Taiwan FDA registration 70fc820b075493e573ad7cec51eae2f8
Duncon blood glucose monitoring system
TW: 德恩康血糖監測系統
Taiwan·Risk Class 2·OK BIOTECH CO., LTD.·Registered Jul 16, 2021 – Jul 16, 2026ExpiredRegistration details
- Analysis ID
- 70fc820b075493e573ad7cec51eae2f8
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, quantitative detection of fingertips and other blood collection sites (palm, forearm, upper arm, calf and thigh) microvascular whole blood glucose value, not suitable for neonatal testing.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1345 Glucose Test System
- Import Information
- 國產;; QMS/QSD
Dates and status
- Registration Date
- Jul 16, 2021
- Expiry Date
- Jul 16, 2026
About this record
Access comprehensive regulatory information for Duncon 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 70fc820b075493e573ad7cec51eae2f8 and manufactured by OK BIOTECH CO., LTD.. The authorized representative in Taiwan is OK BIOTECH CO., LTD..
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