Pure Global

BECKMAN COULTER BECKMAN COULTER DxC 700 AU - HSA Registration DE0510522

Access comprehensive regulatory information for BECKMAN COULTER BECKMAN COULTER DxC 700 AU 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 DE0510522 and owned by Beckman Coulter Inc. The device was registered on April 01, 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 Database
Powered by Pure Global AI
HSA Official Data
CLASS C IVD
DE0510522
BECKMAN COULTER BECKMAN COULTER DxC 700 AU
HSA Registration Number: DE0510522
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The BECKMAN COULTER DxC 700 AU measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) samples, and other accessories. This system is for in vitro diagnostic use only. Applications include colorimetric, latex agglutination, ion selective electrode and homogeneous enzyme immunoassay. This product measures the chemical components in the sample (serum, plasma, urine, and whole blood (HbA1c only)) by mixing (stirring) the sample and reagent.

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0510522
Registration Date
April 01, 2025
Change Notification Approval Date
May 07, 2025
Retention Due Date
March 31, 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)
BECKMAN COULTER CHEMISTRY ANALYZER DxC 700 AU
Model Identifier(s)
B86444