Sysmex Automated Hematology Analyzer XR-series - HSA Registration DE0510021
Access comprehensive regulatory information for Sysmex Automated Hematology Analyzer XR-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 DE0510021 and owned by SYSMEX CORPORATION. The device was registered on November 08, 2024.
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.
XR-Series Automated Hematology Analyzer is a multi-parameter automated hematology analyzer for classification and quantification of following parameters in whole blood and body fluid 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, MicroR, MacroR, PDW, MPV, P-LCR, PCT, NRBC%, NRBC#, NEUT%, NEUT#, LYMPH%, LYMPH#, MONO%, MONO#, EO%, EO#, BASO%, BASO#, IG%, IG#, AS-LYMP%, AS-LYMP#, RE-LYMP%, RE-LYMP#, NEUT-RI, NEUT-GI, RET%, RET#, IRF, LFR, MFR, HFR, RET-He, RBC-He, Delta-He, HYPO-He, HYPER-He, IPF, IPF#, HPC%, HPC# • Body fluid (Cerebrospinal fluid, serous fluids (peritoneal, pleural), synovial fluids and CAPD (Continuous ambulatory peritoneal dialysis) fluid): WBC-BF, RBC-BF, TC-BF#, MN%, MN#, PMN%, PMN# XR-Series Automated Hematology Analyzer is used by healthcare professionals and properly trained personnel.