Taiwan FDA registration f6d3cec33b27e9f9a6b89ea924d9b579

Sysmex fully automatic urine fractional analysis device

TW: 希森美康全自動尿中有形成分分析裝置

Taiwan·Risk Class 2·SYSMEX CORPORATION;; SYSMEX CORPORATION, I-SQUARE·Registered Jan 26, 2017 – Jan 26, 2027Active

Registration details

Analysis ID: f6d3cec33b27e9f9a6b89ea924d9b579
Customs Code: DHA05602920005

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 in vitro diagnostic analyzer to measure human urine and body fluid samples. This product can only be used to analyze human urine, body fluids and quality control materials.
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: Jan 26, 2017
Expiry Date: Jan 26, 2027

About this record

Access comprehensive regulatory information for Sysmex fully automatic urine fractional analysis device in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number f6d3cec33b27e9f9a6b89ea924d9b579 and manufactured by SYSMEX CORPORATION;; SYSMEX CORPORATION, I-SQUARE. The authorized representative in Taiwan is SYSMEX TAIWAN CO., LTD..

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