FDA.reportPublic FDA data

Plasmapp Co., Ltd.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30160759713016075971Plasmapp Co., Ltd.1N2026-01-01A-1005, 10F, 670, Daewangpangyo-ro, Bundang-gu Seongnam-si Gyeonggi KR 13494

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2977521615048851K231169STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)MLR2023-05-25
2977521879954758K223025Tyvek Roll with CI for STERLINK SterilizerFRG2023-05-09
2977522052733844K223023Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)FRC2023-05-09
2977521177396641K223015STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassetteMLR2023-05-09
2977521568117283K220345STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)MLR2023-04-14
2977521431647886K212200STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM CassetteMLR2021-10-22
2977521212839834K212198Tyvek(R) Roll with CI for STERLINKTM SterilizerFRG2021-10-22
2977521436304602K212198Tyvek(R) Roll with CI for STERLINKTM SterilizerFRG2021-10-22
2977521716294417K212193Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)FRC2021-10-22
2977521761016336K212193Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)FRC2021-10-22

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MLR82023-05-25
FRG52023-05-09
FRC52023-05-09

PMN#