Taiwan FDA registration 3bcd4bf08d6e516fd70b820cb830413d

Proyuan cloud-type blood glucose monitoring system

TW: 普元雲端型血糖監控系統

Taiwan·Risk Class 2·PU YUAN BIOTECH CO., LTD.·Registered Oct 22, 2015 – Oct 22, 2025Cancelled

Registration details

Analysis ID: 3bcd4bf08d6e516fd70b820cb830413d

Company information

Manufacturer: PU YUAN BIOTECH CO., LTD.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: PU YUAN BIOTECH CO., LTD.

Product details

Intended Use: This product uses electrochemical biosensing technology, combined with Puyuan cloud blood glucose test piece, to measure the blood glucose value of fresh fingertips and other blood collection sites (palm, forearm, upper arm, calf and thigh) microvascular blood, this product can provide professional medical personnel or diabetic patients to measure blood sugar. This product is for in vitro testing only, only for blood glucose testing, not to measure neonatal blood, and not 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

Dates and status

Registration Date: Oct 22, 2015
Expiry Date: Oct 22, 2025
Cancellation Date: Nov 05, 2024

Cancellation information

Status: Logged out
Reason: 自請註銷

About this record

Access comprehensive regulatory information for Proyuan cloud-type 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 3bcd4bf08d6e516fd70b820cb830413d and manufactured by PU YUAN BIOTECH CO., LTD.. The authorized representative in Taiwan is PU YUAN BIOTECH CO., LTD..

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