Taiwan FDA registration 5c49118ea2b45bda05f4e761fa10f880
Mediconric blood glucose monitoring system
TW: 美迪康立克血糖監測系統
Taiwan·Risk Class 2·訊影Optoelectronics Co., Ltd.;; Medicon Technology Co., Ltd·Registered Jul 04, 2019 – Jul 04, 2029ActiveRegistration details
- Analysis ID
- 5c49118ea2b45bda05f4e761fa10f880
Company information
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- MEDICARE TECH CO., LTD.
Product details
- Intended Use
- This product is only for in vitro testing, quantitatively detecting the blood glucose value of fresh microvascular whole blood from fingertips and other blood collection sites (palm, forearm, upper arm, calf and thigh), and is not suitable for neonatal testing. This product can be used by professional medical professionals or diabetic patients to measure blood glucose levels, and is not intended as the final diagnosis of diabetes.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1345 Glucose Test System
- Import Information
- Domestic;; Contract manufacturing
Dates and status
- Registration Date
- Jul 04, 2019
- Expiry Date
- Jul 04, 2029
About this record
Access comprehensive regulatory information for Mediconric blood glucose 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 5c49118ea2b45bda05f4e761fa10f880 and manufactured by 訊影Optoelectronics Co., Ltd.;; Medicon Technology Co., Ltd. The authorized representative in Taiwan is MEDICARE TECH CO., LTD..
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