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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.

As of 2026-10-10, Plasmapp Co., Ltd. has 23 Korean MFDS device approvals, 8 US FDA clearances/approvals, 10 PubMed-indexed papers on record (counted by the MAA Company Index from its own matching of public databases).

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Market cap

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
  • FDATyvek Roll with CI for STERLINK Sterilizer2023-05-09
    510(k) · TraditionalGeneral HospitalK223025
  • 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
  • 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
  • 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
  • FDASTERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette2021-10-22
    510(k) · TraditionalGeneral HospitalK212200
  • 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

Key disclosures

KRX KIND via OpenDART

Publications

PubMed · affiliation-matched

Patents

KIPRIS · applicant-matched
Show 181 more patents

AI reads

MAA server logs · IP-verified
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Measured since Aug 27, 2026 · 4 AI engines · last read Oct 9, 2026

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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

Founded in 2015 and listed on KOSDAQ in 2025, ASTERASYS manufactures HIFU and RF-based aesthetic skin devices.

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.

INTEROJO CO. LTD.100

Interojo, founded 2000 and KOSDAQ-listed 2010, manufactures contact lenses under its Clalen brand domestically and via OEM/ODM overseas.

MITECH CO.,LTD.100

MITECH CO.,LTD., founded in 1991 and listed on KOSDAQ in 2018, makes non-vascular stents and distributes Fujifilm endoscopy equipment.

JETEMA Co.,Ltd.90

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

Corentec Co., Ltd.85

Founded in 2000 and KOSDAQ-listed in 2013, Corentec makes artificial joints; hip and knee implants exceed 85% of revenue.

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.

Sources and updates

Counts on this page are not company-reported figures. MAA matched records from DART, the Korean MFDS, the US FDA, ClinicalTrials.gov, PubMed and KIPRIS to this company itself, by business registration number or registered name, never by name similarity. They may differ from figures the company publishes.

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
Approvals & clinical trials
Korean MFDS (data.go.kr) · US FDA openFDA — updated weekly
Key disclosures
KRX KIND via OpenDART exchange filings — updated daily
Global clinical trials
ClinicalTrials.gov (US NIH) — sponsor-matched, updated weekly
Financials
DART corporate disclosure filings — annual
Publications
PubMed (US National Library of Medicine) — affiliation-matched, updated daily
Patents
KIPRIS (Korea Institute of Patent Information) — applicant-matched, updated monthly
AI reads
Our server logs, IP-verified every 6 hours
AI visibility
Measured 2026-10-01

This page is compiled from public sources without the company's involvement. If anything is inaccurate or incomplete, please let us know. Materials provided by the company are labelled as such.

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