Taiwan FDA registration 7d992a8c3c92ad2f4c543e76ebbd7d1f
"Sysmecon" erythrocytolytic agent II (unsterilized)
TW: “希森美康”紅血球溶解劑二代 (未滅菌)
Registration details
- Analysis ID
- 7d992a8c3c92ad2f4c543e76ebbd7d1f
- Customs Code
- DHA09402280307
Company information
- Manufacturer Country
- Japan
- Authorized Representative
- SYSMEX TAIWAN CO., LTD.
Product details
- Intended Use
- Limited to the classification and grading management measures for medical devices, the first level identification range of "red blood cell lytic agent (B.8540)".
- Product Type (Level 1)
- B Hematology, pathology, and genetics
- Product Type (Level 2)
- B.8540 紅血球溶解劑
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- May 17, 2022
- Expiry Date
- May 17, 2027
About this record
Access comprehensive regulatory information for "Sysmecon" erythrocytolytic agent II (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 7d992a8c3c92ad2f4c543e76ebbd7d1f and manufactured by SYSMEX CORPORATION;; SYSMEX CORPORATION Ono Factory. The authorized representative in Taiwan is SYSMEX TAIWAN CO., LTD..
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