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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 030 02 21 000 | Schiller AG | FRED Easy defibrillator, FRED Easy Skity defibrillator | BfArM | | mdprc 029 02 21 000 | Recipe Chemicals & Instruments GMBH | ClinCal Whole Blood Calibrator for Immunosuppressants | BfArM | | mdprc 025 02 21 000 | Weinmann | MEDUMAT Transport emergency and transport ventilator | BfArM | | mdprc 017 02 21 000 | Molnlycke Health Care AB. | Mölnlycke® Procedure Trays & Single Packed Sterile Trocars | BfArM | | mdprc 016 02 21 000 | Nuvasive Specialized Orthopaedics Inc. | All Precice System Devices | BfArM |
NCMDR
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| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 003 03 21 000 | Ortho-Clinical Diagnostics | VITROS® Chemistry Products TIBC Kit | NCMDR | | mdprc 001 03 21 000 | Stryker | LIFEPAK® CR2 Defibrillator | NCMDR | | mdprc 009 10 20 001 | Acutronic Medical Systems AG | fabian HFO and fabian +nCPAP evolution ventilators | NCMDR, Swissmedic | | mdprc 028 02 21 000 | Biosense Webster Inc. | CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath | NCMDR | | mdprc 026 02 21 000 | Roche Diagnostics Corp | Anti-Xa (cobas t 511 / cobas t 711) | 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
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 002 03 21 000 | Olympus | OLYMPUS DUODENOVIDEOSCOPE, OLYMPUS EVIS EXERA III DUODENOVIDEOSCOPE, EVIS LUCERA ELITE DUODENOVIDEOSCOPE, and SINGLE USE DISTAL COVER | Swissmedic | | mdprc 027 02 21 000 | MicroVention Europe | PHIL (Precipitating Hydrophobic Injectable liquid) | Swissmedic | | mdprc 005 02 20 005 | Roche Diagnostics Corp | Elecsys CA 19-9 | NCMDR | | 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 |
TGA
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| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 036 12 20 001 | Radiometer Medical | All AQT90 FLEX analyzers with serial numbers of 393-838R0564 onwards and all E3800 spare part CPU units, 910-415 | BfArM | | mdprc 007 06 20 001 | Siemens Healthcare Diagnostics GmbH | Atellica IM 1300 Analyser / Atellica IM 1600 Analyser | TGA, Swissmedic | | mdprc 020 02 21 000 | SIEMENS | syngo.via software update VB20A | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00360-1 | | mdprc 018 02 21 000 | Siemens Healthcare Diagnostics GmbH | Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex Reagent Cartridge | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00323-1 | | mdprc 015 02 21 000 | SIEMENS | SOMATOM CT scanners running on syngo CT VB20A_SP3 | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00352-1 |
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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