Taiwan FDA registration 4e26f5fdc435c9ce3933b30eeb9a3f56

Sisme fully automatic urine cell analyzer

TW: 西斯美全自動尿液細胞分析儀

Taiwan·Risk Class 2·SYSMEX CORPORATION;; SYSMEX CORPORATION, KAKOGAWA FACTORY·Registered Nov 11, 2005 – Nov 11, 2025Expired

Registration details

Analysis ID: 4e26f5fdc435c9ce3933b30eeb9a3f56
Customs Code: DHA00601463302

Company information

Manufacturer: SYSMEX CORPORATION;; SYSMEX CORPORATION, KAKOGAWA FACTORY
Manufacturer Country: Japan
Authorized Representative: SYSMEX TAIWAN CO., LTD.

Product details

Intended Use: A fully automated urine cell analyzer for the analysis of tissue composition in urine in clinical laboratories.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.5200 Automated Cell Counter
Import Information: import

Dates and status

Registration Date: Nov 11, 2005
Expiry Date: Nov 11, 2025

About this record

Access comprehensive regulatory information for Sisme fully automatic urine cell analyzer in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 4e26f5fdc435c9ce3933b30eeb9a3f56 and manufactured by SYSMEX CORPORATION;; SYSMEX CORPORATION, KAKOGAWA FACTORY. The authorized representative in Taiwan is SYSMEX TAIWAN CO., LTD..

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