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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 001 02 23 000 | Schiller AG | AT-102 / AT-102 plus / AT-10 plus /AT-104 PC / AT-104 PC ErgoSpiro MS-2007 / MS-2010 / MS-2015 / CS-200 / CS-200 ErgoSpiro | BfArM | | mdprc 014 01 23 000 | Draeger Medical Systems Inc | NovaStar plus and Nova Star TS | BfArM | | mdprc 013 01 23 000 | Weinmann | MEDUMAT Standard² | BfArM | | mdprc 009 01 23 000 | FUJIFILM Medical Systems | DR-XD 1000(FDR Nano) | BfArM | | mdprc 041 12 22 000 | Draeger Medical Systems Inc | Zeus, Zeus IE, and Zeus Kit C500 Anesthesia Workstations with DIVA Sevoflurane Modules | BfArM | | mdprc 038 12 22 000 | Leica Biosystems Newcastle Ltd | Novocastra Liquid Mouse Monoclonal Antibody Muscle Specific Actin | BfArM | | mdprc 032 12 22 000 | Cooper Surgical Inc. | NEO-fit Neonatal Endotracheal Tube Grip | BfArM | | mdprc 022 12 22 000 | Ivoclar Vivadent AG.. | VivaPen Snap-On Cannula and Adhese Universal in the Vivapen | BfArM | | mdprc 021 12 22 000 | ENDO-FLEX GmbH | Biopsy Forceps SU | BfArM | | mdprc 014 12 22 000 | HUMAN Gesellschaft für Biochemica und Diagnostica GmbH | HumaTex RF complete kit & RF Latex Reagent | BfArM |
NCMDR
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| Reference Number | Manufacturer | Device Type | Report Source |
|---|
| mdprc 020 01 23 000 | Intuitive Surgical Inc. | da Vinci X/Xi SureForm 45 and SureForm 60 Staplers | NCMDR | | mdprc 020 03 22 001 | Abbott Molecular Inc. | Alinity m HBV AMP Kit and Alinity m HBV Application Specification File | NCMDR | | mdprc 002 10 22 001 | Becton Dickinson & Co. (BD) | BD Trucount™ Tubes | NCMDR | | mdprc 019 01 23 000 | Becton Dickinson & Co. (BD) | BD Alaris™ System PC Unit 8015; Alaris™ PC Unit 8015 | NCMDR | | mdprc 079 06 19 002 | MAQUET Cardiovascular LLC | Datascope Intra-Aortic Balloon Pumps | NCMDR | | mdprc 004 06 22 002 | Philips Healthcare | Philips V680 Ventilator | NCMDR | | mdprc 018 01 23 000 | Dragerwerk AG & Co. KGaA | Anesthes ia Set Flex, Anesthesia Set Flex CHN, Vent Set Flex | NCMDR | | mdprc 017 01 23 000 | Beckman Coulter | Access 2 Immunoassay Analyzer, Access 2 Section, DxC 600i | NCMDR | | mdprc 016 01 23 000 | Siemens Healthcare Diagnostics | Atellica IM Folate | NCMDR | | mdprc 015 01 23 000 | Siemens Healthcare Diagnostics Inc. | ADVIA Centaur® XP, ADVIA Centaur® XPT | NCMDR |
SFDA
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| Reference Number | Manufacturer | Device Type | Report Source |
|---|
| mdprc 027 12 22 000 | APOLLO | Ti-Base (Uniabutment) | SFDA | | mdprc 015 12 22 000 | MEDEX | FlowSens | SFDA | | mdprc 012 12 22 000 | Shifaa United for Medical Devices | Unomed Calcium Alginate Dressing | SFDA | | mdprc 003 12 22 000 | OPTOFLEX S.r.l | COMFORT PLUS Soft+HA (CONTACT LENSES SOUOLTUION) | SFDA | | 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 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
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| Reference Number | Manufacturer | Device Type | Report Source |
|---|
| mdprc 029 11 22 001 | SIEMENS | Syngo.via with VB20, VB30, VB40, VB60 and VB70 software | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00043-1 | | mdprc 006 01 23 000 | Agilent Technologies, Inc. | Dako CoverStainer CS10030 | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-01581-1 | | mdprc 044 12 22 000 | AGFA Corp. | Enterprise Imaging XERO Viewer | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01511-1 | | mdprc 040 12 22 000 | Philips Healthcare | Philips 12-Lead Chest Lead-set | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01345-1 | | mdprc 013 12 22 000 | DiaMed GmbH. | ID-DiaPanel | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-01445-1 | | mdprc 008 12 22 000 | Ortho-Clinical Diagnostics | VITROS Immunodiagnostic Products Intact PTH Reagent Pack | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01472-1 | | mdprc 007 12 22 000 | Olympus | Endoeye Flex 3d Deflectable Videoscope, LTF-190-10-3D | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01441-1 | | mdprc 006 12 22 000 | SIEMENS | Sensis, Sensis Vibe Hemo, Sensis Vibe Combo | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-01459-1 | | 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 |
U.S FDA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 039 12 22 000 | Hill Rom Inc | Hill-Rom Progressa Bed System | FDA | | 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 |
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