Taiwan FDA registration 9b146df56e30af93cab772b30878b8b7
"Helena" QuickGel Lipoprotein kit (Non-sterile)
TW: "海倫那" 脂蛋白試劑組 (未滅菌)
Taiwan·Risk Class 1·MD·HELENA LABORATORIES, INC.·Registered Aug 23, 2016 – Aug 23, 2021ExpiredRegistration details
- Analysis ID
- 9b146df56e30af93cab772b30878b8b7
- License Form
- Ministry of Health Medical Device Import No. 016917
- Customs Code
- DHA09401691700
Company information
- Manufacturer
- HELENA LABORATORIES, INC.
- Manufacturer Country
- Japan
- Authorized Representative
- SHANG LI INSTRUMENTS CO., LTD.
Product details
- Intended Use
- Limited to the first level recognition range of the lipoprotein test system (A.1475) of the medical device management method.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A1475 Lipoprotein Testing System
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Aug 23, 2016
- Expiry Date
- Aug 23, 2021
About this record
Access comprehensive regulatory information for "Helena" QuickGel Lipoprotein kit (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 9b146df56e30af93cab772b30878b8b7 and manufactured by HELENA LABORATORIES, INC.. The authorized representative in Taiwan is SHANG LI INSTRUMENTS CO., LTD..
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