Taiwan FDA registration 47770bf18707fe2d212ce9fa569eb060
"Kangyang" Pouver blood glucose monitoring system
TW: “康揚” 普弗血糖監測系統
Taiwan·Risk Class 2·OK BIOTECH CO., LTD.·Registered Aug 22, 2024 – Dec 19, 2029ActiveRegistration details
- Analysis ID
- 47770bf18707fe2d212ce9fa569eb060
Company information
- Manufacturer
- OK BIOTECH CO., LTD.
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- OK BIOTECH CO., LTD.
Product details
- Intended Use
- This product is only for in vitro testing to quantitatively measure the blood glucose value of 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 to measure blood glucose levels by professionals or diabetics. Not as a 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
Dates and status
- Registration Date
- Aug 22, 2024
- Expiry Date
- Dec 19, 2029
About this record
Access comprehensive regulatory information for "Kangyang" Pouver 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 47770bf18707fe2d212ce9fa569eb060 and manufactured by OK BIOTECH CO., LTD.. The authorized representative in Taiwan is OK BIOTECH CO., LTD..
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