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Singapore HSA registration DE0504987

Sysmex HISCL HBsAg

Singapore flagSingapore·CLASS D IVD·SYSMEX CORPORATION·Registered September 28, 2020
Device classification
Device Class
CLASS D IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0504987
Registration Date
September 28, 2020
Change Notification Approval Date
April 22, 2025
Retention Due Date
September 27, 2026
Product description
For In Vitro Diagnostic Use. Measurement of Hepatitis B Surface Antigen in serum or plasma.
Product Owner
Name
SYSMEX CORPORATION
Short Name
SYSMEX CORPORATION
Address
4-4-4 Takatsukadai, Nishi-ku, Kobe 651-2271, 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)
HISCL HBsAg Calibrator HISCL Washing Solution HBV Immunoassay Control HISCL Substrate Reagent Set Viratrol HISCL Washing Solution HISCL HBsAg Assay kit HISCL HBsAg Assay kit HISCL Diluent
Model Identifier(s)
054-2311-1 054-2361-8 064-1021-4 064-4331-9 AT-474-543 CH-219-079 CH-617-178 CJ-989-655 CS-617-657
About this record

Access comprehensive regulatory information for Sysmex HISCL HBsAg in the Singapore medical device market through Pure Global AI's free database. This CLASS D IVD medical device is registered under HSA registration number DE0504987 and owned by SYSMEX CORPORATION. The device was registered on September 28, 2020.

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 D IVD