【Bionime】Announcement: Company's "RIGHTEST iFree2 Continuous Glucose Monitoring System (CGM)" Obtains Class II Medical Device Approval Notice from Taiwan Food and Drug Administration (TFDA)
Bionime Corporation announced that its second-generation continuous glucose monitoring system, "RIGHTEST iFree2 CGM," has received Class II medical device approval from the Taiwan Food and Drug Administration (TFDA). This system is designed to help diabetic patients aged 18 to 80 manage their blood sugar.
📋 Article Processing Timeline
- 📰 Published: April 29, 2026 at 09:00
- 🔍 Collected: April 30, 2026 at 08:00 (23h 0m after Published)
- 🤖 AI Analyzed: April 30, 2026 at 08:03 (3 min after Collected)
1. Date of occurrence of the event: 2026/04/29
2. Company name: Bionime Corporation
3. Relationship with the Company (please enter "the Company" or "subsidiary"): the Company
4. Mutual shareholding ratio: Not applicable
5. Reason for occurrence: The second-generation continuous glucose monitoring system developed and produced by the Company, "RIGHTEST iFree2 Continuous Glucose Monitoring System (CGM)," has obtained the Class II medical device approval notice (Ministry of Health and Welfare Medical Device Manufacturing No. 008731) issued by the Taiwan Food and Drug Administration (TFDA).
6. Countermeasures: This announcement is being made.
7. Other matters to be specified (If the subject of the event or resolution is a public company or above, this material information also complies with Article 7, Paragraph 9 of the Enforcement Rules of the Securities and Exchange Act, which specifies matters that have a material impact on shareholders' equity or stock price): The RIGHTEST iFree2 Continuous Glucose Monitoring System (CGM) is applicable to diabetic patients aged 18 to 80 who require blood sugar management. This product can continuously detect the user's interstitial fluid glucose concentration, helping users observe glucose trend changes and replacing finger-prick blood glucose measurements. This product also assists in detecting hyperglycemia and hypoglycemia events, serving as a reference for acute and long-term treatment. When interpreting the results of this product, it should be based on both glucose trend changes and continuous readings.
2. Company name: Bionime Corporation
3. Relationship with the Company (please enter "the Company" or "subsidiary"): the Company
4. Mutual shareholding ratio: Not applicable
5. Reason for occurrence: The second-generation continuous glucose monitoring system developed and produced by the Company, "RIGHTEST iFree2 Continuous Glucose Monitoring System (CGM)," has obtained the Class II medical device approval notice (Ministry of Health and Welfare Medical Device Manufacturing No. 008731) issued by the Taiwan Food and Drug Administration (TFDA).
6. Countermeasures: This announcement is being made.
7. Other matters to be specified (If the subject of the event or resolution is a public company or above, this material information also complies with Article 7, Paragraph 9 of the Enforcement Rules of the Securities and Exchange Act, which specifies matters that have a material impact on shareholders' equity or stock price): The RIGHTEST iFree2 Continuous Glucose Monitoring System (CGM) is applicable to diabetic patients aged 18 to 80 who require blood sugar management. This product can continuously detect the user's interstitial fluid glucose concentration, helping users observe glucose trend changes and replacing finger-prick blood glucose measurements. This product also assists in detecting hyperglycemia and hypoglycemia events, serving as a reference for acute and long-term treatment. When interpreting the results of this product, it should be based on both glucose trend changes and continuous readings.