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Medical DevicesKOSDAQ 386380Innovative Medical Device12 approvals

Sky Labs Inc.

Official website

Ring-type cuffless blood pressure monitors and a platform that turns everyday physiological signals into clinical data.

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Business overview

Source: DART corporate disclosure

Sky Labs Inc., founded in 2015 and listed on KOSDAQ in September 2026, develops ring-type cuffless blood pressure monitoring devices and describes itself as a medical data production platform. Its CART line includes CART BP pro for clinical use, cleared by the Korean MFDS in 2023 and launched domestically in 2024, where 24-hour ambulatory blood pressure monitoring (E6547) is reimbursed under national health insurance, and CART ON, cleared and launched in 2025. The devices carry Korean MFDS, European CE and UK MHRA clearances; the ring-type continuous blood pressure monitor was designated an Innovative Medical Device by the MFDS in 2023, and the company is extending measurement from blood pressure to blood glucose and lipids.

Products & technology

  • CART BP proRing-type cuffless blood pressure monitoring for clinical settingsKorean MFDS clearance 2023 · launched in Korea 2024
  • CART ONRing-type physiological signal monitoring deviceKorean MFDS clearance and launch 2025
  • CART BPRing-type cuffless blood pressure monitor for consumers

Regulatory approvals

data.go.kr

1 Innovative Medical Device designations · 2023 / 11 Korean MFDS device approvals · 2020–2026

  • InnovativeSL-MRA1K06외 7건2023-01-09
    Innovative Medical Device designation
  • MFDSPulse oximeter, line-powered2026-05-28
    Product approval · Class 2제인 26-4475 호
  • MFDSProduct name not recorded2025-10-29
    Product approval · Class 2인 25-4043 호
  • MFDSMonitor, blood pressure2024-07-31
    Product approval · Class 2제인 24-734 호
  • MFDSProduct name not recorded2024-07-31
    Product approval · Class 2인 24-734 호
  • MFDSMonitor, blood pressure2023-08-18
    Product approval · Class 2제인 23-5024 호
  • MFDSProduct name not recorded2023-08-18
    Product approval · Class 2인 23-5024 호
  • MFDSSphygmomanometers and sphygmographsRevoked2023-07-10
    Product approval · Class 2제허 23-768 호
  • MFDSPulse oximeter, line-poweredRevoked2022-04-07
    Product approval · Class 2제인 22-4283 호
  • MFDSU-healthcare gateway, class 1Revoked2022-02-17
    Product approval · Class 1제신 22-217 호
  • MFDSElectrocardiographic Holter analyser2021-12-20
    Product approval · Class 2제허 21-1026 호
  • MFDSElectrocardiographic Holter analyserRevoked2020-05-21
    Product approval · Class 2제인 20-4401 호

Global clinical trials

ClinicalTrials.gov · sponsor-matched

R&D and key agreements

Source: DART corporate disclosure

Extending measurement beyond blood pressure to additional physiological markers such as blood glucose and blood lipids.

The ring-type continuous blood pressure monitor was designated an Innovative Medical Device by the Korean MFDS in 2023.

Included in the Korean Society of Hypertension (KSH) clinical practice guidelines in 2026.

Partnerships with Omron Healthcare (strategic investment and consumer distribution) and Otsuka Pharmaceutical (hospital distribution), both in Japan.

Key disclosures

KRX KIND via OpenDART

Publications

PubMed · affiliation-matched

AI reads

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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.

MEZOO Co., Ltd.4 shared

KOSDAQ-listed medical device company developing the HiCardi wearable patch-type patient monitor.

MEDIANA Co.,LTD4 shared

Founded in 1995 and listed on KOSDAQ in 2014, Mediana is a hospital medical device maker developing and manufacturing patient monitors and automated external defibrillators under its own brand and via ODM.

SEERS Co., Ltd.4 shared

Founded in 2009, SEERS provides the wearable ECG analysis solution mobiCARE and the inpatient monitoring solution thynC, based on AI vital-sign analytics.

MEKICS Co., Ltd2 shared

KOSDAQ-listed critical-care medical device company manufacturing ventilators, the OmniOx respiratory therapy device series, and patient monitors.

CU MEDICAL SYSTEMS Inc.2 shared

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

Bistos Co., Ltd.2 shared

Founded in 2001 and KOSDAQ-listed in 2022, Bistos manufactures fetal, neonatal, and patient monitoring medical devices.

BITComputer1 shared

Founded in 1985, BITComputer provides hospital information systems such as bitnixHIS and CLEMR, alongside digital healthcare and IT education businesses.

JLK, Inc.1 shared

JLK offers the stroke AI solution MEDIHUB STROKE and holds 78 global regulatory approvals, including US FDA and Japan PMDA clearances.

SELVAS Healthcare, Inc.1 shared

SELVAS Healthcare operates the ACCUNIQ medical diagnostic device brand and the HIMS assistive technology device brand.

Yuyu Pharma, Inc.1 shared

Founded in 1941 and listed on the KOSPI in 1975, Yuyu Pharma is a pharmaceutical company with a co-promotion agreement with Dong-A ST for Tanamin.

VUNO, Inc.1 shared

Founded in 2014, VUNO provides AI-based vital-sign and medical imaging diagnostic solutions, including VUNO Med-DeepCARS and VUNO Med-Fundus AI.

INTEROJO CO. LTD.100

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

Sources and updates

Company basics
Korea Exchange · DART
Business content
Company website (pre-filing)
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

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