(주)제이에스알메디컬 뉴스레터/JSR Medical Newsletter – March 2025
(주)제이에스알메디컬 SAGES 2025 학회 성공적으로 마무리 2025년 3월 12일부터 4일간 미국 롱비치 컨벤션 센터에서 열린 SAGES (미 위장관/내시경 외과 학회; Society of American Gastrointestinal and Endoscopic Surgeons) 2025 학회를 성공적으로…
JSR Medical holds the world’s best minimally invasive colorectal surgical technology.
We develop innovative surgical device and treatment method which minimize patient’s stress and promote fast recovery.
Our goal is to enhance patient’s quality of life through development of revolutionary surgical device and technology.
- March 2016 Establishment of JSR Medical Co., Ltd.
- April 2016 Medical Device Sales Registration (MFDS 2016-3430019-00008)
- August 2018 DGIST Authentication (Industry-University Cooperation 2018-031)
- November 2018 Frontier Venture Certification (0068)
- May 2020 Medical Device Manufacturer Registration (MFDS 6855)
- July 2020 Medical Device Manufacturing & Export Registration (MFDS 20-550)
- November 2020 Excellent Technology Company Certification (FTS-2020-03072) / Venture Company Certification (20200116111)
- December 2020 Manufacturing Site Registration (272902020549805)
- January 2021 ISO 13485:2016 Approval (GIS-5073-MD)
- June 2021 ‘COLO-BT’ Brand Registration (40-1741587 and 1 other)
- November 2021 Corporate R&D Center Registration (2021115800)
- January 2022 KGMP Approval (KCL-AABA-13323)
- July 2022 EN ISO 13485:2016 Approval (Medical Device Class IIa)
- August 2022 FDA Registration (Medical Device Class I)
- December 2022 MDSAP Approval (MDSAP 757220)
- January 2023 FDA IDE Approval (G220334 – Medical Device Class III)
- February 2023 MOU with K-MEDI hub Preclinical Center Signed
- April 2023 Multicenter-Pivotal Clinical Trial at State University of New York Starts
PRODUCT
FDD
Development Background
Conventional standard of care for protecting anastomotic wound is to construct a stoma.
However, there are various complications associated with stoma and the occurrence rate of these complications is 25 – 50%. Furthermore, 12 – 40% of patients cannot have stoma reversal surgery and must wear ileostomy bag for rest of their lives.
JSR has invented an innovative medical device that minimizes complications and eliminates the need for stoma which significantly improves quality of patient’s life.
However, there are various complications associated with stoma and the occurrence rate of these complications is 25 – 50%. Furthermore, 12 – 40% of patients cannot have stoma reversal surgery and must wear ileostomy bag for rest of their lives.
JSR has invented an innovative medical device that minimizes complications and eliminates the need for stoma which significantly improves quality of patient’s life.
Indication for Use
- Alternative treatment device to the temporary ileostomy following the colorectal surgery.
- Protects patient's skin and anastomotic wound to prevent complication from anastomotic leakage and to provide access for colonic irrigation.
NEWS & EVENT
JSR News
CONTACT
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jsrmedical@jsrmed.co.kr
