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Medical DevicesKOSDAQ 40500031 approvals

Plasmapp Co., Ltd.

Official website

KOSDAQ-listed medical device company producing the STERLINK plasma sterilizer and other plasma-based devices.

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Business overview

Source: DART corporate disclosure

Founded in 2015 as a KAIST physics lab spinoff and listed on KOSDAQ in 2022, Plasmapp is a plasma technology medical device company. It produces the STERLINK plasma sterilizer, ACTILINK plasma surface activator, and PLASMA ENDO periodontal/root canal treatment device; STERLINK uses the STERPACK direct sterilant-injection pouch to complete low-temperature sterilization within 7 minutes. STERLINK obtained Korean MFDS approval in 2017, European CE MDD certification in 2018, approvals in Canada, Australia, and Brazil in 2019, and US FDA clearance in 2021, and is used in ophthalmology, dentistry, orthopedics, dermatology, plastic surgery, and veterinary clinics.

Products & technology

  • STERLINKlow-temperature plasma sterilizer for surgical devices
  • STERPACKdirect sterilant-injection high-speed sterilization pouch
  • ACTILINKplasma surface activator for medical implants
  • PLASMA ENDOplasma periodontal and root canal treatment device

Regulatory approvals

data.go.kr · openFDA

23 Korean MFDS device approvals · 2016–2026 / 8 US FDA 510(k) · 2021–2023

  • MFDSElectrode, external2026-05-06
    Product approval · Class 1제신 26-561 호
  • MFDSSterilizer, plasma, low temperature2025-04-10
    Product approval · Class 2제인 25-4302 호
  • MFDSSterilizer, plasma, low temperature2024-09-24
    Product approval · Class 2제인 24-877 호
  • MFDSSterilizer, plasma, low temperature2024-09-24
    Product approval · Class 2제인 24-876 호
  • MFDSSterilizer, plasma, low temperature2024-06-12
    Product approval · Class 2제인 24-586 호
  • MFDSSterilizer, plasma, low temperature2024-02-23
    Product approval · Class 2제인 24-205 호
  • MFDSSterilizer, plasma, low temperature2023-12-28
    Product approval · Class 2제인 23-5406 호
  • MFDSSterilizer, plasma, low temperature2023-09-26
    Product approval · Class 2제인 23-5126 호
  • MFDSSterilizer, plasma, low temperature2023-09-26
    Product approval · Class 2제인 23-5125 호
  • MFDSSterilizer, plasma, low temperature2023-09-26
    Product approval · Class 2제인 23-5122 호
  • MFDSSterilizer, plasma, low temperature2023-07-24
    Product approval · Class 2제인 23-4933 호
  • MFDSSterilizer, plasma, low temperature2023-06-21
    Product approval · Class 2제인 23-4821 호
Show 19 more
  • MFDSSterilizer, plasma, low temperature2023-06-01
    Product approval · Class 2제인 23-4778 호
  • FDASTERLINK 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)2023-05-25
    510(k) · SpecialGeneral HospitalK231169
  • FDASTERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette2023-05-09
    510(k) · TraditionalGeneral HospitalK223015
  • FDATerragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)2023-05-09
    510(k) · TraditionalGeneral HospitalK223023
  • FDATyvek Roll with CI for STERLINK Sterilizer2023-05-09
    510(k) · TraditionalGeneral HospitalK223025
  • FDASTERLINK 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)2023-04-14
    510(k) · TraditionalGeneral HospitalK220345
  • MFDSSterilizer, plasma, low temperature2022-03-28
    Product approval · Class 2제인 22-4250 호
  • FDATyvek(R) Roll with CI for STERLINKTM Sterilizer2021-10-22
    510(k) · TraditionalGeneral HospitalK212198
  • FDASTERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette2021-10-22
    510(k) · TraditionalGeneral HospitalK212200
  • FDATerragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)2021-10-22
    510(k) · TraditionalGeneral HospitalK212193
  • MFDSSterilizer, plasma, low temperature2019-04-26
    Product approval · Class 2제인 19-4339 호
  • MFDSSterilizer, plasma, low temperature2019-01-16
    Product approval · Class 2제인 19-4028 호
  • MFDSPhysical devices for medical use2019-01-08
    Product approval · Class 3제허 19-22 호
  • MFDSSterilizer, plasma, low temperature2018-01-31
    Product approval · Class 2제인 18-4069 호
  • MFDSSterilizer, plasma, low temperature2017-07-24
    Product approval · Class 2제인 17-4579 호
  • MFDSSterilizer, plasma, low temperature2017-05-16
    Product approval · Class 2제인 17-4348 호
  • MFDSSterilizer, plasma, low temperature2017-02-27
    Product approval · Class 2제인 17-4140 호
  • MFDSSterilizer, plasma, low temperature2017-01-04
    Product approval · Class 2제인 17-4007 호
  • MFDSSterilizer, plasma, low temperature2016-03-30
    Product approval · Class 2제인 16-4279 호
Not yet compiled: business overview · R&D. Send us materials and we will add them

Companies approved for the same productsMedical Devices

Ranked by how many MFDS product categories overlap. Not a ranking — a pointer to where to look.

ASTERASYS Co., Ltd.1 shared
BIO PROTECH INC.1 shared

Manufactures biosensors for electronic medical device consumables, including ECG measurement electrodes.

CLASSYS Inc.1 shared

CLASSYS Inc., established in 2015 and listed on KOSDAQ, makes aesthetic medical devices using HIFU, MRF, MNRF, and laser technologies.

CU MEDICAL SYSTEMS Inc.1 shared

Founded in 2001 and KOSDAQ-listed in 2011, CU Medical Systems makes AEDs and other emergency medical devices.

Hironic Co.,Ltd1 shared

KOSDAQ-listed medical device company producing HIFU devices DOUBLO/V-RO and the Synerjet non-invasive drug delivery system for aesthetic dermatology.

REMED CO.,LTD.1 shared

KOSDAQ-listed magnetic stimulation medical device company developing TMS-based brain rehabilitation devices and PMS pain management devices.

SHINHUNG CO.,LTD1 shared

Founded in 1964 and KOSPI-listed in 1991, Shinhung manufactures and distributes dental equipment and materials.

JETEMA Co.,Ltd.90

Founded 2009, listed on KOSDAQ in 2019, JETEMA develops hyaluronic acid fillers, botulinum toxin biopharmaceuticals, and lifting threads.

i-SENS, Inc.90

Founded in 2000 and KOSDAQ-listed in 2013, i-SENS makes blood glucose monitors and point-of-care testing devices.

SEJONG MEDICAL Co.Ltd.,85

Founded in 2010 and KOSDAQ-listed in 2018, Sejong Medical manufactures laparoscopic surgical instruments.

NanoenTek,Inc.85

Founded in 1987 and listed on KOSDAQ in 2000, NanoenTek develops Lab-On-a-Chip in-vitro diagnostic devices and life science instruments.

Noul Co., Ltd.85

Founded in 2015 and listed on KOSDAQ in 2022, Noul develops the on-device AI diagnostic platform miLab™ for blood and cancer testing.

Sources and updates

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
AI visibility
Measured 2026-08-13

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