Pure Global

Siemens Atellica CH Urine Albumin (UAlb) - HSA Registration DE0510453

Access comprehensive regulatory information for Siemens Atellica CH Urine Albumin (UAlb) in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0510453 and owned by Siemens Healthcare Diagnostics Inc. The device was registered on March 12, 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 B IVD
DE0510453
Siemens Atellica CH Urine Albumin (UAlb)
HSA Registration Number: DE0510453
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The Atellicaยฎย CH Urine Albumin (UAlb) assay is for inย vitro diagnostic use in the quantitative determination of albumin in human urine using the Atellica Analyzers. Measurement of albumin aids in the diagnosis of kidney diseases.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0510453
Registration Date
March 12, 2025
Retention Due Date
March 11, 2026
Product Owner
Short Name
Siemens Healthcare
Address
511 Benedict Avenue, Tarrytown, NY 10591-5097, UNITED STATES
Registrant
Address
60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Importer
Address
60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Model Information
Model Name(s)
Atellica CH Urine Albumin (UAlb) Atellica CH Urine Albumin Calibrator (UAlbย CAL)
Model Identifier(s)
11537225 11537247