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)
Taiwan flagTaiwan·Risk Class 1·SYSMEX CORPORATION;; SYSMEX CORPORATION Ono Factory·Registered May 17, 2022 – May 17, 2027Active
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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