BIONANO Blood Glucose Monitoring System - Taiwan Registration da9940dd775741156ad3a1364c5efe5f
Access comprehensive regulatory information for BIONANO 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 da9940dd775741156ad3a1364c5efe5f and manufactured by OK BIOTECH CO., LTD.. The authorized representative in Taiwan is OK BIOTECH CO., LTD..
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Device Details
Registration Details
da9940dd775741156ad3a1364c5efe5f
Ministry of Health Medical Device Manufacturing No. 007586
Product Details
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 professionals or diabetic patients to measure blood glucose values and should not be used as the final judgment of diabetes.
A Clinical chemistry and clinical toxicology
A1345 Glucose Test System
Produced in Taiwan, China; GMP
Dates and Status
Feb 20, 2023
Feb 20, 2028