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Singapore HSA registration DE0010898

Sysmex Automated Urine Analyzer UX-2000 System

Singapore flagSingapore·CLASS B IVD·SYSMEX CORPORATION·Registered September 17, 2012
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration information
Registration Number
DE0010898
Registration Date
September 17, 2012
Change Notification Approval Date
May 15, 2025
Retention Due Date
September 16, 2025
Product description
A fully automated urinalysis system that perform the chemistry and sediment analysis in urine samples.
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)
PNEUMATIC UNIT PU-17 UFII CONTROL UFII CALIBRATOR Fully Automated Integrated Urine Analyzer UX-2000 MEDITAPE CHECK 2 MEDITAPE II 10U MEDITAPE II 9U UXII PACK-BAC CDR_ASSY NO.64 UXII SEARCH-BAC UXII SEARCH-SED MEDITAPE CHECK 1 UX CLEAN-C UX-2000 SUPPLY PARTS MEDITAPE II 10K UXII SHEATH UXII PACK-SED UXII PACK-BAC UXII SHEATH UXII PACK-SED
Model Identifier(s)
01330061 06404115 06404310 AB541668 AF797144 AL255106 AQ995607 AR379938 AY036908 BA649537 BD563893 BD724145 BE301124 BP791510 BQ879825 BS503938 CM021064 ZPPAR379938 ZPPBS503938 ZPPCM021064
About this record

Access comprehensive regulatory information for Sysmex Automated Urine Analyzer UX-2000 System 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 DE0010898 and owned by SYSMEX CORPORATION. The device was registered on September 17, 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