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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 042 08 23 000 | HAMILTON MEDICAL AG | Hamilton Medical Ventilators HAMILTON-C1/T1/C2/C3 with Neonatal Option | BfArM | | mdprc 024 08 23 000 | Arthrex | KNEE SCORPION | BfArM | | mdprc 021 08 23 000 | Diatron MI Plc | Diacon 3 hematology control ( (Low) 6x, (Normal), (High) 6 ) | BfArM | | mdprc 020 08 23 000 | Ethicon, Inc. | PDS TM II (polydioxanone) Suture, PDS TM Plus Antibacterial (polydioxanone) Suture | BfArM | | mdprc 014 08 23 000 | W.L. Gore & Associates Inc. | Gore tips set | BfArM | | mdprc 012 08 23 000 | Drager Medical Systems Inc | Filter/HME TwinStar® Plus | BfArM | | mdprc 025 07 23 000 | Omixon Biocomputing Ltd. | Omixon HLA Twin | BfArM | | mdprc 022 07 23 000 | CellaVision-RAL Diagnostics | Buffer solution for SP automated systems | BfArM | | mdprc 014 06 23 001 | EKU Elektronik GmbH. | NO-Therapy device NO-A (in combination with ventilators Servo-n and Servo-u) | BfArM, NCMDR | | mdprc 018 06 23 000 | Draeger Medical Systems Inc | Oxylog 3000 plus | BfArM |
NCMDR
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 031 09 23 000 | Atrium Medical Corp | Atrium Ocean, Oasis, and Express Chest Drains | NCMDR | | mdprc 030 09 23 000 | Roche Diagnostics GmbH | Specific Lots of VENTANA anti-ALK (D5F3) Antibody | NCMDR | | mdprc 029 09 23 000 | Ortho-Clinical Diagnostics | Proboscis/Piston Assembly for VITROS 5,1 FS/XT 3400/4600 Chemistry Systems, VITROS 3600 Immunodiagnostic Systems, VITROS 5600/XT 7600 Integrated Systems | NCMDR | | mdprc 028 09 23 000 | iLine Microsystems S.L | MicroINR easy control | NCMDR | | mdprc 027 09 23 000 | Randox Laboratories Ltd. | RX Daytona Plus (with ISE), RX Daytona Plus (without ISE), RX Imola, RX Modena, RX Monaco | NCMDR | | mdprc 026 09 23 000 | Randox Laboratories Ltd. | Immunoassay Speciality I Level 1 | NCMDR | | mdprc 012 07 23 001 | Alcon Laboratories Inc…. | Alcon Phaco Tips when used with included plastic wrench | NCMDR | | mdprc 025 09 23 000 | Leica Mikrosysteme Vertrieb GmbH | M530 OHX, PROvido, Proveo 8 | NCMDR | | mdprc 023 09 23 000 | Instrumentation Laboratory SpA | HemosIL von Willebrand Factor Antigen | NCMDR | | mdprc 022 09 23 000 | Randox Laboratories Ltd. | Randox Liquid Protein Calibrators | NCMDR |
SFDA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
|---|
| mdprc 010 09 23 000 | ARW Manufacturing Company | ARW Alcohol Prep Pads | SFDA | | mdprc 009 09 23 000 | Saudi Mais for Medical Products | Sodium Bicarbonate | SFDA | | mdprc 005 08 23 000 | I-CODI CO. LTD | Contact lenses - Anesthesia | SFDA | | mdprc 004 08 23 000 | Unknown | Single Use Surgical Skin Staple Remover Premium Extractor.
Disposable Proctoscope. | SFDA | | mdprc 003 08 23 000 | TECHNOLOGIE MEDICALE | TUBE 10 FILTERS PLASTIQUW RV2/RV3 | SFDA | | mdprc 026 07 23 000 | Great glove xinghua co LTD. | Nahdi examination gloves | SFDA | | mdprc 024 07 23 000 | BU KWANG MEDICAL INC. | BU KWANG Crystal-Ject | SFDA | | mdprc 032 06 23 000 | Saudi Mais for Medical Products | Dr.Disinfectant Instrument Transport Gel | SFDA | | mdprc 022 06 23 000 | Allied Healthcare Products Inc. | The Timeter Sure Grip Flowmeter | SFDA | | mdprc 012 06 23 000 | Guilin Woodpecker Medical Instrument Co., Ltd | I-sensor/H2 | 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 004 09 23 000 | Shenzhen Mindray Bio-medical Electronics Co., Ltd, | SV600/800 Mindray Ventilator | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00730-1 | | mdprc 002 09 23 000 | Siemens Medical Solutions | ACUSON Redwood 2.0 ultrasound systems - 18L6 transducer | TGA | | mdprc 039 08 23 000 | Ortho-Clinical Diagnostics | ORTHO Sera Anti-Lea Murine Monoclonal IgM. | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00742-1 | | mdprc 018 08 23 000 | Instrumentation Laboratory SpA, a Werfen Company | ACL TOP | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00591-1 | | mdprc 011 08 23 000 | Draeger Medical Systems Inc | Babyleo TN500 IncuWarmer | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00352-1 | | mdprc 016 10 22 001 | Siemens Healthcare Diagnostics GmbH | Atellica CH 930 Analyzer, Lithium and Lithium_2 | BfArM | | mdprc 002 08 23 000 | Bio-Rad Laboratories Inc | Liquichek Pediatric Control. | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00649-1 | | mdprc 029 07 23 000 | Ventana Medical Systems | UltraView Universal AP Red Detection Kit | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00561-1 | | mdprc 033 03 22 001 | Atrium Medical Corporation | Atrium Advanta V12 Covered Stent System | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-00419-1 | | mdprc 039 06 23 000 | Johnson & Johnson Surgical Vision, Inc. | VERITAS Advanced Infusion and Fluidics Packs | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00519-1 |
U.S FDA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
|---|
| mdprc 027 06 23 000 | SIEMENS | Luminos Agile Max.
Luminos dRF Max | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=199944
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=199947 | | 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 |
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