Singapore HSA registration DE0510543
Beckman Coulter Access 2 Immunoassay System Remanufactured
Singapore·CLASS D IVD·Beckman Coulter Inc·Registered April 03, 2025Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0510543
- Registration Date
- April 03, 2025
- Retention Due Date
- April 02, 2026
Product description
The Access 2 system is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Product Owner
- Short Name
- Beckman Coulter Inc
- Address
- 250 S. Kraemer Blvd, Brea California USA 92821, UNITED STATES
Registrant
- Address
- 70 BENDEMEER ROAD, LUZERNE, #03-04, SINGAPORE 339940
Importer
- Address
- 70 BENDEMEER ROAD, LUZERNE, #03-04, SINGAPORE 339940
Model information
- Model Name(s)
- Access 2 Access Immunoassay System Remanufactured
- Model Identifier(s)
- 386220 (Refurbished)
About this record
Access comprehensive regulatory information for Beckman Coulter Access 2 Immunoassay System Remanufactured in the Singapore medical device market through Pure Global AI's free database. This CLASS D IVD medical device is registered under HSA registration number DE0510543 and owned by Beckman Coulter Inc. The device was registered on April 03, 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 D IVD