Pure Global
Singapore HSA registration DE0010928

Sysmex Automated Hematology Analyzer pocH series

Singapore flagSingapore·CLASS B IVD·Sysmex Corporation·Registered September 18, 2012
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Hematology
Registration information
Registration Number
DE0010928
Registration Date
September 18, 2012
Change Notification Approval Date
January 22, 2025
Retention Due Date
September 17, 2025
Product description
The Sysmex pocH-100i is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories. The pocH-100i shall only be used for in vitro analysis of human blood or artificial control blood. Any other use is regarded as non-specified.
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)
EIGHTCHECK-3WP-N EIGHTCHECK-3WP-L EIGHTCHECK-3WP-H AUTOMATED HEMATOLOGY ANALYZER pocH-100i pocH-pack D, PPD-300 pocH-pack L, PPL-200A SCS-1000, CAL-100C WRP CHECK EIGHTCHECKTM -3WP-N EIGHTCHECKTM -3WP-L EIGHTCHECKTM -3WP-H SCSTM-1000 CELLCLEAN, CL-50 RANGE CHECK X II IQAS - EIGHTCHECK pocH-pack D (II), PPD-310A pocH-pack L (II), PPL-210A
Model Identifier(s)
00403915 00404015 00404112 02318413 02409714 02409919 160-4002-0 230302 720017828 720017829 720017830 720017831 83401621 CK955301 IQAS P03409418 P03409515
About this record

Access comprehensive regulatory information for Sysmex Automated Hematology Analyzer pocH 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 DE0010928 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD