Singapore HSA registration DE0014075
Sysmex Automated Hematology Analyzer XT series
Singapore·CLASS B IVD·Sysmex Corporation·Registered October 18, 2013Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Hematology
Registration information
- Registration Number
- DE0014075
- Registration Date
- October 18, 2013
- Change Notification Approval Date
- January 22, 2025
- Retention Due Date
- October 17, 2025
Product description
The Sysmex XT series is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories. Only human blood or artificial control blood should be run. Any other use is regarded as non-specified.
Product Owner
- Short Name
- Sysmex
- Address
- 1-5-1 Wakinohama-Kaigandori,, Chuo-ku, Kobe 651-0073, JAPAN
Registrant
- Address
- 9 TAMPINES GRANDE, #06-18, SINGAPORE 528735
Importer
- Address
- 9 TAMPINES GRANDE, #06-18, SINGAPORE 528735
Model information
- Model Name(s)
- Automated Hematology Analyzer XT-2000i XT Supply Parts Assy Pneumatic Unit (PU-17) Sampler Unit (OPSU-10) Patient Information Manager XT-2000i XT-BR Complete Assy Automated Hematology Analyzer XT-1800i Patient Information Manager XT-1800i/PIM MCP Unit (XT-MCP) Twin Connection Manager XT-2000i/TCM Twin Connection Manager XT-1800i/TCM Upgrade Software for Automated Hematology analyzer XT pro STROMATOLYSER-4DL, FFD-220A e-CHECK (XE) L1 e-CHECK (XE) L2 e-CHECK (XE) L3 e-CHECK (XE) Assay CD WRP CHECK CELLCLEAN, CL-50 CELLPACK, PK-30L CELLPACK, CPK-310A SULFOLYSER, SLS-220A STROMATOLYSER-FB, FBA-200A SCS-1000, CAL-100C RET-SEARCH II, RED-700A STROMATOLYSER-4DS, FFS-800A STROMATOLYSER-4DL, FFD-200A XT-4000i Supply Parts Automated Hematology Analyzer XT-4000i RANGE CHECK X II Upgrade Software for Automated Hematology Analyzer XT pro (XT RET master) Upgrade Software for Automated Hematology analyzer XT pro (XT IG master) CELLPACK, PK-30L SULFOLYSER, SLS-220A STROMATOLYSER-FB, FBA-200A STROMATOLYSER-4DS, FFS-800A STROMATOLYSER-4DL, FFD-200A STROMATOLYSER-4DL, FFD-220A CELLPACK, CPK-310A RET-SEARCH II, RED-700A
- Model Identifier(s)
- 01325318 01325446 01330061 01330439 01337024 02300114 02305316 02305427 02305511 02314824 02314841 03310429 05433212 06442011 06442119 06442216 06443211 230302 83401621 88408711 88408915 90411414 94404516 97407314 98416211 98417216 98417615 AU344564 BY539823 CK955301 CU560676 CW599882 P88408711 P90411414 P94404516 P98417216 P98417615 ZPP05433212 ZPP88408915 ZPP98416211
About this record
Access comprehensive regulatory information for Sysmex Automated Hematology Analyzer XT 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 DE0014075 and owned by Sysmex Corporation. The device was registered on October 18, 2013.
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