Guangdong Shengze Kanghua Biomedical Co., Ltd.'s self-developed ophthalmic IVD product has successfully passed the review of the Thai Food and Drug Administration (TFDA) and obtained the Thai medical device registration certificate , officially gaining approval to enter the Thai market!
The approved products include:

✅ i-ImmunDx Analyzer
✅ Alpha-lymphotoxin (LTA) test kit
✅ Tear Total Immunoglobulin E (Total IgE) Detection Reagent
✅ Human matrix metalloproteinase 9 (MMP-9) detection reagent
✅ Micro-liquid collector
Expanding overseas to create new opportunities
From Europe to Southeast Asia, another key move has been made in the globalization strategy.

This further expands the company's international footprint. Previously, Shengze Kanghua's comprehensive ophthalmic diagnostic solutions had been successfully implemented in several European countries , including the UK, Italy, and Spain, achieving stable commercial sales and gaining widespread recognition in overseas markets. Obtaining TFDA certification this time signifies the company's successful expansion from Europe into the core Southeast Asian market , steadily accelerating its globalization strategy.
Based on stringent international certification standards, our integrated ocular surface diagnostic solution can accurately and quickly detect indicators related to ocular surface inflammation, allergies, and damage. Equipped with micro-tear sampling equipment, it offers accurate testing, convenient operation, and stable results, making it highly adaptable to the clinical testing and screening needs of medical institutions at all levels worldwide.
Based on innovation and committed to quality, Shengze Kanghua will continue to advance its globalization strategy and deliver high-quality, standardized ophthalmic IVD solutions, bringing the benefits of "Made in China" to more patients and medical institutions worldwide.

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