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The History of ONSE Medical Inc.

The History of ONSE Medical Inc.

2020
  • Jan.registered the Vascular Catheter Guidewire (NC-MT) to MFDS and received the importing approval
2019
  • Feb.On-site audit for Innovize Inc. (USA) and obtained KGMP Certification (Renewal)
2018
  • Dec.registered the Polygraph (Model: Finapres NOVA) to MFDS and received the importing approval
  • Jun.On-site audit for Demcon Production B.V. (Netherlands) and obtained KGMP Certification (Initial)
  • Mar.Distributorship/Agency agreement with Boston Scientific Korea for the CRM and EP products
  • Feb.Distributorship agreement termination with Abbott Medical Korea
2016
  • Feb.On-site audit for Innovize Inc. (USA) and obtained KGMP Certification (Initial)
2015
  • Dec.On-site audit for NC-MT (China) and obtained KGMP Certification (Initial)
  • Oct.registered the Balloon Inflation Device (NC-MT, China) to MFDS and received the importing approval
  • June.On-site audit for Finapres Medical Systems B.V. (Netherlands) and obtained KGMP Certification (Renewal)
2014
  • Apr.registered the GuardacareXR Surgical (Hemostasis dressing) to KFDA and received the importing approval
  • Sep.registered the GuardacareXR Surgical (Hemostasis dressing) to KFDA and received the importing approval
2012
  • Apr.registered the Hemcon Patch (Hemostasis dressing) to KFDA and received the importing approval
2011
  • May.

    obtained the distributorship agreement with Hemcon Medical Technologies for the Hemcon Patch (Hemostasis dressings) to sell in Korean Cardiology and Radiology markets

2010
  • Oct.

    exhibited our FMS' products (Finometer and Portapres) at the Annual Scientific Meeting of the Korean Society of Cardiology

  • Apr.

    transferred the importing licenses for the Cryocath Technoligies'products to Medtronic Korea

2008
  • Aug.

    registered the Freezor Max Cryoablation Catheter to the KFDA and received the importing approval

  • Aug.

    sponsored the 7th Electrical Intervention Symposium in ASAN Medical Center

2007
  • Aug.

    sponsored the 6th Electrical Intervention Symposium in ASAN Medical Center

  • Aug.

    received a GIP (Good Importing Process) certification, for the imported products

2006
  • Aug.

    sponsored the 6th Electrical Intervention Symposium in ASAN Medical Center

2005
  • Oct.

    registered the products from the FMS (Finometer and Portapres) to the KFDA and received the importing approval for the Non-invasive Blood monitoring systems

  • Aug.

    sponsored the 5th Electrical Intervention Symposium in ASAN Medical Center

  • Mar.

    obtained an exclusive distributorship agreement with Finapres Medical Systems B.V., the Netherlands

  • Feb.

    registered the CryoCath System (Cryo-Console and Freezor &Freezor Xtra Catheter) to the KFDA and received the importing approval

2004
  • Dec.

    received a quality audit for our imported products by KOTRIC &KFDA, successfully obtained the Quality Management Assurance Certification

  • Aug.

    sponsored the 4th Electrical Intervention Symposium in ASAN Medical Center

2003
  • Aug.

    sponsored the 3rd Electrical Intervention Symposium in ASAN Medical Center

2002
  • Aug.

    sponsored the 2nd Electrical Intervention Symposium in ASAN Medical Center, the biggest hospital in South Korea

  • Feb.

    obtained a distributorship agreement with CryoCath Technologies, CANADA

2001
  • Nov.

    obtained a distributorship agreement with St. Jude Medical Korea for the EP products (DAIG) to sell in Korea

  • Oct.

    opened our first website (http://www.onsemedical.co.kr) for the patients implanted with ICDs &Pacemakers in Korea

2000
  • Nov.

    obtained a distributorship agreement with St. Jude Medical Korea for the CRM Products (Pacemakers &ICDs) to sell in Korea

  • Oct.

    changed the company name to ONSE MEDICAL Inc. from CMEK

1993
  • Oct.

    CMEK Trading Corp. was established in Seoul, South Korea
    First products to be distributed were:
    - Cardio Vascular Items (Heart Valve, Oxygenators)
    - EP Items (Pacemaker, ICD, Cardiac Stimulators)
    - Neuro Items (Spinal Cord Stimulator(SCS) &Deep Brain Stimulator(DBS))

  • obtained the distributorship agreement with Medtronic Korea