Taiwan FDA registration b1ec8f9fc352d4185b1cc8d597215569
"Helena" Cholesterol/Triglycerides Complex (Unsterilized)
TW: "海倫那" 膽固醇/三酸甘油脂複合試劑 (未滅菌)
Registration details
- Analysis ID
- b1ec8f9fc352d4185b1cc8d597215569
- Customs Code
- DHA09401694301
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 identification range of the Measures for the Administration of Medical Devices "Triglycerides Test System (A.1705)" and "Cholesterol (Total) Test System (A.1175)".
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1705 Triglyceride test system;; A.1175 Cholesterol (Total) Testing System
- Import Information
- import
Dates and status
- Registration Date
- Aug 31, 2016
- Expiry Date
- Aug 31, 2021
- Cancellation Date
- Sep 23, 2023
Cancellation information
- Status
- Logged out
- Reason
- 自行鍵入
About this record
Access comprehensive regulatory information for "Helena" Cholesterol/Triglycerides Complex (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number b1ec8f9fc352d4185b1cc8d597215569 and manufactured by HELENA LABORATORIES, INC.. The authorized representative in Taiwan is SHANG LI INSTRUMENTS CO., LTD..
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