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Sysmex Automated Hematology Analyzer XP series - HSA Registration DE0010936

Access comprehensive regulatory information for Sysmex Automated Hematology Analyzer XP 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 DE0010936 and owned by Sysmex Corporation. The device was registered on September 18, 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.

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CLASS B IVD
DE0010936
Sysmex Automated Hematology Analyzer XP series
HSA Registration Number: DE0010936
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Product Description

The XP series shall only be used for in vitro analysis of human blood or artificial control blood. Any other use is not recommended. The clinical judgment based on the analysis result must be decided by doctor(s) in conjunction with the clinical condition and other examination results.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Hematology
Registration Information
Registration Number
DE0010936
Registration Date
September 18, 2012
Change Notification Approval Date
January 22, 2025
Retention Due Date
September 17, 2025
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)
EIGHTCHECK-3WP-N EIGHTCHECK-3WP-L EIGHTCHECK-3WP-H SCS-1000, CAL-100C WRP CHECK EIGHTCHECKTM-3WP-N EIGHTCHECKTM -3WP-L EIGHTCHECKTM -3WP-H SCSTM-1000 CELLCLEAN, CL-50 CELLPACK, PK-30L CELLPACK, CPK-310A STROMATOLYSER-WH, SWH-200A Automated Hematology Analyzer XP series, XP-300 CARD_ASSY NO.25 Automated Hematology Analyzer XP series, XP-100 RANGE CHECK X II IQAS - EIGHTCHECK CELLPACK, PK-30L STROMATOLYSER-WH, SWH-200A CELLPACK, CPK-310A
Model Identifier(s)
00403915 00404015 00404112 160-4002-0 230302 720017828 720017829 720017830 720017831 83401621 88408711 88408915 97405216 AP807129 BD347455 BS649542 CK955301 IQAS P88408711 P97405216 ZPP88408915