Taiwan FDA registration 02a37148a7872cc3a37686fc9824ce75

Sismex rapid hemolytic agent II generation

TW: 西斯美快速溶血劑二代

Taiwan·Risk Class 2·SYSMEX CORPORATION;; SYSMEX INTERNATIONAL REAGENTS CO., LTD., ONO FACTORY·Registered Nov 27, 2005 – Nov 27, 2015Cancelled

Registration details

Analysis ID: 02a37148a7872cc3a37686fc9824ce75
Customs Code: DHA00601503306

Company information

Manufacturer: SYSMEX CORPORATION;; SYSMEX INTERNATIONAL REAGENTS CO., LTD., ONO FACTORY
Manufacturer Country: Japan
Authorized Representative: Sandong Instrument Co., Ltd

Product details

Intended Use: It is used in the Sysmex Semi-Automatic Hematology Analyser F-800 as a disruptive fluid for white blood cell counts and for the detection of heme concentration in the blood.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.5620 Automated Heme Analysis System
Import Information: import

Dates and status

Registration Date: Nov 27, 2005
Expiry Date: Nov 27, 2015
Cancellation Date: Apr 07, 2016

Cancellation information

Status: Logged out
Reason: 自請註銷

About this record

Access comprehensive regulatory information for Sismex rapid hemolytic agent II generation in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 02a37148a7872cc3a37686fc9824ce75 and manufactured by SYSMEX CORPORATION;; SYSMEX INTERNATIONAL REAGENTS CO., LTD., ONO FACTORY. The authorized representative in Taiwan is Sandong Instrument Co., Ltd.

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