Taiwan FDA registration a625a8d9e33b6e157fa9ef905fc52229
"MajorCare AP-Duo" Total Cholesterol Test Strips (Non-Sterile)
TW: "美捷克艾斐德" 總膽固醇試片 (未滅菌)
Registration details
- Analysis ID
- a625a8d9e33b6e157fa9ef905fc52229
- License Form
- Ministry of Health Medical Device Manufacturing No. 006905
Company information
- Manufacturer
- Metalgen Biotechnology Co., Ltd
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- Metalgen Biotechnology Co., Ltd
Product details
- Intended Use
- Limited to the first level identification range of the "Cholesterol (Total) Test System (A.1175)" of the Measures for the Administration of Medical Devices.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A1175 Cholesterol (total) test system
- Import Information
- Produced in Taiwan, China
Dates and status
- Registration Date
- Aug 29, 2017
- Expiry Date
- Aug 29, 2022
About this record
Access comprehensive regulatory information for "MajorCare AP-Duo" Total Cholesterol Test Strips (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number a625a8d9e33b6e157fa9ef905fc52229 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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