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Singapore HSA registration DE0012339

Sysmex Fully Automated Urine Particle Analyzer

Singapore flagSingapore·CLASS B IVD·SYSMEX CORPORATION·Registered February 13, 2013
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration information
Registration Number
DE0012339
Registration Date
February 13, 2013
Change Notification Approval Date
May 15, 2025
Retention Due Date
February 12, 2026
Product description
Automated urine particle analyzer system for in vitro diagnostic use in screening patient populations found in clinical laboratories. It analyzes the following parameters in urine samples: RBC, WBC, Epithelial Cells, Cast, and Bacteria
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)
URINE CELL ANALYZER UF-1000i MAIN UNIT UF-1000i SUPPLY PARTS (AP) CDR2U1K1 ASSY SAMPLER FOR UF-1000i UASU3 MAIN COMP ASSY UF-1000i MANUAL COVER ASSY UF1K UASU-4 UFII PACK-SED UFII PACK-BAC UFII SEARCH-SED UFII SEARCH-BAC UFII SHEATH UFII CONTROL UFII CALIBRATOR UF-500i COMPLETE CDR_ASSY NO.10 U5H SUPPLY PARTS (AP) UFII PACK-SED UFII PACK-BAC UFII SHEATH
Model Identifier(s)
05366719 05371649 05371910 05372010 05372818 06387717 06401615 06401712 06401810 06401917 06402017 06404115 06404310 AT487702 BQ916498 CJ948502 ZPP06401615 ZPP06401712 ZPP06402017
About this record

Access comprehensive regulatory information for Sysmex Fully Automated Urine Particle Analyzer 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 DE0012339 and owned by SYSMEX CORPORATION. The device was registered on February 13, 2013.

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