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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 028 06 21 000 | Accelerate Diagnostics Inc | Accelerate Pheno system. | BfArM | | mdprc 020 06 21 000 | G. Heinemann Medizintechnik GmbH | MODULA series ENT treatment units | BfArM | | mdprc 016 06 21 000 | Delta Med spa | Medical devices within shelf life that were sterilized at Steril Milano. | BfArM | | mdprc 007 06 21 000 | ConMed Corporation | Buffalo Filter® LaparoVue® Visibility System | BfArM | | mdprc 003 06 21 000 | CeramOptec GmbH Sub biolitec AG | FiLaC® Fistula Kit, LHP® Procedure Kit, HeLP® Procedure Kit | BfArM |
NCMDR
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| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 037 06 21 000 | HTL-STREFA S.A. | Droplet pen needle | NCMDR | | mdprc 036 06 21 000 | Abbott | Secondary Tubes (Push) | NCMDR | | mdprc 035 06 21 000 | GE Healthcare | Revolution CT system | NCMDR | | mdprc 034 06 21 000 | Philips Healthcare | V60/V60 Plus Ventilators | NCMDR | | mdprc 031 06 21 000 | DiaSorin Inc | LIAISON IGF-I | NCMDR |
SFDA
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| Reference Number | Manufacturer | Device Type | Report Source |
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| 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 023 06 21 000 | Randox Laboratories Ltd. | NEFA (Non-esterified fatty acid) | Swissmedic | | mdprc 022 06 21 000 | Cerus Corporation | INTERCEPT Blood System for Plasma, Processing Set for Plasma | Swissmedic | | mdprc 035 08 20 001 | Siemens Healthcare Diagnostics GmbH | Dimension® EXL™ integrated chemistry system, LOCI Module | Swissmedic | | mdprc 017 06 21 000 | bioMerieux Inc | VIDAS® Anti-HBs Total II | Swissmedic | | mdprc 013 06 21 000 | Boston Scientific Corporation | INGENIO, VITALIO, and ADVANTIO pacemakers and INLIVEN, INTUA, and INVIVE cardiac resynchronization therapy pacemakers (CRT-Ps) | Swissmedic |
TGA
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| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 032 06 21 000 | Siemens Healthcare Diagnostics GmbH | Atellica CH 930 Analyser, Atellica IM 1300 Analyser and Atellica IM 1600 Analyser | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01278-1 | | mdprc 011 06 21 000 | Siemens Healthcare Diagnostics | Atellica UAS 800 Urine Sediment Analyser and Atellica 1500 Automated Urinalysis System | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01232-1 | | mdprc 016 05 21 000 | Beckman Coulter | Access Sensitive Estradiol | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-01015-1 | | mdprc 009 05 21 000 | Beckman Coulter | Access 25(OH) Vitamin D Total for use in Access 2 and DxI Immunoassay systems | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00958-1 | | mdprc 008 05 21 000 | Beckman Coulter | Access Sensitive Estradiol | https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-00961-1 |
U.S FDA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 033 06 21 000 | Fujifilm Medical Systems U.S.A., Inc. | Synapse PACS - Radiological Image Processing System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=186333 | | mdprc 021 06 21 000 | Terumo Cardiovascular Systems Corporation | Sarns TCM II and TCM & Terumo HX2 Temperature Management System | U.S. FDA | | mdprc 019 10 20 001 | ESAOTE S.P.A | AC/DC POWER SUPPLY for 7400 | NCMDR | | mdprc 036 10 20 000 | Quidel Corporation | Sofia SARS Antigen FIA Package Insert | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=183267 | | mdprc 034 10 20 000 | Gentian AS. | Gentian Cystatin C Immunoassay | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=183752 |
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