Taiwan FDA registration 7ff9d832956c305101e7ead3c7119098
MajorCare AP-5100 Blood Glucose Monitoring System
TW: 美捷克愛彼德進階二代血糖測試系統
Taiwan·Risk Class 2·MD·Metalgen Biotechnology Co., Ltd·Registered Jun 22, 2020 – Jun 22, 2025ExpiredRegistration details
- Analysis ID
- 7ff9d832956c305101e7ead3c7119098
- License Form
- Ministry of Health Medical Device Manufacturing No. 006717
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 quantitatively measured by microvascular whole blood and venous whole blood from fresh fingertips, not suitable for newborns, can be used by diabetics or medical personnel to monitor blood glucose values (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
Dates and status
- Registration Date
- Jun 22, 2020
- Expiry Date
- Jun 22, 2025
About this record
Access comprehensive regulatory information for MajorCare AP-5100 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 7ff9d832956c305101e7ead3c7119098 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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