Taiwan FDA registration 8e786197a99a6cf544311355815eb995
"Laetise" rapid pregnancy test
TW: “蕾蒂絲” 快速驗孕試劑
Taiwan·Risk Class 2·TONYAR BIOTECH. INC.·Registered Jul 08, 2015 – Sep 28, 2025ExpiredRegistration details
- Analysis ID
- 8e786197a99a6cf544311355815eb995
Company information
- Manufacturer
- TONYAR BIOTECH. INC.
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- JIEDUO ENTERPRISE CO., LTD.
Product details
- Intended Use
- Serum or urine is tested for human chorionic gonadotropin (HCG). The change in efficacy (removal of serum source and addition of non-specialist use) is the qualitative test of urine for human chorionic gonadotropin (HCG).
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1155 Human chorionic gonadotropin testing system
- Import Information
- Domestic;; Contract manufacturing
Dates and status
- Registration Date
- Jul 08, 2015
- Expiry Date
- Sep 28, 2025
About this record
Access comprehensive regulatory information for "Laetise" rapid pregnancy test in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 8e786197a99a6cf544311355815eb995 and manufactured by TONYAR BIOTECH. INC.. The authorized representative in Taiwan is JIEDUO ENTERPRISE CO., LTD..
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