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Rimsys NumberNameStatusVersionOwnerAuthorityTemplateCreatedUpdated
SUB-071FlexCath Pro FDA 510(k) eSTARIn Progress1Bruce McKeanFDAFDA 510(k) eSTAR Template2026-08-242026-08-26
SUB-054FlexCath Pro EU MDR Technical FileIn Progress2Jay PatelEUUniversal nIVD Template2026-08-182026-08-25
SUB-062EU nIVD Test FOr AppasamyNot Started1Jay PatelEUEU nIVD Template2026-08-252026-08-25
SUB-061HC nIVDNot Started1Bruce McKeanHCHC nIVD Template2026-08-102026-08-10
SUB-047MAGIC Microcatheter Submission Tech FileNot Started2Bruce McKean---Universal nIVD Template2026-07-212026-07-21
SUB-009SSP+ 300mL (Apheresis) — Egypt SubmissionNot Started2Jay Patel---Universal nIVD Template2026-07-212026-07-21
SUB-008RevitaGlow Handpiece — Japan ShoninIn Progress1Priya RamanPMDAUniversal nIVD Template2026-06-302026-07-15
SUB-006FlexCath Pro — Health Canada Licence AmendmentCompleted3Dana WhitfieldHCHC nIVD Template2026-05-122026-06-28