HSA · registration DE0510528

BECKMAN COULTER BECKMAN COULTER CHEMISTRY ANALYZER AU5800

Name: BECKMAN COULTER BECKMAN COULTER CHEMISTRY ANALYZER AU5800 — HSA DE0510528
Creator: Beckman Coulter Inc
Keywords: BECKMAN COULTER BECKMAN COULTER CHEMISTRY ANALYZER AU5800, BECKMAN COULTER BECKMAN COULTER CHEMISTRY ANALYZER AU5800, DE0510528, Clinical chemistry, HSA

SingaporeClinical chemistryClass CBeckman Coulter Inc

Verified

Official record identity

Registration number: DE0510528
Model name: BECKMAN COULTER CHEMISTRY ANALYZER AU5800
Model identifier: B96697
Registration date: April 01, 2025
Source update date: May 07, 2025

Classification

Risk class: Class C
Published category: Clinical chemistry

Published parties

Product owner: Beckman Coulter Inc
Registrant / registration holder: BECKMAN COULTER SINGAPORE PTE. LTD.

Official description

The AU5800 Chemistry Analyzer measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material, and other accessories. This system is for in vitro diagnostic use only.

Additional source fields

Product owner address: 250 S. Kraemer Blvd, Brea California USA 92821, United States
Registrant address: 11 COLLYER QUAY, #05-06C, THE ARCADE, Singapore 049317

About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.