Taiwan FDA registration d0c4a9d28007452e99aefb5bfdc0c9f6

OKmeter Vita Blood Glucose Monitoring System

TW: 歐克元氣血糖監測系統

Taiwan·Risk Class 2·MD·OK BIOTECH CO., LTD.·Registered Sep 21, 2023 – Sep 21, 2028Active

Registration details

Analysis ID: d0c4a9d28007452e99aefb5bfdc0c9f6
License Form: Ministry of Health Medical Device Manufacturing No. 007607

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 for in vitro testing only to quantitatively measure the blood glucose level of fresh microvascular whole blood from fingertips and other blood collection sites (palm, forearm, upper arm). This product can be used to measure blood glucose levels by healthcare professionals or diabetic patients, and is not intended as a final diagnosis of diabetes.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A1345 Glucose Test System
Import Information: Produced in Taiwan, China; GMP

Dates and status

Registration Date: Sep 21, 2023
Expiry Date: Sep 21, 2028

About this record

Access comprehensive regulatory information for OKmeter Vita 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 d0c4a9d28007452e99aefb5bfdc0c9f6 and manufactured by OK BIOTECH CO., LTD.. The authorized representative in Taiwan is OK BIOTECH CO., LTD..

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.