Taiwan FDA registration 7250ac4cf38b2b629cdf3fb5a8e82c84
FlexTest GC Blood Glucose/Cholesterol Dual Function Monitoring System
TW: 易立測 GC 血糖/膽固醇雙功能監測系統
Taiwan·Risk Class 2·BIOPTIK TECHNOLOGY, INC.·Registered Jan 20, 2021 – Jan 20, 2026ExpiredRegistration details
- Analysis ID
- 7250ac4cf38b2b629cdf3fb5a8e82c84
Company information
- Manufacturer
- BIOPTIK TECHNOLOGY, INC.
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- BIOPTIK TECHNOLOGY, INC.
Product details
- Intended Use
- This product is only suitable for in vitro diagnosis, and the blood glucose and cholesterol content are quantified by measuring fresh fingertip microvascular whole blood. This product is intended for single use only, but is not intended for testing of newborns.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1345 Glucose Test System
- Import Information
- QMS/QSD;; 國產
Dates and status
- Registration Date
- Jan 20, 2021
- Expiry Date
- Jan 20, 2026
About this record
Access comprehensive regulatory information for FlexTest GC Blood Glucose/Cholesterol Dual Function Monitoring System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 7250ac4cf38b2b629cdf3fb5a8e82c84 and manufactured by BIOPTIK TECHNOLOGY, INC.. The authorized representative in Taiwan is BIOPTIK TECHNOLOGY, INC..
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.
Free DatabasePowered by Pure Global AI89,000+ Devices