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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 014 06 22 001 | Lohmann & Rauscher | Gauze compresses with x-ray thread | BfArM, NCMDR | | mdprc 011 08 22 000 | FUJIFILM Healthcare Corporation | SCENARIA View / Supria / Speedia | BfArM | | mdprc 010 08 22 000 | Waldemar LINK GmbH & Co | Endo-Model-M and Endo-Model SL (Tibial Components) | BfArM | | mdprc 009 08 22 000 | Siemens Healthcare Diagnostics Product | IMMULITE 2000, IMMULITE 2000 Xpi | BfArM | | mdprc 025 07 22 000 | Schiller AG | DEFIGARD Touch7 | BfArM | | mdprc 036 06 22 000 | Abbott | Merlin Patient Care System (PCS) and Merlin.net MN 5000 Remote Monitoring Application | BfArM | | mdprc 028 06 22 000 | SIEMENS | Sensis, Sensis Vibe Combo | BfArM | | mdprc 022 06 22 000 | Bohus BioTech AB | Microvisc 1%,Microvisc Plus 1,4%,Microvisc Phaco 2,5% | BfArM | | mdprc 019 06 22 000 | Instrumentation Laboratory SpA, a Werfen Company | ILab Taurus analyzers with software versions 1.20p (and up) and firmware version 2.06 (and up) | BfArM | | mdprc 030 05 22 000 | Siemens Healthcare Diagnostics GmbH | Atellica IM 1300/1600 Analyzer T3 Assay | BfArM |
NCMDR
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| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 016 09 22 000 | Integra LifeSciences Production Corporation | Codman CereLink ICP Monitor | NCMDR | | mdprc 023 11 21 001 | Medtronic Navigation, Inc. | Synergy Cranial (9733763) and StealthStation Cranial (9735585) | NCMDR | | mdprc 014 07 22 001 | Roche Diagnostics GmbH. | cobas pure e 402 analytical unit, cobas e 801 analytical unit, cobas pure sample supply unit, cobas pro sample supply unit, cobas pro SSU cobas 8000 core unit | NCMDR | | mdprc 015 09 22 000 | Gelita Medical GmbH | GELITA TUFT-IT® | NCMDR | | mdprc 014 09 22 000 | Carl Zeiss Meditec Inc. | ZEISS CLARUS | NCMDR | | mdprc 013 09 22 000 | bioMerieux Inc. | VIDAS® TB IGRA 60 TESTS | NCMDR | | mdprc 012 09 22 000 | Abbott | Alinity hq Analyzer, Alinity hs Slide Maker Stainer Module | NCMDR | | mdprc 011 09 22 000 | DiaMed GmbH. | IH-QC8 | NCMDR | | mdprc 010 09 22 000 | Abbott Vascular. | MitraClip™ G4 Clip Delivery System, MitraClip™ NTR/XTR Clip Delivery System, TriClipTM NT/XT Clip Delivery System, and TriClipTM G4 Clip Delivery System. | NCMDR | | mdprc 007 09 22 000 | Ortho-Clinical Diagnostics | VITROS Immunodiagnostic Products HIV Combo Reagent Pack (ROW), VITROS Immunodiagnostic Products HIV Combo Calibrators (ROW) | NCMDR |
SFDA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 050 03 22 000 | Cardia Innovation AB | CarbonAid Co2 Diffuser | SFDA | | 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 045 12 20 001 | DiaMed GmbH. | ID-DiaCell; ID-Dia Screen; ID-Dia Panel | Swissmedic, NCMDR | | mdprc 013 02 22 000 | bioMerieux Inc | VIDAS High sensitive Troponin I | Swissmedic | | mdprc 023 01 22 000 | Xstrahl Limited | Xstrahl X150 / Gulmay Medical 150 | Swissmedic | | mdprc 019 01 22 000 | Implantcast | AGILON glenoid components | Swissmedic | | mdprc 016 01 22 000 | Liko AB | Liko M220, Liko M230 | Swissmedic | | mdprc 002 03 21 001 | Olympus | OLYMPUS DUODENOVIDEOSCOPE, OLYMPUS EVIS EXERA III DUODENOVIDEOSCOPE, EVIS LUCERA ELITE DUODENOVIDEOSCOPE, and SINGLE USE DISTAL COVER | Swissmedic, BfArM | | mdprc 004 01 22 000 | MAQUET Cardiopulmonary GmbH | Heater-Cooler Unit HCU 40. | Swissmedic | | mdprc 002 01 22 003 | D.O.R.C. Dutch Opthalmic Research Center | EFTIAR Octane, syringes and vial, 5 ml and 7 ml | Swissmedic | | mdprc 001 01 22 000 | Abbott | Alinity m System | Swissmedic | | mdprc 027 12 21 000 | Abbott | Alinity m System | Swissmedic |
