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Medical DevicesKOSDAQ 3769004 approvals

ROKIT HEALTHCARE Inc.

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KOSDAQ-listed medical device company with an organ regeneration platform expanding from diabetic foot skin regeneration into cartilage and kidney regeneration.

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Business overview

Source: DART corporate disclosure

Founded in 2012 and listed on KOSDAQ in 2025, ROKIT HEALTHCARE is a company specializing in an organ regeneration platform. It is expanding its skin regeneration platform, centered on diabetic foot treatment, into pressure ulcers, burns, traumatic defects, post-skin-cancer-excision defects, and breast reconstruction, while conducting preclinical, clinical, and joint research in cartilage and kidney regeneration. It has obtained ISO13485 (2019), KGMP (2023), CE MDR (2023), and U.S. FDA (2023) certifications, and has signed skin regeneration platform contracts with LABORATOIRE BENEWMEDICAL and others, and cartilage regeneration platform contracts with Bioethic Pharma S.A and others.

Products & technology

  • Skin regeneration platformSkin regeneration treatment for diabetic foot, pressure ulcers, burns, traumatic defects, post-skin-cancer-excision defects, and breast reconstruction
  • Cartilage regeneration platformCartilage regeneration treatment
  • Kidney regeneration platformKidney regeneration treatment

Regulatory approvals

data.go.kr

4 Korean MFDS device approvals · 2020–2023

  • MFDSFat separator, filter2023-01-05
    Product approval · Class 3제허 23-9 호
  • MFDSPerimeter, automaticRevoked2021-08-19
    Product approval · Class 1수신 21-1580 호
  • MFDSFat separator, filter2021-03-30
    Product approval · Class 3제허 21-206 호
  • MFDSHuman cell & Tissue culture incubator2020-01-20
    Product approval · Class 1체외 제신 20-86 호

R&D and key agreements

Source: DART corporate disclosure

연골재생 및 신장재생 전임상·임상 공동연구 · 연골, 신장 · 전임상·임상 진행중 · 5-person technology research institute conducting clinical work and organ regeneration protocol development for skin, cartilage, and kidney regeneration

Not yet compiled: business overview. 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.

CELLUMED CO., LTD.1 shared

KOSDAQ-listed holding company making medical devices and biologics including bone graft rhBMP2 and knee implant TKR.

Huvitz Co., Ltd.1 shared

KOSDAQ-listed medical device company producing auto refractors, auto lensmeters, and other ophthalmic equipment.

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.

DRGEM CORPORATION85

KOSDAQ-listed manufacturer of diagnostic X-ray imaging systems and core components such as generators and tubes.

LabGenomics. Co., Ltd.85

KOSDAQ-listed molecular genetic diagnostics company providing NGS-based non-invasive prenatal testing (NIPT) under the MomGuard brand.

Corentec Co., Ltd.85

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

OSTEONIC Co., Ltd.85

Established in 2012 and listed on KOSDAQ in 2018, Osteonic manufactures implants for the CMF, Trauma, Sports Medicine, and Spine categories.

Genesystem Co., Ltd85

Founded 2010, listed on KOSDAQ in 2021, Genesystem develops molecular diagnostic systems, biochips, test kits, and reaction reagents.

Sources and updates

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

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