Taiwan FDA registration 94bb05dadfc51e61a601cd5b16c99da3
Imat's Smart Blood Glucose Measurement System
TW: 宜瑪氏巧捷型血糖量測系統
Registration details
- Analysis ID
- 94bb05dadfc51e61a601cd5b16c99da3
Company information
- Manufacturer
- EPS BIO TECHNOLOGY CORP.
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- EPS BIO TECHNOLOGY CORP.
Product details
- Intended Use
- This product is suitable for Ima-style blood glucose test tablets to measure the glucose content in fresh microvascular whole blood samples. It is used for in vitro measurement, suitable for diabetic patients to use at home, and can help monitor the effectiveness of diabetes control. Not suitable for plasma or serum testing, nor for 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
- Sep 22, 2020
- Expiry Date
- Sep 22, 2025
About this record
Access comprehensive regulatory information for Imat's Smart Blood Glucose Measurement System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 94bb05dadfc51e61a601cd5b16c99da3 and manufactured by EPS BIO TECHNOLOGY CORP.. The authorized representative in Taiwan is EPS BIO TECHNOLOGY CORP..
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