Taiwan FDA registration 02d6082633fdf11afe90da51394ecfb0
Askine blood glucose test piece
TW: 愛思金血糖試片
Registration details
- Analysis ID
- 02d6082633fdf11afe90da51394ecfb0
Company information
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- Ace Medical Technology Co., Ltd.
Product details
- Intended Use
- This product is used to quantitatively measure glucose concentration in fresh fingertip microvascular blood and venous blood. It is used with the Dibao blood glucose analyzer No. 000490 (model: HL568HS, HL568HD) of the Department of Health. It is suitable for professionals or users with diabetes to monitor blood glucose levels at home or in medical units, and cannot be used for diabetes diagnosis and screening.
- 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
- Apr 15, 2021
- Expiry Date
- Apr 15, 2026
About this record
Access comprehensive regulatory information for Askine blood glucose test piece in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 02d6082633fdf11afe90da51394ecfb0 and manufactured by Jinhong Medical Materials Technology Co., Ltd. Taoyuan Factory. The authorized representative in Taiwan is Ace Medical Technology Co., Ltd..
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