Pure Global
Singapore HSA registration DE0510478

Sysmex XQ-Series Automated Hematology Analyzer

Singapore flagSingapore·CLASS B IVD·Sysmex Corporation·Registered March 19, 2025
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Hematology
Registration information
Registration Number
DE0510478
Registration Date
March 19, 2025
Retention Due Date
March 18, 2026
Product description
XQ-Series Automated Hematology Analyzer is a multi-parameter automated hematology analyzer for classification and quantification of following parameters in whole blood as an aid to diagnosis of patient populations found in clinical laboratories. Whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, RDW-SD, RDW-CV, PDW, P-LCR, PCT, MPV, NEUT#, LYMPH#, MXD#, NEUT%, LYMPH%, and MXD% XQ-Series Automated Hematology Analyzer is intended to be used by healthcare professionals and properly trained personnel.
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 EIGHTCHECK-3WP-N EIGHTCHECK-3WP-L EIGHTCHECK-3WP-H SCS-1000 WRP CHECK EIGHTCHECK-3WP-N EIGHTCHECK-3WP-L EIGHTCHECK-3WP-H SCS-1000 CELLCLEAN CELLPACK CELLPACK STROMATOLYSER-WH XQ-320 XQ-Series Automated Hematology Analyzer CELLPACK STROMATOLYSER-WH CELLPACK
Model Identifier(s)
403613 403711 403818 403915 404015 404112 160-4002-0 230302 720017828 720017829 720017830 720017831 834-0162-1 884-0871-1 884-0891-5 974-0521-6 BU954129 P88408711 P97405216 ZPP88408915
About this record

Access comprehensive regulatory information for Sysmex XQ-Series Automated Hematology Analyzer 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 DE0510478 and owned by Sysmex Corporation. The device was registered on March 19, 2025.

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