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Competent Authorities Composite Listing
BfArM
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
|---|
| mdprc 019 05 23 000 | Huntleigh Healthcare | Team3 Fetal Monitor | BfArM | | mdprc 018 05 23 000 | Illumina Inc | NextSeq 550 Dx and MiSeq Dx instruments | BfArM | | mdprc 011 05 23 000 | PTW-Freiburg Physikalisch-Technische Werkstatten Dr. Pychlau GmbH | PTW ArrayCal - module of BeamAdjust | BfArM | | mdprc 016 04 23 000 | Draeger Medical Systems Inc | Seattle PAP plus, Neo disposable breathing systems, Coax ventilation hoses, Pediatric disposable breathing systems, Set2Go & Pack2Go | BfArM | | mdprc 014 04 23 000 | Instrumentation Laboratory SpA, a Werfen Company | ACL ELITE/ELITE PRO HEMOSTASIS TESTING SYSTEMS | BfArM | | mdprc 013 04 23 000 | Reproline medical GmbH | SOFT DENUDATION TIPS AND FOLLICLE PUNCTION SYSTEMS | BfArM | | mdprc 012 04 23 000 | Samsung Electronics | Digital Diagnostic Mobile X-ray System GM85 | BfArM | | mdprc 024 03 23 000 | Draeger Medical Systems Inc | Infinity CentralStation, Infinity M300/M300+ | BfArM | | mdprc 023 03 23 000 | Coloplast | Titan Inflatable Penile Prosthesis | BfArM | | mdprc 007 02 23 000 | Tracoe medical GmbH | TRACOE experc Set twist, twist plus, vario | BfArM |
NCMDR
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
|---|
| mdprc 005 06 23 000 | Philips Healthcare | IntelliVue G7m Anesthesia Gas Modules | NCMDR | | mdprc 032 06 22 001 | Medtronic SA | HeartWare™ Ventricular Assist Device (HVAD™) System | NCMDR | | mdprc 004 06 23 000 | Full Vision, Inc. | Treadmill TMX428 110V, Treadmill TMX428 220V, Treadmill TMX428CP 110V, Treadmill TMX428CP 220V | NCMDR | | mdprc 003 06 23 000 | Siemens Healthcare Diagnostics Inc. | Aptio Automation | NCMDR | | mdprc 002 06 23 000 | Siemens Healthcare Diagnostics GmbH | Aptio Automation | NCMDR | | mdprc 001 06 23 000 | Cook Medical Europe Limited | Hemospray Endoscopic Hemostat | NCMDR | | mdprc 031 05 23 000 | Gyrus ACMI | UroPass® Ureteral Access Sheath | NCMDR | | mdprc 029 05 23 000 | Philips Healthcare | INTELLIVUE MX40 PATIENT MONITOR | NCMDR | | mdprc 028 05 23 000 | TEI Biosciences | SurgiMend® PRS / SurgiMend® PRS Meshed / SurgiMend®/ SurgiMend® MP | NCMDR | | mdprc 027 05 23 000 | QIAGEN Ltd | QIAstat-Dx® Gastrointestinal Panel | NCMDR |
SFDA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
|---|
| mdprc 007 06 23 000 | Guilin Woodpecker Medical Instrument Co., Ltd | I-sensor/H2 | SFDA-0022-2023 | | mdprc 006 06 23 000 | Unknown (Not registered) | Articulating Paper | SFDA-0021-2023 | | mdprc 008 04 23 000 | Saudi Mais for Medical Products | Syringe | SFDA | | mdprc 008 02 23 000 | Pregna International Ltd. | Silverline Cu 380 Ag | SFDA | | 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
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 030 05 23 000 | Biocartis NV. | BRAF Mutation Assay | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00328-1 | | mdprc 009 03 23 000 | Sebia | CAPILLARYS 3 TERA, CAPILLARYS 3 OCTA | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-01399-1 | | 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 |
U.S FDA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
|---|
| mdprc 021 05 23 000 | DermLite LLC | DERMLITE DL4W | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=199376 | | 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 |
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