Taiwan FDA registration 3fdc88d382a61333d2926f26af29c141

Sysmex Automatic Blood Analyzer XN-L Series

TW: 希森美康全自動血液分析儀XN-L系列

Taiwan·Risk Class 2·SYSMEX CORPORATION;; SYSMEX CORPORATION, KAKOGAWA FACTORY·Registered Nov 29, 2016 – Nov 29, 2026Active

Registration details

Analysis ID: 3fdc88d382a61333d2926f26af29c141
Customs Code: DHA05602897102

Company information

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

Product details

Intended Use: This product is a fully automatic blood and body fluid analyzer for in vitro diagnosis in clinical laboratories, which is only used to measure human blood, body fluids or quality tube blood.
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 29, 2016
Expiry Date: Nov 29, 2026

About this record

Access comprehensive regulatory information for Sysmex Automatic Blood Analyzer XN-L Series in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 3fdc88d382a61333d2926f26af29c141 and manufactured by SYSMEX CORPORATION;; SYSMEX CORPORATION, KAKOGAWA FACTORY. The authorized representative in Taiwan is SYSMEX TAIWAN CO., LTD..

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