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Singapore HSA registration DE0010232

Sysmex Automated Hematology Analyzer KX series

Singapore flagSingapore·CLASS B IVD·Sysmex Corporation·Registered September 05, 2012
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Hematology
Registration information
Registration Number
DE0010232
Registration Date
September 05, 2012
Change Notification Approval Date
January 22, 2025
Retention Due Date
September 04, 2025
Product description
The Sysmex KX series is an automatic multi-parameter blood cell counter for in vitro diagnostic use in clinical laboratories.
Product Owner
Name
Sysmex Corporation
Short Name
Sysmex
Address
1-5-1 Wakinohama-Kaigandori,, Chuo-ku, Kobe 651-0073, JAPAN
Registrant
Name
SYSMEX ASIA PACIFIC PTE. LTD.
Address
9 TAMPINES GRANDE, #06-18, SINGAPORE 528735
Importer
Name
SYSMEX ASIA PACIFIC PTE. LTD.
Address
9 TAMPINES GRANDE, #06-18, SINGAPORE 528735
Model information
Model Name(s)
EIGHTCHECK-3WP-N EIGHTCHECK-3WP-L EIGHTCHECK-3WP-H WRP CHECK CELLCLEAN, CL-50 CELLPACK, PK-30L CELLPACK, CPK-310A Automated Hematology Analyzer KX-21 Host Output Unit No.1 STROMATOLYSER-WH, SWH-200A SCS-1000, CAL-100C KX-21 Printer Unit Automated Hematology Analyzer KX-21N RANGE CHECK X II IQAS - EIGHTCHECK CELLPACK, PK-30L STROMATOLYSER-WH, SWH-200A CELLPACK, CPK-310A
Model Identifier(s)
00403915 00404015 00404112 230302 83401621 88408711 88408915 97327012 97345311 97405216 97407314 98302714 99327218 CK955301 IQAS P88408711 P97405216 ZPP88408915
About this record

Access comprehensive regulatory information for Sysmex Automated Hematology Analyzer KX series in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0010232 and owned by Sysmex Corporation. The device was registered on September 05, 2012.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD