1. Date of Event: 115/07/10 2. Company Name: Huakwang Biotechnology Co., Ltd. 3. Relationship with Company:本公司 (This Company) 4. Cross-shareholding Ratio: Not applicable 5. Reason for Occurrence: The Continuous Glucose Monitoring System developed and manufactured by the company has passed the EU Medical Device Regulation (MDR) certification (Certificate No. MDR 832658). 6. Response Measures: Issuance of this announcement. 7. Other Matters to be Disclosed: The certified product, the 'Continuous Glucose Monitoring System (CGM)', is intended for use in diabetic patients aged 18 years and above, to detect glucose trends and assist in blood glucose management. The system is designed to replace traditional finger-prick blood glucose testing as a basis for diabetes treatment decisions. It can also aid in detecting hyperglycemic and hypoglycemic events, serving as a reference for both acute and long-term treatment adjustments. Interpretation of results should be based on both glucose trend patterns and continuous readings.
FACT BOX
- Source: PR Times
- Category: New Product
- Dates in source: 115/07/10
- Products / services: CGM