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Singapore HSA registration DE0010968

Sysmex Automated Hematology Analyzer XS series

Singapore flagSingapore·CLASS B IVD·Sysmex Corporation·Registered September 19, 2012
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Hematology
Registration information
Registration Number
DE0010968
Registration Date
September 19, 2012
Change Notification Approval Date
January 22, 2025
Retention Due Date
September 18, 2025
Product description
The Sysmex XS series is an Automated Hematology Analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratory.
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)
Automated Hematology Analyzer XS series, XS-1000i Automated Hematology Analyzer XS-1000i supply parts Automated Hematology Analyzer XS series, XS-800i Automated Hematology Analyzer XS-800i supply parts CDR1XSI1 ASSY XS sample unit (OPSU-11) STROMATOLYSER-4DL, FFD-220A e-CHECK (XS) L2 e-CHECK (XS) L1 e-CHECK (XS) L3 e-CHECK (XS) Assay CD WRP CHECK CELLCLEAN, CL-50 CELLPACK, PK-30L CELLPACK, CPK-310A SULFOLYSER, SLS-210A SCS-1000, CAL-100C STROMATOLYSER-4DS, FFS-800A STROMATOLYSER-4DL, FFD-200A XS-500i SUPPLY PARTS Automated Hematology Analyzer XS series, XS-500i RANGE CHECK X II CDR_ASSY NO.61 CELLPACK, PK-30L SULFOLYSER, SLS-210A STROMATOLYSER-4DS, FFS-800A STROMATOLYSER-4DL, FFD-200A STROMATOLYSER-4DL, FFD-220A CELLPACK, CPK-310A
Model Identifier(s)
05342311 05347144 05347211 05347543 05347610 05363119 05433212 05438511 05438619 05438716 05439011 230302 83401621 88408711 88408915 90411317 97407314 98417216 98417615 AG260123 CH642457 CK955301 CR079123 P88408711 P90411317 P98417216 P98417615 ZPP05433212 ZPP88408915
About this record

Access comprehensive regulatory information for Sysmex Automated Hematology Analyzer XS 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 DE0010968 and owned by Sysmex Corporation. The device was registered on September 19, 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