Taiwan FDA registration 2f3813b1cc475e42e33b4c4528a72242
Yilimei blood glucose/blood ketone monitoring system
TW: 易立測 血糖/血酮 監測系統
Taiwan·Risk Class 2·Naohara Biotechnology Co., Ltd.;; Yuxin Biotechnology Co., Ltd·Registered Mar 24, 2023 – Mar 24, 2028ActiveRegistration details
- Analysis ID
- 2f3813b1cc475e42e33b4c4528a72242
Company information
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- EASY LIFE GREEN TECHNOLOGY CORPORATION
Product details
- Intended Use
- This product is only suitable for in vitro diagnosis, using fresh fingertip microvascular whole blood to measure and quantitatively detect blood glucose and blood ketone content. This product can be used by self-testing and professionals, but is not intended for testing of newborns.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1435 Ketone (non-quantitative) testing system;; A.1345 Glucose Test System
- Import Information
- QMS/QSD;; 委託製造;; 國產
Dates and status
- Registration Date
- Mar 24, 2023
- Expiry Date
- Mar 24, 2028
About this record
Access comprehensive regulatory information for Yilimei blood glucose/blood ketone 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 2f3813b1cc475e42e33b4c4528a72242 and manufactured by Naohara Biotechnology Co., Ltd.;; Yuxin Biotechnology Co., Ltd. The authorized representative in Taiwan is EASY LIFE GREEN TECHNOLOGY CORPORATION.
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