Taiwan FDA registration 4367ae498b664686e9d43978f9b6f24c

"Sysmecon" fully automatic urine sediment analyzer

TW: "希森美康" 全自動尿液沉渣分析儀

Taiwan·Risk Class 2·SYSMEX CORPORATION;; SYSMEX CORPORATION, I-SQUARE·Registered Jan 03, 2023 – Jan 03, 2028Active

Registration details

Analysis ID: 4367ae498b664686e9d43978f9b6f24c
Customs Code: DHA05603589704

Company information

Manufacturer: SYSMEX CORPORATION;; SYSMEX CORPORATION, I-SQUARE
Manufacturer Country: Japan
Authorized Representative: SYSMEX TAIWAN CO., LTD.

Product details

Intended Use: 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.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.5200 Automated Cell Counter
Import Information: Input;; QMS/QSD

Dates and status

Registration Date: Jan 03, 2023
Expiry Date: Jan 03, 2028

About this record

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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