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Singapore HSA registration DE0504934

SYSMEX HISCL Automated Immunoassay System

Singapore flagSingapore·CLASS D IVD·Sysmex Corporation·Registered September 17, 2020
Device classification
Device Class
CLASS D IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0504934
Registration Date
September 17, 2020
Change Notification Approval Date
December 10, 2024
Retention Due Date
September 16, 2025
Product description
The SYSMEX HISCL Automated Immunoassay System is for in vitro diagnostic use in clinical laboratories. Only the samples specified in the package insert for each reagent can be analyzed. Any other use is outside the specified scope of use. Use only the reagents, detergents, and supplies indicated in this manual. The intended use includes observance of the specified cycles for cleaning and maintenance.
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)
PNEUMATIC UNIT PU-17 HISCL Washing Solution HISCL Probe Washing Solution HISCL Substrate Reagent Set HISCL Line Washing Solution HISCL DISPOSABLE TIP PNEUMATIC UNIT PU-13 HISCL-800 SUPPLY PARTS(AP) Automated Immunoassay System HISCL-800 Automated Immunoassay System HISCL-5000 HISCL Line Washing Solution HISCL-5000 SUPPLY PARTS(AP) HISCL Washing Solution HISCL Cuvette L HIC-5_SAMPLER HISCL-Series Protocol Disc
Model Identifier(s)
1330061 054-2361-8 054-2541-4 064-4331-9 064-4341-6 064-5141-9 7316038 AB411036 AE999369 AF022051 AM-523-382 BL652514 CH-219-079 CP-815-570 CW757027 HISCL-Series Protocol Disc
About this record

Access comprehensive regulatory information for SYSMEX HISCL Automated Immunoassay System 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 DE0504934 and owned by Sysmex Corporation. The device was registered on September 17, 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