Taiwan FDA registration 6a17cb48fb85b1949fc53187cab2ea51
Helena QickGel Cholesterol reagent kit (Non-sterile)
TW: “海倫娜”膽固醇試劑(未滅菌)
Taiwan·Risk Class 1·MD·HELENA LABORATORIES CORP.·Registered Apr 23, 2019 – Apr 23, 2024ExpiredRegistration details
- Analysis ID
- 6a17cb48fb85b1949fc53187cab2ea51
- License Form
- Ministry of Health Medical Device Import No. 020353
- Customs Code
- DHA09402035305
Company information
- Manufacturer
- HELENA LABORATORIES CORP.
- Manufacturer Country
- United States
- Authorized Representative
- SHANG LI INSTRUMENTS 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
- Imported from abroad
Dates and status
- Registration Date
- Apr 23, 2019
- Expiry Date
- Apr 23, 2024
About this record
Access comprehensive regulatory information for Helena QickGel Cholesterol reagent 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 6a17cb48fb85b1949fc53187cab2ea51 and manufactured by HELENA LABORATORIES CORP.. The authorized representative in Taiwan is SHANG LI INSTRUMENTS 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.
Free DatabasePowered by Pure Global AI89,000+ Devices