TGA
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| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 007 03 22 001 | SIEMENS | ARTIS icono biplane, ARTIS icono floor, and ARTIS pheno Systems with syngo Application Software | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=194235 | | mdprc 009 09 22 000 | Siemens Healthcare Diagnostics GmbH | Dimension Magnesium (MG) Flex reagent cartridge. | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01197-1 | | mdprc 008 09 22 000 | bioMerieux Inc | VIDAS 3 system | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01198-1 | | mdprc 006 09 22 000 | SIEMENS | Artis system | TGA | | mdprc 004 08 22 000 | SIEMENS | AXIOM Sensis XP, Sensis / Sensis Lite or Sensis Vibe Combo | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-00969-1 | | mdprc 032 07 22 000 | Smiths Medical International Limited | Level 1 Fast Fluid Flow Fluid Warmers | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-00850-1 | | mdprc 026 07 22 000 | Tandem Diabetes Care, Inc | t:slim X2 Insulin Pump | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00627-1 | | mdprc 008 07 22 000 | 3Shape Medical A/S. | 3Shape Implant Studio software | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00835-1 | | mdprc 007 07 22 000 | DiaMed GmbH. | ID-DiaPanel Plus 6 | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00844-1 | | mdprc 006 07 22 000 | Sysmex Corporation Japan | SP-50 slidemaker-stainer | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00724-1 |
U.S FDA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 021 06 22 001 | Instrumentation Laboratory SpA, a Werfen Company | ACL TOP 300 CTS, ACL TOP 350 CTS, ACL TOP 500 CTS, ACL TOP 550 CTS, and ACL TOP 970 CL | FDA, NCMDR | | mdprc 011 07 22 000 | Diagnos Inc. | CARA (Computer Assisted Retinal Analysis) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=192285 | | mdprc 019 05 22 000 | SIEMENS | SOMATOM with software syngo CT VA30A_SP4 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=192851 | | mdprc 039 03 22 000 | Bio-Rad Laboratories Inc | BioPlex 2200 SYPH T PACK Syphilis Total & RPR Reagent Pack & BioPlex 2200 Syphilis Total & RPR Calibrator Set CAL | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=192210 | | mdprc 021 03 22 000 | Smiths Medical International Limited. | Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=190636 | | mdprc 006 03 22 000 | Hill Rom Inc | NaviCare and Voalte Nurse Call Systems | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=189999 | | mdprc 026 12 21 000 | Wright Medical Technology, Inc. | Stryker CLAW II ORTHOLOC and Stryker DARCO Screw | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=190461 | | mdprc 019 11 21 000 | Hitachi Ltd. | Arietta 850 Ultrasound; Lisendo 880 Ultrasound | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=189705 | | mdprc 015 11 21 000 | Dentech Corp. | Rubber Dam Clamp, KSK | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=187238 | | mdprc 022 09 21 000 | Siemens Healthcare Diagnostics, Inc | Atellica IM BR 27.29 (BR) Assay 250 Test Kit | US. FDA |
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