LELTEK’s technology has obtained CE, FDA, and TFDA certifications, and the company has established a market presence in over 10 countries across Europe and Asia. As one of the few Taiwanese handheld ultrasound brands with dual international medical device certifications, LELTEK demonstrates clear global growth potential.
Product Market Entry Strategy
- Certification as a Market Entry Point, Engaging Distributors
- Upsynergy successfully matched LELTEK with a well-connected, resourceful distributor in Thailand and assisted in market potential analysis and scenario introduction. The distributor fully covered the costs for Class II medical device certification and proactively registered the LU700 and LU710 with the Thai FDA, completing registration in 2021 and 2023, respectively.
- Clinical Education and KOL (Key Opinion Leader) Establishment
- In collaboration with the distributor, multiple clinical workshops and exhibitions were held (e.g., with emergency and orthopedic associations). Feedback from local opinion leaders was used to continuously optimize hardware and software functions.
- Flexible Authorization and Local Marketing Support
LELTEK adopts a flexible cooperation model, aligning with local marketing rhythms, providing demo units and technical training packages to help distributors quickly enter the market and reduce the sales learning curve
Upsynergy’s Successful Support Summary
- Thailand Distributor Matchmaking and Certification Success
- LU-700 series achieved Class II medical device registration in Thailand in 2021.
- LU-710 series completed similar certification in 2023.
- All certification costs were fully covered by the distributor, demonstrating high trust and deep cooperation.
- Precision Sales Channel Introduction and Educational Promotion
- Upsynergy and the Thai distributor jointly established medical education venues, rapidly introducing the products into high-demand settings such as emergency, internal medicine, and OB/GYN departments. LELTEK achieved early adoption in local markets (e.g., military and private hospitals).
- Building a Replicable Market Expansion Template
- This model is now considered LELTEK’s template for expanding into other Southeast Asian markets (e.g., Indonesia, Vietnam). Leveraging Upsynergy’s international business network and local regulatory expertise accelerates entry into emerging markets.
