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Singapore HSA registration DE0501016

Sysmex Semi-Automated Urine Chemistry Analyzer UC-1000

Singapore flagSingapore·CLASS B IVD·SYSMEX CORPORATION·Registered December 26, 2017
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration information
Registration Number
DE0501016
Registration Date
December 26, 2017
Change Notification Approval Date
May 15, 2025
Retention Due Date
December 25, 2025
Product description
UC-1000 is a semi-automated urine chemistry analyzer to be used only by trained healthcare professionals in laboratories and for near-patient testing for screening purposes to measure diagnostic parameters in human urine, using test strips and the photometric measurement method. Semi-quantitative results for following parameters will be obtained, depending on the test strip: Urobilinogen, red blood cell, hemoglobin, protein, glucose, ketones, bilirubin, nitrite, specific gravity, leukocytes, pH, creatinine, albumin, protein/creatinine ratio, albumin/creatinine ratio
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)
UC-1000 SUPPLY PARTS UC-CONTROL MEDITAPE UC-10S Semi-Automated Urine Chemistry Analyzer UC-1000 MEDITAPE UC-12S CDR_ASSY NO.307
Model Identifier(s)
AB719767 AU448468 BB087038 BM161975 BN756610 CW007277
About this record

Access comprehensive regulatory information for Sysmex Semi-Automated Urine Chemistry Analyzer UC-1000 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 DE0501016 and owned by SYSMEX CORPORATION. The device was registered on December 26, 2017.

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