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Singapore HSA registration DE0510497

Abbott UroColor 11 Test Strips

Singapore flagSingapore·CLASS B IVD·Abbott Diagnostics Korea Inc.·Registered March 25, 2025
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration information
Registration Number
DE0510497
Registration Date
March 25, 2025
Change Notification Approval Date
April 09, 2025
Retention Due Date
March 24, 2026
Product description
UroColor provides tests for blood, bilirubin, urobilinogen, ketone, protein, Nitrite, glucose, pH, specific gravity, leucocytes and ascorbic acid in urine specimens. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance, and urinary tract infection. The UroColor test is for in vitro diagnostic use. It is intended only for professional use in a laboratory setting. The test can be read either visually by a laboratory professional or instrumentally using the UroMeter urine chemistry analyzer
Product Owner
Name
Abbott Diagnostics Korea Inc.
Short Name
Abbott Diagnostics Korea Inc.
Address
65, Borahagal-ro, Giheung-gu,, Yongin-si, Gyeonggi-do 17099, KOREA, REPUBLIC OF
Registrant
Name
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
Name
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED DCH AURIGA SINGAPORE
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352 10 RAEBURN PARK, #01-33, SINGAPORE 088702
Model information
Model Name(s)
UroColor 11 UroMeter 120 UroMeter 720
Model Identifier(s)
10UK11 UM0120 UM0720
About this record

Access comprehensive regulatory information for Abbott UroColor 11 Test Strips 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 DE0510497 and owned by Abbott Diagnostics Korea Inc.. The device was registered on March 25, 2025.

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