Taiwan FDA registration ce019e641fa45c440a64d05b318bd8ac
"Sysmecon" nucleic acid amplification analyzer (unsterilized)
TW: “希森美康”核酸放大擴增分析儀(未滅菌)
Taiwan·Risk Class 1·SYSMEX CORPORATION;; SYSMEX CORPORATION, I-SQUARE·Registered Oct 07, 2021 – Oct 07, 2026ActiveRegistration details
- Analysis ID
- ce019e641fa45c440a64d05b318bd8ac
- Customs Code
- DHA09402267409
Company information
- Manufacturer Country
- Japan
- Authorized Representative
- SYSMEX TAIWAN CO., LTD.
Product details
- Intended Use
- Limited to the classification and grading management method of medical equipment, the first level identification range of microchemical analyzer (A.2170) used in clinical use.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.2170 Microchemical analyzer for clinical use
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Oct 07, 2021
- Expiry Date
- Oct 07, 2026
About this record
Access comprehensive regulatory information for "Sysmecon" nucleic acid amplification analyzer (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number ce019e641fa45c440a64d05b318bd8ac and manufactured by SYSMEX CORPORATION;; SYSMEX CORPORATION, I-SQUARE. The authorized representative in Taiwan is SYSMEX TAIWAN CO., LTD..
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