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Beckman Coulter Access 2 Immunoassay System Remanufactured - HSA Registration DE0510543

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.

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CLASS D IVD
DE0510543
Beckman Coulter Access 2 Immunoassay System Remanufactured
HSA Registration Number: DE0510543
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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.

Device 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 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)