Singapore HSA registration DE0010287

Sysmex Automated Hematology Analyzer XE series

Singapore·CLASS B IVD·Sysmex Corporation·Registered September 06, 2012

Device classification

Device Class: CLASS B IVD
Medical Speciality Area: Hematology

Registration information

Registration Number: DE0010287
Registration Date: September 06, 2012
Change Notification Approval Date: January 22, 2025
Retention Due Date: September 05, 2025

Product description

The Sysmex Automated Analyzer XE series are automated hematology analyzers to perform blood tests 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): Hematology AlphaN Transportation System (AlphaN Supply Parts) Database software (XE-5000) HS Transportation System (HST-N Supply Parts) Sampler Unit (OPSU-10 (C-2)) XE-pro Software XE IG master Software XE 4 units connection master software XE HPC master Software HEMATOLOGY ANALYZER XE-2100D SP-1000i Beta System Kit (S-White) XE RET master Software SP-1000i ACC for HST (White) XE IPF master Software STROMATOLYSER-4DL, FFD-220A HEMATOLOGY ANALYZER XE-5000 Sampler Unit (OPSU-12) Hematology AlphaN Transportation System (AlphaN-XESU) Hematology AlphaN Transportation System (AlphaN-SPSU) Starting Pool Unit (STY-N) Finish Pool Unit (SKY-N) Conveyor Unit (CVR-N) Rack Slider Unit (RS-N) WAGON XE-N (S-White) WAGON SP-N (S-White) WAGON SA-N (S-White) WAGON SK-N (S-White) HST-N PC Rack for XE-IPU (S-White) WAGON RS-N (S-White) Automated Hematology Slide Preparation Unit, SP-1000i Turn Unit (TU-1) Line Controller Unit (LC-2) Barcode Terminal Unit e-CHECK (XE) L1 e-CHECK (XE) L2 e-CHECK (XE) L3 e-CHECK (XE) Assay CD WRP CHECK RL-BELT L RL-ENTRY MODULE RL-EXIT MODULE I/O RL-BELT 2 WAGON TS-500 TFT RACK MOUSE PLATEAU EL-SKY WAGON EL-STY WAGON WAGON EL-SKY 300MM TFT RACK Expertline controller license CELLSHEATH, SE-90L CELLCLEAN, CL-50 CELLPACK, PK-30L CELLPACK, CPK-310A SULFOLYSER, SLS-220A WAGON TU (S-White) STROMATOLYSER-IM, SIM-220A STROMATOLYSER-FB, FBA-200A RBU-1 (S-White) SCS-1000, CAL-100C HEMATOLOGY ANALYZER XE-2100 Sampler Unit (OPSU-7) HST-XE Acc. (White) LASC-HST System Software (LASC-HST) LASC-Alpha System Software (LASC-Alpha) RET-SEARCH II, RED-700A STROMATOLYSER-NR, SNR-700A STROMATOLYSER-4DS, FFS-800A STROMATOLYSER-4DL, FFD-200A Patient Information Manager XE-PIM Patient Information Manager XE-2100L-PIM Patient Information Manager XE-2100D-PIM Twin Connection Manager XE-TCM Twin Connection Manager XE-2100L-TCM Twin Connection Manager XE-2100D-TCM HEMATOLOGY ANALYZER XE-2100L RANGE CHECK X II CELLPACK, PK-30L SULFOLYSER, SLS-220A STROMATOLYSER-FB, FBA-200A STROMATOLYSER-4DS, FFS-800A STROMATOLYSER-4DL, FFD-200A STROMATOLYSER-4DL, FFD-220A CELLSHEATH, SE-90L CELLPACK, CPK-310A RET-SEARCH II, RED-700A
Model Identifier(s): 00308339 00318089 00320461 01330522 01344129 01344226 01344421 02314519 03309411 03320627 04303729 04305733 04391224 05433212 06376017 06377439 06381412 06381617 06381919 06382213 06382418 06382612 06382817 06382914 06383014 06383111 06383219 06383316 06383910 06384117 06384516 06384818 06442011 06442119 06442216 06443211 230302 370009401 370009431 370009451 370009501 37000961 37000969 37000971 37000981 37000986 37000991 38004030 83400324 83401621 88408711 88408915 90411414 91325133 93403213 94404516 97300930 97407314 98313519 98319365 98354633 98385022 98386826 98416211 98416717 98417216 98417615 99300736 99300740 99300784 99300820 99300847 99300881 99337416 CK955301 P88408711 P90411414 P94404516 P98417216 P98417615 ZPP05433212 ZPP83400324 ZPP88408915 ZPP98416211

About this record

Access comprehensive regulatory information for Sysmex Automated Hematology Analyzer XE 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 DE0010287 and owned by Sysmex Corporation. The device was registered on September 06, 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