Singapore HSA registration DE0502178
Trinity Biotech Premier Hb9210™ HbA1c System
Singapore·CLASS B IVD·Trinity Biotech plc·Registered September 20, 2018Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0502178
- Registration Date
- September 20, 2018
- Retention Due Date
- September 19, 2025
Product description
The Premier Hb9210™ system is intended for the quantitative measurement of hemoglobin A1c (HbA1c) in human capillary and venous whole blood. It is indicated for the monitoring of long-term glycemic control in individuals with diabetes mellitus. For in vitro diagnostic use only.
Product Owner
- Short Name
- Trinity Biotech plc
- Address
- One Southern Cross, IDA Business Park Bray, Co Wicklow, IRELAND, IRELAND
Registrant
- Address
- 1 KAKI BUKIT ROAD 1, ENTERPRISE ONE, #02-44, SINGAPORE 415934
Importer
- Address
- 160 PAYA LEBAR ROAD, ORION @ PAYA LEBAR, #05-03, SINGAPORE 409022
Model information
- Model Name(s)
- Premier Buffer A Reagent -3.8L Premier Buffer B Reagent -3.8L Premier Buffer A Reagent-940mL Premier Buffer B Reagent-940mL Premier Diluent Reagent-3.8L Premier Wash Reagent-940mL Glycated Hemoglobin Controls Level I & Level II Boronate Affinity HbA1c Assay (400μL) Glycated Hemoglobin Calibrators Level 1 & Level 2 Boronate Affinity HbA1c Assay (400μL) Glycated Hemoglobin Controls Level I & Level II Boronate Affinity HbA1c Assay (500μL) Glycated Hemoglobin Calibrators Level 1 & Level 2 Boronate Affinity HbA1c Assay (500μL) Trinity Biotech Premier Hb9210™ HbA1c System Premier Affinity A1c3000 Premier Affinity A1c500 Premier Affinity A1c1000 Premier Hb9210 HbA1c Analytical Column (1000) Premier Hb9210 HbA1c Analytical Column (500)
- Model Identifier(s)
- 01-03-0080 01-03-0081 01-03-0095 01-03-0096 01-03-0097 01-03-0098 01-04-0015 01-04-0018 01-04-0020 01-04-0022 09-00-0001 09-03-0007 09-03-0008 09-03-0010 09-06-0046 09-06-0050
About this record
Access comprehensive regulatory information for Trinity Biotech Premier Hb9210™ HbA1c 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 DE0502178 and owned by Trinity Biotech plc. The device was registered on September 20, 2018.
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