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Competent Authorities Composite Listing
BfArM
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 035 11 22 000 | Lohmann & Rauscher | Vliwaktiv Absorbent activated charcoal dressing | BfArM | | mdprc 034 11 22 000 | Draeger Medical Systems Inc | Polaris Multimedia | BfArM | | mdprc 022 11 22 000 | Roche Diagnostics GmbH | VENTANA PD-L1 | BfArM | | mdprc 002 11 22 001 | Regen Lab SA | A-CP Kits Family, RegenKit-BCT Family | BfArM | | mdprc 012 11 22 000 | Siemens Healthcare Diagnostics Product | IMMULITE and IMMULITE 1000 | BfArM | | mdprc 001 11 22 000 | Huntleigh Healthcare | Sonicaid Freedom | BfArM | | mdprc 018 10 22 000 | Siemens Healthcare Diagnostics Inc | Atellica CH 930 Analyzer | BfArM | | mdprc 015 10 22 000 | Nutricia Medical Devices | Nutricia Flocare Infinity II enteral feeding pump | BfArM | | mdprc 020 09 22 000 | Lowenstein Medical GmbH &Co.KG | elisa 600/800/800VIT ventilator | BfArM | | mdprc 014 06 22 001 | Lohmann & Rauscher | Gauze compresses with x-ray thread | BfArM, NCMDR |
NCMDR
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
|---|
| mdprc 033 11 22 000 | BioMerieux Inc. | VIDAS PC software | NCMDR | | mdprc 032 11 22 000 | Nucletron B.V. | Oncentra Brachy | NCMDR | | mdprc 031 11 22 000 | Medtronic MiniMed. | Guardian App | NCMDR | | mdprc 030 11 22 000 | Tanaka Sangyo Co. Ltd. | KBM Digital Blood Pressure Monitor | NCMDR | | mdprc 028 11 22 000 | Randox Laboratories Ltd. | Specific Protein Control Level 1-3 | NCMDR | | mdprc 003 09 22 001 | Philips Respironics. | Amara View Minimal Contact Full-Face Mask, DreamWear Full Face Mask, DreamWisp Nasal Mask with Over the Nose Cushion, Wisp Nasal Masks and Wisp Youth Nasal Masks, Therapy Mask 3100 NC/SP | NCMDR | | mdprc 027 11 22 000 | Philips Healthcare. | Philips Fetal Spiral Electrode | NCMDR | | mdprc 026 11 22 000 | Philips Healthcare. | Ingenia Elition, SmartPath to Ingenia Elition X, MR 7700 and ‘Upgrade to MR 7700’ MR systems | NCMDR | | mdprc 025 11 22 000 | GE Healthcare. | Centricity Universal Viewer with PACS-IW foundation | NCMDR | | mdprc 024 11 22 000 | Becton Dickinson & Co. (BD) | BD Alaris Infusion Devices | NCMDR |
SFDA
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| Reference Number | Manufacturer | Device Type | Report Source |
|---|
| 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
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 005 02 20 007 | Roche Diagnostics Corp | Elecsys CA 19-9 | NCMDR | | 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 |
TGA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
|---|
| mdprc 029 11 22 000 | SIEMENS | Syngo.via with VB20, VB30, VB40, VB60 and VB70 software | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01330-1 | | mdprc 026 10 22 000 | FUJIFILM Medical Systems | Synapse PACS Version 5.x | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01311-1 | | mdprc 020 10 22 001 | Phadia Ltd | ImmunoCAP Allergen f76. | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01308-1 | | mdprc 016 10 22 000 | Siemens Healthcare Diagnostics GmbH | Atellica CH 930 Analyzer, Lithium and Lithium_2 | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01290-1 | | mdprc 014 10 22 000 | Cepheid | Xpert EV | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01236-1 | | mdprc 005 10 22 000 | ZOLL Medical Corp | Li-ion Battery Model 100 (AutoPulse brand) used with ZOLL’s AutoPulse Resuscitation System | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01270-1 | | 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 |
U.S FDA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
|---|
| mdprc 021 09 22 001 | Philips Healthcare | DigitalDiagnost C50 1.1 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=195576 | | mdprc 019 09 22 000 | ICU Medical, Inc. | MicroClave | http://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 22 000 | ICU Medical, Inc | ChemoLock Closed System Drug Transfer Device | https://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 22 001 | 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 |
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