Data / Medical devices / South Korea / Plasmapp Co., Ltd.
Plasmapp Co., Ltd.: FDA-registered device maker in Seongnam-si Gyeonggi, South Korea, 8 510(k) clearances
Plasmapp Co., Ltd. is registered with the FDA (registration 3016075971) in Seongnam-si Gyeonggi, South Korea. It lists 4 device types. The FDA files 8 510(k) clearances under its listings, the newest dated May 25, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016075971
- Address
- A-1005, 10F, 670, Daewangpangyo-ro, Bundang-gu, Seongnam-si Gyeonggi, South Korea, 13494
- Owner or operator
- Plasmapp Co., Ltd. (10083074)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- October 23, 2021
- Registered through
- 2026
- Brand names listed
- STERLINK Mini Sterilizer With STERLOAD Mini Cassette, STERLINK plus Sterilizer with STERLOAD Cassette, STERLINK FPS-15s Plus with STERLOAD, STERLINK Plus Sterilizer With STERPACK Plus Cassette, Terragene Bionava SCBI (BT96),Bionova Reader Incubators (IC10/20FRLCD, Mini-bio),Chemdye (CD42),Cintape (CT40), Terragene Bionova SCBI (BT96), Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Chemdye (CD42), Cintape (CT40), Tyvek®Roll With CI For STERLINK Sterilizer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Indicator, Biological Sterilization Process | FRC | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Sterilizer, Chemical | MLR | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 25, 2023 | K231169 | STERLINK 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) | MLR | Substantially Equivalent | Plasmapp Co,., Ltd. | accessdata.fda.gov |
| May 9, 2023 | K223025 | Tyvek Roll with CI for STERLINK Sterilizer | FRG | Substantially Equivalent | Plasmapp Co,., Ltd. | accessdata.fda.gov |
| May 9, 2023 | K223023 | Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | FRC | Substantially Equivalent | Plasmapp Co,., Ltd. | accessdata.fda.gov |
| May 9, 2023 | K223015 | STERLINK FPS-15s Plus sterilizer with STERPACK plus cassette | MLR | Substantially Equivalent | Plasmapp Co,., Ltd. | accessdata.fda.gov |
| April 14, 2023 | K220345 | STERLINK 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) | MLR | Substantially Equivalent | Plasmapp Co,., Ltd. | accessdata.fda.gov |
| October 22, 2021 | K212200 | STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette | MLR | Substantially Equivalent | Plasmapp Co,., Ltd. | accessdata.fda.gov |
| October 22, 2021 | K212198 | Tyvek(R) Roll with CI for STERLINKTM Sterilizer | FRG | Substantially Equivalent | Plasmapp Co,., Ltd. | accessdata.fda.gov |
| October 22, 2021 | K212193 | Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | FRC | Substantially Equivalent | Plasmapp Co,., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Indicator, Biological Sterilization Process
- All makers of Indicator, Physical/Chemical Sterilization Process
- All makers of Sterilizer, Chemical
- All makers of Wrap, Sterilization
Updated May 25, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.