Taiwan FDA registration 08c0c5563658d2e7bbdd86a2c66bb414
MajorCare Eco Chek Blood Glucose Monitoring System
TW: 美捷克益捷測血糖測試系統
Taiwan·Risk Class 2·MD·Metalgen Biotechnology Co., Ltd·Registered Aug 21, 2020 – Aug 21, 2025ExpiredRegistration details
- Analysis ID
- 08c0c5563658d2e7bbdd86a2c66bb414
- License Form
- Ministry of Health Medical Device Manufacturing No. 006730
Company information
- Manufacturer
- Metalgen Biotechnology Co., Ltd
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- Metalgen Biotechnology Co., Ltd
Product details
- Intended Use
- This product is used to quantitatively measure blood glucose values from microvascular whole blood and venous whole blood from fresh fingertips, and is not suitable for neonatal diagnosis. Can be used by diabetics or healthcare professionals (for single use only).
- 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
- Aug 21, 2020
- Expiry Date
- Aug 21, 2025
About this record
Access comprehensive regulatory information for MajorCare Eco Chek 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 08c0c5563658d2e7bbdd86a2c66bb414 and manufactured by Metalgen Biotechnology Co., Ltd. The authorized representative in Taiwan is Metalgen Biotechnology 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.
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