 015 01 21 000 | Olympus | Colonovideoscope and Gastrointestinal Videoscope | NCMDR | | mdprc 014 01 21 000 | Medtronic | Medtronic Strata II, Delta, and CSF-Flow Control Valves and Shunts | NCMDR | | mdprc 013 01 21 000 | OxyNov inc | FREE O2 Automated Oxygen Therapy Device | NCMDR | | mdprc 012 01 21 000 | DexCom Inc | G6 Sensors | NCMDR | | mdprc 011 01 21 000 | Cardinal Health | Cardinal Health Isolation Gowns, Lab Coats, and Kendall Gowns | NCMDR |
SFDA
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| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 126 05 18 000 | Philips Healthcare | HeartStart FRx, HeartStart Home, and Heartstart OnSite AEDs | SFDA |
Swissmedic
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| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 024 12 20 001 | Siemens Healthcare Diagnostics GmbH | Atellica IM 1300 Analyzer, Atellica IM 1600 Analyzer, and Atellica CH 930 Analyzer | Swissmedic | | mdprc 003 01 21 000 | QIAGEN Ltd | QIAstat-Dx Respiratory SARS-CoV-2 Panel | Swissmedic | | mdprc 045 12 20 000 | DiaMed GmbH. | ID-DiaCell; ID-Dia Screen; ID-Dia Panel | Swissmedic | | mdprc 044 12 20 000 | Argon Medical Devices Inc. | TLAB Transjugular Liver Biopsy System | Swissmedic | | mdprc 032 12 20 000 | Becton Dickinson & Co. (BD) | BD Syringes and Needles | Swissmedic |
TGA
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| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 004 02 20 003 | Siemens Healthcare Diagnostics Inc | Atellica CH Reaction Cuvette Segment | Swissmedic | | mdprc 005 01 21 000 | Becton Dickinson & Co. (BD) | Alaris GP Volumetric Pump with Plus software | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-01389-1 | | mdprc 051 05 19 001 | Medtronic | Medtronic HeartWare Monitor AC Adapter | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-01420-1 | | mdprc 036 12 20 000 | Radiometer Medical | All AQT90 FLEX analyzers with serial numbers of 393-838R0564 onwards and all E3800 spare part CPU units, 910-415 | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-01399-1 | | mdprc 035 12 20 000 | Terumo BCT Inc | Spectra Optia Apheresis System | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-01359-1 |
U.S FDA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 036 10 20 000 | Quidel Corporation | Sofia SARS Antigen FIA Package Insert | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=183267 | | mdprc 034 10 20 000 | Gentian AS. | Gentian Cystatin C Immunoassay | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=183752 | | mdprc 026 10 20 000 | Beckman Coulter | UIBC System reagent | U.S. FDA | | mdprc 019 10 20 000 | ESAOTE S.P.A | AC/DC POWER SUPPLY for 7400 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=183272 | | mdprc 002 06 19 003 | Teleflex Medical | RUSCH LASERTUBE (Rubber) | NCMDR |
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