Taiwan FDA registration 35ee4f4eae418b94bffb58289a5d5727
Ecome blood glucose/blood ketone monitoring system
TW: 易康 血糖/血酮 監測系統
Taiwan·Risk Class 2·Naohara Biotechnology Co., Ltd.;; Yuxin Biotechnology Co., Ltd·Registered Oct 17, 2023 – Mar 24, 2028ActiveRegistration details
- Analysis ID
- 35ee4f4eae418b94bffb58289a5d5727
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
- Oct 17, 2023
- Expiry Date
- Mar 24, 2028
About this record
Access comprehensive regulatory information for Ecome 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 35ee4f4eae418b94bffb58289a5d5727 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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