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"Sysmecon" fully automatic urine sediment analyzer - Taiwan Registration 4367ae498b664686e9d43978f9b6f24c

Access comprehensive regulatory information for "Sysmecon" fully automatic urine sediment analyzer in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 4367ae498b664686e9d43978f9b6f24c and manufactured by SYSMEX CORPORATION;; SYSMEX CORPORATION, I-SQUARE. The authorized representative in Taiwan is SYSMEX TAIWAN CO., LTD..

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4367ae498b664686e9d43978f9b6f24c
Registration Details
Taiwan FDA Registration: 4367ae498b664686e9d43978f9b6f24c
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Device Details

"Sysmecon" fully automatic urine sediment analyzer
TW: "ๅธŒๆฃฎ็พŽๅบท" ๅ…จ่‡ชๅ‹•ๅฐฟๆถฒๆฒ‰ๆธฃๅˆ†ๆžๅ„€
Risk Class 2

Registration Details

4367ae498b664686e9d43978f9b6f24c

DHA05603589704

Company Information

Product Details

This instrument is an automatic analyzer, used for quantitative, qualitative or semi-quantitative measurement of parameters in human urine and body fluids (detailed in Chinese instructions), human urine parameter analysis results can be used as screening or clinical laboratory patient diagnosis aid, human body fluid parameter analysis results can be used as clinical laboratory patient diagnosis aid. The new (model UF-1500) is an automatic analyzer, which is used for quantitative, qualitative or semi-quantitative measurement of parameters in human urine (detailed in Chinese instructions), and the results of human urine parameter analysis can be used as a diagnostic aid for screening or clinical laboratories.

B Hematology, pathology, and genetics

B.5200 Automated Cell Counter

Input;; QMS/QSD

Dates and Status

Jan 03, 2023

Jan 03, 2028