Company Milestone

Year Important Events
2004Founded in Dajia District, Taichung City, producing minimally invasive surgical instruments and medical devices
2005Obtained GMP Taiwan and ISO 13485 certificates
2007Passed EU MDD (93/42/EEC) certification, obtained European sales approval
2009Passed Japan PMD Act certification, obtained Japanese sales approval Passed US FDA (510k) certification, obtained US sales approval
2010Groundbreaking of Dajia Young Lion Factory Passed Korea KGMP certification, obtained Korean sales approval Passed Brazil ANVISA GMP certification, obtained Brazilian sales approval Passed Australia TGA certification, obtained Australian sales approval Passed China CFDA certification, obtained Chinese sales approval
2011Implemented ERP system
2012Completion and official relocation to Dajia Young Lion Factory Phase 1 Passed Canada CMDCAS certification, obtained Canadian sales approval
2013Groundbreaking of Dajia Young Lion Factory Phase 2
2014Introduced automated production equipment; Phase 2 officially launched Awarded “Top 10 Outstanding Enterprises” and “Top 10 Outstanding Innovation and R&D” by Golden Peak Award Received Dun & Bradstreet SME Elite Certificate
2015Awarded “18th Little Giant Award” Received National Biotechnology and Medical Quality Award
2016Completed Ministry of Economic Affairs Industrial Bureau “Biotechnology Industrialization Excellence Program” - Development of anti-adhesion coating for minimally invasive bipolar electrosurgical instrument tips Passed Ministry of Economic Affairs Industrial Bureau SBIR innovation R&D project approval - Development of multi-purpose gun-type suction and irrigation tube for minimally invasive surgery Won Taipei Biotechnology Award “International Excellence Award” Received 25th National Rock Award Won Taichung Golden Hand Award
2017Passed Malaysia MDA certification, obtained Malaysian sales approval
2018Passed Singapore HSA certification, obtained Singapore sales approval Completed ISO 13485:2016 quality management system transition Filed for initial public offering (IPO) at Taipei Exchange, effective January 16, 2019
2019Obtained BSI CE certificate Passed Serbia ALIMS certification, obtained Serbian sales approval Completed NT$11 million cash capital increase, increasing paid-in capital to NT$304.769 million Listed shares on Taipei Exchange Emerging Stock Market on November 8, 2019
2020Electrosurgical suction system obtained Korean sales approval Dajia Young Lion Factory Phase 2 obtained factory registration and manufacturing business license Trocar, SI-450CT, and SI-450C obtained Singapore sales permits
2021Installed solar power system for energy saving and carbon reduction Reassessed new factory construction for Phase 2 and passed Ministry of Economic Affairs “Accelerated Investment Action Plan for Taiwan-based Companies” EBH-0709 and EB-0709 obtained Malaysian sales permits
2022Implemented Material Flow Cost Accounting (MFCA) system Trocar obtained BSI Class IIa MDR certificate Dajia Young Lion Factory Phase 2 demolition and reconstruction commenced TR, TRO, and TRE obtained Albanian sales permits
2023EB, EBH, and SI obtained Brazilian sales permits Completed product certification transition from MDD to MDR
2024Passed ISO 14001 Environmental Management System certification Introduced greenhouse gas inventory system Balloon-type puncture sheath (TRS) obtained Taiwan sales approval Pressure device (IP) obtained UK sales approval Electrosurgical suction system (SAP) obtained Thailand sales approval Suction tube (SA) and endoscopic instruments (DI, EI) obtained Australian sales approval Insufflation needle (IN), suction tube (SA), endoscopic instruments (DI, EI), and wound retractors (WR) obtained El Salvador sales approval Puncture sheath (TR) obtained Israel and Bahrain sales approvals Wound retractors (WR) and airtight covers (CP) obtained Ecuador sales approval Passed MDSAP certification Dajia Young Lion Factory Phase 2 obtained occupancy permit
2025Dajia Young Lion Factory Phase 2 obtained factory registration Dajia Young Lion Factory Phase 2 obtained manufacturing business license for medical devices