Taiwan FDA registration 6a4844046db47f041b72c924a5956f84

Sismet automated blood analyzer

TW: 西斯美自動血液分析儀

Taiwan·Risk Class 2·SYSMEX CORPORATION;; SYSMEX CORPORATION, KAKOGAWA FACTORY·Registered Nov 01, 2005 – Nov 01, 2025Expired

Registration details

Analysis ID: 6a4844046db47f041b72c924a5956f84
Customs Code: DHA00601343605

Company information

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

Product details

Intended Use: The Sysmex KX-21N is an automated multiparameter blood cell counter for in vitro diagnostic use in clinical laboratories. The Sysmex K-4500 is a fully automated blood analyzer for in vitro diagnostic use in clinical laboratories. The Sysmex XE-2100/XE-2100L/XE-2100D Series is a fully automated hematology analyzer that provides clinical laboratories to perform blood testing. The Sysmex XT-1800i/XT-2000i is an automated blood analyzer for in vitro diagnostic use 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 01, 2005
Expiry Date: Nov 01, 2025

About this record

Access comprehensive regulatory information for Sismet automated blood analyzer in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 6a4844046db47f041b72c924a5956f84 and manufactured by SYSMEX CORPORATION;; SYSMEX CORPORATION, KAKOGAWA FACTORY. The authorized representative in Taiwan is SYSMEX TAIWAN CO., LTD..

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