Taiwan FDA registration 32dc42a29feac02b793f8407e5dfead8
AsiaGen One-step Pregnancy Rapid Test
TW: 亞洲基因驗孕試劑
Taiwan·Risk Class 2·MD·Asia Gene Technology Co., Ltd. Shanhua Factory·Registered Sep 10, 2015 – Sep 10, 2025ExpiredRegistration details
- Analysis ID
- 32dc42a29feac02b793f8407e5dfead8
- License Form
- Ministry of Health Medical Device Manufacturing No. 004953
Company information
- Manufacturer
- Asia Gene Technology Co., Ltd. Shanhua Factory
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- Asia Gene Technology Co., Ltd. Shanhua Factory
Product details
- Intended Use
- This product is used to detect human chorionic gonadotropin (hCG) in urine for early detection of pregnancy.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A1155 Human chorionic gonadotropin test system
- Import Information
- Produced in Taiwan, China
Dates and status
- Registration Date
- Sep 10, 2015
- Expiry Date
- Sep 10, 2025
About this record
Access comprehensive regulatory information for AsiaGen One-step Pregnancy Rapid Test in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 32dc42a29feac02b793f8407e5dfead8 and manufactured by Asia Gene Technology Co., Ltd. Shanhua Factory. The authorized representative in Taiwan is Asia Gene Technology Co., Ltd. Shanhua Factory.
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