Singapore HSA registration DE0502934
Instrumentation Laboratory ACL Acustar Analyser
Singapore·CLASS C IVD·Instrumentation Laboratory Company·Registered March 25, 2019Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Hematology
Registration information
- Registration Number
- DE0502934
- Registration Date
- March 25, 2019
- Change Notification Approval Date
- May 12, 2024
- Retention Due Date
- March 24, 2026
Product description
The ACL AcuStar is an automated immunoassay analyzer designed specifically for in vitro diagnostic use in a clinical laboratory. The assay analysis is based on chemiluminescent technology.
Product Owner
- Short Name
- Instrumentation Laboratory Company
- Address
- 180 Hartwell Road, Bedford MA 01730, United States of America, UNITED STATES
Registrant
- Address
- 18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966
Importer
- Address
- 18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966
Model information
- Model Name(s)
- ACL AcuStar Analyzer ACL AcuStar Cuvettes HemosIL ACL AcuStar System Rinse HemosIL ACL AcuStar Triggers HemosIL AcuStar Cleaning Solution
- Model Identifier(s)
- 0009801000 0009801100 0009802200 0009802201 0009802204
About this record
Access comprehensive regulatory information for Instrumentation Laboratory ACL Acustar Analyser in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0502934 and owned by Instrumentation Laboratory Company. The device was registered on March 25, 2019.
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 C IVD